Belgium
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In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases
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.
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UCB Muscle Disease Drug Wins FDA Nod on Heels of Rival’s Regulatory Approval
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.
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Eli Lilly Places a Small Bet on Confo’s Early-Stage, Non-Opioid Pain Drug
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.
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UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug
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.
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Two fatalities lead Celyad to pause test of off-the-shelf CAR T in colorectal cancer
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.”
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UCB is expanding its reach in epilepsy with $1.9B Zogenix acquisition
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.
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GSK joins chase for hot cancer target, paying iTeos $625M in new alliance
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.
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Artificial Intelligence, BioPharma
Belgium’s UCB to incorporate Accenture’s AI tech into pharmacovigilance efforts
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.
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UCB psoriasis drug beats J&J’s second top-selling product in Phase III study
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.
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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UCB to acquire Ra Pharmaceuticals for $2.1B
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.
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May postpones vote on Brexit agreement that pharma sector had supported
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.
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NASDAQ bound: Argenx eyes a $75 million IPO
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.
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Phthalates, chemicals used in some medical devices, could be creating attention deficit in children
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.
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Remote monitoring startup for cardiac implant patients raises $1.6M
LindaCare is a health IT startup developing remote monitoring tools aimed at minimizing alert fatigue for hospitals.