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Sarepta Will Resume Gene Therapy Shipments After FDA Review of Recent Patient Death

Donald Trump · Washington

Sarepta Will Resume Gene Therapy Shipments After FDA Review of Recent Patient Death

Coverage: 20 sources

WASHINGTON (AP) — Shares of beleaguered drugmaker Sarepta Therapeutics jumped in afterhours trading Monday after the company said it would resume shipping its gene therapy for some patients, following a brief pause requested by regulators. The Food and Drug Administration said it recommended lifting the hold for young patients with Duchenne’s muscular dystrophy who are still able to walk. Regulators had requested the pause after the deaths of tw…See the Story

Eli Lilly Obesity Drug Mounjaro Beats Legacy Trulicity On Cardio-Renal Health - Eli Lilly (NYSE:LLY)

Eli Lilly Obesity Drug Mounjaro Beats Legacy Trulicity On Cardio-Renal Health - Eli Lilly (NYSE:LLY)

75% Center coverage: 8 sources

Eli Lilly's Mounjaro matched Trulicity in heart outcomes and showed added benefits on A1C, weight, kidney function, and mortality in a major trial.See the Story

Novo Nordisk Slumps as It Cuts Sales Forecast, Names New CEO

Diabetes · Denmark

Novo Nordisk Slumps as It Cuts Sales Forecast, Names New CEO

67% Left coverage: 6 sources

Novo Nordisk has a new CEO, facing an uphill battle to restore the fortunes of its US business as diabetes and obesity drugs come under pressure See the Story

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How FDA’s ISTAND Initiative Supports Innovative Tools in Drug Discovery and Development

100% Center coverage: 1 sources

The program has been transitioned to a permanent pathway that is designed to support innovative tools like artificial intelligence, wearables, and biomarkers in drug development and trials.FDA See the Story

Sanofi grabs Chinese rights to Arrowhead rare disease drug

100% Center coverage: 1 sources

Sanofi has paid $130 million upfront for Chinese rights to an Arrowhead Pharma drug for rare disease familial chylomicronaemia syndrome.China · China See the Story

Sandoz bolsters in-house biosimilar manufacturing with Evotec acquisition

Sandoz will acquire Just – Evotec Biologics’ biosimilar development and manufacturing plant in Toulouse for $300m.Toulouse · Toulouse Read Article

Manufacturing issues at Novo facility disrupt Regeneron drug review - Pharmaceutical Technology

Issues were picked up during an FDA inspection of Novo Nordisk-owned Catalent’s mammoth filling plant.United States · United States Read Article

Europe’s cannabis pharmaceuticals market matures amid cautious investment - Pharmaceutical Technology

Europe’s cannabis pharmaceutical sector is shifting as scientific rigour, regulatory clarity and cautious capital define its next chapter.Read Article

#BeOne Medicines Achieves EMA PRIME Designation for BGB-16673 and Prepares for EHA 2025 with Cutting-Edge Clinica...

BeOne Medicines: Pioneering Oncology Innovations with PRIME Designation and Groundbreaking Research at EHA 2025 SAN CARLOS, Calif. In a significant development for the oncology sector, BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) has received the coveted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for its experimental Bruton Tyrosine Kinase (BTK) degrader, BGB-16673. This innovative therapy is …San Carlos · San Carlos See the Story

Trump Demands Drugmakers Slash U.S. Price Now

100% Center coverage: 1 sources

Today's biotech news features Trump's demands that drugmakers slash U.S. price now, what Vinay Prasad's ouster means for biotech, and more.Donald Trump · United States See the Story

Dupixent Sales Spur Sanofi Growth, but Profits Fall Short - Pharmaceutical Technology

Heavy investment into R&D for Dupixent’s successor meant earnings per share fell short of expectations.France · France See the Story