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POZEN third quarter revenue increases to $4.9 million

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the third quarter ended September 30, 2011.

3 Nov 2011

Columbia Laboratories third quarter total net revenues decrease to $4.9 million

Columbia Laboratories, Inc. today reported financial results for the three- and nine-month periods ended September 30, 2011.

3 Nov 2011

Galectin Therapeutics forms Liver Fibrosis Clinical Trials Advisory Board

Galectin Therapeutics Inc., the leader in developing carbohydrate-based therapeutic compounds to inhibit galectin receptors, today announced the formation of its Liver Fibrosis Clinical Trials Advisory Board comprised of key opinion leaders from Emory Hospital and School of Medicine, Massachusetts General Hospital and Harvard School of Medicine, University of Michigan Hospital and School of Medicine, Mount Sinai Hospital and School of Medicine, and University of Wisconsin Hospital and School of Medicine.

3 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

NPS announces new data from GATTEX Phase 3 study on short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced new data from STEPS 2, a long-term open-label study, showing that GATTEX (teduglutide) was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome.

1 Nov 2011

Teva reports data from QNASL studies on seasonal and perennial allergic rhinitis

Teva Pharmaceutical Industries Ltd. today announced that data from four late-stage studies examining QNASL (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) symptoms, will be presented at the 2011 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Boston, Mass., November 3-8, 2011.

1 Nov 2011

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Hercules Pharma granted rights to license 22nd Century's X-22 smoking cessation aid

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that the company licensed Hercules Pharmaceuticals LLC, its wholly-owned pharmaceutical subsidiary, exclusive worldwide rights to X-22.

31 Oct 2011

Massachusetts court awards injunction preventing Watson from selling Amphastar's generic LOVENOX

Watson Pharmaceuticals, Inc., today confirmed that the United States District Court for the District of Massachusetts has granted Momenta Pharmaceuticals, Inc. and Sandoz Inc.'s request for a preliminary injunction preventing Watson and Amphastar Pharmaceuticals, Inc. from marketing or selling Amphastar's Enoxaparin Sodium Injection, a generic equivalent to Sanofi-aventis' LOVENOX.

29 Oct 2011

Gilead submits Quad NDA to FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.

28 Oct 2011

Mylan receives final FDA approval for Morphine Sulfate ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Extended-release (ER) Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg, the generic version of Purdue Pharma's MS Contin, an opioid analgesic for moderate to severe pain management.

27 Oct 2011

FDA responds to Delcath's request for pre-NDA meeting

Delcath Systems, Inc. announced today that the U.S. Food and Drug Administration (FDA) has responded to the Company's request made in September for a pre-New Drug Application (NDA) meeting and has scheduled a date in mid-January 2012.

27 Oct 2011

FDA's ODAC to review Affymax peginesatide NDA for treatment of CKD-associated anemia

Affymax, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

24 Oct 2011

Top-line results from Exelixis' cabozantinib phase 3 trial on medullary thyroid cancer

Exelixis, Inc. today reported top-line results from the ongoing phase 3 clinical trial of cabozantinib in patients with advanced medullary thyroid cancer (MTC), known as the EXAM trial.

24 Oct 2011

FDA accepts Ironwood and Forest Laboratories' linaclotide NDA for review

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation.

24 Oct 2011

Forest Laboratories second quarter net sales increase 9.0% to $1,130.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that reported earnings per share equaled $0.91 in the second quarter of fiscal 2012. Reported earnings per share in the second quarter of fiscal 2011 were $1.00.

18 Oct 2011

NanoViricides President completes stock sales program

NanoViricides, Inc. announced that its President, Dr. Anil Diwan, has completed the programmed sale of the NanoViricides stock that he had obtained as a founder.

18 Oct 2011

VIVUS announces Qnexa NDA resubmission for treatment of obesity

VIVUS, Inc. today announced that the company has resubmitted the New Drug Application (NDA) for Qnexa to the U.S. Food and Drug Administration.

18 Oct 2011

Watson confirms patent challenge of generic Daytrana

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 Methylphenidate Transdermal System, 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs, and 30 mg/9 hrs.

15 Oct 2011

Noven claims patent infringement over Daytrana, files lawsuit against Watson

Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court of New Jersey against Watson Pharmaceuticals for infringement of certain Noven patents by Watson.

14 Oct 2011