Catégorie - ASTRAZENECA
AstraZeneca to acquire French Novexel
On Wednesday, AstraZeneca announced a $350 million deal for the purchase of French antibiotics manufacturer Novexel. The acquisition will boost the Anglo-Swedish pharmaceuticals giant's portfolio of anti-infection drugs.
2009-12-24 -
The Local
ONGLYZA-metformin combination: FDA accepts NDA for review
Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.
2010-03-17 -
News-Medical-Net
Volume gains sweeten U.S. pill for drugmakers
Source: Reuters * U.S. bill short-term EPS pain, long-term sales gain * Shares of Pfizer, Bristol-Myers, AstraZeneca outperform * Sanofi-Aventis slips after setback for heart drug Multaq (Adds analyst comments ...
2010-03-22 -
AlertNet
Abbott's combo drug hit by FDA setback
(Reuters) — A experimental two-in-one heart drug from AstraZeneca and Abbott Laboratories has been knocked back by U.S. regulators who want more information about the product, the companies said on Tuesday. The move looks certain to delay approval of the drug beyond the target time of ...
2010-03-30 -
Crain's Chicago Business
Legality of patent deals is uncertain
Patent settlements reached by drug companies including AstraZeneca may violate antitrust laws, a US appeals court has said, citing a rise in cases in which makers of brand-name medicines pay rivals to delay generic products.
2010-05-01 -
The News Journal
VIMOVO delayed-release tablets receive FDA approval
AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
2010-05-03 -
News-Medical-Net
POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO
POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.
2010-05-26 -
News-Medical-Net
Asthma drug warning ordered
WASHINGTON - US HEALTH regulators have finalized new warnings for controversial inhaled asthma drugs, but exercised new powers to order the changes on products made by GlaxoSmithKline Plc and AstraZeneca. The warnings, expected since February, say medicines known as long-acting beta-agonists, or LABAs, should never be used on their own to treat asthma, Food and Drug Administration officials said ...
2010-06-03 -
Straits Times
Pfizer joins brain-disease coalition
Pfizer Inc. has joined such other major pharmaceutical firms as Abbott, AstraZeneca, Bristol-Myers, Eli Lilly & Co., Novartis and Johnson & Johnson in forming the Coalition Against Major Diseases
2010-06-15 -
The Day
Hospira's generic antibiotic gets FDA green light
(AP) — Hospira Inc. said Tuesday the Food and Drug Administration has approved its generic version of AstraZeneca's antibiotic Merrem. The FDA cleared Hospira's version of intravenous meropenem in 500-milligram and 1-gram vials. Hospira said U.S. sales of Merrem totaled $200 million in 2009.
2010-06-22 -
Crain's Chicago Business
FDA approves Hospira's meropenem for injection, USP (I.V.)
Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has received U.S. Food and Drug Administration (FDA) approval for meropenem for injection, USP (I.V.) 500 mg and 1 g vials. The medication, a carbapenem that belongs to the beta-lactam class of antibiotics, is a generic version of AstraZeneca's Merrem® I.V. Sales of the name-brand product in the United ...
2010-06-23 -
News-Medical-Net