Theratechnologies (TSX:TH) announced that it has received feedback from the FDA regarding the timeline to review tesamorelin’s New Drug Application for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. The FDA has indicated that the review is progressing well. The Company now expects to have an official response in the fourth quarter of 2010. Theratechnologies and the Agency continue the positive and constructive dialogue regarding the regulatory process for tesamorelin.

We have been told that the delay is due to labeling issue, we believe the issue is minor. The fact  that labeling discussions are ongoing is a clear indication that we are moving towards approval. This delay for labeling issue reminds us Nuvo Research (TSX:NRI) story, they also had a delay for labeling issue and investors got another opportunity to buy the weakness just before another huge run-up to the final FDA decision. This is exactly what should happen here again for Theratechnologies.

We believe Its a buying opportunity here as we feel, as do BMO and other analysts that approval is kinda in the bag. Why do you discuss labeling if you are not going to need a label? Usually when you talk about labeling, you have reach the latest point of the FDA approval process.

There has been zero insider transactions in the last month. Almost all insider activity in the last year has been buying. BMO’s latest note, maintained a buy rating, maintained price target, and recommended buying on current weakness.

You may read our latest article about Theratechnologies:

www.thecleverbull.com/articles/view/article/2/Tesamorelin-PDUFA-date-July-27th

Full Disclosure:

-Long position on TH
-The Clever bull has not been compensated in any way by theratechnologies to promote or write this article.

The Clever Bull team.

By reading The Clever Bull you agree to the disclaimer, and thereby will not hold The Clever Bull accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

TheCleverBull.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. The Clever Bull has not been compensated by any of the above mentioned companies. Please read our report and visit our Web site, www.thecleverbull.com, for complete risks and disclosures.

Cepheid (NASDAQ:CPHD) after the market close today announced that the company is initiating a recall of all lots of Xpert® MRSA/SA BC (blood culture) product. The recall is a corrective action, which does not require return of product to the manufacturer. Customers may continue to use the product; however, when a MRSA negative/SA positive result is obtained, the result should be interpreted as “MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending.” Further testing should be performed using a FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle, as instructed in the Corrective Action Notice dated July 1, 2010. MRSA positive/SA positive results can still be reported as such. The new instructions will be incorporated in the product labeling. The Xpert MRSA/SA BC product produces false-negative MRSA results, which could potentially contribute to incorrect treatment of an MRSA infection.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK) after the bell announced that it received a warning letter from the FDA. The warning letter primarily dealt with the marketing of several products that FDA states require FDA approval and manufacturing practices related to those products. The Company will respond to the warning letter and intends to meet with FDA to determine how best to resolve these issues. Hi-Tech is suspending sales of these products until the issue is resolved. Sales of these products totaled approximately $5 million in fiscal year 2010. Other than the suspended products, Hi-Tech does not anticipate any interruption in supply of its products.

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products for the general healthcare industry. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company’s Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace. Hi-Tech’s ECR Pharmaceuticals division markets branded prescription products.

Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

As part of the marketing and supply agreement, Arena has granted Eisai exclusive U.S. rights to commercialize lorcaserin. Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution in the United States.

“Through this agreement, we believe Eisai has an opportunity to bring a new option to market to address the significant and growing need for obesity treatments,” said Lonnel Coats, President and Chief Executive Officer of Eisai Inc. “Additionally, by building on our expertise and success in the primary care and specialty areas, with strong synergy in our gastrointestinal franchise, this arrangement for the marketing of lorcaserin will enable Eisai to establish a strong presence in the United States for the medical management of obesity.”

Under the terms of the agreement, Arena will receive an upfront payment of $50 million from Eisai and, upon regulatory approval and the delivery of product supply for launch, up to an additional $90 million in milestone payments. Arena will sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai’s annual net product sales, and the purchase price will increase on a tiered basis to as high as 36.5% on the portion of annual net product sales exceeding $750 million. Arena is also eligible to receive $1.16 billion in one-time purchase price adjustment payments based on annual sales levels of lorcaserin and up to an additional $70 million in regulatory and development milestone payments.

“Execution of this commercial agreement is a major milestone in our plans for lorcaserin,” said Jack Lief, Arena’s President and Chief Executive Officer. “We believe in Eisai’s human health care mission to satisfy unmet medical needs and increase benefits to patients and their families. With Eisai, we have the right company to market lorcaserin in the United States, the right type of agreement to optimize lorcaserin’s medical and commercial potential and the shared recognition that it is the right time to enter into this agreement to prepare for launch following FDA approval.”

Shares of Arena surged nearly 16% or 49 cents, ending the day at $3.56.

Cell Therapeutics, Inc. (NASDAQ:CTIC) rose more than 12% today after the company announced that it has deposited $39.3 million in cash as trust funds with U.S. Bank National Association, as the trustee of the outstanding 4% convertible senior subordinated notes, which is an amount sufficient to pay and discharge the entire amount due on the Notes, including accrued and unpaid interest.

