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Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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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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After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.
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Scrutiny of WuXi Raises Potential Opportunities for Indian CDMOs
As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.
When moving to a new role at the same company, it’s important to create a transition plan, understand your responsibilities and expectations and get to know your new team.
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After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.
It’s important to maintain anonymity when seeking your next executive role, as your departure could impact other employees and the organization.
Following success in several indications including ulcerative colitis, J&J’s blockbuster drug Tremfya failed to meet a mid-stage study’s primary endpoint in treating giant cell arteritis.
Citing issues with a third-party manufacturer, the FDA has issued another Complete Response Letter to AbbVie rejecting its New Drug Application for ABBV-951, a proposed treatment for motor fluctuations in adults with advanced Parkinson’s disease.
AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.
If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.
After being spun off of sequencing giant Illumina, Grail on Tuesday is set to start trading on the Nasdaq Global Select Market following a years-long antitrust battle with regulators.