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ADVENTRX' ANX-530 NDA: FDA issues refuse to file letter

ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.

1 Mar 2010

Vion Pharmaceuticals' Onrigin SPA: FDA responds

VION PHARMACEUTICALS, INC. announced today that it had received a response from the U.S. Food and Drug Administration on a Special Protocol Assessment for its oncology therapeutic Onrigin™ (laromustine) Injection.

26 Feb 2010

Arena Pharmaceuticals' lorcaserin NDA: FDA assigns PDUFA date

Arena Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of October 22, 2010, for the review of the lorcaserin New Drug Application (NDA). The acceptance of the lorcaserin NDA filing confirms that the application is sufficiently complete to permit a substantive review, and the PDUFA date is the goal date for the FDA to complete its review of the NDA.

26 Feb 2010

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).

25 Feb 2010

Orexo partner submits NDA for cancer pain drug Abstral in Japan

Orexo AB today announces that its partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA) in Japan for the cancer pain drug KW-2246 (Abstral).

25 Feb 2010

EpiCept provides business update and fourth-quarter financial highlights

EpiCept Corporation today announced operating and financial results for the fourth quarter and year ended December 31, 2009, and provided an update on Ceplene® and several of the Company’s key product candidates.

25 Feb 2010

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

Arena Pharmaceuticals, Inc. announced today that its New Drug Application (NDA) for lorcaserin, Arena's internally discovered and developed drug candidate for weight management, including weight loss and maintenance of weight loss, has been accepted for filing by the US Food and Drug Administration (FDA). Arena submitted the lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The PDUFA date is the target date for the FDA to complete its review of an NDA.

24 Feb 2010

Emerging oral atypical antipsychotics to compete in increasingly crowded schizophrenia drug market

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the world's major pharmaceutical markets, emerging oral atypical antipsychotics will compete against each other and against established drugs for the same niche patient population in the treatment of schizophrenia.

24 Feb 2010

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

Forest Laboratories, Inc. announced today that the U.S. Food and Drug Administration did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA).

23 Feb 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.

23 Feb 2010

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2009.

23 Feb 2010

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

23 Feb 2010

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

BioSante Pharmaceuticals, Inc., today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review, the DMC once again unanimously recommended continuation of the study as described in the FDA-agreed LibiGel safety study protocol, with no modifications.

22 Feb 2010

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Shire reports total revenues of $3,008 million for 2009

Shire plc the global specialty biopharmaceutical company, announces results for the year to December 31, 2009.

22 Feb 2010

Nuvo Research reports net income in fourth-quarter, driven by FDA approval of Pennsaid

Nuvo Research Inc., a Canadian drug development company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced its financial and operational results for the year and the fourth quarter ended December 31, 2009.

19 Feb 2010

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets.

19 Feb 2010

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that delays in the U.S. approval and launch of Theravance/Astellas's Vibativ (telavancin) for the treatment of nosocomial pneumonia will reduce by more than half the commercial impact that it was previously forecasted to garner in the methicillin-resistant Staphylococcus aureus (MRSA) drug market.

19 Feb 2010

VIRxSYS announces results from prophylactic HIV vaccine study at 2010 CROI conference

VIRxSYS Corporation, a privately held company developing vaccines and RNA therapies for serious human diseases such as HIV and cardiovascular diseases, announced results from its prophylactic HIV vaccine (VRX1023) study in Rhesus Macaque monkeys during a presentation today at the 2010 Annual Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, CA.

19 Feb 2010

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

BioSante Pharmaceuticals, Inc., will present a LibiGel clinical update at the 2010 Annual Meeting of the International Society for the Study of Women’s Sexual Health (ISSWSH), being held from February 18-20, 2010 in St. Petersburg, Florida.

19 Feb 2010

New Drug Application News and Research

ADVENTRX' ANX-530 NDA: FDA issues refuse to file letter

Vion Pharmaceuticals' Onrigin SPA: FDA responds

Arena Pharmaceuticals' lorcaserin NDA: FDA assigns PDUFA date

FDA sets new PDUFA action date for exenatide once weekly NDA

Orexo partner submits NDA for cancer pain drug Abstral in Japan

EpiCept provides business update and fourth-quarter financial highlights

FDA accepts Arena Pharmaceuticals' lorcaserin NDA

Emerging oral atypical antipsychotics to compete in increasingly crowded schizophrenia drug market

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Gross sales of Acorda Therapeutics' ZANAFLEX CAPSULES and tablets increase 9.1% to $58.3M in 2009

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

BioSante Pharmaceuticals' ongoing LibiGel Phase III clinical development program: Additional positive data

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

Shire reports total revenues of $3,008 million for 2009

Nuvo Research reports net income in fourth-quarter, driven by FDA approval of Pennsaid

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Delay in Vibativ's approval for nosocomial pneumonia to reduce previously forecasted commercial impact

VIRxSYS announces results from prophylactic HIV vaccine study at 2010 CROI conference

BioSante Pharmaceuticals' LibiGel clinical update to be presented at 2010 ISSWSH annual meeting

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