News

EMA to analyse patient data

Thursday 14 July 2022
Country
Netherlands

As part of its strategy to incorporate big data into regulatory decision-making, the European Medicines Agency is to invite pharma companies to apply for a pilot project under which they would submit patient data from clinical trials as part of their marketing authorisation applications. The project is expected to start in September and last up to two years. It would cover about 10 regulatory procedures.

Second Covid-19 booster for the elderly

Monday 11 July 2022
Country
Netherlands

A second booster dose of one of the two messenger RNA (mRNA) vaccines approved in the EU for Covid-19 is being recommended for adults between the ages of 60 and 79 years. This is to protect against a new wave of infections caused by a variant of the SARS-CoV-2 virus. The recommendation was issued on 11 July by the European Centre for Disease Prevention and Control and the European Medicines Agency.

Meeting Report: Cell and gene therapy manufacture

Sunday 10 July 2022
Country
United Kingdom

It is often said that cell and gene therapies are a ‘process’ rather than typical drugs. This is based on the fact that their success depends on the quality of their starting materials and how they are manufactured. This could be an autologous chimeric antigen receptor (CAR) T cell-based gene therapy, or any one of the many allogeneic products in clinical development. Manufacturing is the key strategic issue for developers of these therapies, according to speakers at the On Helix annual meeting in Cambridge, UK on 7 July.

AZ to acquire TeneoTwo

Tuesday 5 July 2022
Country
United Kingdom

AstraZeneca Plc is to pay up to $1.27 billion to acquire the US company TeneoTwo Inc in a bid to strengthen its pipeline of medicines for haematologic malignancies. TeneoTwo’s portfolio features an early clinical stage T cell engager. These are bispecific antibody therapeutics which are engineered to redirect the immune system’s T cells to recognise and kill cancer cells.

NewAmsterdam outlicenses cholesterol drug

Tuesday 5 July 2022
Country
Netherlands

NewAmsterdam Pharma BV has secured a licensing deal for its lead drug, a cholesterol lowering agent for patients who aren’t well controlled on statins. The partner is the Menarini Group of Italy which already has a cardiology portfolio of 18 products and is prepared to pay up to €1 billion for rights to the new product candidate.

Oncogeni gets new owner

Tuesday 5 July 2022
Country
United Kingdom

Oncogeni Ltd, a company founded in 2019 by the British scientist and Nobel Laureate Martin Evans is to be acquired by Roquefort Therapeutics Plc in order to progress its preclinical assets for cancer. The all-share transaction, announced on 22 June, has been valued at around £4 million. Concurrently, the enlarged company will have two new investors: Daiichi Sankyo Co Ltd and the venture capital investor CH Health.

New home for F-star Therapeutics

Monday 4 July 2022
Country
United Kingdom

F-star Therapeutics Inc is to be acquired by a subsidiary of a large Chinese pharma group giving it a new setting in which to develop its bispecific antibodies for cancer. The acquirer is invoX Pharma, a subsidiary of Sino Biopharmaceutical Ltd which has a portfolio of small molecule drugs and biologics to treat cancer and other diseases.

Ipsen to acquire Epizyme

Monday 4 July 2022
Country
France

Ipsen SA is to expand its oncology portfolio with the acquisition of Epizyme Inc, a US developer of epigenetic medicines. Epizyme’s lead product, Tazverik (tazemetostat) has been approved for two cancer indications in the US – diseases that are not covered by Ipsen’s current portfolio.

NOXXON updates strategy

Friday 1 July 2022
Country
Germany

NOXXON Pharma NV has updated its drug development strategy in light of further positive data for its aptamer drug NOX-A12 in patients with glioblastoma. The company’s resources will now be fully deployed to advance NOX-A12 towards registration. Other research projects will be put on hold, the company announced on 23 June 2022.

VIVEbiotech expands viral vector capacity

Friday 1 July 2022
Country
Spain

Spain-based VIVEbiotech SL has received regulatory approval for an upgrade of its lentiviral vector manufacturing capacity that will significantly expand its ability to produce vectors for both in vivo and ex vivo gene therapies. The company currently has 40 programmes ongoing with four dedicated to in vivo administration.