Biotech business news and analysis
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Novo Nordisk plans for life after Wegovy, setting up roots in Boston to try and find its future

LEXINGTON, Mass. — The world’s second-most valuable pharma company is on the hunt for its next big breakthrough, and it thinks the sequel to Ozempic or Wegovy could be discovered in Boston. On Wednesday, the Danish diabetes and obesity drugmaker Novo Nordisk unveiled its new R&D facility just outside the city, pitching it as a US flagship to match...

Wed Feb 28, 2024 23:29
Argenx rolls out new campaign for rare autoimmune condition as it awaits FDA ruling

Argenx is taking a page from its own commercialization playbook with a new rare disease campaign. The unbranded “Shining through CIDP” campaign showcases real stories of caregivers and people living with chronic inflammatory demyelinating polyradiculoneuropathy, similar to its 2020 “MG United” campaign and docuseries about myasthenia gravis. The campaign...

Wed Feb 28, 2024 22:28
Moderna spells out rare disease ambitions: 'We have a bunch of INDs planned'

Moderna said in June that it was “quadrupling down” on rare disease. Right now, that looks like nine or so INDs in the planning phase and potentially “many more coming after,” according to head of development for therapeutics and oncology Kyle Holen. The public focus at Moderna has been trained on RSV and the challenges of shifting out of a pandemic...

Wed Feb 28, 2024 21:28
Califf lays out drug shortage landscape, talks post-market data collection for accelerated approvals

Efforts to inspect generic drug facilities around the world could end up worsening US shortages of several key medicines if they lead to halted manufacturing, said FDA Commissioner Robert Califf, underscoring the challenges faced by the agency on drug supply issues. Califf, speaking at a virtual event hosted by Reuters, said that the FDA’s inspection...

Wed Feb 28, 2024 21:28
Amman Pharma receives FDA warning letter over repeated violations, remains on import alerts

Generic drug manufacturer Amman Pharmaceutical Industries has been issued an FDA warning letter after being placed on several import alerts, with inspectors finding “fundamental design flaws” and “serious data breaches” at its facility in Jordan’s capital. The FDA noted the facility had “unacceptable conditions” which can lead to drug contamination....

Wed Feb 28, 2024 20:58
Only a small fraction of rare pediatric designations have led to vouchers, new FDA analysis shows

Out of hundreds of potential drugs with rare pediatric disease designations, only 7% of them have won priority review vouchers from the FDA, according to an agency review of a decade’s worth of data that are being made public for the first time. The analysis, published Monday in the Orphanet Journal of Rare Diseases, looked at 569 rare pediatric disease...

Wed Feb 28, 2024 19:26

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