New Drug Application News and Research

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Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

29 Aug 2009

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

28 Aug 2009

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin(R) to be approved by the U.S. Food and Drug Administration (FDA).

27 Aug 2009

Alexza completes acquisition of Symphony Allegro after sharholders' approval

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced that during a special meeting of stockholders held today, its stockholders approved the proposal to issue shares of the Company's common stock and warrants to purchase shares of the Company's common stock to Symphony Capital Partners, LP and their co-investors. Subsequent to this vote, Alexza completed its acquisition of Symphony Allegro, and as a result, Alexza reacquired all rights to AZ-004, AZ-104 and AZ-002.

27 Aug 2009

Viral Genetics cautions investors and the public to rely only on its own releases and disclosures

Viral Genetics (Pink Sheets: VRAL), a biotechnology company that develops drug compounds for HIV/AIDS, autoimmune diseases, and cancer, is issuing this announcement in response to a series of press releases distributed by collegestock.com on August 25 and August 26, and an article published on Today's Financial News entitled "TFN Reader Grapevine: There's Something About Viral Genetics, Inc. (VRAL)," on August 25.

27 Aug 2009

European Medicines Agency validates Schering-Plough's MAA for nomegestrol acetate/17 beta-estradiol

Schering-Plough Corporation, (NYSE: SGP), today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for a fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years of age and older.

27 Aug 2009

QRxPharma completes its pilot evaluation study investigating the efficacy of MoxDuo capsules

QRxPharma Limited and announced today successful completion of its pilot study to evaluate the analgesic efficacy and safety profile of MoxDuo(TM) IR (immediate release) capsules in patients with moderate to severe pain following total knee replacement surgery.

27 Aug 2009

Prevention and eradication of FVIII antibodies could improve hemophilia treatment

Octapharma AG is leading an international initiative focused on confronting the major risk associated with hemophilia A therapy - anti-factor VIII (FVIII) antibodies, also known as inhibitors. This initiative, combined with Octapharma's efforts to pursue the first recombinant FVIII therapy produced from a human cell line, could dramatically impact the treatment of an estimated one in every 5,000 to 10,000 men born with hemophilia A worldwide.

27 Aug 2009

BioAlliance Pharma posts revenue of €4.1 million for the first half of 2009

BioAlliance Pharma SA (Paris:BIO) (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today presented its consolidated half-year accounts to June 30, 2009.

27 Aug 2009

Endo Pharmaceuticals gets exclusive rights to commercialize ProStrakan's FORTESTA in the U.S.

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it has signed an agreement with U.K.-based ProStrakan Group plc (LSE: PSK) for the exclusive right to commercialize FORTESTA(TM) (testosterone gel) 2 percent in the United States.

26 Aug 2009

FDA to review Acorda Therapeutics’ NDA for Fampridine-SR

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the U.S. Food and Drug Administration (FDA) has confirmed that its Peripheral and Central Nervous System Drugs Advisory Committee will review the Company’s New Drug Application (NDA) for Fampridine-SR on October 14, 2009.

26 Aug 2009

FDA recommends electronic report formats to strengthen postmarket safety data collection

The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format.

26 Aug 2009

FDA accepts Labopharm's response for its novel trazodone formulation

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's response regarding its novel formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission. The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.

26 Aug 2009

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

26 Aug 2009

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Gloucester Pharmaceuticals today announced that it has raised $29 million in a Series D financing. The proceeds will be used to support the ongoing development of romidepsin, a novel histone deacetylase (HDAC) inhibitor for the treatment of T-cell lymphomas and other hematologic malignancies.

26 Aug 2009

Seattle Genetics completes enrollment of its pivotal clinical trial of brentuximab vedotin

Seattle Genetics, Inc. today announced that it has completed enrollment of its pivotal clinical trial of brentuximab vedotin (SGN-35) for relapsed and refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30 utilizing the company’s proprietary ADC technology.

25 Aug 2009

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company’s New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.

25 Aug 2009

Retigabine's Phase IIa clinical trial preliminary results announced

Valeant Pharmaceuticals International today announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.

24 Aug 2009

Profibrix raises funds for clinical and preclinical development

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced the successful closing of a US $11 million series B investment. The financing round was led by new investor Gilde Healthcare Partners, a leading European life sciences investor, who joins existing investor Index Ventures. Dirk Kersten from Gilde will join the company's Supervisory Board.

24 Aug 2009

New Drug Application News and Research

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Alexza completes acquisition of Symphony Allegro after sharholders' approval

Viral Genetics cautions investors and the public to rely only on its own releases and disclosures

European Medicines Agency validates Schering-Plough's MAA for nomegestrol acetate/17 beta-estradiol

QRxPharma completes its pilot evaluation study investigating the efficacy of MoxDuo capsules

Prevention and eradication of FVIII antibodies could improve hemophilia treatment

BioAlliance Pharma posts revenue of €4.1 million for the first half of 2009

Endo Pharmaceuticals gets exclusive rights to commercialize ProStrakan's FORTESTA in the U.S.

FDA to review Acorda Therapeutics’ NDA for Fampridine-SR

FDA recommends electronic report formats to strengthen postmarket safety data collection

FDA accepts Labopharm's response for its novel trazodone formulation

FDA issues warning letters to eight companies for selling illegal OTC ibuprofen drugs

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Seattle Genetics completes enrollment of its pivotal clinical trial of brentuximab vedotin

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Retigabine's Phase IIa clinical trial preliminary results announced

Profibrix raises funds for clinical and preclinical development

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