Under an agreement with Zumutor, Catalent Biologics initiates clinical manufacture of the latter’s lead candidate targeting solid tumors, ahead of FDA filing.
Aiming to facilitate and accelerate discovery of biologics, Aridis’ Apex platform can also discover antibodies against viruses ‘within one day of a pandemic’.
Almirall enters drug discovery agreement with WuXi Biologics, gaining access to the WuXiBody platform to develop antibodies for the treatment of dermatological diseases.
US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.
Lonza already manufacturers three out of five commercially available ADCs but is preparing for additional demand with a two-year expansion project at its Visp site.
Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.
WuXi Biologics expands its biologics conjugation solution center to include space for commercial manufacturing of antibody-drug conjugates for the biopharma industry.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Harbour BioMed and an unnamed ‘leader’ in immunology enter license agreement to develop, discover, and commercialize biologic therapeutics using the former’s transgenic mouse platform.
Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
As technology has advanced, rare diseases have been met with therapies that target the cause of the condition, enabling the global market for orphan drugs to reach an expected $262bn by 2024.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.
ABL will use WuXi’s platforms in an extended agreement for the development and commercialization of its bispecific antibodies, using the recently launched WuXiBody platform.
Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.
AbbVie and Teneobio enter an agreement to develop and commercialize an immunotherapeutic for the treatment of multiple myeloma using the latter’s proprietary anti-CD3 platform.
Reaching the central nervous system is a difficult task, and getting a high enough dose to it poses an issue as well, but innovations are well underway to bridge a path across the blood-brain barrier.
How to best safeguard the biopharmaceutical supply chain? What more can be done to reduce the cost of medicines? This and more was discussed at the Annual bioProcess UK Conference this week in Scotland.
Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
Lonza Pharma & Biotech will expand two of its manufacturing sites to reach the capabilities necessary to produce compounds bio-conjugates through to commercialization.
Daiichi Sankyo announced it has entered into a clinical trial collaboration agreement with Merck & Co. to evaluate an investigational lung cancer treatment.
Sanofi has awarded Meditope Biosciences a BioLabs’ “Golden Ticket” to support the development of its bioconjugation platform and create new antibody-based therapeutic constructs.
