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Merck KGaA News | The Pharmaletter
2025年1月30日 · US pharma giant Merck & Co today revealed an early stop to the Phase III HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.
StemCyte gains FDA nod for cord blood therapy
2024年11月25日 · StemCyte has received FDA approval for Regenecyte, a cord blood-derived stem cell therapy for hematopoietic disorders. The company is advancing Phase II trials for long COVID, stroke, and aging-related diseases. StemCyte is also preparing for a listing on the Taipei Stock Exchange, marking a key growth milestone.
Pharma, Biotech and Generics Industry News | The Pharmaletter
2025年1月2日 · Shares of US drugmaker Vertex Pharmaceuticals jumped 8.4% to $475.00 in after-hours trading yesterday after it announced that the US Food and Drug Administration (FDA) has approved Journavx (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain.
UCB News - The Pharmaletter
2025年1月15日 · Danish CNS specialist Lundbeck announced positive results from the 12-month open-label extension of the Phase Ib/IIa PACIFIC trial, evaluating bexicaserin in participants aged 12-65 with developmental and epileptic encephalopathies (DEEs).
FDA tests let military use expired drugs
2000年4月5日 · This article is accessible to registered users, to continue reading please register for free.. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week.
BioAge Lab | The Pharmaletter
2025年1月30日 · A clinical-stage biopharma company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. The company has nominated a member of this class, the orally available, small-molecule brain-penetrant NLRP3 inhibitor BGE-102, as a ...
Takeda withdrawing Alofisel from EU market | The Pharmaletter
2024年12月16日 · Japan’s largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), announced it is working with the European Medicines Agency (EMA) to voluntarily withdraw the marketing authorization of Alofisel (darvadstrocel), a treatment for complex perianal fistulas in patients with Crohn’s disease, in the European Union (EU).
Trump vs Harris—who's on Big Pharma's side? | Pharmaceutical
2024年9月22日 · In the 2024 US presidential election, health policy will remain a key issue for pharma. Both Donald Trump and Kamala Harris have criticized high drug prices, raising uncertainty for the industry. While Trump targeted generics, biosimilars, and international price comparisons during his term, Harris has been associated with pricing transparency and the Inflation Reduction Act (IRA), which ...
FDA panel flags risks as AstraZeneca seeks full Andexxa approval
2024年11月22日 · AstraZeneca faces challenges in securing full FDA approval for Andexxa, its anticoagulant reversal therapy, due to safety concerns raised during an advisory committee meeting. Despite positive data on brain bleeds, higher clotting events in patients treated with Andexxa have cast doubt on its benefits.
Concerns about tablet-splitting of muscle relaxant
2004年5月23日 · Back and neck pain sufferers who divide the most frequently-prescribed muscle relaxant may be getting anywhere from half to one-and-a-half times the amount of medicine they believe they are taking, suggests a new study examining the practice of tablet-splitting.