A new U.S.-China drug discovery deal focused on developing bispecific therapies for cancer could bring Woburn, Mass.-based Abpro Therapeutics Inc. as much $4 billion, including $60 million in near-term R&D funding from its Chinese partner, NJCTTQ, a subsidiary of Nanjing Chia Tai Tianqing Pharmaceutical Group Co. Ltd. Outside of China and Thailand, Abpro will retain all commercial rights for any approved molecules, while NJCTTQ will retain rights in China. Read More
Novavax Inc. execs tried to shift the focus to promising secondary and exploratory endpoint data showing efficacy of its Resvax respiratory syncytial virus (RSV) vaccine on the severe impacts of RSV infection, but Wall Street refused to be diverted Thursday, sending company shares (NASDAQ:NVAX) to a 52-week low on news of the primary endpoint miss in the phase III Prepare maternal immunization study. Read More
The dataset that emerged from Dublin-based Horizon Pharma plc's phase III trial with teprotumumab for active thyroid eye disease (TED) is "not just OK – it's amazing," said Raymond Douglas, co-principal investigator in the phase II and phase III programs with the compound. Read More
The five-week government shutdown that ended earlier this month was "the most difficult operational challenge we have faced in modern times," FDA Commissioner Scott Gottlieb told a House Appropriations subcommittee Wednesday. Read More
Centogene AG is teaming up with Sarepta Therapeutics Inc., of Cambridge, Mass., to identify patients with Duchenne muscular dystrophy (DMD) in the Middle East and North Africa region. As part of the collaboration, Rostock, Germany-based Centogene will perform complete molecular diagnostic testing, as well as provide diagnostic services to physicians treating patients exhibiting symptoms related to DMD. Read More
HYDERABAD, India – Indian pharma companies have started taking baby steps toward using data analytics and artificial intelligence in drug discovery and development, joining a global trend of pharma companies embracing digital and cloud technologies. But those efforts are still ad-hoc and experimental. Read More
Startup Rani Therapeutics LLC has gotten positive safety results in a first-in-human trial of its pill that's designed to enable painless injections of biologic drugs into the small intestine. Later this year, the San Jose, Calif.-based company plans to start a clinical trial with the robotic pill that includes a drug-filled resorbable needle – the initial safety test was without any drug. Read More
Gain Therapeutics SA, of Lugano, Switzerland, said it received funding support from The Michael J. Fox Foundation for Parkinson's Research and The Silverstein Foundation for Parkinson's with GBA to advance its noncompetitive molecular chaperones for Parkinson's disease. The grant support recognizes the company's therapeutic approach for Parkinson's with mutations in the glucocerebrosidase (GBA) gene. Read More
The FDA warned Canarx Services Inc. this week that if it doesn't cease its business practice of supplying misbranded drugs to people in the U.S., it could face seizure or an injunction. Read More
Pacira Pharmaceuticals Inc., of Parsippany, N.J., reported fourth-quarter GAAP net income of $8.3 million, or 20 cents per diluted share, and full-year 2018 GAAP net loss of $500,000, or 1 cent per basic and diluted share, on fourth-quarter Exparel (bupivacaine extended release) net sales of $94.4 million – a 20 percent increase over $78.7 million in the same period in 2017 – and full-year 2018 net sales of $331.1 million, a 17 percent increase over $282.9 million reported in 2017. Read More
Kaleido Biosciences Inc., of Lexington, Mass., priced its IPO of 5 million shares at $15, $5 below the low end of its intended range, to raise $75 million. Kaleido granted underwriters a 30-day option to purchase up to 750,000 additional shares, potentially adding $11.25 million. Read More
