Catch up on all the biggest news to hit the pharmaceutical industry over the last month including new appointments, mergers and acquisitions, approvals and more
Words by Jade Williams
2 September
The FDA approves the second mpox vaccine to combat outbreaks of the virus. The approval of Emergent BioSolutions’ smallpox/mpox vaccine follows the approval of Bavarian Nordic’s smallpox/mpox candidate and is a welcome addition to the global defence against the virus.
10 September
A partial clinical hold on Rezolute’s treatment for hyperinsulinism is lifted by the FDA after promising new research is released. The findings suggest that previous adverse results in laboratory rats may not have been caused by the drug itself but by the type of rat used for testing. This reconsideration comes after a follow-up toxicology study showed no liver abnormalities.
13 September
A new industry report finds that HCPs are increasingly basing their prescribing decisions on the reputation of pharmaceutical companies. The findings revealed that HCPs consider trust, corporate transparency and the company’s track record in patient care when choosing between two drugs with similar efficacy.
17 September
Warner Biddle is appointed CEO of Kyverna Therapeutics, a biopharmaceutical company focused on cell therapies for autoimmune diseases, following the resignation of Peter Maag. Biddle will also join the company’s board of directors, along with Christi Shaw, a prominent life sciences leader and former CEO and colleague of Biddle’s at Kite Pharma.
23 September
The Association of the British Pharmaceutical Industry publishes an an updated Code of Practice, incorporating recent guidance from the Prescription Medicines Code of Practice Authority. Updates include guidance on including prescribing information on QR codes and an improved complaints procedure.
24 September
The US pledges to donate one million doses of mpox vaccine to help control the spread of the virus. With global health organisations warning that the virus is spreading in at-risk regions, the contribution, along with an additional $500m in aid, is aimed at strengthening Africa’s health infrastructure to fight the outbreak.
26 September
Evotec, a German drug development company, joins forces with Novo Nordisk in a technology development partnership to expand the latter’s stem cell research capabilities. The collaboration will provide Evotec with significant funding for technology development in Germany and Italy, as well as additional support for R&D.
30 September
The FDA approves the use of dupilumab, a biologic developed by Sanofi and Regeneron, for treating adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Previously used to treat asthma, eczema and other allergic conditions, dupilumab’s expansion into COPD is expected to significantly improve quality of life for patients struggling with respiratory symptoms.