NHS England has struck new pricing agreements that expands access in the U.K. to blood thinning direct oral anticoagulants (DOACs) to tackle strokes in patients with atrial fibrillation. Though still available to NHS clinicians, Boehringer Ingelheim GmbH’s blockbuster DOAC Pradaxa (dabigatran) is notably not involved.
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.
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.
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.
A closely watched oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Britain after a conditional authorization by the U.K. Medicines and Healthcare products Regulatory Agency. Developed by Ridgeback Biotherapeutics Inc. and Merck & Co. Inc., the drug will be marketed as Lagevrio (molnupiravir) and made available via a national study this winter, the government said.
A more than 20-year uneasy biopharma romance between two Swiss giants will be ending as Novartis AG plans to sell its stake in Roche Holding AG back to Roche for about $20.7 billion. Roche described it as a “disentanglement of the two competitors” that will allow it to regain “full strategic flexibility.” Basel, Switzerland-based Novartis currently owns about one-third of Roche, whose shareholders get the final say-so when they vote yea or nay at the company’s Nov. 26 extraordinary general meeting. Novartis was very clear about how it views its stake in Roche, as the company said it “does not consider the financial investment in Roche as part of its core business and therefore not a strategic asset” and that it’s time to “monetize our investment.”
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