Articles By Cyndi Root
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Weekly FDA Enforcement Report For Drugs And Biologics 5/7/14
5/8/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for May 7, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.
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Weekly FDA Enforcement Report For Drugs And Biologics 4/30/14
5/5/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 30, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily, or the FDA initiates the action. View the recalls by Biologics or Drugs and by Classification.
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AstraZeneca Rejects Pfizer's Takeover Attempt Again
5/1/2014
In a move marketed as beneficial to both companies’ shareholders, Pfizer has again approached AstraZeneca to take over the company. In a press release, Pfizer said that it was a possible offer, not a firm offer, and fell under Rule 2.4 of the City Code on Takeovers and Mergers. Pfizer said the reasons for the offer were primarily to bring together two established and complementary businesses and increase shareholder value.
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Weekly FDA Enforcement Report For Drugs And Biologics 4/23/14
4/25/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 23, 2014. The agency publicizes recalls in its weekly report. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification (the danger level.)
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Bristol-Myers Squibb and Samsung BioLogics Increase The Scope Of Manufacturing Agreement
4/25/2014
Bristol-Myers Squibb Company and Samsung BioLogics announced in a press release that they will expand their manufacturing agreement. The two companies began their alliance in July of 2013 with an agreement to manufacture Bristol-Myers’ antibody cancer drug. The newly expanded agreement covers several medicines to be manufactured at Samsung’s manufacturing site in Incheon, South Korea.
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U.S. District Court Suspends Massachusetts' Zohydro Ban
4/23/2014
A U.S. District court issued a ruling that a Massachusetts ban on Zohydro, an opioid pain reliever, is unconstitutional.
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Aesica Implements Serialization Services In Italy
4/22/2014
Aesica, an Italian pharmaceutical contract development and manufacturing organization (CDMO), announced in a press release that it has begun producing serialized drugs for one of its partners.
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FDA Approves GlaxoSmithKline's Tanzeum For Type 2 Diabetes
4/21/2014
GlaxoSmithKline (GSK) announced in a press release that the Food and Drug Administration (FDA) has approved Tanzeum (albiglutide).
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Weekly FDA Enforcement Report For Drugs And Biologics 4/16/14
4/21/2014
The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for April 16, 2014.
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Actavis And Valeant Announce FDA Approval For Metronidazole
4/7/2014
Actavis and Valeant Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved Metronidazole 1.3% Vaginal Gel. The approved New Drug Application (NDA) is for an antibiotic to treat bacterial vaginosis (BV).