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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

AP/Houston Chronicle examines telepharmacies in North Dakota

The AP/Houston Chronicle on Saturday examined telepharmacies -- virtual pharmacy systems located in rural drug stores -- in North Dakota.

10 Sep 2008

Counterfeit drugs for malaria, other diseases threaten public health, WHO Director-General Chan says

The increasing availability of counterfeit drugs for malaria and other diseases poses a threat to public health, and governments must take action to supply affordable and effective treatments, World Health Organization Director-General Margaret Chan said Monday at the 26th Southeast Asia Region Health Ministers Meeting in New Delhi, Bernama/Daily Malaysian News reports.

10 Sep 2008

The Hill examines Presidential candidates' positions on prescription drug issues

The Hill on Tuesday examined how Democratic presidential nominee Sen. Barack Obama (Ill.) and Republican presidential nominee Sen. John McCain (Ariz.) are perceived by the drug and biotech industries.

10 Sep 2008

GlaxoSmithKline and Cellzome announce major strategic alliance

Cellzome Inc. and GlaxoSmithKline have announced the signing of a worldwide strategic alliance to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.

10 Sep 2008

Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Pfizer Inc today announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. new drug application (NDA) and the European marketing authorization application (MAA).

9 Sep 2008

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

The U.S. Supreme Court in November will consider whether to shield the makers of prescription and over-the-counter drugs from liability lawsuits, the Los Angeles Times reports.

9 Sep 2008

Pharmaceutical News

FDA warns Ranbaxy Labs and issues import alert

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

FDA grants priority review status to Novartis' ACT Coartem

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

Pathways to clinical goals speeds cancer therapy approval

European disparities in access to cancer drugs

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

New cannabis-like drugs could block pain without affecting brain

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

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

FDA approves Gamunex for chronic inflammatory demyelinating polyneuropathy

Untapped potential of antidepressants for cancer

Starpharma, SSL International reach marketing agreement over VivaGel condoms

Schering-Plough launches Bridion (sugammadex) in Europe

AP/Houston Chronicle examines telepharmacies in North Dakota

Counterfeit drugs for malaria, other diseases threaten public health, WHO Director-General Chan says

The Hill examines Presidential candidates' positions on prescription drug issues

GlaxoSmithKline and Cellzome announce major strategic alliance

Pfizer to withdraw global marketing applications for Dalbavancin to conduct a new trial

Supreme Court to consider whether to bar liability lawsuits against pharmaceutical companies

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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