Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.
Swiss-headquartered Novartis Pharmaceuticals plans to add 40 positions to its manufacturing facility in Morris Plains, New Jersey, to focus on cell therapies.
An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.
LSNE Contract Manufacturing has signed a manufacturing supply agreement with Selecta Biosciences, Inc. through which the CDMO will advance Selecta’s lead candidate, SEL-212.
Its new Singapore single-use plant is a fraction of the size of a conventional commercial facility but next-generation biomanufacturing at Amgen points to even smaller, more integrated sites.
Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.
Sartorius Stedim Biotech (SSB) has announced it will combine technologies with US-based cell culture analysers Nova Biomedical, as a result of increased customer demand.
Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.
Dr Reddy’s will expand its biosimilar manufacturing capacity in Hyderabad by 4,000L using GE Healthcare’s FlexFactory platform based on single-use technologies.
Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).
Thermo Fisher says Patheon will become the most competitive biologics CDMO in the market through direct access to its bioprocessing technologies and capabalities.
Long life-cycles and significant consolidation in the manufacturing space have led to a lack of skilled workers in the vaccine space, says Sanofi Pasteur.
Stelis Biopharma has partnered with Germany’s Merck on a bioprocessing services centre in Bangalore and says single-use systems could kickstart India’s biomanufacturing sector.
Takeda has teamed up with GammaDelta Therapeutics to develop novel T-cell-based therapies in a deal that includes an option to buy the year-old UK biotech.
Avantor has agreed to purchase independent laboratory product, supply chain and service provider VWR for approximately $6.4bn (€5.9bn), reflecting a share price of $33.25.
Integrating single-use, automation and continuous processing equipment will be the future for bioproduction says Thermo Fisher acquisition Finesse Solution.
Eli Lilly has confirmed it will build a three-story biomanufacturing facility at its site in Kinsale three months after rumours the project had been put on hold.
The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.
A WuXi Biologics facility tipped to be the world’s largest single-use mammalian cell culture site will be equipped with disposable systems from Thermo Fisher.
A second single-use production line could offer commercial-scale capacity for bispecific antibodies but Glenmark says it would need to scale-up further to support more traditional biologics.
Biologics contracting drove growth in fiscal Q3 according to Catalent, which predicted the proportion of revenue it generates from large molecule work will continue to increase.
Shire has begun adding capability within its own network to manufacture the Hereditary Angioedema (HAE) product Cinryze, currently being made by Dutch CMO Sanquin.
Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.
update - WHO outlines biosimilarity requirements and inspection plan
The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.
Avid Bioservices will add multiple MilliporeSigma 2,000L bioreactors at its Californian single-use production plant in an effort to its increase annual revenue to over $100m.
Pall Corporation, GE Healthcare and LEWA Process Technologies showed off their latest downstream offerings to Biopharma-Reporter in Amsterdam last week.
The European Commission has urged UK Pharma firms to check how Brexit will impact their drugs, pointing out that EU law requires that authorisation holders have a base in a member state or EEA country.
An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.
