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Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has accepted and has filed for review the Company's New Drug Application (NDA) for pixantrone as treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). A Prescription Drug User Fee Act (PDUFA) date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.

24 Aug 2009

Lundbeck to launch Sabril in the US following FDA's NDA approval

Lundbeck Inc. (“Lundbeck”), a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen: LUN), announced today that the U.S. Food and Drug Administration (FDA) has granted two New Drug Application (NDA) approvals for Sabril® (vigabatrin) Tablets and Oral Solution. Lundbeck plans to launch Sabril in the United States in the third quarter.

24 Aug 2009

Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") previously announced that the New Drug Application (NDA) filing for the antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma") had been accepted by the U.S. Food and Drug Administration (FDA) for standard review. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL®.

24 Aug 2009

FDA issues complete response letter regarding the NDA for carisbamate

The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.

23 Aug 2009

Peplin completes four-week enrolment phase for REGION-Ib trial

Peplin, Inc. (ASX:PLI) today announced completion of enrolment in its second Phase 3 clinical trial for the use of PEP005 (ingenol mebutate) Gel to treat actinic (solar) keratoses (AK), a common pre-cancerous skin lesion, on non-head treatment areas, which include the trunk and extremities. This completes enrolment in the final of four pivotal trials planned for the submission of the New Drug Application (NDA) for AK.

20 Aug 2009

U.S. FDA approval of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad((R)) mucoadhesive buccal tablets (MBT) to treat oropharyngeal candidiasis (OPC).

19 Aug 2009

BioAlliance Pharma's new drug application for oropharyngeal candidiasis treatment accepted by the FDA

BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for miconazole Lauriad® (Loramyc®) Mucoadhesive Buccal Tablets (MBT) to treat oropharyngeal candidiasis (OPC). Miconazole Lauriad® delivers the antifungal miconazole via a mucoadhesive buccal tablet that is designed to enable once-daily dosing of the active ingredient at the site of infection.

19 Aug 2009

Transcept Pharmaceuticals' agreement with Purdue Pharmaceutical Products may lead to staff reduction

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced plans to reduce operating expenses by eliminating certain staff positions following its recently announced License and Collaboration Agreement with Purdue Pharmaceutical Products to commercialize Intermezzo((R) )(zolpidem tartrate sublingual tablet) in the United States.

19 Aug 2009

FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Geron Corporation (Nasdaq:GERN) today announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

19 Aug 2009

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Amira Pharmaceuticals, Inc. announced today the submission of an Investigational New Drug application (IND) of AM461, its internally-discovered, oral drug candidate for the treatment and control of inflammatory and allergic disease linked to the arachidonic acid pathway, to the U.S. Food and Drug Administration.

19 Aug 2009

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

18 Aug 2009

ADVENTRX Pharmaceuticals reports Q2 2009 financials

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today reported financial results for the three and six months ended June 30, 2009.

12 Aug 2009

Neurologix announces Q2 2009 financials

Neurologix, Inc. (OTCBB:NRGX) announced today its financial results for the second quarter and six months ended June 30, 2009.

12 Aug 2009

Forest Labs and Astrazeneca to co-develop and commercialize ceftaroline

Forest Laboratories (NYSE:FRX) and AstraZeneca (NYSE:AZN) announced today they have entered into a definitive collaboration agreement to co-develop and commercialize ceftaroline in all markets outside the United States, Canada and Japan.

12 Aug 2009

Inhibitex reports Q2 2009 financials

Inhibitex, Inc. (Nasdaq: INHX), today announced its financial results for the second quarter ended June 30, 2009. The Company held cash, cash equivalents and short-term investments of $24.5 million at June 30, 2009, as compared to $33.1 million at December 31, 2008.

12 Aug 2009

Labopharm submits response to FDA for formulation of the antidepressant trazodone

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted its response to the U.S. Food and Drug Administration's (FDA) complete response letter regarding the Company's novel formulation of the antidepressant trazodone.

11 Aug 2009

Teva announces approval of Oxaliplatin injection

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced U.S. Food and Drug Administration (FDA) approval and launch of Oxaliplatin Injection.

11 Aug 2009

Additional trial to be conducted for KYNAPID under FDA special protocol agreement

Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that Astellas will undertake a single confirmatory additional Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. The trial, to be called ACT 5, is expected to begin enrolling patients by the end of 2009, with completion expected in the first half of 2011.

11 Aug 2009

Mylan receives FDA approval for generic Imitrex

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). This product is manufactured in Mylan's Morgantown, W.Va. facility.

10 Aug 2009

Vion Pharmaceuticals announces ODAC meeting for lead oncology therapeutic Onrigin

Vion Pharmaceuticals (OTC Bulletin Board: VION) today announced the date and location of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which its lead oncology therapeutic Onrigin(TM) (laromustine) Injection will be presented.

10 Aug 2009

New Drug Application News and Research

Cell Therapeutics' NDA for Pixantrone accepted by the FDA

Lundbeck to launch Sabril in the US following FDA's NDA approval

Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

FDA issues complete response letter regarding the NDA for carisbamate

Peplin completes four-week enrolment phase for REGION-Ib trial

U.S. FDA approval of miconazole MBT represents a significant milestone for Strativa Pharmaceuticals

BioAlliance Pharma's new drug application for oropharyngeal candidiasis treatment accepted by the FDA

Transcept Pharmaceuticals' agreement with Purdue Pharmaceutical Products may lead to staff reduction

FDA places Geron Corporation's IND for spinal cord injury on clinical hold

Amira Pharmaceuticals submits IND for inflammatory and allergic disease treatment candidate

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

ADVENTRX Pharmaceuticals reports Q2 2009 financials

Neurologix announces Q2 2009 financials

Forest Labs and Astrazeneca to co-develop and commercialize ceftaroline

Inhibitex reports Q2 2009 financials

Labopharm submits response to FDA for formulation of the antidepressant trazodone

Teva announces approval of Oxaliplatin injection

Additional trial to be conducted for KYNAPID under FDA special protocol agreement

Mylan receives FDA approval for generic Imitrex

Vion Pharmaceuticals announces ODAC meeting for lead oncology therapeutic Onrigin

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