FDA approval of Ascendis Pharma’s Yorvipath is just in time for patients with hypoparathyroidism as Takeda Pharmaceutical will soon stop making the only drug therapy for the rare disorder. But competition could come from others, including an AstraZeneca peptide in late-stage development.
Orbis Medicines is developing macrocyclic peptides that address a wider range of targets and can be taken as oral pills. Novo Holdings and Forbion are backing the startup, which is based on research from the scientific co-founder of peptide drug developer Bicycle Therapeutics.
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Novo Nordisk is expanding its cardiometabolic drug pipeline with the acquisition of Embark Biotech, a startup developing drugs for a novel target that can suppress appetite and boost calorie burning in cells. Embark’s science comes University of Copenhagen research on a novel fat cell target.
Hemab Therapeutics will apply its Series B financing toward clinical development of its lead drug candidate, a potential treatment for Glanzmann thrombasthenia. The capital will also support the rest its pipeline addressing rare bleeding and thrombotic diseases with no approved therapies.
Evotec is an old player in the life sciences, but in offering new shares on the Nasdaq, the Germany-based company plans to bolster its new biologics manufacturing capabilities in the U.S and Europe. In other stock market debuts, IO Biotech’s IPO raised $100 million as it prepares a pivotal test of its lead cancer immunotherapy.
The Seagen and Genmab antibody drug conjugate (ADC), named Tivdak, is approved to treat cases of cervical cancer that have returned or spread following treatment with chemotherapy. Tivdak is Seagen’s third ADC; for Genmab, the drug will become its first commercialized product.
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Orphazyme’s corporate restructuring comes less than two weeks after the FDA rejected arimoclomol, a drug developed to treat the rare Niemann-Pick disease type C. The company said it is now focused on securing regulatory approval in Europe and finding a path forward for the small molecule with the FDA.
The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.
The deal, which includes a hefty $750 million upfront payment to Genmab, focuses on bispecific antibodies and also a drug discovery research partnership.
The agency announced the approval of Bavarian Nordic's Jynneos. A 2003 outbreak in the Midwest marked the first time monkeypox was found outside of its native Africa. Smallpox has been eradicated, but bioterrorism concerns remain.
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The company, whose FDA-approved products include the myeloma drug Darzalex and the chronic leukemia drug Arzerra, hopes to launch its own proprietary product by 2025.
LEO Pharma, which has had a primary focus on skin conditions like psoriasis, has launched its new Innovation Lab to further explore treatment options that don't involve medication.
It’s no secret that big pharma has been getting leaner, with companies buying and selling businesses to play to their strengths. Novo Nordisk‘s plans to spin off its IT solutions business, NNIT, fits that pattern too. Although it announced intentions to review this option earlier this year, a few different press organizations, including Reuters, have […]