Gilead Sciences Inc and Galapagos NV have dropped plans to make a new submission in the US for their small molecule drug Jyseleca (filgotinib) in rheumatoid arthritis (RA) following a meeting with the Food and Drug Administration. The parties discussed the points raised in the agency’s complete response letter in August in which it refused to approve the drug because of concerns about its benefit/risk profile at a dose of 200 mg.
Hemab ApS, a new company led by scientists with experience in haemophilia drug development, has been launched in Copenhagen, Denmark to develop bispecific antibodies for treating rare bleeding disorders. The company was incubated by Novo Seeds, the early-stage investment arm of Novo Holdings A/S. The size of the seed funding was not disclosed.
Johan Faber and Søren Bjørn, formerly with Novo Nordisk A/S, are the company’s founders, having previously been involved in research and development for new haemophilia drugs. Mr Faber is also the company’s chief executive officer.
AstraZeneca Plc is to acquire the US specialty pharmaceutical company Alexion Pharmaceuticals Inc for $39 billion – at once giving it five marketed drugs and more than 20 development programmes for rare diseases and immunology. The cash and share offer will be paid in part with an underwritten bridge-financing facility. The transaction is expected to close in the third quarter of 2021 and be immediately earnings accretive.
Evotec SE and the service group Sartorius AG are taking a controlling stake in a new German company, Curexsys GmbH, in order to support the emerging science of therapeutic exosomes. Exosomes are small vesicles that transfer proteins and nucleic acids from one cell to another. Researchers have shown that exosomes can be engineered to contain drugs, something that is being exploited by a growing number of biotech companies.
The US has become the second western country to give an emergency use authorisation to a Covid-19 vaccine developed by BioNTech SE in partnership with Pfizer Inc. The vaccine, BNT162b2, is based on messenger RNA (mRNA), a technology never before used in a human vaccine. It was given an emergency authorisation by the Food and Drug Administration on 11 December for individuals 16 years and over.
Sanofi SA and its partner GlaxoSmithKline Plc are to test a new antigen formulation for their Covid-19 vaccine in order to generate a better response from older adults. Assuming all data are positive, the vaccine would be available in the 2021 fourth quarter rather than mid-2021, the companies announced on 11 December 2020.
Boehringer Ingelheim GmbH is to pay €1.18 billion to acquire NBE-Therapeutics GmbH, a Swiss developer of antibody-drug conjugates (ADCs), in order to expand its portfolio of drugs targeting difficult-to-treat solid tumours. NBE-Therapeutics’ lead compound NBE-002 is currently in Phase 1 clinical studies for triple negative breast cancer, an aggressive form of breast cancer with limited treatment options.
Forbion Capital Partners of the Netherlands has secured €460 million for an oversubscribed fifth fund, the proceeds of which will be used to build a portfolio of 15 companies developing new medical therapeutics. About 80% of the investments are expected to be made in Europe, with the balance targeting assets in North America.
Astra Zeneca Plc has announced the publication on 8 December of interim Phase 3 data of a Covid-19 vaccine that it is developing with the University of Oxford in The Lancet. The interim analysis for efficacy and safety, as outlined in the article, are in line with previous disclosures, the company said.
An estimated 44% of patients with advanced lymphoma are still alive four years after receiving a single infusion of Yescarta (axicabtagene ciloleucel) for their disease. The new long-term survival data were presented by Gilead Sciences Inc at the annual meeting of the American Society of Hematology (ASH), further illustrating the efficacy of the chimeric antigen receptor (CAR) T cell therapy class.