A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.
PARIS – Bone 3D SAS has signed a partnership with Stratasys Ltd. to put 3D printing technology directly into the hands of all 3,000 French hospitals and their front-line medical professionals. This new service, called Hospifactory, makes it possible to leverage additive manufacturing to produce medical equipment and devices directly on site at the hospital.
A research report by global investment bank Jefferies has found increased investor optimism in the health care market amid COVID-19, with respondents expecting stocks to rise throughout 2022. The Jefferies Healthcare Temperature Check summarizes the views of 500 leaders across the health care sector. Sixty percent of respondents said they believed the MSCI World Health Care Index would be higher by the end of 2022 than at present.
LONDON – There’s not yet proof of the pudding, but Omass Therapeutics Ltd.’s new structure-based technology has passed a key test, in enabling the discovery of orally available small molecules aimed at intractable and poorly drugged membrane and complex-bound protein targets. The targets, including G protein-coupled receptors (GPCRs), intracellular protein complexes and solute carriers, are relevant to immunology indications and rare diseases with high unmet need.
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
The University of Oxford has begun recruiting for a phase I Ebola vaccine trial, with the first vaccinations based around the same technology as the university’s COVID-19 vaccine.
Given the negative response to a proposed amendment allowing the price of NHS-dispensed drugs to be listed on labeling, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has decided not to go forward with the policy, it announced Nov. 11.
LONDON – Intensive monitoring of health care workers at two hospitals in London showed that despite having a blood biomarker of infection, 58 of them did not test positive for COVID-19 at any point, suggesting they may have been clearing subclinical infections before seroconversion.
PARIS – Royal Philips NV has signed a deal to acquire Cardiologs Technologies SAS and its artificial intelligence technology. The financial terms surrounding the transaction have not been disclosed. The two companies expect to close the deal in the coming months.
LONDON – A pilot study has shown that whole genome sequencing can pinpoint the genetic causes of rare diseases, even in people who had previously not been given a diagnosis after undergoing sequencing of their protein coding exome.
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