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XARELTO achieves net clinical benefit in treatment of patients with DVT

Bayer HealthCare Pharmaceuticals today announced that XARELTO (rivaroxaban), a novel anti-clotting therapy, achieved improvement in net clinical benefit in a study looking at treatment of patients with deep vein thrombosis. DVT is the formation of a blood clot in a deep vein, usually in the legs, that partially or totally blocks the flow of blood.

2 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

Biodel replaces Linjeta with trade name VIAject

Biodel Inc. announced today that Linjeta™ (pronounced lin-JET-uh) will replace VIAject as the proposed trade name for Biodel's most advanced product candidate.

2 Sep 2010

QRxPharma announces interim analysis of MoxDuo IR clinical program

QRxPharma announced today a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission.

2 Sep 2010

Nabi Biopharmaceuticals, Diosynth sign long-term commercial manufacturing agreement

Nabi Biopharmaceuticals announced today that it has entered into a long-term commercial manufacturing agreement with Diosynth RTP, Inc. for the manufacture of Drug Substance integral to the production of NicVAX, Nabi's innovative and proprietary investigational vaccine for the treatment of nicotine addiction and prevention of smoking relapse.

2 Sep 2010

Unitract Tuberculin syringe clears FDA 510k market clearance

Unilife Corporation, today announced that its Unitract Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).

2 Sep 2010

Involving pharmacists in direct patient care activities has favorable effects: Study

Incorporating pharmacists as members of the health care team in direct patient care roles is a viable solution to help improve U.S. health care, according to the results of a comprehensive, systematic review of the health care literature set to be published in the October 2010 edition of Medical Care.

2 Sep 2010

FDA approves Atomoxetine HCl capsules for ADHD

Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD).

2 Sep 2010

Pharmacor 2010 findings predict COPD drug market rise to $13 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues finds that, through 2019, an expanding aging population and increases in diagnosis and drug treatment will fuel steady 4.6 percent annual growth in the chronic obstructive pulmonary disease (COPD) drug market.

2 Sep 2010

USFDA grants Sun Pharma subsidiary approval for generic Strattera capsules ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Strattera ®, atomoxetine hydrochloride capsules.

2 Sep 2010

FDA approves LUMIGAN eye drops for intraocular pressure reduction in open-angle glaucoma patients

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

2 Sep 2010

Event Pulse report reveals impact of new therapies on MS drug market

The study titled Event Pulse Preview: Multiple Sclerosis shows that 84% of neurologists expect to prescribe Gilenia for some MS patients if approved, but prescribing will likely be limited to second- or third-line therapy until concerns about safety and monitoring requirements are resolved.

1 Sep 2010

Report finds some donated malaria drugs are being stolen, resold In Africa

Some of the malaria drugs given to Africa by international donors are "being stolen and resold on commercial markets," according to a study to be released Thursday in the journal Research and Reports in Tropical Medicine, the Associated Press reports.

1 Sep 2010

Unpleasant short term side-effects of sunburn dont put off sun-seeking Brits

The research - commissioned by Superdrug and Cancer Research UK as part of their joint campaign to encourage people to enjoy the sun safely this summer - highlights the worrying lengths sun-seeking Brits are prepared to go to in search of a tan.

31 Aug 2010

pSivida announces FDA Priority Review status for Iluvien NDA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

31 Aug 2010

Stromedix's STX-100 receives orphan drug status from FDA for treatment of IPF

Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced today that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis, a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung.

31 Aug 2010

Halozyme identifies strategy to reintroduce HYLENEX

Halozyme Therapeutics, Inc. today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy.

31 Aug 2010

Naurex announces GLYX-13 molecule recognized in “Top 10 to Watch" list for depression treatment

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that its clinical stage candidate for the treatment of depression, GLYX-13, and its second-generation NRX-1050 series have been selected for inclusion on Windhover's list of the "Top 10 Most Interesting Neuroscience Projects to Watch."

31 Aug 2010

TearLab and AMO Canada enter cooperative marketing agreement

TearLab Corporation today announced that it has entered into a cooperative marketing agreement with Abbott Medical Optics Inc.'s subsidiary, AMO Canada Company. Under the agreement, AMO Canada's sales force will directly sell the TearLab™ Osmolarity System in Canada while TearLab will help promote AMO Canada's products for the relief of dry eye symptoms, including Blink® Moisturizing Eye Drops. Financial terms were not disclosed.

31 Aug 2010

Nutritional recommendations for management of sarcopenia published

Nutritional recommendations for the management of sarcopenia -- also described as age-related muscle and functional loss -- were published this past week in the clinical publication, Journal of American Medical Directors Association.

31 Aug 2010