Coming out of the IPO gate strong was Lausanne, Switzerland-based ADC Therapeutics SA, which priced about 12 million shares at $19 each, for gross proceeds of about $232.7 million in an upsized deal. Shares (NYSE:ADCT) ended the day at $29.65, up $10.65, or 56%. Read More
A new phase IIb readout at odds with earlier data suggesting PTI-125 would diminish key biomarkers of neuroinflammation and neurodegeneration in Alzheimer’s patients has left Cassava Biosciences Inc. President and CEO Remi Barbier looking for answers. Read More
DUBLIN – Affibody AB is getting $10 million up front and up to $215.5 million in regulatory and sales milestones from a licensing deal with Inmagene Biopharmaceuticals Co. Ltd., in which the latter firm gains commercial rights to its interleukin-17 inhibitor ABY-035 in China, Hong Kong, Taiwan, Macau and South Korea. Read More
HONG KONG – France’s Sanofi SA has informed Hanmi Pharmaceuticals Co. Ltd. of its intention to return all the rights to efpeglenatide, the South Korean company’s diabetes drug candidate. Read More
So far, the excitement surrounding “living drugs” is that of pioneer work, with the Carl June and Steve Rosenberg playing the roles of Lewis and Clark or the Wright brothers. Read More
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s (NMPA) nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM. Read More
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date. Read More
HONG KONG – Blockchain technology usually is associated with digital currencies. However, it’s now emerging as an important platform for COVID-19 management. It’s been a focus in China, where a top-down approach is key to driving sectors and technology. Read More
BioWorld looks at translational medicine, including: Acid test for therapeutic peptides; Designer proteins for RSV vaccine; Subdividing and conquering PDAC; The world according to GARP; Cell competition links hyperinsulinemia to cancer. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Blueprint, BMS, Can-Fite, Clovis, Deciphera, Kancera, Leading Biosciences, Neuraptive, Seelos. Read More
While a significant number of clinical trial delays occurred during the month of April, it was business as usual from a regulatory standpoint for companies with late-stage therapies ready for the market and for those targeting underserved patient populations. Read More