“We are pleased that with recent successful financings we were in a position to retire all of our Notes with a maturity in 2010,” said James A. Bianco, M.D., CEO of CTI. “This should eliminate shareholder concerns over our ability to repay the Notes with a maturity in 2010, and we will continue our focus on moving our products forward through the clinic and the regulatory approval process as expeditiously as possible.”

Compugen Ltd. (NASDAQ:CGEN) announced today that administration of CGEN-15001 in an animal model of multiple sclerosis (MS) has been shown to completely abolish spontaneous relapses. In addition, administration of this novel molecule prior to disease onset demonstrated a pronounced delay of disease onset and a significant decrease in disease symptoms. These results, together with complementary results from earlier studies, strongly support a significant potential therapeutic utility for CGEN-15001 in the treatment of multiple sclerosis and other autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and type 1 diabetes.

Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s sapacitabine (CYC682) product candidate for the treatment of both acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

“Orphan drug designation for both AML and MDS significantly strengthens the value proposition represented by sapacitabine and enhances our opportunity to advance this promising product candidate to late stage clinical development and commercialization,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.

DARA (NASDAQ:DARA) moved higher today after the company announced it has decided to,effective immediately, indefinitely suspend the public offering of $10 million of units comprised of shares of common stock and warrants that was announced on May 17th. Several important factors have influenced this decision. Principally, SurgiVision, Inc, of which DARA is the second largest shareholder after Boston Scientific Corporation (BSX), announced it had received clearance from the Food and Drug Administration (FDA) to market its ClearView System. On June 16, 2010 SurgiVision filed an Amendment to its S-1 Registration Statement containing additional information regarding its planned Initial Public Offering (IPO). In addition, high value licensing transactions in the pharmaceutical industry have accelerated with deals being consummated at earlier stages of development with significant upfront payments. The Board of Directors, management, and company advisors have concluded that given these positive developments and uncertain and volatile market conditions, raising capital at this time would pose unwarranted dilution to our shareholders.

Endo Pharmaceuticals (NASDAQ:ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company’s receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company’s Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA’s review period for Class 2 resubmissions typically is six months.

“We are optimistic that our expeditious and careful response to the FDA’s requests will lead to the agency’s approval of FORTESTA,” said Julie McHugh, chief operating officer, Endo Pharmaceuticals. “We are committed to making this testosterone gel formula available as soon as possible and will continue to work closely with the FDA toward our goal of making this product available for the treatment of low testosterone in men.”

Dendreon Corp. (NASDAQ:DNDN) fell sharply in after-hours trading after the CMS (Center for Medicare & Medicaid Services) issued a report regarding coverage on cancer drug Provenge. The report on the CMS website said:

“We are opening this national coverage analysis to determine whether or not autologous cellular immunotherapy is reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act.”

Dendreon issued the following statement early this evening:

Dendreon Corporation announced that the Centers for Medicare and Medicaid Services (CMS) today initiated a National Coverage Analysis (NCA) of PROVENGE® (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is the first in a new therapeutic class known as autologous cellular immunotherapies.

In CMS’s announcement of the NCA, CMS is requesting public comments on the effects of PROVENGE on health outcomes in patients with prostate cancer. It is not a change in Medicare coverage policy.

NCAs do not impact existing coverage decisions, nor do they restrict local Medicare contractors from covering PROVENGE. Therefore, Medicare beneficiaries are still able to access PROVENGE and private payers can also still cover PROVENGE.

Dendreon welcomes the opportunity to continue our discussions with CMS about how PROVENGE will be provided to Medicare beneficiaries, particularly given the survival benefit and safety profile of PROVENGE. We plan on continuing to work closely with CMS during this process to ensure patients with advanced prostate cancer have broad access to PROVENGE.

In the after-hours session, shares of Dendreon fell $5.64 to $26.69.

Exelixis, Inc. (NASDAQ:EXEL) after the market close today announced that Michael Morrissey, Ph.D., currently President of Research and Development at Exelixis, has been named by the Board of Directors to serve as President and Chief Executive Officer, effective July 15, 2010. He will replace George Scangos, Ph.D., who has resigned effective July 15, 2010 to become President and Chief Executive Officer of Biogen Idec, Inc. The company also announced that Dr. Morrissey will become a member of the Board of Directors of Exelixis. Dr. Scangos will continue to serve as a member of the Exelixis Board of Directors for the remainder of his current term.

Shares of Exelixis fell 29 cents to $3.18 in extended trading.

