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Sarepta Gene Therapy Misses in Phase 3; Prospects Now Rely on FDA Flexibility

Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy fell short of its main Phase 3 goal, but the firm contends the full body of evidence supports expanding the therapy’s label to all patients who have the muscle-wasting disease. Analysts say prospects of the therapy, Elevidys, rest on FDA willingness to exercise flexibility it has already shown to rare disease drugmakers, including Sarepta.
United Kingdom Joseph Schwartz Tim Lugo Doug Ingram William Blair Reata Pharmaceuticals

48 Senators Urge Biden Administration To Mandate Coverage of OTC Contraceptives

Several senators wrote a letter to the Biden Administration asking for action that ensures coverage of over-the-counter birth control without the need for a prescription. The letter was led by Senators Patty Murray (D-Washington), Tammy Baldwin (D-Wisconsin), Bernie Sanders (I-Vermont) and Ron Wyden (D-Oregon).
Tammy Baldwind Wisconsin Patty Murrayd Washington Bernie Sandersi Vermont Ron Wydend Oregon Dana Singiser Access Initiative

MedCity Moves Podcast: Recent Hires, Layoffs & an Interview with Jeff Smith, CEO of Bamboo Health

For the October episode, we discuss some recent executive hires and departures occurring in the healthcare sector, as well as layoffs affecting the industry. We also hear from Jeff Smith, who became the new CEO of Bamboo Health this month.
Jeff Smith Intermountain Health Novant Health Bamboo Health Medcity Moves Podcast Sana Biotechnology

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Merck KGaA Puts Up €160M for Drug to Rival DNA Damage Cancer Meds From AstraZeneca, Gilead

A Hengrui drug that interferes with a cancer cell’s DNA damage response is heading to Merck KGaA for €160 million up front and up to €1.4 billion tied to milestones. The deal also gives the German company an option to license a Hengrui antibody drug conjugate.
Merck Kgaa Hengrui Daiichi Sankyo Merck Kga Jiangsu Hengrui Pharmaceuticals Gilead Sciences Merck Kgaa

Novartis Drug From $3.2B Deal Succeeds in Phase 3, 2024 FDA Filing Is Planned

Novartis drug candidate atrasentan met the main goal of a pivotal study in the chronic kidney disease IgA nepropathy. It’s one of two drugs added via the multi-billion dollar acquisition of Chinook Therapeutics; together with a homegrown therapeutic candidate, they give Novartis three different approaches to treat the rare disorder.
Shreeram Aradhye Chinook Therapeutics Therapeutic Tarpeyo Travere Therapeutics Novartis President Chief Medical Officer

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