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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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Samsung Bioepis allegedly entered into an agreement with a third-party health company, allowing it to market its own private label of a Stelara biosimilar.
Deerfield Management claims that Alcon Research is seeking a discounted takeover of Aurion Biotech while blocking the startup’s efforts to go public.
The industry remains unwavering in the commitment to increased clinical trial accessibility and representation.
Price-negotiation provisions that are out of step with reality are discouraging funders and Big Pharma partners from investing in potentially transformative therapies. Fixing some of the unintended consequences of the IRA will clear the way for innovative medicines to reach patients in need.
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.
The World Health Organization names antimicrobial resistance as one of the most urgent public health threats, but it remains an unattractive target for the pharmaceutical industry due to its weak profitability.
President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.
Ctexli’s approval further entrenches Mirum as a leader in rare liver diseases, alongside its cornerstone product Livmarli and upcoming drug volixibat.
Drug development powered by artificial intelligence is countering incentives from the Inflation Reduction Act and making small molecules more attractive in the complex inflammatory & immunology disease space.