Regulatory
After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details. Here’s what experts say is working.
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
The regulator approved the combination of Pfizer’s Braftovi and Mektovi for the treatment of metastatic non-small cell lung cancer in adult patients with a BRAF V600E mutation.
The first two weeks of October saw BMS’s $4.8 billion buyout of Mirati, Lilly’s $1.4 billion purchase of Point, Kyowa Kirin’s $387 million acquisition of Orchard and AbbVie’s $110 million Mitokinin deal.
Last year, the FDA declined to approve a drug that appears to reverse a rare and debilitating enzyme deficiency. Some experts say it’s emblematic of a need for more flexibility around therapeutics targeting rare diseases.
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
Despite winning the backing of an FDA advisory committee, the regulator in a Complete Response Letter declined Alnylam’s bid to expand Onpattro’s label to cardiomyopathy in ATTR amyloidosis.
Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment.
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