With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
Microbiome specialist Enterobiotix Ltd. has raised £27 million (US$34.2 million) in a series B round as it starts a phase II trial of EBX-102-02 in the treatment of irritable bowel syndrome.
Investors might not have been overly excited, but Genmab A/S executives enthused about the “complementarity” of its proposed acquisition of antibody-drug conjugate (ADC) specialist Profoundbio Inc. for $1.8 billion in cash. The deal, expected to close in the first half of 2024, marks the biggest by far for the Copenhagen, Denmark-based biopharma and the latest transaction for the red hot ADC space.
Addex Therapeutics has offloaded its portfolio of preclinical allosteric modulation drugs into Neurosterix, a new company that arrives on the scene with a $63 million series A round.
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.
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