A judge has ruled in favour of AbbVie, finding that Boehringer should disclose its US launch plans for its Humira biosimilar if it wants to prove patent protection inhibited its commercial release.
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.
GE announced a change of plans regarding its GE Healthcare business, choosing to sell off the BioPharma business for $21.4bn rather than initiate an IPO.
Celltrion Healthcare’s head of medical and marketing outlines how the US biosimilar market is evolving and how manufacturing efficiency could become a key distinguisher from competitors.
In its full-year financials, Novartis announced plans to transform its cell therapy manufacturing process through greater investment and utilisation of digital technologies.
In addition to the $55m previously invested, Novartis will spend a further $60m in expanding AveXis’ site in North Carolina enabling the manufacture of multiple gene therapies simultaneously.
The WHO establishes a multi-disciplinary committee to advise on the ethical and scientific challenges of human genome editing, as the technology’s capability and utilization grows in the industry.
Oxford Genetics and Sphere Fluidics to partner, alongside additional biopharma organizations, to develop automated systems for high-throughput gene editing in mammalian cell lines.
Pfizer’s Zirabev receives approval from the European Commission as a biosimilar to Roche’s Avastin, which brought in sales of CHF1.8bn in Europe during 2018.
Health Canada opts not to include the additional suffix after biologics’ non-proprietary name, instead relying on the brand name and products’ identification number.
In full-year financials, AstraZeneca announced that its R&D arm, MedImmune, will be absorbed into the overall company as it restructures its R&D units into specific therapy areas.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
While last month saw many pharma executives leaving their positions to head towards smaller biotech companies, this month saw members of the industry climbing the ladder from various different starting points.
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.
The US market for insulin biosimilars is set to open up in 2020, and the head of biopharmaceuticals at Sandoz explained why he is confident of an ‘acceleration’ of the US biosimilar market in the coming years.
ICT is developing upon CAR-T cell technology to enable T-cells to persist against cancer’s attempt to program death into a patient’s defensive T-cells, which could potentially treat solid tumors.
Renaissance BioScience enters a partnership with Mitacs to test its yeast-based, RNAi production platform for biocontrol and biotherapeutics applications.
NICE recommends CAR T-cell treatment Kymirah to be covered by the Cancer Drugs Fund to treat adult patients with lymphoma, despite previous negative appraisals.
Fujifilm Diosynth announces the inception of its FDB center of excellence in bioprocessing 2.0 to extend its bioprocessing innovations with a network of researchers.
Active competition law enforcement is encouraging the pharmaceutical industry to provide more affordable medicines and promotes innovation, suggests EC report.