Medical Dynamics

“Bioethecist R. Alta Charo Comes to FDA After Stints On IoM Drug Safety Group, NIH Embryo Research Panel” (The Pink Sheet)

Bioethicist R. Alta Charo has made many recommendations about how FDA should structure its oversight functions, and beginning Aug. 31 she may get a chance to work on implementing them. She’s joining FDA as a senior advisor, reporting to Assistant Commissioner for Policy David Horowitz.

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“As Amgen’s Prolia Goes, So Goes The Market: Reaction To AC Recs” (The Pink Sheet)

FDA and the Reproductive Health Drugs Advisory Committee’s focus on small imbalances in Amgen’s trial data for Prolia (denosumab) sparked disparate reactions on the Street, with some analysts trimming their estimates and others holding tight.

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“FDA Rules on INDs May Embolden More Patients To Ask For Trial Drugs” (The Pink Sheet)

Pharma firms will see few policy changes following the publication of FDA’s final regulations on expanded access to investigational medicine, but the revisions could nevertheless mean more patients and doctors will come knocking on their doors asking for experimental drugs.

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“UPDATE 1-Pharming gets U.S. okay for Prodarsan Trial” (Reuters)

“UPDATE 1-Schering wins U.S. approval for antipsychotic” (Reuters)

“Shering-Plough Announces FDA Approval of Saphris (asenapine)” (PharmaLive.com)

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“Neurobiological Technologies Announces Termination of its License and Cooperation Agreement with Merz and Children’s Medical Center” (Financials.com)

“Study traces steady declines in U.S. cancer deaths” (Reuters)

“Schering Puts Last Nail In Clarinex’ Coffin” (The Pink Sheet)

Lights will go out on Schering-Plough’s Clarinex (desloratadine) franchise beginning Jan. 1, 2012, as generic versions begin to flood the market.

Schering announced an agreement with Orchid Chemicals & Pharmaceuticals and Orgenus Pharma on Aug. 12 that effectively marks the end of all pending patent litigation.

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“Schering-Plough Announces Resolution of Litigations on U.S,Marketing of Generic Forms of Solid Oral Dosage Forms of Clarinex” (PharmaLive.com)

“Javelin Pharmaceuticals Reports Ereska (Intranasal Ketamine) Phase III Trial Results in Postoperative Orthopedic Pain” (PharmaLive.com)

“Statement on Fosamax (alendronate sodium) Product Liability Trial in U.S. District Court” (PharmaLive.com)

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“50 million women in Asia at risk of HIV infection: UNAIDS” (Reuters)

“U.S. religious left wades into healthcare fight” (Reuters)

“Insurers in crosshairs of health reformers” (Reuters)

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“A Primer on the Details of Heath Care Reform” (New York Times)

“Positive Top Line Results from Phase III Study (MARVEL) of anti-influenza Virus Agent ‘CS-8959’” (Pharmalive.com)

“Sepracor Announces New Drug Submission (NDS) to Health Canada for STEDESA as Adjunctive Treatment for Epilepsy” (PharmaLive.com)

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“Prix Galien USA Announces 2009 Final Candidates” (PR Newswire)

“Plastic Surgery Tax” (The National Journal)

“Clinical Trials of H1N1 Vaccines to Launch Soon” (Elsevier Global Medical News)

Abstract:

A series of U.S. clinical trials aimed at gathering critical data about influenza vaccines, including two candidate vaccines against the novel influenza A(H1N1) virus, will launch “in a matter of days,” according to the director of one of the trial sites.

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“The New Wave of Corporate Medicine – How We All Might Benefit” (NEJM)

“White House Affirms Deal on Drug Cost” (New York Times)

“Only Half of Surveyed Physicians Recommend HPV Vaccine for Girls Aged 11-12 Years” (Elsevier Global Medical News)

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“More Pharma Mergers to Come?” (BusinessWeek)

“Asthma and Posttraumatic Stress Symptoms 5 to 6 Years Following Exposure to the World Trade Center Terrorist Attack” (JAMA)

“Merck to Pay $80 Million to Settle Some Vioxx Cases” (Insurance Journal)

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“Experts find new targets to stop breast cancer” (Reuters)

“Senate Democrats impatient with healthcare pace” (Reuters)

“Growth Factor Eye Drops May Provide Neuroprotection for Glaucoma” (Elsevier Global Medical News)

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