Santarus, Inc. (NASDAQ:SNTS) announced after the bell today “In connection with the anticipated launch of a competitor’s generic version of prescription ZEGERID Capsules, Santarus is ceasing promotion of ZEGERID prescription products effective immediately and is implementing a corporate restructuring, including a workforce reduction of approximately 37%, or approximately 120 employees, in its commercial organization and certain other operations. Santarus is also significantly reducing the number of contract sales representatives that it utilizes. Santarus expects to retain up to approximately 110 sales representatives, including a small number of contract sales representatives, to promote GLUMETZA® (metformin HCl extended release tablets), a product for the treatment of patients with type 2 diabetes”

“This is an extremely difficult decision for our company, but a necessary one in light of the anticipated launch of a generic version of ZEGERID,” said Gerald T. Proehl, president and chief executive officer. “I want to acknowledge the dedication and commitment of all of our employees, especially those whose positions have been eliminated, and sincerely thank them for their hard work and their contribution to the growth of Santarus.”

Celgene Corporation (NASDAQ:CELG) and Abraxis BioScience Inc. (NASDAQ:ABII) today jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience. Under the terms of the merger agreement, each share of Abraxis BioScience common stock will be converted into the right to receive an upfront payment of $58.00 in cash and 0.2617 shares of Celgene common stock. The upfront payment values Abraxis BioScience at approximately $2.9 billion, net of cash. Each share will also receive one tradeable Contingent Value Right (CVR), which entitles its holder to receive payments for future regulatory milestones and commercial royalties. The transaction is expected to be modestly dilutive to non-GAAP earnings in 2011 and accretive in 2012 and beyond.

The acquisition of Abraxis BioScience accelerates Celgene’s strategy to become a global leader in oncology. The transaction adds ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) to the Company’s existing portfolio of leading cancer products. ABRAXANE was approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE was approved by the European Medicines Agency in January 2008 for a similar indication. Additionally, ABRAXANE® has received orphan drug designation for stage IIB-IV melanoma and pancreatic cancer.

“The acquisition of Abraxis BioScience is an exceptional strategic fit that will accelerate our strategy of becoming a global leader in oncology,” said Bob Hugin, Chief Executive Officer of Celgene Corporation. “We are excited by the opportunity to leverage our clinical, regulatory and commercial capabilities to provide metastatic breast cancer patients with an innovative treatment in ABRAXANE. We are also excited by the potential of ABRAXANE to treat additional solid tumor malignancies such as non-small cell lung and pancreatic cancer. Finally, the potential of nab®-based therapeutics developed by Abraxis coupled with Celgene’s innovative science offers the potential to deliver long-term value to patients, doctors and all of our stakeholders.”

“Our nab technology platform is changing the treatment paradigm for difficult-to-treat cancers,” said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience. “In Celgene we have found the ideal partner to further expand the reach of ABRAXANE and our other treatments, in order to improve the lives of patients worldwide.”

Shares of ABII gained more than 21% or $12.89, closing the day at 74.20

SuperGen, Inc. (NASDAQ:SUPG) shares dropped today after the company reported that its Phase III clinical trial of Dacogen for Injection in elderly patients with acute myeloid leukemia (AML) did not achieve statistically significant superiority over the control arm.

The company did say however that its partner, Eisai Inc. is planning to submit to the FDA a supplemental New Drug Application (sNDA) for Dacogen in the treatment of elderly patients with AML and poor- or intermediate-risk cytogenetics by March 31, 2011.

Shares of SuperGen fell 30 cents or nearly 13% to close the day at $2.02.

ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company’s intended commercial manufacturing site. The 9-month stability data are on track to support the submission of a New Drug Application (NDA) for Exelbine.

“These results are consistent with our expectations and what we anticipate from the 12-month data,” said Brian M. Culley, Chief Executive Officer of ADVENTRX. “Once the 12-month data is analyzed, we will prepare and submit the Exelbine NDA, which we expect will take place in the fourth quarter of this year.”

Cubist Pharmaceuticals, Inc.(NASDAQ:CBST), a leading acute care therapeutics company, today after the market close announced that the recently-completed Phase 2 study of CXA-101, a novel cephalosporin, compared to ceftazidime for the treatment of complicated urinary tract infections (cUTI) in adults met its study objectives. Cubist is developing CXA-201 as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections in the hospital, including those caused by multi-drug resistant Pseudomonas aeruginosa. CXA-201 is a combination of CXA-101 and the beta-lactamase inhibitor tazobactam. Cubist acquired rights to CXA-101, and products which incorporate CXA-101, through its purchase of Calixa Therapeutics Inc. in December 2009.

The study met its objectives of assessing safety and efficacy of CXA-101 in comparison to ceftazidime. CXA-101 additionally demonstrated favorable microbiological and clinical outcomes at the Test of Cure Visit, 6 – 9 days after end of therapy, which were the primary and secondary outcome measures in this study, respectively.

Cubist’s Chief Medical Officer, Santosh Vetticaden, PhD, MD said, “We are pleased with the results of this trial, which provide information that we intend to utilize in developing appropriate Phase 3 registration studies for CXA-201 in cUTI in consultation with the FDA.”

EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, after the market closed announced that its Board of Directors has approved a 1-for-6 reverse split of its common stock, to be effective upon the close of trading on July 9, 2010. The reverse split is part of the Company’s plan to regain compliance with the $1.00 minimum bid price required for continued listing on the NASDAQ Capital Market. The Company’s common stock will begin trading on a split adjusted basis on the NASDAQ Capital Market when the market opens on July 12, 2010.

MELA Sciences, Inc. (NASDAQ:MELA) after the bell today announced its intention to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. The Company also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. The Company intends to use the net proceeds from the sale of the shares to fund the pursuit of its pre-market approval application (PMA) for MelaFind®, the continued development and, if and when approved by the U.S. Food and Drug Administration (FDA), the commercialization of MelaFind®, and for general corporate purposes, including working capital.

TomoTherapy Incorporated (NASDAQ:TOMO), after the bell the maker of advanced radiation therapy solutions for cancer care, announced that it has signed an equipment supply group purchasing agreement with Premier Purchasing Partners, L.P., the group purchasing unit of Premier Inc. The agreement provides TomoTherapy greater reach into Premier’s not-for-profit hospitals and health centers, which includes 2,300 U.S. hospitals and more than 67,000 other healthcare facilities, while enabling Premier members to access special pricing and terms for innovative radiation oncology solutions and establishing a streamlined purchasing solution for them.

TomoTherapy’s radiation therapy solutions enable high treatment quality for a broad patient population, with capabilities to treat cancers throughout the body.

Aeterna Zentaris Inc. (NASDAQ: AEZS), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer. The trial is being sponsored by Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ:KERX), Aeterna Zentaris’ licensee for perifosine in North America. Aeterna Zentaris has also out-licensed rights for perifosine to Handok for South Korea while retaining rights for the rest of the world. The Scientific Advice from the EMA indicates that the ongoing study, in conjunction with safety data generated from other clinical studies with perifosine, is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in advanced colorectal cancer. Therefore, the Company does not intend to initiate any additional study with perifosine for this indication.

EpiCept Corporation (NASDAQ:EPCT) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Ceplene® (histamine dihydrochloride). EpiCept is seeking approval for Ceplene, administered concomitantly with low-dose interleukin-2 (IL-2), for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first complete remission. Ceplene was approved for this indication by the European Commission in October 2008 and is currently available in the United Kingdom, Germany and Austria. Ceplene is expected to be available throughout most of the European Union within twelve months.

In its application, EpiCept requested priority review of the NDA. If granted, priority review should result in an FDA decision date in late December 2010. A decision with respect to the granting of priority review must be made within 45 days of the filing date. Ceplene has been granted orphan drug status in the United States, providing seven years’ marketing exclusivity from the NDA approval date.

“This filing is a very important milestone in our strategy for Ceplene, and we are delighted to submit the NDA consistent with the timetable we publicly announced,” stated Jack Talley, President and Chief Executive Officer of EpiCept. “There are an estimated 9,000 deaths caused by AML each year in the U.S. with no effective maintenance therapy currently available. We believe that Ceplene, if approved, would favorably impact the prognosis of patients with this lethal disease.”

Javelin Pharmaceuticals, Inc. (AMEX:JAV) soared after the bell today after Hospira, Inc. (NYSE:HSP) announced its intention to complete the tender offer by Discus Acquisition Corporation, a wholly owned Hospira subsidiary, for all outstanding shares of the common stock of Javelin. upon its currently scheduled expiration at 12:00 midnight, New York City time, on June 30, 2010.

Javelin has notified Hospira that it is prepared to deliver a closing certificate in accordance with the merger agreement among the parties confirming the accuracy of its representations and warranties and its performance of all of its obligations under the merger agreement as of the end of the current offer period. Based on Javelin’s notification, Hospira expects that all of the conditions to the tender offer will be satisfied upon its currently scheduled expiration, and intends to accept for payment, purchase and promptly pay for all shares of Javelin common stock validly tendered and not withdrawn prior to the expiration of the offer.

Shares of Javelin shot up more than 57% after the bell, rising 79 cents to $2.17.

American Medical Systems (NASDAQ:AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, announced after the bell that the Food and Drug Administration has cleared the MiniArc® Precise Single-Incision Sling System, a product for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the next generation sling in the MiniArc family sling system, the number one selling single-incision sling in the United States.

BioMimetic Therapeutics, Inc. (NASDAQ:BMTI) after the market close announced the Food & Drug Administration has accepted for review its Premarket Approval (PMA) application for Augment™ Bone Graft for use in foot and ankle fusions in the U.S. The FDA has now filed the application and begun the comprehensive review of the clinical module.

DARA BioSciences, Inc. (NASDAQ:DARA), announced after the bell that SurgiVision, Inc., a privately held company of which DARA owns 1,613,258 shares and warrants to purchase an additional 405,000 shares, has received 510(k) clearance from the Food and Drug Administration to market their ClearPoint system in the United States for general neurological interventional procedures.

