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Brazil to produce generic version of Merck's antiretroviral Efavirenz

Brazilian Health Minister Jose Gomes Temporao on Wednesday said Brazil will begin producing a generic version of Merck's antiretroviral efavirenz, the AP/USA Today reports.

22 Sep 2008

Review of drug delivery market

Combating losses due to patent expiries has become a high priority for pharmaceutical companies. Investing in new drug delivery technologies is becoming a critical strategy for them to maintain a strong presence in this cut-throat market as they offer the potential to enhance the life cycle of established drugs.

18 Sep 2008

GlaxoSmithKline and XenoPort submit NDA for Solzira for restless legs syndrome

GlaxoSmithKline and XenoPort, Inc. announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

16 Sep 2008

Mylan receives FDA approval for generic version of Risperdal

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 Risperidone Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

16 Sep 2008

AIDS Healthcare Foundation says "shame on Abbott"

As part of its ongoing campaign to lower drug prices and improve access to lifesaving AIDS treatments globally, AIDS Healthcare Foundation (AHF), which operates three free treatment clinics in Mexico (Puerto Vallarta, Cancun and Tuxtla Gutierrez) today unveiled a new print advertisement criticizing Abbott Laboratories, Inc. for the steep price it charges for its key AIDS drug Kaletra in Mexico.

16 Sep 2008

FDA warns Ranbaxy Labs and issues import alert

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

16 Sep 2008

CMS to suspend competitive acquisition program for medications covered under Medicare Part B

A CMS official last week said that the agency on Jan. 1 will suspend the Competitive Acquisition Program, launched in 2006 to supply certain medications to physician offices, because of "contractual issues" related to proprietary data, CQ HealthBeat reports.

16 Sep 2008

FDA grants priority review status to Novartis' ACT Coartem

Swiss pharmaceutical company Novartis on Monday announced that FDA has granted priority review status for its malaria treatment Coartem, Dow Jones reports.

16 Sep 2008

FDA grants approval to Talecris Biotherapeutics for Gamunex for neurological disorder CIDP

Talecris Biotherapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills.

15 Sep 2008

Pathways to clinical goals speeds cancer therapy approval

Although cancer remains a leading cause of death in America, it can take up to 12 years to bring a new anti-cancer agent before the FDA and the success rate for approval is only five to 10 percent. That means many research hours and dollars are wasted chasing avenues that will not bring fruit.

15 Sep 2008

European disparities in access to cancer drugs

New research has highlighted stark disparities in access to the latest cancer drugs across European Union nations, according to data presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm.

15 Sep 2008

Lawmakers warn federal officials to fix problems with Medicare information phone line

CMS has improved 1-800-Medicare, a toll-free telephone line that beneficiaries can call for information on the prescription drug benefit, but the agency needs to address some serious problems that remain before the next annual enrollment period begins on Nov. 15, advocates for seniors and lawmakers said on Thursday during a hearing of the Senate Special Committee on Aging, CQ HealthBeat reports. CMS has five call centers nationwide for the telephone line, which served about 30 million callers in 2007.

15 Sep 2008

New cannabis-like drugs could block pain without affecting brain

A new type of drug could alleviate pain in a similar way to cannabis without affecting the brain, according to a new study published in the journal Pain on Monday 15 September.

15 Sep 2008

Keppra XR approved in the U.S. for partial onset seizures

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra XR (levetiracetam extended-release tablets) for use as an add-on to other antiepileptic treatments for people with partial onset seizures who are 16 years of age and older. Keppra XR is expected to be available in U.S. pharmacies at the end of September 2008.

15 Sep 2008

FDA approves expanded uses for Gardasil for vaginal and vulvar cancer caused by HPV

The U.S. Food and Drug Administration has announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26.

14 Sep 2008

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

The U.S. Food and Drug Administration has announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms.

14 Sep 2008

Untapped potential of antidepressants for cancer

A comprehensive review of current scientific literature, published in the peer-reviewed journal ecancer, has suggested that antidepressants can help the human body fight cancer by boosting its own immune response, amongst other mechanisms.

11 Sep 2008

Starpharma, SSL International reach marketing agreement over VivaGel condoms

The Australia-based Starpharma on Tuesday announced that its VivaGel-coated condom will be sold by SSL International, the owner of the Durex condom brand, Bloomberg reports.

11 Sep 2008

Schering-Plough launches Bridion (sugammadex) in Europe

Schering-Plough Corporation has announced that the European launch of Bridion (sugammadex) injection has begun with its introduction this week in Sweden, and that the product is expected to be available soon in the United Kingdom and Germany, with several other European markets to follow by the end of the year and in early 2009.

10 Sep 2008