Pharmaceutical News

RSS

Drug payment database spurs local reports

A database put together by ProPublica of drugmakers' payments to physicians for promoting their products is now spurring local inquiries and garnering some response from physicians.

22 Oct 2010

Research suggests lowering cholesterol can reduce benign prostatic hyperplasia

A cholesterol-lowering drug reduced the enlarged prostates of hamsters to the same extent as a drug commonly used to treat benign prostatic hyperplasia (BPH), report researchers at Children's Hospital Boston and their colleagues in the October issue of the Journal of Urology. Together, the drugs worked even better.

22 Oct 2010

$Medtronic's Xpander II receives FDA clearance for vertebral compression fractures$

Medtronic's Xpander II receives FDA clearance for vertebral compression fractures

Medtronic Inc. today announced Food and Drug Administration (FDA) clearance of the Kyphon Xpander II Inflatable Bone Tamp (IBT) for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty

22 Oct 2010

Neoprobe submits BLA response letter to FDA to commercialize RIGS technology

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan technology Biologic License Application (BLA).

22 Oct 2010

Biogen, Genentech announce new structure of anti-CD20 collaboration

Biogen Idec and Genentech, Inc. a wholly owned member of the Roche Group today announced that they have agreed to amend their collaboration on antibodies targeting CD20.

22 Oct 2010

Daiichi Sankyo launches Inavir inhalation powder in Japan

Hovione has been advised by Daiichi Sankyo Company Ltd that Inavir(R) has been launched in Japan. Inavir(R) is an inhalation powder which is delivered by the TwinCaps(R) inhaler to treat influenza. TwinCaps(R) was specifically designed by Hovione for this indication and is licensed to Daiichi Sankyo and to Biota Holdings Ltd.

22 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

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 Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex Tablets, a Parkinson's disease treatment.

21 Oct 2010

Genmab A/S reports DKK 78 million in net sales for Arzerra

Genmab A/S announced today that the net sales for Arzerra(R) (ofatumumab) during the third quarter of 2010 were approximately DKK 78 million (approximately USD 14 million).

21 Oct 2010

New PharmaDeals v4 online resource to support pharmaceutical industry

In the current BioPharma economic climate; with smaller companies desperately needing the right development partners for survival and larger ones needing to support their existing businesses through making the right deals, having the best, most comprehensive, intelligence and insights are absolutely essential for success.

21 Oct 2010

Nonprescription drug manufacturing and marketing costs increase: Kline

A number of costs associated with nonprescription drug manufacturing and marketing have increased over the past two and a half years. Certain material costs for plastic bottles and blister packs have risen by double digits during this time, increasing packaging expenses.

21 Oct 2010

FDA asks manufacturers to add new warnings to labeling of prostate cancer drugs

The U.S. Food and Drug Administration today asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer.

21 Oct 2010

PMAI offers new addiction treatment options for opioid dependence

Punyamurtula S. Kishore MD, MPH, FASAM, of Preventive Medicine Associates, Inc. (PMAI), the largest outpatient substance dependence provider in Massachusetts, announced today his 37 clinical locations will be offering new addiction treatment options through the use of VIVITROL (naltrexone for extended-release injectable suspension), which was approved on Tuesday, October 12, 2010 by the U.S. Food and Drug Administration (FDA) for the prevention of relapse to opioid dependence.

21 Oct 2010

Valensa enters agreement with Mercola for Flex Pro ES formulation

Valensa International and Mercola Health Resources, LLC announced today that they have entered into a license and supply agreement that provides Mercola Health Resources with Valensa's new Flex Pro ES(TM) joint health formulation.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Genentech, a member of the Roche Group today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

21 Oct 2010

Cipla launches generic Pirfenidone for IPF

Cipla, among the world's leading generic pharmaceutical companies, has introduced Pirfenidone in India under the brand name Pirfenex, for the treatment of IPF. A chronic progressive form of lung disease, IPF has average survival rates as low as 3-5 years which is less than many cancers. Till now there is no approved treatment for IPF.

20 Oct 2010

BREAKYL drug receives European approval

BioDelivery Sciences International, Inc. and Meda today announced approval of BEMA Fentanyl in Europe via the Decentralized Procedure, with Germany acting as Reference Member State.

20 Oct 2010

Pfizer enters partnership with Teuto to develop, commercialize generic medicines

Pfizer Inc. announced today that it is entering into a partnership with Laboratorio Teuto Brasileiro S.A., a leading company in the Brazilian generics industry, to develop and commercialize generic medicines.

20 Oct 2010

CRN reinforces importance of DHA before, during and after pregnancy

In response to a study regarding fish oil use during pregnancy published in the October 19 issue of the Journal of the American Medical Association (JAMA), the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, reminds pregnant and lactating women of the undisputed importance of consuming the recommended amounts of docosahexaenoic acid (DHA) throughout pregnancy.

20 Oct 2010