The U.S. FDA accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan to treat adults with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease.
Jumping in for the first time to the hot antibody-drug conjugate (ADC) space, Paris-based Ipsen SA pulled in exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc. in a deal worth up to $900 million. STRO-003, the first ADC to join Ipsen’s portfolio, contains an anti-ROR1 human IgG1 antibody (SP-11385) conjugated to an exatecan warhead, or payload.
Europe may still await its first disease-modifying Alzheimer’s drug after the EMA postponed its decision on Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd) on March 22, but leading members of the World Dementia Council were in an optimistic mood when they convened in London four days later.
In what co-founder and CEO Claudia Ulbrich called the “right decision with right partner at the right point in time,” Cardior Pharmaceuticals GmbH agreed to an acquisition by Novo Nordisk A/S in a deal worth up to €1.025 billion (US$1.1 billion) that puts a potentially disease-modifying heart failure candidate in the hands of a big pharma player in the midst of establishing its presence in cardiovascular disease.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
Serac Healthcare Ltd.’s imaging agent, 99m Tc-maraciclatide, enables visualization of early-stage endometriosis, preliminary data from a study presented last week at the Society for Reproductive Investigation conference in Vancouver demonstrated. With millions of women suffering from the debilitating condition globally, maraciclatide has the potential to not only help with diagnosis but also with the development of new therapeutics, David Hail, CEO of Serac, told BioWorld.
After months of wrangling, the update of the EU pharmaceutical legislation passed an important milestone on March 19, when members of parliament on the health committee reconciled their opposing views and voted the file through.
An MHRA investigation that began in the U.K. 16 years ago has concluded with Kamlesh Vaghjiani, a former director of Kappin Ltd., being sentenced to concurrent prison sentences of eight and seven months, both of which are suspended for a year and a half.
Precision psychiatry got some love at two quite different meetings this week, the European Congress of Neuropsychopharmacology’s New Frontiers meeting and BioEurope Spring. The New Frontiers Meeting, an annual two-day meeting dedicated to cutting-edge issues in brain disease research, focused on big-picture and scientific – at times almost philosophical – questions of how to get to a classification scheme for brain disorders that aligns with the underlying biology.
Aignostics GmbH has embarked on raising a €20-€30 million (US$21.74-$32.61 million) series B round after validating its artificial intelligence (AI)-driven precision oncology platform by signing a co-development deal with Bayer AG. This is the first pharma partnership for the Berlin, Germany-based company. Financial terms were not disclosed, but Aignostics will receive an up-front payment and is eligible to receive success-based milestone payments and royalties on any commercialized therapies that result from the collaboration.
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