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Meda acquires exclusive rights for use of flupirtine to treat fibromyalgia from Adeona Pharmaceuticals

Meda has acquired exclusive US, Canadian and Japanese rights for the use of flupirtine to treat fibromyalgia from Adeona Pharmaceuticals. As part of the agreement, Meda is taking over full responsibility for development and commercialization of the compound. Flupirtine is currently in phase II development for the patented indication fibromyalgia.

7 May 2010

Sun Pharmaceutical subsidiary granted USFDA approval for generic Namenda tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets.

7 May 2010

Keryx Biopharmaceuticals commences Phase 3 registration program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today the initiation of its short-term Phase 3 study of Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

6 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Biovail reports 27% increase in first-quarter 2010 total revenues

Biovail Corporation today announced its financial results for the three-month period ended March 31, 2010.

6 May 2010

New film on depression, drugs and alternative paths to better mental health

A new film on depression, drugs and alternative paths to better mental health will premiere Wednesday, May 12th at UltraStar Cinemas in Del Mar, CA. An answer to the pharmaceutical industry's media blitz, Living Life Films' "Changing Our Minds" questions society's values while revealing interesting and disturbing truths about psychiatry and the drug industry.

6 May 2010

EpiCept provides update on corporate strategy, reports net loss of $4.5M for first-quarter 2010

EpiCept Corporation today announced operating and financial results for the three months ended March 31, 2010, and provided an update with respect to the Company's key business initiatives.

6 May 2010

Alexza Pharmaceuticals secures $15M working capital loan from Hercules Technology Growth Capital

Alexza Pharmaceuticals, Inc. announced today that it has executed a $15 million working capital loan agreement with Hercules Technology Growth Capital. The funds available under the loan will be used for capital equipment and working capital purposes. In connection with the loan, Alexza issued Hercules warrants to purchase 376,394 shares of common stock at an exercise price of $2.69 per share, which was the 50-day average daily weighted average trading price at the time the term sheet for the loan was issued by Hercules.

6 May 2010

Pharmacyclics reports total GAAP revenues of $2.1 million for third-quarter fiscal 2010

Pharmacyclics, Inc. today reported financial results for its third quarter ended March 31, 2010.

6 May 2010

Watson Laboratories files raloxifene hydrochloride tablet ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a raloxifene hydrochloride tablet. Watson's raloxifene hydrochloride tablet is a generic version of Eli Lilly's EVISTA®.

6 May 2010

Jazz Pharmaceuticals reports 59% increase in first-quarter 2010 revenue

Jazz Pharmaceuticals, Inc. announced financial results for the first quarter ended March 31, 2010 and updated guidance for sales and expenses for 2010.

6 May 2010

Cadence Pharmaceuticals resubmits OFIRMEV NDA

Cadence Pharmaceuticals, Inc. announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, OFIRMEV™ (acetaminophen) injection, for the treatment of pain and fever in adults and children.

5 May 2010

LightLab Imaging granted FDA clearance for C7-XR Imaging System and C7 Dragonfly Imaging Catheter

LightLab Imaging, Inc., the pioneer and leader in the development of Optical Coherence Tomography (OCT) technology for vascular and other imaging applications, has received clearance from the U.S. Food and Drug Administration (FDA) for the C7-XR Imaging System and companion C7 Dragonfly Imaging Catheter.

5 May 2010

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

ARIAD Pharmaceuticals, Inc. today announced that it has restructured its July 2007 collaboration with Merck, Sharpe & Dohme Corp. for the development, manufacture, and commercialization of ridaforolimus - ARIAD's investigational mTOR inhibitor.

5 May 2010

Alexza Pharmaceuticals announces filing of universal shelf registration statement with SEC

Alexza Pharmaceuticals, Inc. announced today that it has filed a universal shelf registration statement with the Securities and Exchange Commission (SEC) that, if declared effective by the SEC, will allow the Company to sell, from time to time, up to $75 million of its common stock, preferred stock, debt securities and/or warrants, either individually or in units, in one or more offerings.

5 May 2010

Additional pivotal Phase 3 trial data for MoxDuo IR released

QRxPharma announced today the release of additional pivotal Phase 3 trial data for MoxDuo IR, an immediate-release Dual-Opioid pain therapy. Required for New Drug Application submission with the United States Food and Drug Administration, this "combination rule" study compared the efficacy and safety profiles of MoxDuo IR against component doses of morphine and oxycodone alone for the management of moderate to severe post-operative pain following bunionectomy surgery.

5 May 2010

Mylan Pharmaceuticals receives FDA approval for Bupropion HCl ER Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Bupropion Hydrochloride Extended-release Tablets USP, 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban.

4 May 2010

ADVENTRX Pharmaceuticals announces 6-month stability data for Exelbine

ADVENTRX Pharmaceuticals, Inc. 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 6-month stability data are on track to support the submission of the New Drug Application (NDA) for Exelbine.

4 May 2010

Hologic commences enrollment in European trial of Gestiva for prevention of recurrent preterm birth

K-V Pharmaceutical Company announced today it has been informed by Hologic, Inc. that site initiation and patient enrollment has begun at international clinical trial sites in Europe in the ongoing trial of Gestiva™ (hydroxyprogesterone caproate injection, 250 mg/1 mL), commonly referred to as "17P," for the prevention of preterm birth in women pregnant with a single baby with a history of singleton spontaneous preterm birth.

From Hologic, Inc. 4 May 2010

Sepracor issued FDA Complete Response Letter for STEDESA NDA

Sepracor Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA, or Agency) has issued a Complete Response Letter to Sepracor's New Drug Application (NDA) for its antiepileptic drug candidate, STEDESA™, which is the company's proposed trade name for eslicarbazepine acetate.

4 May 2010

New Drug Application News and Research

Meda acquires exclusive rights for use of flupirtine to treat fibromyalgia from Adeona Pharmaceuticals

Sun Pharmaceutical subsidiary granted USFDA approval for generic Namenda tablets

Keryx Biopharmaceuticals commences Phase 3 registration program for Zerenex

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Biovail reports 27% increase in first-quarter 2010 total revenues

New film on depression, drugs and alternative paths to better mental health

EpiCept provides update on corporate strategy, reports net loss of $4.5M for first-quarter 2010

Alexza Pharmaceuticals secures $15M working capital loan from Hercules Technology Growth Capital

Pharmacyclics reports total GAAP revenues of $2.1 million for third-quarter fiscal 2010

Watson Laboratories files raloxifene hydrochloride tablet ANDA

Jazz Pharmaceuticals reports 59% increase in first-quarter 2010 revenue

Cadence Pharmaceuticals resubmits OFIRMEV NDA

LightLab Imaging granted FDA clearance for C7-XR Imaging System and C7 Dragonfly Imaging Catheter

ARIAD restructures collaboration with Merck for ridaforolimus mTOR inhibitor

Alexza Pharmaceuticals announces filing of universal shelf registration statement with SEC

Additional pivotal Phase 3 trial data for MoxDuo IR released

Mylan Pharmaceuticals receives FDA approval for Bupropion HCl ER Tablets

ADVENTRX Pharmaceuticals announces 6-month stability data for Exelbine

Hologic commences enrollment in European trial of Gestiva for prevention of recurrent preterm birth

Sepracor issued FDA Complete Response Letter for STEDESA NDA

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