The German mRNA giant BioNTech has sealed a pact worth up to $1 billion with Biotheus to develop the Chinese biotech company’s bispecific antibody cancer drug PM8002 in all territories except for Greater China.
Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells...
Merck will acquire Prometheus Biosciences, a San Diego biotech working on a precision medicine approach for developing therapeutics for the treatment of immune-mediated diseases.
InflaRx’s Gohibic (vilobelimab), a monoclonal anti-human complement factor C5a antibody, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.
BioNTech and OncoC4 have announced a worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications....
Releasing the first global Phase 3 data for crovalimab, Roche highlights the potential for 'robust disease control with less frequent treatment intervals'.
The project is the first phase of a wider strategic initiative to expand capacity and enhance end-to-end biologics development and manufacturing services at the US CDMO.
Thermo Fisher Scientific will provide biologic manufacturing capabilities and scale-up capacity to manage clinical supply of eblasakimab for future Phase 3 studies.
Roche announced yesterday that Phase 3 studies for its Alzheimer’s drug gantenerumab failed to meet the primary endpoint of slowing clinical decline. Although disappointed, Alzheimer’s associations are hopeful there is still a lot that can be learned...
One dose of an antibody drug protected from malaria infection during the malaria season in Mali, showing up to 88% effectiveness: demonstrating for the first time that a monoclonal antibody can prevent malaria in an endemic region.
Biogen has started a global Phase 2/3 study for litifilimab, a humanized IgG1 monoclonal antibody (mAb), in participants with cutaneous lupus erythematosus (CLE).
Biotimize has announced the opening of a $30m Series A fundraising round: with the investment set to enable Biotimize to build the first biological CDMO in Brazil and to become the first end-to-end biological CDMO in South America.
Process intensification is the natural next step for the biopharma industry as it transitions from a focus on global blockbuster drugs to a diversified portfolio of specialized biopharmaceuticals, finds a study.
The compelling benefits of single-use technologies (SUT) have been demonstrated in bioprocessing for many years. They are deemed to have a role to play in facilitating process intensification through enabling low capital costs and fast change-over time...
The World Health Organization (WHO) has published its first guidelines for Ebola virus disease therapeutics, issuing ‘strong recommendations’ for the use of two monoclonal antibodies.
Regeneron Pharmaceuticals will purchase Sanofi's stake in their collaboration on Libtayo (cemiplimab) for an upfront payment of $900m, giving Regeneron exclusive worldwide rights to the medicine.
RQ Biotechnology is launching as a new UK-based biotech: following the completion of a successful licensing deal with AstraZeneca for early-stage monoclonal antibodies targeted against SARS-CoV-2.
In a simulation model, lecanemab treatment was estimated to potentially slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of mild cognitive impairment (MCI) due to early AD.
Sanofi and Blackstone today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences will contribute up to €300m ($329m) to accelerate development for subcutaneous formulation and delivery of anti-CD38 antibody...
Alexion, AstraZeneca’s Rare Disease group, has closed an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
Alexion, AstraZeneca’s Rare Disease group, has entered into an exclusive global collaboration and licence agreement with Neurimmune AG for NI006, an investigational human monoclonal antibody currently in Phase Ib development for the treatment of transthyretin...
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
The European Commission has extended the marketing authorisation for Actemra/RoActemra (tocilizumab) to include the treatment of severe COVID-19 in adults.
Chinook Therapeutics, Inc. has announced the formation of SanReno Therapeutics - a joint venture with an investor syndicate led by Frazier Healthcare Partners and Pivotal bioVenture Partners China - to develop, manufacture and commercialize kidney disease...
CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drug delivery systems for newly developed biologics along with medical and diagnostic products.
Construction of Samsung Biologics’ new facility is on track, with the CDMO saying pre-sales activities are ongoing for Plant 4, as it is known, despite the challenging business environment amid the COVID-19 pandemic.
Waters has announced a five-year investment to develop new analytical technology for bioprocessing and biomanufacturing with the University of Delaware.
Boehringer Ingelheim has inaugurated a state-of-the-art biopharmaceutical production facility in Vienna, Austria: representing the single largest investment in the company’s history.
AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis.
Eli Lilly and Company and Banner Alzheimer’s Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimer’s disease.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Augmenta Bioworks and TFF Pharmaceuticals Inc have selected their first lead monoclonal antibody (mAb) for clinical development against COVID-19 as part of their collaborative alliance.
A Phase 3 study of BAT1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), has shown equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.
French pharma services provider, Clean Biologics, has acquired Canadian CDMO, Biodextris, in a move it says will boost its analytical and process development, and early-phase clinical manufacturing and quality control testing services for clients in the...
US pharma group, Lilly, has requested the US FDA revoke the Emergency Use Authorization (EUA) for bamlanivimab 700 mg alone due to the evolving variant landscape in the US.
The European Medicines Agency (EMA) concludes that Celltrion’s monoclonal antibody, regdanvimab, can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.
GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.
In 2020, GSK and Vir Biotechnology partnered to research and develop therapies for coronaviruses. This agreement has now been extended to include new therapies for influenza and other respiratory viruses, with GSK investing $345m in the extended partnership.