Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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After the FDA released draft guidance on increasing diversity in clinical trials, companies have been left to figure out the details.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.
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
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.
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong.
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.