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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
FDA
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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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During the second quarter, NRx reactivated the development of NRX-101 and intends to initiate a Phase IIb/III study for ASIB by the end of this year or early 2023.
As the biotech world awaits the announcement of Merck’s anticipated buyout of Seagen, an arbitrator came down on the side of Daiichi Sankyo in a patent battle against the Seattle-based biotech.
Novartis released results from the Phase III CANOPY-A trial, showing that its canakinumab candidate failed to meet its primary efficacy endpoint in adult NSCLC patients.
The U.K’s MHRA has granted conditional authorization to Moderna’s newest vaccine candidate, making it the first Omicron-specific COVID-19 booster vaccine approved by a regulatory agency.
BrainStorm Cell Therapeutics said it will submit a Biologics License Application to the FDA for ALS hopeful NurOwn. Additionally, a correction has been made to analyses of the Phase III clinical trial.
The 3D-printed acoustic hologram could be very important to the delivery of certain therapeutics for Alzheimer’s Disease (AD) and other neurological disorders.
This week holds moments of truth for Provention’s type 1 diabetes drug and bluebird bio’s gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
CRISPR Therapeutics, Clovis Oncology and VistaGen all released Q2 results this week, while GreenLight Biosciences has some extra cash to work with.
FDA
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.