Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia. Read More
The FDA's Antimicrobial Drugs Advisory Committee backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR. Read More
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully-human BCMA CAR T for treating relapsed or refractory multiple myeloma. Read More
While other industries have completely modernized the way they manufacture their products, the biopharma industry, in large part, is stuck in the "this is how we've always done it" mode. Read More
DUBLIN – Amarna Therapeutics BV raised €10 million (US$11.1 million) in new financing to move its SV40-based gene therapy platform, SVac, toward the clinic. Read More
HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN). But, while the Seoul-based company, formerly known as Viromed, said VM-202 met the primary safety and secondary efficacy endpoints for a DPN therapy at 12 months, investors are doubting that the results are trustworthy. Read More
Petagene Ltd., of Cambridge, U.K., said its Petasuite software has been selected to compress the genomics datasets for Cambridge, U.K.-based Astrazeneca plc's Centre for Genomics Research (CGR). To date, the center has processed more than 200,000 genomics datasets, generating over a petabyte of data. The compression software will enable the CGR to compress more than 200,000 BAM files in a 24-hour period and will add the compressed data to tiered cloud storage. Read More
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, sold about 2.3 million common shares at a weighted average price of $6.40 each under its previously announced open sales agreement, which grossed the company approximately $15 million. At this time, Aurinia doesn't have plans to sell more shares in the at-the-market offering. Read More
The FDA continues to break records in approving generics to ramp up competition in the U.S. drug market. In fiscal 2019, the agency approved 1,171 generic drug approvals – 935 full approvals and 236 tentative approvals. That breaks fiscal 2018's record of 971 approvals, Acting FDA Commissioner Ned Sharpless said. The 2019 approvals included 125 applications for first generics of drugs that had no generic competition. Read More
With Alexion Pharmaceuticals Inc.'s acquisition of Achillion Pharmaceuticals Inc. for about $930 million up front, Alexion expands and diversifies its pipeline into familiar territory – treating complement-mediated diseases. Blue Bell, Pa.-based Achillion is developing oral, small-molecule factor D inhibitors for treating complement alternative pathway-mediated rare diseases, including paroxysmal nocturnal hemoglobinuria and C3 glomerulopathy. Read More
