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US FDA proposes using existing science to speed up gene therapy development

June 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday proposed allowing makers of cell and gene therapies targeting rare and life-threatening diseases to use existing scientific knowledge to expedite development. Here are a few details: • The agency in its draft guidance said ...
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The methodology of an AP-KFF Health News investigation into medical neglect at ICE detention centers

KFF Health News and The Associated Press sifted through thousands of immigration habeas corpus claims to find allegations of medical neglect from people detained by U.S. Immigration and Customs Enforcement during the second Trump administration. Without a comprehensive, publicly available dataset of medical complaints by ...
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US to re-engage with Gavi vaccine alliance amid Ebola outbreak, Rubio says

WASHINGTON, June 2 (Reuters) - U.S. Secretary of State Marco Rubio said on Tuesday that the U.S. would re-engage with the global vaccine alliance Gavi amid the Ebola outbreak in several African countries. Rubio told the Senate Foreign Relations Committee that the decision had been ...
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GIC-backed Asia Healthcare eyes IPO within 12-18 months, cautious on market volatility

By Rishika Sadam and Haripriya Suresh BENGALURU, June 2 (Reuters) - Asia Healthcare Holdings (AHH) is considering listing its shares within the next 12 to 18 months, although it remains wary of market volatility, Executive Chairman Vishal Bali said. The company, which is backed by ...
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Abivax shares sink after key trial results for inflammatory bowel drug

By Gianluca Lo Nostro June 2 (Reuters) - Abivax shares tumbled on Tuesday after the French biotech reported late-stage data for its experimental inflammatory bowel drug, with investors focusing on safety concerns even as the treatment showed strong efficacy. The shares were down 30% in early ...
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Congo re-opens airport at centre of Ebola outbreak

KINSHASA, June 2 (Reuters) - Democratic Republic of Congo has re-opened the airport in the capital city of the province hit hardest by the ongoing Ebola outbreak, a government statement said, reversing a move that some residents said had cut them off from critical ...
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China recognises Brazil as foot-and-mouth disease free, lifts bans

BEIJING, June 2 (Reuters) - China's customs said it has lifted bans related to foot-and-mouth disease in northern Brazil, and recognises the whole of Brazil as free of the disease, according to an official notice released on Tuesday. The announcement is good news for ...
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As Congo grapples with Ebola, volunteers cook up meals to support patients and health workers

BUNIA, Congo (AP) - Arlette Basekawike, a volunteer for the United Nations food agency in Bunia, the heart of Congo's Ebola outbreak, spends most of her time in a small shed outside a health facility preparing meals for patients and health workers. Her hair covered ...
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Fulcrum scraps sickle cell drug program after FDA raises cancer-risk concerns

June 1 (Reuters) - Fulcrum Therapeutics said on Monday it would stop developing its experimental sickle-cell disease drug after the U.S. Food and Drug Administration raised cancer-risk concerns, which left no viable regulatory path for the treatment. The drug developer's shares slumped nearly 50% in ...
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Brazil authorities say two suspected Ebola cases tested negative

SAO PAULO, June 1 (Reuters) - Brazil has cleared two suspected cases of Ebola after both patients tested negative for the virus, local authorities said on Monday. The suspected cases emerged over the weekend from patients with related symptoms who had recently been in ...
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Praxis Precision’s epilepsy drug misses main goal of mid-to-late stage study

June 1 (Reuters) - Praxis Precision Medicines said on Monday its experimental epilepsy drug failed to meet the main goal of a mid- to late-stage study, prompting it to pause enrollment in another ongoing study while it reassesses the program. Shares of the biotech firm ...
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West Pharma names former Thermo Fisher executive Lagarde as CEO

June 1 (Reuters) - West Pharmaceutical said on Monday it appointed former Thermo Fisher Scientific executive Michel Lagarde as its top boss, effective August 31, succeeding longtime chief Eric Green. • Green, who has led the medical equipment maker since 2015 and became ...
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