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An FDA Anti-Infective Drugs Advisory Committee will examine Theravance’s Vibativ (telavancin) for nosocomial pneumonia on Nov. 29. This event will be webcast on the Bloomberg terminal. Briefing documents for the panel will be released by the FDA by Nov. 27. To continue reading click here.
Dynavax’s lead compound Heplisav, a vaccine for hepatitis B, will be reviewed by the FDA Vaccines and Related Biological Products Advisory Committee on Nov. 15. Briefing documents for the panel will be released by the FDA by Nov. 13. Read more>>
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review Novo Nordisk’s insulin Degludec (Tresiba) and DegludecPlus (Ryzodeg, insulin Degludec/insulin aspart) for type I and type II diabetes on Nov. 8. Read more>>
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Aegerion’s lead drug candidate lomitapide and Sanofi and partner Isis Pharmaceutical’s mipomersen will be discussed by a panel advising the FDA this week. Both drugs were developed to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder. Read more>>
Celgene’s Abraxane may receive FDA approval for lung cancer by Oct. 12. The company applied for approval of the drug in combination with carboplatin as a treatment for first-line non-small cell lung cancer (NSCLC) patients who are not candidates for potentially curative surgery and/or radiation therapy. Read more>>
The European Association for the Study of Diabetes (EASD) annual meeting will take place in Berlin on Oct. 1-5. Novo Nordisk will present data from the Phase III program of its basal insulin Tresiba that is under FDA and European regulatory review for type I and type II diabetes. Read more>>
The 2012 European Society for Medical Oncology (ESMO) Congress takes place this week in Vienna from Sept. 28 to Oct. 2. Roche will present data from a Phase III trial called Hera on Oct. 1 that may show the length of use of Herceptin in the adjuvant setting in HER2-positive breast cancer can be doubled. Herceptin, [...]
Regeneron’s Eylea may receive FDA approval for a second use on Sept. 23 that would further expand the commercial opportunity for the company. The drug, which is already approved for neovascular age-related macular degeneration (wet AMD) is under review for use in central retinal vein occlusion (CRVO). In wet AMD, Eylea competes with Roche/Novartis’ Lucentis and [...]