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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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The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
As Humira global revenues fall 25%, AbbVie looks to Rinvoq and Skyrizi to fill in the gap. The company also announced it is cutting cystic fibrosis and Crohn’s disease candidates.
Prevnar 20 is indicated for the prevention of invasive pneumococcal disease and otitis media in children.
In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese.
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
The French pharma drops another BTK inhibitor program from Principia and an anti-TNFa from Ablynx.
The leadership shuffle comes as BMS is facing one of the steepest patent cliffs in biopharma, with exclusivity of three of its top drugs lapsing this decade.
To be self-employed in the life sciences, you must have a strong network and background and experience in a relevant area.