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The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
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The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Less than six months after cutting 20% of its employees, Vedanta Biosciences has again laid off staff. According to one affected staffer, half of the Cambridge, Massachusetts–based biotech’s workforce is being cut while most of the rest are furloughed.
Following rusfertide’s triumphant Phase III trial last year, Protagonist must decide how involved to be in future development. Hundreds of millions of dollars are on the line.
Ocular Therapeutix’s lead asset is Axpaxli, being developed for wet age-related macular degeneration. A Phase III study is underway, with data expected this quarter.
Speaking on the sidelines of the J.P. Morgan Healthcare Conference, Novo business development executive Tamara Darsow said the company is gunning for obesity and diabetes assets.
The Novo Nordisk Foundation’s funds will go toward supporting early-stage companies working in “human health, planetary health and societal resilience.”
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
After a cacophony of troubles hit the RNA editing biotech last fall, CEO Ram Aiyar is in San Francisco to develop partnerships, pitch the potential of its new AATD program and find more money to keep the dream alive.
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
Strive Compounding Pharmacy alleged in its lawsuit that Eli Lilly and Novo Nordisk have worked to lock telehealth providers in exclusive partnerships, disallowing them from offering compounded versions of GLP-1 medicines.