FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.
The FDA approved UCB’s Rystiggo for treating generalized myasthenia gravis. Drugs are already available for the rare neuromuscular disorder, but Rystiggo’s approval includes treatment of a subset of patients not addressed by other products.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Eli Lilly is paying $40 million up front for rights to a Confo Therapeutics drug in Phase 1 testing as a potential treatment for neuropathic pain. Confo develops drugs that target G-protein coupled receptors.
The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.
Celyad Ocology has voluntarily paused a clinical study evaluating its off-the-shelf CAR T-cell therapy in colorectal cancer following the report of two patient deaths. The investigation is ongoing, but the company said that both patients exhibited “similar pulmonary findings.”
Epilepsy is a small part of UCB’s neurology pipeline, but its proposed Zogenix acquisition would broaden the Belgium-based drugmaker's ability to address that market. Zogenix’s Fintepla is approved in the U.S. and Europe for a rare type of epilepsy called Dravet syndrome, and is in development for other rare epilepsies.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
GlaxoSmithKline is paying iTeos Therapeutics $625 million up front to share in the development of an antibody that targets the TIGIT protein, a hot target in cancer immunotherapy R&D. The deal comes less than a month after rival Bristol Myers Squibb inked its own deal securing rights to a TIGIT-targeting Agenus drug.
The Belgian drugmaker will use Accenture's INTIENT Pharmacovigilance to monitor the safety of its drugs, including those that are on the market and in clinical trials. Germany's Bayer inked a similar deal with Genpact last year.
Results of the BE VIVID study showed that UCB's bimekizumab showed a statistically significant improvement in skin clearance compared with J&J's Stelara and placebo.
The Brussels-based drugmaker said the acquisition of Ra would boost its potential for leadership in the autoimmune disease myasthenia gravis, as both companies have drugs in Phase III development for it.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Several patients in the trial of CYAD-101 combined with chemotherapy responded to treatment, but both a company executive and a gastrointestinal cancer expert cautioned the data were too preliminary to draw conclusions.
The agreement would have allowed UK pharmaceutical regulations to remain under EMA authority after Brexit. Uncertainty around the planned withdrawal has caused worry in the life sciences sector.
The unassuming llama may be the star of a new $75 million initial public offering, announced Monday by the Netherlands and Belgium-based biotech argenx.
Currently in the U.S., six types of phthalates have been banned from use in children's toys for health risks, but they are still present in so many of the devices that are designed to be flexible or pliable.
LindaCare is a health IT startup developing remote monitoring tools aimed at minimizing alert fatigue for hospitals.