Government
BioSpace gathered together a roundup of global biopharma news from the past week. Bayer and Orion Corporation, Themis Bioscience, Axonics Modulation Technologies, and more are mentioned in this edition.
Could a product in a weed killer contribute to the development of a cancer? That is the question a jury will answer as Bayer faces accusations that glyphosate, the active ingredient in its top=selling weed killer Roundup, caused cancer in some individuals who have used the product.
Shares of Adamis Pharmaceuticals are down nearly 5 percent this morning after the company announced late Tuesday that the U.S. Food and Drug Administration rejected its sublingual tadalafil product for erectile dysfunction, an alternative to the blockbuster Cialis.
Shares of Karyopharm Therapeutics are crashing again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.
U.S. Senator Chuck Grassley (R-Iowa) set the tone early, mentioning his constituents rationing drugs because of high prices or “leaving their prescription on the pharmacy counter because it costs too much,” but acknowledging that innovations “take time and money.”
Roche’s Flatiron Health and the U.S. Food and Drug Administration’s Information Exchange and Data Transformation (INFORMED) Program expanded a two-year-old collaboration agreement.
More news has come from China about the two babies born following He Jiankui’s experiment using CRISPR to make the children resistant to HIV while they were still embryos. Now, there is some evidence to suggest that the two infants could develop genetically-enhanced brains.
The FDA noted some concerns over the drug’s safety profile. Treatment with selinexor is associated with significant toxicity, the agency noted in its materials.
Court documents have shown how invested Richard Sackler was in the drive at Purdue Pharma to make OxyContin a success. A recent deposition that was unsealed has revealed just how far Sackler was willing to go.
The Florida-based company points to inaccuracies in the letter Sanders sent earlier this month regarding the price of LEMS treatment Firdapse.
PRESS RELEASES