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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
FEATURED STORIES
Heading into the final quarter of a year that has seen dramatic upheaval at the FDA—from the exodus of numerous senior leaders to unclear policy changes and a safety saga that engulfed the gene therapy space—drug approvals appear roughly on par with recent years.
Therapies from industry leaders BioMarin and Ascendis Pharma supply a key hormone that promotes bone growth. In order to move the field forward, challengers are looking to address the underlying cause of the rare, genetic disease.
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
Job Trends
GRAIL, Inc. announced its spin-off from Illumina is complete, and GRAIL will be listed and commence regular-way trading on the Nasdaq under the symbol “GRAL” as of tomorrow, June 25, 2024.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
Novo Nordisk, under new CEO Maziar Mike Doustdar, has a new attitude. It’s making Pfizer livid.
Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.
Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a VEGF-C inhibitory RNAi with Regeneron’s Eylea into a single ocular injection.
Before being discontinued, the P2X7 receptor blocker had cleared a master protocol study in chronic pain, though Eli Lilly said that results were not sufficient for advancement of the Asahi Kasei–partnered asset.
Gilead is actively looking for late-stage and de-risked assets for potential deals across various therapeutic spaces, including liver disease, cancer and immunology.
With the shutdown ongoing, Evommune plans to close its IPO on Nov. 5 via a Securities Act clause that allows registrations to come into effect after a certain window has passed.
Ensho Therapeutics CEO Neena Bitritto-Garg, recently named to BioSpace’s 40 Under 40, proved her mettle managing one of the toughest partnerships out there: the one between Eisai and Biogen that led to new Alzheimer’s drugs Aduhelm and Leqembi.
CEO David Ricks wants Eli Lilly’s upcoming obesity pill to be accessible to patients who need it, but the company still needs to pay for the next generation of obesity medicines to come after that.
While the company’s sales outlook was otherwise rosy, Merck took sales hits on Gardisil, Proquad, Varivax and Vaxneuvance.