DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33. Read More
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened. Read More
The importance of artificial intelligence and machine learning (AI/ML) has not been lost on drug development companies. Recently, to help accelerate the discovery of therapies to treat COVID-19, several deals have been established to help deploy those tools. Read More
Immatics Biotechnologies GmbH, of Tuebingen, Germany, and Arya Sciences Acquisition Corp. plan to merge as Immatics NV. Immatics will receive gross proceeds of up to $252 million at closing, which is expected in the second quarter of 2020. Read More
BEIJING – Biotech companies in China were among the first to experience disruptions in their operations and development plans from the COVID-19 outbreak, with employees unable to report to work and difficulties continuing trials. Read More
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China. Read More
Sen. Amy Klobuchar (D-Minn.) has posted new legislation that would bolster antitrust enforcement and deter anticompetitive behavior in the private sector, but the bill faces considerable opposition. Glenn Lammi of the Washington Legal Foundation told BioWorld that the legislation would blunt investment in the life sciences due to provisions that would make the possession of a patent an indication of legally actionable anticompetitive behavior. Read More
Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications. Read More
New hires and promotions in the biopharma industry, including: Achilles, Affimed, Atyr, Capricor, Curevac, Imcheck, Logicbio, Memgen, Morphic, Recursion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Abeona, Adial, Arch, Astrazeneca, Blueprint, Eton, Inventiva, Inxmed, Lattice, Merck, Oncosec, Provention, Recce, Surface Oncology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: DBV, Mallinckrodt. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Illumina, Sequenom, Roche, Boehringer Ingelheim, Mylan. Read More
