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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.
IPO
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.
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The mpox vaccine induced an antibody response in adolescents aged 12 to 17 years that matched that in adults, suggesting the shot can be used to protect the highly susceptible group.
Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine.
Thursday’s agreement with Orano Med is the second in as many months. Sanofi in September made its first foray into the radioligand space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix.
In a tough labor market where layoffs continue, some are considering—or even moving—from industry to academia, according to a BioSpace poll. A career coach, scientist and general practitioner turned research coordinator share their thoughts.
Artificial intelligence won’t replace people in biopharma, but it is infiltrating every step of drug development, including in some ways that aren’t so obvious.
Wave Life Sciences in a Tuesday filing with the SEC said Takeda has elected to terminate its option to continue work on Wave’s WVE-003 clinical-stage Huntington’s disease program—a potential $5 billion commercial opportunity, according to the biotech.
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
The lawsuits claim that Moderna used and profited from crucial mRNA technology in its COVID-19 vaccine Spikevax and respiratory syncytial virus shot mResvia.
Johnson & Johnson is cutting several programs—most of which are in neurology and psychiatry—as the company also pulls back from the infectious diseases market.
Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq.