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Why Pfizer Will Not Make Another Mega M&A Deal Anytime Soon

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:BioPharma

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-news-815x425-pfizer.jpg" NAME"Why Pfizer Will Not Make Another Mega M&A Deal Anytime Soon" ALT"Why Pfizer Will Not Make Another Mega M&A Deal Anytime Soon"March 15, 2017By Mark Terry, BioSpace.com Breaking…

Continue ReadingWhy Pfizer Will Not Make Another Mega M&A Deal Anytime Soon

Reminder: Centene Corporation's 2017 First Quarter Financial Results Conference Call

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue ReadingReminder: Centene Corporation's 2017 First Quarter Financial Results Conference Call

Actelion's R&D Discovery Biz Gets a Name,

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:BioPharma

  Life Sciences Jobs   ... Source: BioSpace

Continue ReadingActelion's R&D Discovery Biz Gets a Name,

FDA Hits Two API Firms With Warning Letters for Data Integrity, Misbranding

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug Industry Daily

The FDA has issued warning letters to two API manufacturers, citing branding and data integrity issues. Source: Drug Industry Daily

Continue ReadingFDA Hits Two API Firms With Warning Letters for Data Integrity, Misbranding

Mylan Settles with Roche, Genentech; Clearing Path for Herceptin Biosimilar

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug Industry Daily

Mylan reached a settlement with Roche and Genentech that paves the way for the generic drugmaker to market a biosimilar version of the blockbuster drug Herceptin. Source: Drug Industry Daily

Continue ReadingMylan Settles with Roche, Genentech; Clearing Path for Herceptin Biosimilar

Patent Office Affirms Four of Acorda’s Patents on MS Drug Ampyra Pending Court Ruling

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug Industry Daily

The USPTO's Patent Trial and Appeal Board validated four of Acorda’s patents on the multiple sclerosis drug Ampyra, but a federal court still has to determine whether five of the…

Continue ReadingPatent Office Affirms Four of Acorda’s Patents on MS Drug Ampyra Pending Court Ruling

Amgen to Supreme Court: 180-Day Notification for Biosimilar Launch Must Come After FDA Approval

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug Industry Daily

Amgen is calling on the U.S. Supreme Court to rule that biosimilar makers must wait six months after an FDA approval to market their therapy. Source: Drug Industry Daily

Continue ReadingAmgen to Supreme Court: 180-Day Notification for Biosimilar Launch Must Come After FDA Approval

FDA Advisory Committees Say Opana ER Benefits No Longer Outweigh Risks

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug Industry Daily

Two FDA advisory committees voted Tuesday that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse. Source: Drug Industry Daily

Continue ReadingFDA Advisory Committees Say Opana ER Benefits No Longer Outweigh Risks

India Proposes Pre-Inspections to Find Substandard Drugs

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug GMP Report

India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that…

Continue ReadingIndia Proposes Pre-Inspections to Find Substandard Drugs

China to Reform Oversight of GMP Compliance

  • Post author:Sam
  • Post published:March 14, 2017
  • Post category:Drug GMP Report

China’s State Council is ordering the China Food and Drug Administration to implement stricter policies for drug GMP compliance. Source: Drug GMP Report

Continue ReadingChina to Reform Oversight of GMP Compliance
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