As investors and big pharma pile on developers of antibody-drug conjugates (ADCs), Bright Peak Therapeutics has attracted $90 million based on the promise of a related type of technology called immunoconjugates.
The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Janssen’s CARVYKTI (cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).
The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).
The antibody drug nipocalimab, developed by the Janssen Pharmaceutical...
The FDA recently granted approval for Johnson & Johnson’s (J&J) Akeega, a novel first-in-class combination tablet treatment for adults with breast cancer gene (BRCA)-positive, metastatic castration-resistant prostate cancer (mCRPC).
Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted approval by the European Commission (EC) for use in certain patients with relapsed or refractory multiple myeloma (RRMM).
Janssen Pharmaceuticals has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Talvey (talquetamab).
Johnson and Johnson (J&J) recently granted permission to Stop TB Partnership to distribute its generic TB drug bedaquiline (SIRTURO) to the majority of low- and middle-income countries.
Janssen Biotech has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies....
Evotec has entered into a strategic collaboration and licence agreement with Janssen Biotech: with the partnership focusing on developing targeted immune-based therapies for oncology.
Janssen’s experimental HIV vaccine regimen was found to be safe but ineffective in the Phase 3 Mosaico clinical trial: and as a result the company is discontinuing the study.
Johnson & Johnson (J&J) has officially informed Emergent BioSolutions Inc of its decision to terminate its agreement with the contract manufacturer in relation to the pharma group’s COVID-19 vaccine.
Johnson & Johnson has announced its intent to separate its Consumer Health business into a new publicly traded company: allowing J&J to put a sharpened focus on pharmaceuticals and medical devices.
Johnson & Johnson has announced results from the primary analysis of its Imbokodo Phase 2b HIV vaccine clinical trial, with data showing the investigational HIV vaccine candidate did not provide sufficient protection against HIV infection. A Phase...
The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.
Emergent BioSolutions, a contract development and manufacturing organization (CDMO), has agreed with the US FDA not to manufacture any new COVID-19 vaccine materials at its Bayview facility in Baltimore, Maryland, while the regulator investigates the...
The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnson’s COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZeneca’s COVID-19 shot.
Emergent BioSolutions Inc yesterday reported that is on target in terms of all its commitments for COVID-19 vaccine production; it also reaffirmed its financial guidance, after a production issue at its Baltimore plant last week saw a massive batch of...
J&J will supply the African Vaccine Acquisition Trust (AVAT) with up to 220 million doses of its single-shot vaccine, with the potential to increase the order to a total of 400 million.
Merck’s US facilities will help manufacture Johnson & Johnson’s COVID-19 vaccine: which a $268.8m injection from the US government helping it adapt existing facilities for COVID-19 vaccines and medicines.
The FDA has outlined its analysis of Johnson & Johnson's single-shot COVID-19 vaccine, ahead of a meeting of the Vaccines and Related Biological Products Advisory Committee Meeting to assess the candidate's application for Emergency Use...
Locus Biosciences says the results of its early stage clinical trial for CRISPR-enhanced bacteriophage therapy shows its precision medicine asset is safe and well tolerated.
South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following...
J&J pledges to start shipping doses of its COVID-19 vaccine in the US as soon as Emergency Use Authorization (EUA) is received from the Food and Drug Administration, while it plans to apply for Conditional Marketing Authorization in the EU in the...
Johnson & Johnson intends to file for US Emergency Use Authorization (EUA) for its COVID-19 vaccine in early February, having reported the vaccine is 66% effective at preventing moderate to severe COVID-19.
Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciences’ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial is for a 1-dose regimen).
Johnson & Johnson says it is preparing to resume recruitment in its Phase 3 Janssen COVID-19 vaccine trial in the US: after the trial was paused because of an unexplained illness earlier this month.
Johnson & Johnson has paused dosing in all its COVID-19 vaccine candidate clinical trials – including its Phase 3 trial – due to an unexplained illness in a study participant.
A contract between the EU and Janssen Pharmaceutica NV will see Janssen supply 200 million doses of a COVID-19 vaccine, with the potential for an additional 200 million doses.
Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.
