News
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.
FEATURED STORIES
BioNTech said in 2022 that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Now, the mRNA biotech is buying that very company.
Sanofi paid a more than 300% premium on its acquisition of Vigil Neuroscience, suggesting a fierce battle to seal the deal. Across biopharma, companies are sometimes willing to put it all on the line for the right buyout. Novartis’ recent acquisition of Regulus for $800 million upfront provides a case study.
AstraZeneca, Pfizer and more are leveraging the computational power of AI to better design trials, predict the potential efficacy and safety profiles of their molecules and synthesize massive multi-omic information to gain a more complete understanding of challenging cancers.
Job Trends
Regeneron Pharmaceuticals, Inc. announced that 14-month median follow-up data from the pivotal Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory multiple myeloma were shared during an oral presentation at the European Hematology Association Congress 2024 and published in the Journal of Clinical Oncology.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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In advance of this week’s adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.
Shanghai-based LaNova Medicines—which has captured the attention of some of the biggest Western pharmas—will be folded into fellow Chinese company Sino Biopharmaceutical in a deal worth up to $951 million.
In a July 9 memo, the director of the FDA’s Center for Biologics Evaluation and Research contended there was not enough evidence that the benefits of Moderna’s COVID-19 vaccine Spikevax outweighed its risks in healthy children.
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
It’s easy to get caught up in defending yourself against critique that feels unfair. Leadership coach Angela Justice recommends a different approach that can help you better align how you want to be seen with how you’re showing up.
From Wall Street to real estate to a “big, ugly” pharma building, Mayo Venture Partner Audrey Greenberg reflects on a career defined by taking a leap at just the right moment.
Some of the most high-profile acquisitions in recent years have involved women-fronted biotechs. BioSpace reviews five of the most notable here.
Seven biotech unicorns are advancing AI-powered drug discovery and development—but must contend with a difficult investing environment where competition is steep and the usual roads to exit are uncertain.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q2 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.