The ClearPoint system is designed to allow minimally invasive procedures in the brain to be performed in an existing MRI suite. The ClearPoint system is an integrated system of reusable components, disposable components and intuitive, menu-driven software, which is referred to as SurgiVision’s marketed products. Utilization of the ClearPoint system allows a physician to see and select a neurological target, aim the targeting device and watch as the surgical instrument is advanced to the target, significantly reducing the time and complexity of the interventional procedure.

Depomed, Inc. (NASDAQ:DEPO) announced after the market closed that it has received a $10 million milestone payment from Abbott Products, Inc., its licensee of DM-1796, for the U.S. Food and Drug Administration’s acceptance for filing of the New Drug Application (NDA) for DM-1796 for the management of postherpetic neuralgia (PHN), or pain after shingles.

DM-1796 is an investigational, extended release, once-daily tablet formulation of gabapentin designed to reduce dosing frequency and have a low incidence of side effects. The FDA has set the Prescription Drug User Fee (PDUFA) goal date in the first quarter of 2011 for action on the NDA.

“This $10 million milestone payment strengthens our balance sheet and allows us to further advance our other pipeline programs,” said Carl Pelzel, president and chief executive officer of Depomed.

Orexigen Therapeutics, Inc. (NASDAQ:OREX) surged after the company announced over the weekend that results from a 24-week open-label study demonstrating that treatment with Contrave® resulted in significant improvements in depressive symptoms that was accompanied by weight loss and improved control of eating in overweight and obese patients with major depression.

Patients who completed the study lost an average of 9.2% of total body weight and reported substantial reductions in hunger, strength and frequency of food cravings and demonstrated improved control of eating.

“Recent reports in the literature show that the risk of depression is higher in obese people and, at the same time, depression has been associated with increased obesity. In addition, obese women are more than twice as likely to be depressed as non-obese women. In this context, clinicians are in need of new tools to treat obese patients suffering from this common co-morbidity,” said Dr. Susan McElroy, M.D., Lindner Center of HOPE, Mason, Ohio. “This study is the first step in assessing the value of Contrave in this important patient population and these positive results should encourage additional investigation.”

In this study, the most common adverse events were nausea, constipation, headache and insomnia, and, in general, were consistent with past experience in the COR program. There were no serious adverse events reported by the investigator as related or possibly related to Contrave in the trial.

Shares of Orexigen surged more than 18% or 75 cents in Monday trading, closing the session at $4.90.

Cardiome, (NASDAQ:CRME): BRINAVESS, Intravenous or IV Vernakalant announced, EMA issued positive opinion for marketing approval for conversion of recent onset atrial fibrillation to sinus rhythm in adults, marketing authorization is expected later this year and will include  27 EU member countries.

Bio-Path, (OTC:BPTH): Liposomal Grb-2, (BP-100-1.01), anti-sense nucleic acid anti cancer agent announced FDA clearance (IND) to conduct clinical trials in patients with chronic myelogenous leukemia (CML), acute myeloid (AML), acute lymphobiastic leukemia (ALL) and myelodysplastic syndrome (MDS) ; estimate for start of phase 1 clinical trial during 2^nd half of 2010.

AstraZeneca, (NYSE:AZN): The U.S food and drug administration has changed the decision date for its review of motavizumab to Aug 27. Motamizumab is an investigational monoclonal antibody being considered to help prevent serious respiratory synctial virus disease. The original biologics Liscence Application was filled on Jan 30,2008. Motavizumab was reviewed by the FDA antiviral Drugs advisory committee on June 2.

Cyclacel, (NASDAQ:CYCC): Sapacitabine (CYC682) (oral capsules) a nucleoside analogue anti-cancer agent. Announced interim results for myelodysplastic syndromes (MDS) with 1-year survival data expected late 2010, expects interim results for non-small cell lung cancer (NSCLC) during 2h10, expects decision on SPA request for phase 3 acute myeloid leukemia study.

Celgene, (NASDAQ:CELG): Amrubicin, 1 3^rd generation, synthetic anthracycline, analogue has completed patient enrolment of amrubucin for small cell lung cancer (SCLC) with top line data expected during 3^rd qtr 2010, orphan drug designation for the treatment of SCLC.

Biodel Inc. (NASDAQ:BIOD) announced Friday after the bell the final results of a six-month, multi-center, open-label Phase 3 study of VIAject® (more-rapid-acting injectable human insulin) versus regular human insulin (RHI) in 471 patients with type 2 diabetes were presented by Helena Rodbard, M.D., at the 70th Scientific Sessions of the American Diabetes Association.

The study showed that patients with type 2 diabetes receiving VIAject achieved hemoglobin A1c control similar to that for patients receiving regular human insulin, but with twice the reduction in rates of hypoglycemia and significantly less weight gain. Insulin antibody levels and other laboratory tests monitoring safety were similar for both groups.

