Less than a month after would-be competitor DBV Technologies SA suffered a regulatory setback with its peanut allergy patch candidate, Aimmune Therapeutics Inc. – which at the start of the year gained FDA clearance for Palforzia in the same space – is undergoing an all-cash takeover valued at $2.6 billion by Nestle SA unit Nestle Health Science SA. Read More
Times have changed at Ionis Pharmaceuticals Inc. since it spun out Akcea Therapeutics Inc. in 2015. The company’s evolution is such that Ionis is now ready to bring Akcea back into the fold by acquiring the remaining 24% of its affiliate. Read More
It has proved to be a lackluster summer for the biopharmaceutical sector, with the BioWorld Biopharmaceutical index dropping about 2% in value during the past two months, in contrast to the general markets that have enjoyed a much stronger period. Read More
In a bid to build public confidence and demonstrate its transparency in determinations about potential COVID-19 vaccines, the FDA will convene its Vaccine Advisory Committee for a virtual meeting Oct. 22 to discuss the general development of the vaccines for the U.S. market. Read More
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo. Read More
DUBLIN – Shares in Polyphor AG gained as much as 12% during early trading Aug. 31 on news of a deal in China for its lead drug, balixafortide, which is currently undergoing a phase III trial in HER2-negative locally recurrent or metastatic breast cancer. Read More
The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair. Read More
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd. has launched a subcutaneous injection of Enspryng (satralizumab) in Japan to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica (NMO). Read More
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity. Read More
BioWorld looks at translational medicine: Researchers at Emory University have gained new insights into how exercise confers stress resilience. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society of Cardiology Congress 2020, including: Akcea, Amarin, Amgen, Arrowhead, Astrazeneca, Boehringer, Innovent, Lilly, Myokardia, Novartis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Can-Fite, Cormedix, Cstone, FDS, Gilead, Lipocine, Mustang, Omeros, Oncopeptides, Revive, Sound, Spero, Velosbio, Xortx. Read More
