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Pfizer, Bristol-Myers Squibb announce data from ELIQUIS clinical trial on AF

Bristol-Myers Squibb Company and Pfizer Inc. today announced that a large number of data presentations sponsored by the companies on ELIQUIS (apixaban) and the treatment of atrial fibrillation will be presented at the American Heart Association 2012 Scientific Sessions, November 3-7, 2012, in Los Angeles, California.

3 Nov 2012

Lomitapide shows promise in treating homozygous familial hypercholesterolemia

An international effort led by researchers at the Perelman School of Medicine at the University of Pennsylvania has resulted in positive phase 3 clinical trial results for a new medicine to treat patients suffering from a rare and deadly cholesterol disorder.

3 Nov 2012

TransTech Pharma to complete TTP054 Phase 2 trial on type 2 diabetes

TransTech Pharma, Inc., announced today that recruitment of patients for its recently initiated, multi-center Phase 2 clinical trial of TTP054 in type 2 diabetics, is exceeding expectations with initial top line results available in early 2013. The 90-day proof of concept study is being conducted in type 2 diabetics not well controlled with approved oral anti-diabetic agents.

2 Nov 2012

Encouraging results from Gilead’s TAF Phase 2 trial on HIV-1 infection

Gilead Sciences, Inc. today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate, an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.

1 Nov 2012

BioCryst announces withdrawal of BCX5191 IND following discussion with FDA

BioCryst Pharmaceuticals, Inc. announced the withdrawal of its Investigational New Drug application (IND) for the antiviral nucleoside, BCX5191, following a discussion with the U.S. Food and Drug Administration (FDA).

31 Oct 2012

Par to acquire Handa's ANDA for generic Seroquel XR

Par Pharmaceutical Companies, Inc. today announced that its Par Pharmaceutical, Inc. operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC to acquire Handa's Abbreviated New Drug Application (ANDA) for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca's Seroquel XR.

29 Oct 2012

Durata completes target enrollment in dalbavancin Phase 3 trial for ABSSSI

Durata Therapeutics today announced that it has completed its target enrollment for DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), the second global, Phase 3 clinical trial of Durata's lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.

26 Oct 2012

FDA accepts ARIAD’s ponatinib NDA for filing

ARIAD Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD's investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

25 Oct 2012

U.S. Marshals seize dietary supplements and unapproved drugs from Confidence

At the request of the U.S. Food and Drug Administration, U.S. Marshals recently seized dietary supplements and unapproved drugs from Confidence, Inc., of Port Washington, N.Y.

24 Oct 2012

Derma Sciences to initiate DSC127 Phase 3 program in diabetic foot ulcers

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers.

23 Oct 2012

FDA accepts A.P. Pharma’s resubmission of NDA for APF530

A.P. Pharma, Inc., a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of its New Drug Application (NDA) for APF530.

17 Oct 2012

Enrollment complete in Idera's IMO-3100 Phase 2 trial for psoriasis

Idera Pharmaceuticals today announced that it had completed patient enrollment in its randomized, double-blind, placebo-controlled Phase 2 trial of IMO-3100 in patients with moderate-to-severe plaque psoriasis. IMO-3100 is an antagonist of specific Toll-like Receptors (TLRs) that the Company is developing for the treatment of psoriasis and other autoimmune diseases.

15 Oct 2012

Mylan, Shionogi and CIMA Labs to resolve generic Orapred ODT patent litigation

Mylan Inc. today announced that it has entered into a settlement agreement with Shionogi Inc. and CIMA Labs Inc. that will resolve patent litigation related to Prednisolone Sodium Phosphate Orally Disintegrating Tablets (ODT), 10 mg, 15 mg and 30 mg.

10 Oct 2012

QRxPharma, Paladin execute licensing agreement for MOXDUO

QRxPharma Limited announced today execution of a licensing agreement with Paladin Labs Inc. for the Canadian commercialisation rights to MOXDUO, a patented, immediate release formulation of morphine and oxycodone.

10 Oct 2012

Positive results from Noven’s LDMP Phase 3 clinical studies on menopausal VMS

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced positive results from two multicenter, double-blind, randomized, placebo-controlled Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

3 Oct 2012

Exelixis announces interim data from cabozantinib phase 2 trial on metastatic CRPC

Exelixis, Inc. today announced interim data from 51 patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases receiving a 40 mg daily dose of cabozantinib in an ongoing non-randomized expansion (NRE) cohort of a phase 2 randomized discontinuation trial.

1 Oct 2012

Exelix reports preliminary data from cabozantinib phase 1 study on solid tumors

Exelixis, Inc. today reported preliminary data from an ongoing phase 1 dose escalation study of cabozantinib in Japan.

1 Oct 2012

FDA approves Stiefel’s Sorilux Foam sNDA to treat for scalp psoriasis

Stiefel, a GSK company, today announced that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005%. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older.

29 Sep 2012

AVEO submits tivozanib NDA with FDA for treatment of advanced renal cell carcinoma

AVEO Oncology and Astellas Pharma Inc. today announced that AVEO has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for tivozanib in patients with advanced renal cell carcinoma (RCC).

29 Sep 2012

A.P. Pharma resubmits APF530 NDA with FDA for prevention of CINV

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, APF530, for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).

29 Sep 2012