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NextBio receives phase II SBIR grant to add new genomic and proteomic content

NextBio has announced the receipt of a Small Business Innovation Research (SBIR) grant from the U.S. National Institutes of Health (NIH).

14 Apr 2009

Vaccine for Enterotoxigenic E. coli developed

A Michigan State University researcher has developed a working vaccine for a strain of E. coli that kills 2 million to 3 million children each year in the developing world.

14 Apr 2009

FDA imposes restrictions on Coast IRB due to violations

The U.S Food and Drug Administration has announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials.

14 Apr 2009

Medicare payments for outpatient prescription medications jumped $38 billion between 2005 and 2006

Medicare payments for outpatient prescription medications increased by more than $38 billion when comparing 2005 and 2006 data, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.

13 Apr 2009

Health Canada approves Simponi (golimumab) for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis

Centocor Ortho Biotech Inc. and Schering-Plough Corporation has announced that Health Canada has granted approval of Simponi (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

13 Apr 2009

Safety of Bitter orange herbal weight loss product questioned

The Australian Therapeutic Goods Administration (TGA) is reportedly examining whether there are any risks associated with an over-the-counter (OTC) herbal weight loss programme sold in Australia.

13 Apr 2009

PPI prescribed for asthma ineffective and too expensive

According to researchers in the U.S. millions of asthma patients taking the drug Nexium, (esomeprazole), or a similar drug are doing so unnecessarily.

13 Apr 2009

Tolera Therapeutics granted orphan drug status for organ transplant rejection lead candidate drug

Tolera Therapeutics, Inc., was granted orphan drug status by the United States Food and Drug Administration (FDA) for its initial lead candidate, TOL101, for prophylaxis of acute rejection of solid organ transplantation.

12 Apr 2009

FDA stops Neilgen Pharmaceuticals and Advent Pharmaceuticals from making unapproved drugs

The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.

12 Apr 2009

FDA acts to avoid shortage of medically necessary opioid

The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

12 Apr 2009

FDA approves Benzyl alcohol lotion for head lice

The U.S. Food and Drug Administration has approved a new prescription medication for the treatment of head lice (Pediculosis capitis) infestation.

12 Apr 2009

Merck & Co and Cardiome sign agreement for Vernakalant

Merck & Co., Inc. and Cardiome Pharma Corp. has announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.

9 Apr 2009

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

Cancer vaccines receive orphan drug designation for advanced head and neck cancer

Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official.

9 Apr 2009

Health problems associated with Chinese slimming capsules

Taking herbal food supplements is certainly not free of risk. Since 2005, the poison emergency centers in the German cities of Freiburg and Gottingen have registered a total of 17 patients with health problems after taking Chinese slimming capsules.

8 Apr 2009

Coartem tablets approved in U.S. to treat malaria

The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

8 Apr 2009

Withdrawal of Raptiva from U.S. market

Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), has announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market.

8 Apr 2009

Cost-cutting measures are creeping into the medicine cabinet

Cost-cutting measures are creeping into the medicine cabinet. We split pills in half or take the drugs every other day to stretch our doses. We stop filling the prescriptions for our most expensive drugs. We buy prescriptions from online pharmacies with questionable credentials.

6 Apr 2009

Gilead Sciences announces notification of ANDA filing for Atripla

Gilead Sciences, Inc. has announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.

6 Apr 2009

BioDuro and Roche enter into strategic collaboration to provide drug discovery services

BioDuro has announced that they have entered into a strategic partnership with Roche to support discovery phase research efforts at Roche's global research sites.

6 Apr 2009