Dr. Rodbard commented, “This study demonstrated the non-inferiority of the new more-rapid-acting injectable human insulin versus regular human insulin and the favorable impact of the faster-acting insulin on hypoglycemia and weight gain, two key side effects of currently marketed insulins which can be difficult to manage. These findings are encouraging and suggest that we can achieve proper glycemic control with reduced hypoglycemia and weight gain through the use of a more-rapid-acting form of human insulin. I believe these results represent a meaningful advance in the treatment of type 2 diabetes.”

The results of the companion Phase 3 study of VIAject® in patients with type 1 diabetes will be presented at the ADA meeting on June 26. Biodel’s new drug application for VIAject® has been accepted for review by the FDA with a Prescription Drug User Fee Act action date of October 30, 2010.

Shares of Biodel rose 12 cents to $4.18 in the extended session.

Orexigen® Therapeutics, Inc. (NASDAQ:OREX) Friday after the bell announced data from the CORDiabetes trial for Contrave® showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

Over twice as many patients lost at least 5% of their body weight on Contrave versus placebo on an intent-to-treat basis (44.5% vs. 18.9% respectively), according to the data presented today by Dr. Priscilla Hollander, M.D., Baylor Medical Center, at an oral session of the 70th Scientific Sessions of the American Diabetes Association. Importantly, Contrave-treated patients experienced clinically significant reductions in A1C. Average baseline A1C, the standard test for monitoring glycemic control, of approximately 8.0% was reduced by 0.6% for Contrave compared to 0.1% for placebo. This translated to over 44% of Contrave patients reaching the American Diabetes Association (ADA) treatment target for A1C of less than 7%. In comparison, 26% of placebo patients reached the same threshold.

“It is well understood that weight loss is beneficial for glycemic control and slows disease progression in patients with type 2 diabetes,” said Dr. Hollander, a lead investigator on COR-Diabetes. “The COR-Diabetes study demonstrated the potential utility of Contrave for obese patients with diabetes, where weight loss and weight management, coupled with a clinically meaningful improvement in glycemic control, improves overall health.”

Cardiome Pharma Corp. (NASDAQ:CRME) and Merck (NYSE:MRK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS™ (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant. The proposed indication for vernakalant is for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.

“Vernakalant has a unique mechanism of action. If approved in the EU, it will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation,” said Michael E. Mendelsohn, M.D. senior vice president and Head of Cardiovascular Research, Merck Research Laboratories.

Shares of Cardiome shot up 74 cents or more than 9% to $8.68.

Helicos BioSciences Corporation (NASDAQ:HLCS) announced that it is in the early stages of validating molecular diagnostic (MDx) tests that utilize its HeliScope® Single Molecule Sequencer. The HeliScope Sequencer’s ability to sequence single molecules of natural, unamplified DNA or RNA simplifies the diagnostic testing workflow obviating the need for the amplification steps utilized by most genetic analysis methods. This ability to eliminate amplification steps has several advantages including the potential for Helicos to sell its MDx tests for substantially less than the price of comparable existing diagnostic tests.

Helicos said it will first focus on developing a MDx test that will identify gene mutations indicative of a woman’s increased risk of developing hereditary breast or ovarian cancer. The test is scheduled to launch during the second quarter of 2011. Helicos is also developing additional MDx tests in well-established markets. Helicos intends over the longer term to use its core technology’s quantitative capabilities to explore developing MDx tests based upon the detection and quantification of foreign DNA/RNA circulating in the bloodstream, such as a non-invasive prenatal diagnostic test.

“Our plan to develop and market our own MDx (molecular diagnostic ) tests is driven by our confidence in the unique capabilities of the HeliScope Sequencer,” stated Ron Lowy, president and CEO, in a statement. “Over the past months, we have considered a number of alternatives to our long-term strategic focus and consulted with industry experts, many of whom shared our confidence in the HeliScope Sequencer. Ultimately, we decided developing tests for the nascent and expanding diagnostics sequencing market presented the best opportunity to deploy technology that will potentially drive rapid near term revenue growth by providing attractively priced MDx tests.”

Shares of Helicos surged nearly 18% on the news, closing Friday’s trading session at 51 cents, up 7 cents on the day.

OraSure Technologies, Inc. (NASDAQ:OSUR) announced Friday that its OraQuick(R) Hepatitis C (“HCV”) Rapid Antibody Test has been approved by the U.S. Food and Drug Administration for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

“We believe that the OraQuick(R) HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “Obtaining FDA approval of our OraQuick(R) HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company.”

OraQuick(R) HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes. The OraQuick(R) HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.

In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention (“CDC”), new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.

According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.

In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.

As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick(R) HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians’ office market in those countries in which the Company has obtained approval.

Shares of OraSure rose to an intra-day high of $5.63 before pulling back and closing the day at $4.98, up 13 cents.

