FDA approval news from FiercePharma
NewsPreemption debate heats up
That little legal argument known as preemption is back in the news. You know the one: That FDA approval, being federal, supersedes any state-court lawsuits over blessed drugs and devices. Read more...
ALSO NOTED: Apotex assails Canadian goodwill drug program; Amgen CEO: "I felt real economic pain";
> After winning a bid to produce and ship generic AIDS drugs to Rwanda, Apotex says it won't participate in the goodwill program again unless the Canadian government simplifies the process. Read more...
ALSO NOTED: Botox slowdown doesn't dampen Allergan's Q1; Shandong Lunan launches new API plant
> Allergan more than doubled first-quarter profits to $111 million as strong sales of its eye, skin, and nerve drugs offset lower domestic sales growth of its Botox cosmetic treatment. Read more...
Wyeth to slash another 1,200 jobs
And the ax is falling again. Wyeth notified employees last Friday than another 1,200 jobs will be slashed from the payroll. That's on top of the Read more...
ALSO NOTED: Hassan plows $2M into Schering stock; Biopharma wrapped 18 building projects during 1Q;
> As promised, Schering-Plough CEO invested $2 million in the company's common stock, or 110,000 shares. Hassan had pledged to buy the shares just after results of the Enhance trial were released, Read more...
ALSO NOTED: Bayer sues Watson over Yasmin; Zimmer weeds out doc conflicts
> Open another chapter in the Bayer fight to protect Yasmin patents: Watson Pharmaceuticals filed for FDA approval for its copycat version of the birth control pill, and Bayer sued to keep the Read more...
Dems pitch big safety bill
It was inevitable: All the chit-chat about drug safety and the FDA's shortcomings had to result Read more...
ALSO NOTED: Senate panel offers more FDA funding; Japan OKs Roche's Actemra, Abbott's Humira
> A bipartisan Senate panel agreed that the FDA is "seriously underfunded" and asked Commissioner Andrew von Eschenbach for an estimate of how much more money the agency could use wisely in the Read more...
AstraZeneca, Ranbaxy settle Nexium fight
AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. The copycat company agreed to wait till 2014 Read more...
ALSO NOTED: Takeda offering bonuses at Millennium; Atypicals were first-, second-, and third-line in FL;
> Takeda Pharmaceuticals is planning to offer retention bonuses to Millennium Pharma workers, hoping to keep employees through Takeda's takeover of the Boston company. Read more...
| Press ReleasesPRESS RELEASE: FDA Approves Allergan Combo Eye Drop for Glaucoma FDA Approves Allergan Combo Eye Drop for Glaucoma IRVINE, Calif. - Allergan today announced that the U.S. Food and Drug Administration has approved COMBIGAN™ (brimonidine tartrate/timolol maleate Read more... PRESS RELEASE: Theravance Asks for More Information to OK Skin Disease Drug Theravance Asks for More Information to OK Skin Disease Drug SOUTH SAN FRANCISCO, CA and DEERFIELD, IL -- Oct 22, 2007 -- Theravance and Astellas Pharma US, Inc. announced today that the U.S. Food Read more... PRESS RELEASE: Merck's Januvia Wins New Uses but Risks Outlined Merck's Januvia Wins New Uses but Risks Outlined WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Read more... PRESS RELEASE: FDA Approves IXEMPRA, a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer FDA Approves IXEMPRA, a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer PRINCETON, N.J., Oct. 16 -- Bristol-Myers Squibb Company announced today that the U.S. Read more... PRESS RELEASE: FDA Approves SOMA(R) (carisoprodol) 250 mg FDA Approves SOMA(R) (carisoprodol) 250 mg New Recommended Dose for Relief of Discomfort Associated with Acute, Musculoskeletal Conditions such as Back Pain SOMERSET, N.J., Sept. 17 /PRNewswire/ -- Read more... |
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