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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.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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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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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Amgen is implementing organizational changes including laying off approximately 300 team members, confirmed Monday.
Novartis’ SCD therapeutic Adakveo is under review by the EMA after failing to replicate previous efficacy results in a Phase III trial.
The FDA granted Eli Lilly’s Jaypirca accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma.
Sen. Elizabeth Warren (D-MA) voiced concerns to the FTC regarding the prospective acquisitions of Horizon Pharmaceuticals and Opiant Pharmaceuticals by Amgen and Indivior.
Celularity announced Thursday it was conducting a strategic review and warned its workforce to brace for potential layoffs.
XyloCor Therapeutics reported positive topline results Thursday from Phase II of the Phase I/II trial of its gene therapy for refractory angina.
The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
Ocuphire Pharma’s oral diabetic retinopathy drug missed the primary endpoint of an improvement in patient scores on the diabetic retinopathy severity scale.
Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.