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Poor Trial Results May Prompt Maker to Pull ALS Drug, Relyvrio, From Market

Drugs.com

MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.

Marketing 289
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Pfizer to pull sickle cell drug from market, shut down trials

BioPharma Drive: Drug Pricing

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

Trials 277
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Maker Is Pulling Controversial ALS Drug Relyvrio Off the Market

Drugs.com

THURSDAY, April 4, 2024 (HealthDayNews) -- Following disappointing trial results, the maker of a controversial ALS drug said it is pulling the medication off the market. In a statement issued Thursday, Amylyx Pharmaceuticals said that Relyvrio.

Marketing 279
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Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

As clinical trials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinical trial management. Get in touch.

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Lilly’s Zepbound beats Novo’s Wegovy in high-stakes obesity drug trial

BioPharma Drive: Drug Pricing

Results from the head-to-head study showed treatment with Zepbound resulted in 47% greater relative weight loss than Wegovy, a finding that could advantage Lilly in the companies’ market competition.

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GSK cancer drug Blenrep gets surprise trial win

BioPharma Drive: Drug Pricing

market because of negative data, new study results might crack open the door to a relaunch. One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S.

Trials 280
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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