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FDA acceptance of peginesatide NDA triggers $10M milestone payment to Affymax

Affymax, Inc. today announced that it has received a $10 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize peginesatide (formerly known as Hematide™), Affymax's investigational drug for the treatment of anemia in chronic renal failure patients.

10 Aug 2011

Akela announces new corporate focus on PharmaForm

Akela Pharma, Inc. today announced a new strategic focus on its profitable pharmaceutical contract manufacturing business, PharmaForm, LLC.

9 Aug 2011

Genentech, Array BioPharma sign oncology agreement for ChK-1 development program

Array BioPharma today announced an oncology agreement with Genentech, a member of the Roche Group, for the development of each company's small-molecule Checkpoint kinase 1 (ChK-1) program.

9 Aug 2011

A.P. Pharma second quarter net loss decreases to $1.9 million

A.P. Pharma, Inc., a specialty pharmaceutical company, today reported financial results for its second quarter ended June 30, 2011 and highlighted its recent corporate progress.

8 Aug 2011

FDA accepts Teva's NDA for BDP Nasal HFA to treat allergic rhinitis

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing Teva's New Drug Application (NDA) for beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA), a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).

8 Aug 2011

Unigene second quarter revenue decreases to $2.5 million

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced second quarter financial results for the period ended June 30, 2011. The Company highlighted significant progress achieved in the second quarter with the continued execution of its turnaround strategy.

8 Aug 2011

ADVENTRX's second quarter net loss decreases to $4.4 million

ADVENTRX Pharmaceuticals, Inc. today reported financial results for the periods ended June 30, 2011.

8 Aug 2011

U.S. District Court rules in favor of POZEN in Treximet patent litigation

POZEN Inc., a pharmaceutical company committed to transforming medicines that transform lives, today announced that the United States District Court for the Eastern District of Texas has issued a favorable verdict in the litigation between POZEN and several generic pharmaceutical companies which had filed Abbreviated New Drug Applications (ANDAs) seeking approval from the U.S. Food and Drug Administration (FDA) to market generic copies of Treximet.

8 Aug 2011

Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients

Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration in response to a Complete Response Letter (CRL) received in October 2010.

5 Aug 2011

Positive results from Antares Pharma VIBEX MTX clinical study on RA

Antares Pharma, Inc. today announced the positive results of a clinical study evaluating VIBEX MTX, a proprietary auto injector product designed to give a rapid subcutaneous injection of methotrexate (MTX) for the treatment of rheumatoid arthritis.

5 Aug 2011

Boston Therapeutics files chewable metformin ANDA with FDA to treat diabetes

Boston Therapeutics, Inc., a public company registered with the SEC and a developer of diabetes therapeutics, today announced that it has submitted an Abbreviated New Drug Application (ANDA) for chewable metformin with the U.S. Food and Drug Administration.

4 Aug 2011

Columbia Laboratories second quarter total net revenues increase to $19.2 million

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

4 Aug 2011

Pharming, Santarus reach SPA agreement with FDA for RHUCIN Phase III trial

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced that they have reached agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study with the investigational drug RHUCIN under the Special Protocol Assessment (SPA) process that is intended to support the submission of a Biologics License Application.

4 Aug 2011

Par Pharmaceutical reports second quarter total revenues of $224.2 million

Par Pharmaceutical Companies, Inc. today reported results for the second quarter ended June 30, 2011.

3 Aug 2011

Incyte announces FDA acceptance of NDA filing for ruxolitinib to treat myelofibrosis

Incyte Corporation announced today that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Incyte's lead investigational compound, ruxolitinib, as a potential treatment for patients with myelofibrosis.

3 Aug 2011

ARIAD reports $47.8 million net loss for second quarter 2011

ARIAD Pharmaceuticals, Inc. today reported financial results for the second quarter and six months ended June 30, 2010 and provided an update on corporate developments.

2 Aug 2011

Rigel reports net loss of $21.5 million for second quarter 2011

Rigel Pharmaceuticals, Inc. today reported financial results for the second quarter and six months ended June 30, 2011.

2 Aug 2011

FDA accepts MAP Pharmaceuticals' LEVADEX NDA for filing

MAP Pharmaceuticals, Inc. today announced that its New Drug Application (NDA) for LEVADEX® orally inhaled migraine drug for the potential acute treatment of migraine in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).

2 Aug 2011

Merrimack receives FDA orphan drug status for MM-398 to treat pancreatic cancer

Merrimack Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted MM-398 orphan drug status for the treatment of pancreatic cancer.

2 Aug 2011

Alnylam second quarter revenue decreases to $20.6 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the second quarter 2011, and company highlights.

From Precision NanoSystems Inc. 2 Aug 2011