News

The venture capital firm Forbion has announced a large financing for one of its portfolio companies, NewAmsterdam Pharma BV, which is planning Phase 3 development of a cholesterol lowering drug for patients who aren’t well controlled on statins. The oversubscribed €160 million Series A round was led by Forbion and co-led by Morningside Ventures and Ascendant BioCapital.

Sanofi SA is to acquire Kymab Ltd of the UK in order to gain full rights to a monoclonal antibody therapy, KY1005, with potential for treating a wide variety of immune-mediated and inflammatory disorders. The French pharma group is to pay $1.1 billion upfront for the company in addition to milestone payments of up to $350 million. The lead asset reported positive data from a Phase 2a study of patients with atopic dermatitis in August 2020. The same molecule is being studied in acute graft-vs-host disease and other immune disorders.

The European Commission has granted a conditional marketing authorisation for a Covid-19 vaccine developed by Moderna Inc based on clinical data showing an efficacy rate of 94.1%. The vaccine, COVID-19 Vaccine Moderna, is to be administered to people from 18 years of age. It is the second Covid-19 vaccine to be approved by the EU following a recommendation by the European Medicines Agency. The first was a vaccine developed by BioNTech SE and Pfizer Inc. Both vaccines are based on messenger RNA (mRNA) technology.

The US Food and Drug Administration has cautioned against altering the dosing regimen for Covid-19 vaccines launched on the US market, saying that any changes not supported by clinical trial data would be “concerning.” The agency specifically warned against using a single dose regimen and/or administering less than the dose studied in clinical trials.

Angelini Pharma of Italy has agreed to spend up to $960 million to acquire a two-year old Swiss company with rights to an antiepileptic drug for the treatment of partial-onset seizures. The target company, Arvelle Therapeutics GmbH, was launched in 2019 with start-up capital of $207.5 in order to bring the antiepileptic, cenobamate, to the European market.

Twist Bioscience Corp has announced plans to offer a new control that could be used to alter protocols for tests currently in use to diagnose SARS-CoV-2 in order to detect a variant strain of the virus in circulation in the UK and other countries. In a statement issued on 23 December, the company said the new synthetic RNA control should be available by 15 January 2021.

A Phase 3 study of a prospective asthma treatment failed to meet its primary endpoint even though a registration trial for the same drug had positive results. The developers, Amgen Inc and AstraZeneca Plc, said the discrepancy may be due to the design of the failed study, but a further analysis of the data is ongoing.

The US Food and Drug Administration has placed a clinical hold on uniQure NV’s gene therapy programme in haemophilia B following a possibly related serious adverse event, the company announced on 21 December. The hold affects the company’s pivotal Phase 3 study called HOPE-B which recently reported positive initial data at the annual meeting of the American Society of Hematology (ASH).

The Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc received a conditional marketing authorisation in the EU on 21 December – only hours after having been given a positive opinion by the European Medicines Agency.