Opioids Not for Coughs in Kids, FDA Advisory Committee Says
The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Source: Drug Industry Daily
Gottlieb Targets More Efficient Clinical Trials
FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference. Source: Drug Industry Daily
PTO Grants More Reviews of Herceptin Patents After Hospira Challenges
The PTO’s Patent Trial and Appeal Board will evaluate the validity of three Genentech patents covering its blockbuster breast cancer treatment Herceptin, following petitions for inter partes review filed by…
ANDA Submissions Topped 1,000 With Two Months to Go in FY 2017
The generic drug industry maintained its pace for a record-setting year in FDA approvals — and passed 1,000 in ANDA submissions. Source: Generic Line
Teva Sued by Hedge Funds for Late Disclosure of DOJ Subpoena
Hedge fund investors are suing generics manufacturer Teva for not being forthcoming about a federal price-fixing investigation — saying the company’s false statements before the eventual reveal of a subpoena…
FDA Asks Drugmakers to Report PDUFA Products, Orange Book Changes
In anticipation of the passage of PDUFA VI, the FDA called on drug companies to notify agency officials of any eligible products and Orange Book changes involving their products by…
The Search is Over: Struggling Teva Finally Gets a New CEO
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x430-teva-kare-schultz.jpg" NAME"The Search is Over: Struggling Teva Finally Gets a New CEO" ALT"The Search is Over: Struggling Teva Finally Gets a New CEO"September 11, 2017By Alex Keown, BioSpace.com Breaking…
Why This Bay Area Biotech Could be a Cash Cow for Investors
<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x450-stocks.jpg" NAME"Why This Bay Area Biotech Could be a Cash Cow for Investors" ALT"Why This Bay Area Biotech Could be a Cash Cow for Investors"September 11, 2017By Mark Terry,…
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