Archive for the 'New Drugs' Category

New Migraine Use for Botox Could be Worth $1B

Allergan has done it. The FDA finally approved its wrinkle-fighter Botox as a treatment for migraines. The new indication could add $1 billion to its current annual sales of $1.3 billion, analysts say. “This is the most meaningful market expansion that the product has had since it was approved for cosmetic use,” Piper Jaffray’s David Amsellem tells Bloomberg.

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Potent New Hepatitis C Drug?

The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed.  Completion of the initial phase (phase 1a) of trials of INX-189, discovered and first prepared by researchers at Cardiff University’s Welsh School of Pharmacy in 2008, means the chances of it becoming an approved medicine have significantly improved.

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Experts Urge Making Cigarettes Non-Addictive a Research Priority

After a major review of scientific information, six leading tobacco research and policy experts have concluded that a nicotine reduction strategy should be an urgent research priority because of its potential to profoundly reduce the death and disease from tobacco use. Their findings were published in the journal Tobacco Control.

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GSK, Theravance report promising PhII data for Advair successor

GlaxoSmithKline and partner Theravance (THRX) say that their planned successor for the blockbuster Advair turned in a positive performance in a mid-stage study involving 60 people with COPD. Significantly, the new drug–dubbed Relovair–outperformed Advair on a key measure that gauges lung function. And that bodes well for the therapy, which is now in late-stage trials for both COPD as well as asthma.

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Sanofi Target Genzyme More Attractive to Buyers With Unit Sales

Genzyme Corp., a takeover target of Sanofi-Aventis SA, expects to complete sales of its diagnostics and pharmaceutical-ingredients units by the end of the year.  Genzyme has six bidders for the drug business, Chief Financial Officer Michael Wyzga said today at an investor conference. Sale of the units will make Genzyme more appealing to potential buyers, said Michael Yee, with RBC Capital Markets.

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Will Boehringer’s Spiriva challenge Serevent?

Boehringer Ingelheim and co-marketer Pfizer could make a bid to capture more of the respiratory drug market. In a new study, the company’s Spiriva drug proved as effective as GlaxoSmithKline’s Serevent in helping asthmatic adults breathe better. Spiriva is currently approved for COPD, or smoker’s lung, so moving it into the asthma market could boost sales.

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AZ, BMS Tout New Batch of PhIII Diabetes Data for Dapagliflozin

AstraZeneca and Bristol-Myers Squibb are adding a new chapter of positive Phase III data for their Type 2 diabetes drug dapagliflozin, the latest installment in the see-sawing story about their new approach to treating diabetes. This latest data dump revolved around the combination of dapagliflozin and glimepiride, a standard therapy for diabetes. The combo approach performed better than glimepiride alone in lowering a common measure of blood glucose. Dapagliflozin plus glimepiride also “achieved reductions in the secondary efficacy endpoints of change in total body weight, oral glucose tolerance test and fasting plasma glucose levels from baseline at week 24 compared to placebo plus glimepiride.”

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Four Drugs Look to Pass FDA Muster this Month

Brian Orelli of The Motley Fool highlights four drugs–AstraZeneca’s Brilinta, Questcor’s Acthar Gel, Savient’s Krystexxa and Novartis’ Gilenia–that could gain FDA approval this month despite some previous difficulties. However, given recent troubles with other approved drugs, the FDA’s cautious nature could cause issues for some of the drugmakers.

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Nearly 400 Medicines and Vaccines in Development to Fight Infectious Diseases

Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America’s biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.

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Feds Aim to Fortify Biodefense by Fixing Product Development Pipeline

A leaky product development pipeline is hampering the country’s ability to ensure a steady output of new medical countermeasures, such as medications, vaccines, equipment and supplies needed for health emergencies, HHS Secretary Kathleen Sebelius said.

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