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Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Januvia plus metformin at 52 weeks.

28 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

PecFent receives Positive Opinion from CHMP for treatment of BTCP

Archimedes Pharma, a leading specialty pharma company, today announced that its lead product, PecFent, has received a Positive Opinion from the Committee for Human Medicinal Products, of the European Medicines Agency. The CHMP is recommending PecFent, an innovative fentanyl nasal spray, be authorised for marketing in European Union countries for the treatment of breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication.

25 Jun 2010

Investment report on Somaxon Pharmaceuticals

MicroStockProfit.com announces an investment report featuring Somaxon Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

25 Jun 2010

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. 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.

25 Jun 2010

Mylan granted final FDA approval for Procardia XL Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL® Tablets, a treatment for angina and/or hypertension.

25 Jun 2010

FDA cancels Advisory Committee review of Lux Biosciences' voclosporin NDA

Isotechnika Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has cancelled the Dermatology and Ophthalmology Drugs Advisory Committee review of partner, Lux Biosciences', New Drug Application (NDA) for voclosporin on June 28, 2010.

24 Jun 2010

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

Watson's ANDA for Fentanyl Citrate Buccal tablets receives tentative FDA approval

Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories, Inc. has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Fentanyl Citrate Buccal tablets, 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg.

24 Jun 2010

SIGA completes fourth human clinical trial of ST-246 smallpox antiviral drug candidate

SIGA Technologies, Inc., a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today the successful completion of its fourth human clinical trial, supporting the safety and tolerability of the anticipated clinical dose of ST-246®, SIGA's lead smallpox antiviral drug candidate.

23 Jun 2010

AstraZeneca, Targacept commence enrollment in TC-5214 Phase 3 clinical development for MDD

AstraZeneca and Targacept, Inc., today announced the enrollment of the first patient in the Phase 3 clinical development program for TC-5214, a nicotinic channel blocker.

23 Jun 2010

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Neurologix, Inc., today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease, NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.

22 Jun 2010

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer Inc. announced today that based on discussions with the U.S. Food and Drug Administration (FDA), it will be discontinuing commercial availability of Mylotarg® (gemtuzumab ozogamicin for Injection) (used for the treatment of relapsed acute myeloid leukemia (AML)) in the United States and that it will be voluntarily withdrawing the new drug application (NDA) for Mylotarg effective October 15, 2010.

22 Jun 2010

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

22 Jun 2010

Cadence Pharmaceuticals to acquire Incline Therapeutics

Cadence Pharmaceuticals, Inc., a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, announced today that it has signed an agreement providing Cadence with an exclusive option to acquire Incline Therapeutics, Inc., a privately held specialty pharmaceutical company.

22 Jun 2010

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante Pharmaceuticals, Inc., today announced that the independent Data Monitoring Committee (DMC) of the ongoing LibiGel® Cardiovascular (CV) and Breast Cancer Safety Study unanimously recommended study continuation without modifications, after its third review of the study's unblinded safety data. The review was based on data from almost 1,500 women-years of exposure.

21 Jun 2010

BioSante announces $15 million registered direct offering

BioSante Pharmaceuticals, Inc. today announced that it has received commitments from several institutional investors to purchase $15 million of securities in a registered direct offering. The investors are Deerfield Management Company and other institutional investors. BioSante expects to receive net proceeds of approximately $14.2 million after deducting placement agent fees and other offering expenses.

21 Jun 2010

Aradigm announces $5 million private placement

Aradigm Corporation today announced that it has entered into a definitive agreement for the sale of common stock and warrants to three existing shareholders and one new investor in a private placement for aggregate gross proceeds of approximately $5 million. The closing of the private placement is subject to the satisfaction of customary closing conditions.

21 Jun 2010

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. announced guidance today regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed study's design, timing and regulatory review.

21 Jun 2010

Exelixis announces regaining of rights to develop and commercialize XL184

Exelixis, Inc. today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials.

21 Jun 2010

New Drug Application News and Research

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

PecFent receives Positive Opinion from CHMP for treatment of BTCP

Investment report on Somaxon Pharmaceuticals

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Mylan granted final FDA approval for Procardia XL Tablets

FDA cancels Advisory Committee review of Lux Biosciences' voclosporin NDA

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Watson's ANDA for Fentanyl Citrate Buccal tablets receives tentative FDA approval

SIGA completes fourth human clinical trial of ST-246 smallpox antiviral drug candidate

AstraZeneca, Targacept commence enrollment in TC-5214 Phase 3 clinical development for MDD

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Pfizer to discontinue commercial availability of Mylotarg for AML in U.S.

Pfizer announces voluntary withdrawal of Mylotarg from U.S. market following FDA request

Cadence Pharmaceuticals to acquire Incline Therapeutics

Independent DMC recommends continuation of BioSante's ongoing LibiGel CV and Breast Cancer Safety Study

BioSante announces $15 million registered direct offering

Aradigm announces $5 million private placement

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

Exelixis announces regaining of rights to develop and commercialize XL184

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