MannKind Corporation (NASDAQ: MNKD) after the bell today reported that a study, showing that AFREZZA Inhalation Powder, combined with basal insulin is comparable to standard insulin therapy in controlling post-meal blood sugar levels in adult patients with Type 2 diabetes, and offers the added benefits of significantly less weight gain and lower risk of hypoglycemia, will be presented on Saturday, June 26, at a special symposium co-hosted by The Lancet and the American Diabetes (ADA), at the American Diabetes Association’s 70th Scientific Sessions®. The study will also be published in the June 26 issue of The Lancet, one of the world’s leading medical journals.

“Insulin therapy is often a delayed strategy in patients with Type 2 diabetes, because it is associated with weight gain, hypoglycemia and the need for subcutaneous injections,” said Daniel L. Lorber, M.D., F.A.C.P., C.D.E., Medical Director of the Diabetes Control Foundation, Diabetes Care & Information Center in Flushing, NY, and co-author of the published study. “Our findings show that mealtime AFREZZA, in combination with once-daily injected glargine, provides equivalent glucose control with fewer injections, less hypoglycemia and less weight gain than does twice-a-day, premixed insulin.”

After jumping more than 10% earlier in the day, shares of MannKind rose another 24 cents to $6.80 after the bell.

Jazz Pharmaceuticals, Inc. (NASDAQ:JAZZ) after hours announced that the U.S. Food and Drug Administration’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

In February 2010, the FDA accepted for filing and review the New Drug Application of JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.

Shares of Jazz were up 15 cents to $8.34 in extended trading.

ImmunoGen, Inc. (NASDAQ:IMGN), a biotechnology company that develops targeted antibody-based anticancer products, announced after the bell that sanofi-aventis has initiated a Phase I clinical trial with SAR650984, an investigational antibody that targets cancer cells expressing the CD38 protein antigen. This event triggers a $1 million milestone payment to ImmunoGen.

Developed under a research collaboration between ImmunoGen and sanofi-aventis, SAR650984 is being evaluated as a potential treatment for a number of hematological (blood) tumors, including acute and chronic lymphocytic leukemia, acute and chronic myeloid leukemia, multiple myeloma and non-Hodgkin’s lymphoma. In preclinical testing, SAR650984 has been found to be an effective anticancer agent.

ImmunoGen moved 11 cents to $9.95 after hours.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced it has received orphan medicinal product designation for tivozanib, its oral, triple VEGF receptor inhibitor, for the treatment of renal cell carcinoma by the European Medicines Agency. According to the EMA, tivozanib was awarded orphan medicinal product designation based on the prevalence of renal cell carcinoma among people in the European Union; the life-threatening nature of the disease particularly for those with advanced or metastatic renal cell carcinoma; and the assumption that tivozanib may provide significant benefit for patients with renal cell carcinoma, and may be more potent and specific than existing treatments with similar mechanism of action as supported by preliminary clinical results.

Abbott (NYSE:ABT) Following the recent clearance of its FreeStyle Lite® blood glucose test strips, the company today announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips. The new FreeStyle test strips minimize interference during blood glucose testing and are designed to offer a better testing experience.

Biomoda, Inc. (OTC:BMOD) today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath® labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.

Biomoda is seeking Food and Drug Administration approval of its screening technology as a Class III medical device. In addition to FDA approval, Biomoda President John Cousins said the company is pursuing a CE Mark to commercialize CyPath® in Europe. CyPath® is currently for investigational use only.

Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI) after the bell today presented positive data from a completed Phase IIa clinical study of Azedra, the Company’s lead oncology therapeutic that targets neuroblastoma, one of the most common childhood cancer. Phase IIa data showed that the study successfully provided safety, toxicity and response data. The report indiscated that doses of 12 to 18mCi/kg were tolerated without dose limiting toxicity and was also active in tumors, without significant toxicity and showing promising responses.

According to the company the data support proceeding to a pivotal Phase 2 study utilizing the 18 mCi/kg administered therapeutic dose.

Shares of Molecular Insight shot up in the after hour session, jumping 23 cents or more than 14% to $1.83.

Pfizer Inc. (NYSE:PFE) announced today after the bell the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension – which is effective immediately – follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.

The clinical hold includes both the suspension of recruitment of new patients and the dosing of existing patients in the osteoarthritis program, as well as patients with osteoarthritis in other studies. The FDA has asked that, later this week, the company present its assessment of the potential implications of the adverse events in the osteoarthritis program for the other tanezumab clinical programs involving non-osteoporosis patients, which include patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy. The company is actively working with the FDA, to determine the appropriate course of action, which will serve the best interest of patients.

In news from earlier in the day:

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) announced today it will present new analyses from the FREEDOM-301 Phase 3 clinical trial in a late breaker session at the 52nd Annual Scientific Meeting of the American Headache Society (AHS) in Los Angeles, California on Friday, June 25. The presentation will show that the Company’s investigational LEVADEX™ orally inhaled migraine therapy was effective irrespective of when it was administered during a migraine cycle. Separately, the Company also will present efficacy and safety analyses of a subgroup of migraine patients with concomitant asthma.

