PhRMA speaks out against FDA biosimilar flexibility
PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice. May 17 – How to Survive PREDICT
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Undisclosed Clinical Trial Data and Mirapex
Source Over the past few years, a debate has intensified over the extent to which drugmakers should disclose all clinical trial data pertaining to their medicines. The issue has drawn bitter complaints from some physicians and consumer watchdogs, among others, who argue anything less than complete disclosure may deprive the medical community of important info […]
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Merck to expand packaging center in Wilson NC
Merck announced Tuesday that it will spend $15 million renovating and expanding its facility in Wilson NC. May 17 – How to Survive PREDICT The capital projects, which include overhauling existing manufacturing space and adding a cold storage facility for vaccine packaging, will not increase the company’s workforce at the site. Merck employs about 400 […]
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Pfizer Coughs Up $450M to Brigham Young U. Over Celebrex
Source To put an end to what could have been an embarrassing and potentially costly episode, Pfizer has agreed to pay $450 million to Brigham Young University and endow a chair in the name of Daniel Simmons, a professor who claimed the drugmaker wrongfully cheated him out of money and credit for research that led […]
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Four killed, 17 injured in blast in pharma unit’s reactor
Four persons were killed and 17 others injured in a blast in a leading pharmaceutical company’s manufacturing unit at Basauli village near Lalru town in Punjab, Inida. “The blast took place in the chemical reactor of the pharma unit which makes formulations for the antibiotics. Seventeen persons were injured in the incident,” SSP, Mohali, G […]
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Astrazenca Former CEO Gets The Ultimate Golden Parachute
Source Now, that he is retiring after a spell of disappointments on the job, David Brennan may yet have reason to feel cheery. An unconfirmed report in The Sunday Times over the weekend suggests the outgoing ceo – who officially leaves on June 1 – will receive a $65 million exit package that includes an […]
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Abbott Submits Petition to FDA to Not Approve Biosimilar
Source In a move that is sure to raise debate about the path forward for biosimilars, Abbott Laboratories has filed a citizen’s petition with the FDA in which the drugmaker asks the agency not to approve any biosimilar for its Humira treatment for rheumatoid arthritis. On what grounds? Abbott argues that the FDA would have […]
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How the FDA Stifles New Cures, Part III: A Proposal for Reform
On Tuesday, the Manhattan Institute released a study I authored, entitled “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials.†The paper discusses how outdated FDA policies are making drug development too expensive and too risky. In this excerpt, I describe the most promising avenue for FDA reform: a “conditional approval†process that […]
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New ED drug may work in 15 minutes
Look out Viagra – there’s a new erectile dysfunction drug in town. It’s called Stendra (aka Avanafil) and it’s newly approved by the Food and Drug Administration, making it the first ED drug to come out in almost 10 years. Although Stendra has not been tested against what is known as the “Little Blue Pill,” […]
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FDA Cites 10 Companies For DMAA Products Sold Without Evidence Of Safety
Cracking down on dietary supplements containing a substance popularly known as DMAA, the U.S. Food and Drug Administration on Friday issued warning letters to 10 distributors and manufacturers, citing the companies for marketing the products without submitting evidence of their safety to the agency. DMAA is dimethylamylamine, aka 1,3-dimethylamylamine, geranium extract, or methylhexanamine. It is […]
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