Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority…
GSK bolsters vaccines division with $3.3bn swoop on Affinivax
GlaxoSmithKline has agreed a $3.3 billion takeover of US biotech Affinivax, buying a pneumococcal vaccine candidate that is aiming to break into a market that for years has been dominated by Pfizer’s Prevnar franchise. GSK said it is paying $2.1…
As cases rise, WHO says monkeypox risk is “moderate”
The World Health organisation’s latest assessment of the monkeypox outbreak is that it poses a moderate threat to public health, as cases of the infection continue to rise. In an update posted yesterday, the WHO said it had received reports…
Blood drawing robot heading for pivotal trials
In future, blood samples may be taken by an autonomous robot rather than a healthcare professional – if Dutch developer Vitestro can get its prototype approved for marketing. Vitestro’s blood drawing (phlebotomy) robot is designed to offer a solution to…
BMS & BridgeBio Team Up in Nearly $1B Oncology Pact
BridgeBio announced that it has signed an exclusive deal with Bristol-Myers Squibb to develop and commercialize a potential treatment for cancer. The two companies will work together on BBP-398, an SHP2 inhibitor that has the potential to address difficult-to-treat cancers. The drug…
Eli Lilly Deals Another Blow to Diabetes with Latest FDA Approval
Eli Lilly scored another win against diabetes Friday as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration. Late Friday afternoon, the FDA…
Sanofi ingredients spin-out EuroAPI rises on market debut
Sanofi has completed the spin-out of its pharma ingredients business EuroAPI, with shares in the new company rising more than 3% on its starting price of €12 in early trading on the Euronext exchange this morning in a declining market.…
Biogen grabs MS music therapy from MedRhythms in $120m deal
Biogen has licensed rights to a digital therapeutic (DTx) developed by MedRhythms which combines sensors, software, and music to help people with multiple sclerosis tackle mobility problems. The biopharma company – which is one of the top players in MS…
Pfizer’s 1st drug development lab in Asia opens in Chennai
US drug maker Pfizer said it has opened its global drug development centre in Chennai that will work on development of finished dosage formulations, active pharmaceutical ingredients and analytical methods. Pfizer said it has invested ₹150 crore ($20 million) on…
Remote clinical trial monitoring uptake rises but validation questions swirl
DCT Adoption Tracker: Clinical Trials Arena reviews the burgeoning trend on remote monitoring and look into regulatory know-how needed to ensure success. Wearables can be a value-added aspect to data collection in clinical trials, to complement electronic Patient Reported Outcomes…