MAP Pharmaceuticals Inc. said Wednesday it will present a new analysis showing its inhaled drug Levadex was effective in a late-stage study at treating moderate-to-severe migraine pain even when taken up to eight hours after the attack’s onset.

The company has already reported that the study met its key effectiveness and safety goals and a number of secondary goals in the study, called Freedom-301. Levadex, which is the inhaled form of an intravenous migraine treatment administered in hospitals and doctors’ offices, worked when taken at the initial onset of the migraine and as late as eight hours later. The study involved 771 patients.

“Several published studies have shown that the efficacy of triptans is reduced significantly when treatment is delayed. However, many patients may be unable or unwilling to treat migraine early in an attack,” said Stewart Tepper, M.D., director of research for the Center for Headache and Pain at the Cleveland Clinic. “Patients are looking to remedy this with a therapy that works when administered at any time during the migraine cycle.”

Tepper and the company will present the new analysis at the 52nd annual Scientific Meeting of the American Headache Society in Los Angeles on Friday. Data also will show that Levadex was effective and well-tolerated in migraine patients with asthma.

Shares rose 53 cents to close Wednesday’s trading session at $13.24.

SIGA Technologies, Inc. (Nasdaq:SIGA) announced today the successful completion of its fourth human clinical trial, supporting the safety and tolerability of the anticipated clinical dose of ST-246(R), SIGA’s lead smallpox antiviral drug candidate. Analyses of the trial’s results are consistent with findings from previous studies of ST-246 and together show that the drug will likely be found to be a safe and well-tolerated therapeutic for the treatment of orthopoxvirus infections.

“The results of this latest trial support our belief that ST-246 is likely to meet the FDA’s requirements for being safe and well-tolerated. We are now in the planning stage for our expanded safety study of approximately 450 volunteers and are working with the FDA on establishing a protocol for the trial. Enrollment is expected to begin once the procedures have been determined,” said Dr. Eric Rose, SIGA’s Chief Executive Officer.

“As we move toward the goal of commercializing ST-246, our efforts are now directed towards completing the human and animal studies needed for regulatory approval. We are also advancing our efforts to obtain approval on additional indications for ST-246. Separately, we continue to make progress with our clinical pipeline of novel antivirals and apply for non-dilutive government grants and funding,” Dr. Rose concluded.

SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense.

In May 2009, SIGA announced that it had submitted its response to the Biomedical Advance Research and Development Authority (BARDA) regarding the agency’s outstanding RFP for the procurement of 1.7 million courses of a smallpox antiviral. The U.S. government considers the inhaled smallpox virus the single biggest biological threat which could be used against Americans via a terrorist attack.

Shares of SIGA rose 23 cents to $6.87.

Alnylam Biotherapeutics (NASDAQ:ALNY), a leading RNAi therapeutics company, announced today the presentation of new data at the IBC 6th Annual Cell Line Development and Engineering conference held in San Francisco, California from June 21 – 24, 2010. Alnylam established Alnylam Biotherapeutics to focus on the application of RNAi technology in manufacturing processes for biotherapeutics. The new results describe the discovery of highly effective novel delivery lipids (NDLs) that efficiently deliver siRNAs to manufacturing cell lines with no measurable adverse effects on cell density or viability. Furthermore, the NDLs demonstrate durable target gene silencing following a single dose, improved protein quality, and scalability to at least 40 liters.

IsoRay, Inc. (AMEX:ISR) jumped more than 7% after the company announced today that it has completed a license agreement with Hologic, Inc. (NASDAQ:HOLX) for exclusive worldwide distribution rights to the GliaSite® radiation therapy system, the world’s only FDA-cleared balloon catheter device used in the treatment of brain cancer. The system’s balloon catheter is a landmark technology that allows physicians to treat more patients than ever before with brachytherapy or internal radiation and provides important benefits over other radiation treatment options. The GliaSite system offers a number of advantages in brain cancer treatment. It places a specified high dose of a liquid radiation source in the areas most likely to contain cancer after brain tumor removal and is less likely to damage healthy brain tissue. It helps eliminate the ability for the tumor to reoccur, which in turn impacts patient longevity.

NexMed, Inc. (NASDAQ:NEXMD), today announced that Health Canada has confirmed acceptance of the Company’s CMC (Chemistry, Manufacturing and Controls) response for review. The Screening Acceptance Letter from Health Canada was issued in connection with its New Drug Submission for Vitaros®, the Company’s topical treatment for erectile dysfunction. The Acceptance Letter confirms that the CMC response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers will determine the final approvability of the product for marketing in Canada. Based on the date of acceptance, a final approval decision is expected by the end of November 2010.

Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, “Receipt of the Acceptance Letter marks another important milestone in the development history of Vitaros and we remain positive about the possibility for eventual product approval. As such, we anticipate utilizing our Canadian application as the basis for filing new marketing applications in other international markets.”