News
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
FEATURED STORIES
The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
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.
THE LATEST
Though nerves abound for funders and founders in the industry, money continues to flow into startups, sometimes in eye-popping numbers. BioSpace rounds up the biggest raises so far this year.
Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.
The FDA’s dramatic summer continues to unfold as news broke late Tuesday evening that Vinay Prasad will depart the agency, where he had been the head of the Center for Biologics Evaluation and Research for less than three months.
Pascal Soriot’s comments came during AstraZeneca’s Q2 earnings call in regard to President Donald Trump’s newly announced European pharma tariffs. The company also announced estimate-beating earnings, with its cancer portfolio driving earnings despite clinical roadblocks.
CEO Rob Davis referred to the cost reduction program as a ‘reallocation’ rather than a cut, with the savings to be reinvested to support up to 20 new product launches.
In a surprise double announcement Tuesday, Novo reduced sales guidance by 5%—attributing the change to slowed growth of its semaglutide franchise in the U.S.—and named current international operations head Maziar Mike Doustdar as its new president and CEO.
Six weeks after HHS Secretary RFK Jr. cited unexplained conflicts of interest in dismissing all 17 members of the CDC’s vaccine advisory committee, Democrats are asking for details.
While some analysts forecast the tariffs could mean billions in additional industry expenditure, others expect the overall impact to be “manageable.”
In a post on X, Health Secretary Robert F. Kennedy Jr. alleged that the Vaccine Injury Compensation Program has “devolved into a morass of inefficiency, favoritism, and outright corruption.”
BMS is spinning out a new company with five immunology assets, including oral drugs being developed for systemic lupus erythematosus and plaque psoriasis, and $300 million in funds from Bain Capital.