Jonah Comstock

3 days ago | pharmaphorum.com | Jonah Comstock

Sanofi and Regeneron's Dupixent (dupilumab) has been approved by the FDA for the treatment of chronic spontaneous urticaria (CSU), a condition that causes painful hives that often don't respond to antihistamines. It's the seventh approved indication for the IL4 and IL13-inhibiting monoclonal antibody, which is already a blockbuster for Sanofi. CSU has also not had a new treatment approved in more than a decade.

4 days ago | pharmaphorum.com | Jonah Comstock

March was a light month across the board for hires news, but the digital and supplier sectors in biopharma saw a spat of notable appointments. New CEO takes the helm at Evidation. Evidation, a California-based company that helps pharma companies collect real-world evidence (RWE) by connecting them directly with millions of volunteer patients through an app, has hired within for a new CEO, Leslie Oley Wilberforce.

6 days ago | pharmaphorum.com | Jonah Comstock

Market Access In a news release issued yesterday, the FDA has announced a new policy directive to remove pharma industry representatives from advisory committees except where required by statute. While it sends some signals about the priorities of new FDA Commissioner Dr Martin Makary, the actual impact of the directive is likely to be muted: Most of the industry members on advisory committees are required by statute -- the FDA Modernization Act of 1997 requires one on each advisory panel --...

6 days ago | pharmaphorum.com | Jonah Comstock

GSK's Blenrep (belantamab mafodotin) has officially been approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), its first approval in the world for the multiple myeloma drug -- at least the first approval this go-round.

6 days ago | pharmaphorum.com | Jonah Comstock

An international agreement on pandemic preparedness is finally complete after three years of negotiation. The World Health Organization's Intergovernmental Negotiating Body (INB) finished its 30-page draft agreement on Wednesday after 13 formal rounds of meetings. The agreement will now be considered at the upcoming 78th World Health Assembly, beginning in May. If it is ratified by 60 of the 194 WHO member states, it will become international law.