News

AZ vaccine delivers 79% efficacy

Country
United Kingdom

The Astra Zeneca/Oxford University vaccine (AZD1222) has shown an efficacy rate of 79% in preventing symptomatic Covid-19 disease and 100% efficacy at preventing severe disease and hospitalisation, AstraZeneca announced on 22 March. The interim data come from a Phase 3 trial conducted in the US which enrolled 32,449 participants. Speaking to reporters, company executives said data from the trial will be filed shortly with the Food and Drug Administration with a view to gaining an emergency authorisation and starting US distribution soon thereafter.

EMA: Benefits of AZ vaccine outweigh risks

Country
Netherlands

The European Medicines Agency has concluded that the benefits of the AstraZeneca/Oxford University Covid-19 vaccine outweigh the risks despite a possible link to rare blood clots with low blood platelets. The statement was issued on 18 March following a meeting of the agency’s Pharmacovigilance Risk Assessment Committee.

Transformational year for MorphoSys

Country
Germany

MorphoSys AG saw a significant rise in revenue and liquidity in 2020 following the launch of its cancer drug Monjuvi (tafasitamab) in the US. Revenue was €327.7 million, up from €71.8 million in 2019. Liquidity at the end of the year amounted to €1.24 billion compared with €357.4 million at the end of 2019. Driving up revenue in the year were €18.5 million in sales of Monjuvi and royalty income of €42.5 million from Tremfya for plaque psoriasis. Tremfya was developed by Janssen Research & Development LLC using MorphoSys’ antibody technology.

Phase 3 trial of Libtayo stopped early on efficacy

Country
United States

A Phase 3 trial of the checkpoint inhibitor Libtayo (cemiplimab) is to be stopped early after showing an improved overall survival in patients with cervical cancer, reducing the risk of death by 31% compared with chemotherapy, Regeneron Pharmaceuticals Inc and Sanofi SA announced on 15 March. The companies plan regulatory submissions in 2021.

Canakinumab misses endpoint in lung cancer

Country
Switzerland

One of several clinical studies of canakinumab in non-small cell lung cancer has failed to meet its primary endpoint, but other studies in the programme are continuing, Novartis announced on 9 March 2021. Canakinumab is a monoclonal antibody designed to neutralise the bioactivity of human interleukin-1beta (IL-1beta). The Phase 3 CANOPY-2 trial, which was evaluating canakinumab in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival.

EU approves J&J vaccine for Covid-19

Country
Belgium

The European Commission has given a conditional marketing authorisation to the Covid-19 vaccine developed by Janssen Pharmaceutica NV following a positive scientific review by the European Medicines Agency. The decision, announced on 11 March, comes just under two weeks after the US gave the same vaccine an emergency use authorisation.

Meeting Report: The innovation curve is rising

Country
Switzerland

Innovation in the life sciences has increased dramatically in recent years creating a virtuous circle in which more money is coming into biotech and biotech is pioneering more new technologies. This was the conclusion of investment professionals and company executives speaking at the annual Sachs European Life Sciences Forum which took place on Zoom on 10 March.

Exscientia completes financing round

Country
United Kingdom

Exscientia Ltd has enlisted the support of one of the world’s largest asset managers, BlackRock Inc, to support its expansion in artificial intelligence-driven drug discovery. Funds managed by BlackRock joined the company’s Series C investment round in early March, bringing total proceeds to the UK company up to $100 million.

Spinal muscular atrophy drug recommended

Country
Netherlands

The European Medicines Agency is recommending approval of Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) – a rare and often fatal disease affecting neurons in the brain and spinal cord that control muscle movement. SMA is caused by mutations in the SMN1 gene that encodes for the survival motor neuron protein.

Merck withdraws lung cancer indication for Keytruda

Country
United States

Merck & Co Inc has voluntarily withdrawn the metastatic small cell lung cancer indication for Keytruda (pembrolizumab) following the results of a Phase 3 study which didn’t support the terms of its earlier accelerated approval from the US Food and Drug Administration. The FDA awards accelerated approvals to certain drugs, based on surrogate endpoints, but confirmation of clinical benefit needs to be verified in subsequent trials.

The decision doesn’t affect other indications for Keytruda, the company said.