New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
March 13, 2014
11:59 EDTMYL, PFEMylan to launch generic Celebrex after Pfizer patent ruling
Earlier today, Mylan (MYL) confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's (PFE) Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules. Mylan was sued by G.D. Searle and Pfizer Asia Pacific for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application, ANDA, for its generic version of Celebrex. Mylan expects to launch its generic version of Celebrex in May 2014, pending final approval of its ANDA by the U.S. Food and Drug Administration, FDA. Based on available information, Mylan believes it may be entitled to 180 days of shared generic market exclusivity on the 100 mg, 200 mg and 400 mg strengths, subject to the FDA's determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act. Mylan shares are fractionally higher in mid day trading.
News For MYL;PFE From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
1 | 2 | all recent news | >>
October 22, 2014
11:59 EDTMYLStocks with call strike movement; MYL AMZN
Subscribe for More Information
09:16 EDTMYLAbbott sees Q4 reported sales growth in high single digits
Subscribe for More Information
October 21, 2014
07:15 EDTPFEFDA to hold workshop on breast cancer drug development
Subscribe for More Information
07:06 EDTPFEFierce Biotech to hold a breakfast meeting
Subscribe for More Information
October 20, 2014
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
Subscribe for More Information
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
Subscribe for More Information
07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
Subscribe for More Information
07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
Subscribe for More Information
07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
Subscribe for More Information
October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
Subscribe for More Information
October 16, 2014
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
Subscribe for More Information
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
Subscribe for More Information
07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
Subscribe for More Information
October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
Subscribe for More Information
October 14, 2014
11:23 EDTPFEBIND Therapeutics and The Conference Forum hold a conference
Subscribe for More Information
October 13, 2014
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
Subscribe for More Information
October 10, 2014
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
Subscribe for More Information
1 | 2 | all recent news | >>

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use