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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FEATURED STORIES
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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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.
THE LATEST
Shares of Horizon Therapeutics are soaring in premarket trading Wednesday after the rare disease company confirmed it is being courted for a potential acquisition by three pharma giants.
Nimbus reported positive Phase IIb results for NDI-034858 in moderate-to-severe plaque psoriasis, which researchers hope will have the efficacy of JAK inhibitors without the safety issues.
Nectin Therapeutics announced dosing of the first solid tumor patient in a Phase I clinical trial while additional investors jumped in to expand the company’s Series A to just over $25 million.
Full data from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease.
BigHat Biosciences will team up with Merck to design candidates for three drug discovery programs backed by the company’s proprietary AI technology platform.
BMS is terminating a seven-year-old gene therapy collaboration to develop potential treatments for congestive heart failure with uniQure N.V. valued at $1 billion.
With $96 million in Series A financing, Cajal Neuroscience launched Tuesday to develop drug candidates to target neurodegeneration in Alzheimer’s and Parkinson’s diseases.
As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody, Tecentriq, for metastatic bladder cancer.
AstraZeneca and Neogene have entered into a definitive acquisition agreement in which AstraZeneca will buy all outstanding equity in the smaller company.
A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer’s drug lecanemab, according to the journal Science.