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FDA grants 510(k) clearance for Derma Sciences MEDIHONEY Gel Wound and Burn Dressing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's patent-pending MEDIHONEY® Gel Wound and Burn Dressing.

28 Feb 2011

FDA approves Matrix Labs generic Neurontin ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg, the generic version of Pfizer's Neurontin® Capsules used to treat a painful complication of shingles.

28 Feb 2011

Seattle Genetics submits brentuximab vedotin BLA to FDA for treatment of ALCL, Hodgkin lymphoma

Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for the use of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma.

28 Feb 2011

Janssen-Cilag, NovAlix enter research services agreement for chemistry to support drug discovery efforts

NovAlix today announces that it has entered into a multi-year research services agreement for chemistry with Janssen-Cilag, France, to support its drug discovery efforts.

28 Feb 2011

Researchers to examine thrombolysis for treatment of DVT in leg

Blood clots in the leg occur commonly. In one-half of the cases, the blood clot will break loose and travel through the bloodstream to the lungs - which may be life-threatening.

28 Feb 2011

Medunik to introduce novel orphan drugs to Canadians with rare diseases

Éric Gervais, Executive Vice-President of Medunik Canada, is proud to announce the Management Team of this recently created company. Medunik Canada is a Quebec pharmaceutical company with 60 employees and one unique mission - bring novel orphan drugs to Canadians with rare diseases.

28 Feb 2011

Almac's new North American Headquarters launches schedule I-V controlled capabilities

Packaging, storage and distribution of schedule I-V controlled substances is now a fully functional capability of Almac's new North American Headquarters in Souderton, PA. As the phased transition nears its end, the portfolio of services and capacity offered to customers continues to grow as a result of the $120 million investment.

28 Feb 2011

Despite FDA action, Deston still believes Auralgan as a safe and effective drug product

Deston Therapeutics LLC announced today that it is currently exploring its options to respond to a recent seizure of its Auralgan Otic Solution by the Federal Government and that it still believes that Auralgan is a safe and effective drug product.

28 Feb 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

New study identifies recurrent wound botulism among injection drug users

Botulism is a rare disease and recurrent botulism even more rare. However, in California, recurrent wound botulism among injection drug users has been on the rise and makes up three-quarters of reported cases in the United States.

28 Feb 2011

AHRQ: $52.2 billion spent on prescription drugs for treatment of metabolic conditions during 2008

Insurers and consumers spent $52.2 billion on prescription drugs in 2008 for outpatient treatment of metabolic conditions such as diabetes and elevated cholesterol, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

28 Feb 2011

FDA approves GSK's PROMACTA to treat rare blood disorder

GlaxoSmithKline today announced that the United States Food and Drug Administration granted full approval for PROMACTA, an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune thrombocytopenic purpura who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

27 Feb 2011

Experts offer myth-busting advice to fight against spring allergies

Millions of Americans sneeze and wheeze March through June when they use misinformation to manage their spring allergies.

27 Feb 2011

Samsung enters strategic partnership with Quintiles to support biopharmaceuticals market

Samsung Electronics Co., Ltd., the world's largest electronics company, and its affiliated companies have entered into a strategic partnership with Quintiles, the world's leading pharmaceutical services company, to support Samsung's entry into the biopharmaceuticals market, Quintiles announced today.

27 Feb 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Vaccine lawsuit rejected by Supreme Court

The U.S. Supreme Court ruled on Tuesday against the parents of Hannah Bruesewitz, 18, who suffered seizures and permanent brain damage after receiving a diptheria-tetanus-pertussis (DTP) vaccine in 1993. The Bruesewitz family had sued Wyeth who was then the parent company of the maker of the DTP vaccine that Hannah received as an infant.

27 Feb 2011

Avastin debate spills over until June FDA hearing

The U.S. Food and Drug Administration have granted Roche a hearing in June to defend the cancer treatment Avastin. The hearing would examine the effectiveness of the drug in breast cancer.

27 Feb 2011

Takeda receives Japanese approval for additional indications for NESINA

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited's applications for two additional indications for "NESINA®" (alogliptin), combination therapy with sulfonylurea and combination therapy with biguanide for type 2 diabetes, were approved by the Japanese Ministry of Health, Labour and Welfare.

25 Feb 2011

Savient launches KRYSTEXXA in the U.S.

Savient Pharmaceuticals, Inc. announced the official full U.S. commercial launch of KRYSTEXXA™ (pegloticase), which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic gout in adult patients refractory to conventional therapy. KRYSTEXXA is now the first and only therapy available to address this unmet medical need.

25 Feb 2011

Symposium examines Bruesewitz vs. Wyeth Supreme Court case

A March 29 symposium at the New York Academy of Sciences, "Vaccines Under the Gun: Politics, Science, Media and the Law," will feature a presentation by Daniel J. Thomasch, JD, national lead trial counsel for Wyeth, who was involved in the case decided by the Supreme Court yesterday in which the justices rejected a lawsuit claiming injury from a Wyeth vaccine.

25 Feb 2011