The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.
The Charles Stark Draper Laboratory Inc. has inked a three year partnership with Pfizer to create personalised versions of Draper’s Microphysiological Systems (MPS), for cheaper and more effective preclinical testing.
Catalent has partnered with US non-profit PATH for antibody discovery using the CDMO’s GPEx cell line platform, funded by PATH’s Malaria Vaccine Initiative (MVI).
Repligen has bought Novasep subsidiary TangenX Technology for $39m, adding single-use tangential flow filtration (TFF) cassettes to its downstream offering.
The new $50m facility will house 450 scientists in Rockville, Maryland to work across 12 vaccine development programmes, alongside the non-profit Biopreparedness organisation (BPO).
As the patent war over CRISPR gene editing technology continues, experts suggest a “one-stop” licensing alternative could help accelerate advances in new medicines.
bluebird bio Inc has hired apceth Biopharma GmbH to make its candidate ALD cell therapy Lenti-D and its thalassemia treatment LentiGlobin for the European market.
Bristol-Myers Squibb has announced plans to pull the plug on some US facilities and streamline construction and investment around “vibrant academic ecosystems”.
Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.
Avid Bioservices has reported strong contract manufacturing revenues for its Q2 and is confident a planned third facility will not leave the firm with too much capacity.
Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.
While in its early stages, the three-dimensional printing device enclosed in a disposable system could ensure sterile manufacturing of miniaturised organ models or even bioprocessing equipment parts, says Sartorius.
Acticor Biotech has made a deal with Merck KGaA’s CMO MilliporeSigma to use its Provantage End-to-End services to make its anti-thrombotic antibody fragment ACT-017 for stroke.
Sanofi, Merck & Co. and downstream technology firm Natrix have teamed to develop a chromatography system with a productivity level capable to enable a fully-integrated downstream platform.
Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.
Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.
Synthetic biology firm Synpromics will use its PromPT promoter platform to increase stability and reduce the lead time for Sartorius Stedim Cellca’s CHO expression platform.
A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.
Accinov has teamed up with Canadian clinical research organisation (CRO) Biodextris to provide a transatlantic biomanufacturing ‘plug and play’ service for biopharmaceuticals—with a particular expertise in vaccines.
Valitacell has moved into the National Institute for Bioprocessing Research and Training (NIBRT) as it works to further develop its cell performance technologies.
Arrowhead Pharmaceuticals Inc. has also laid off its Chief scientific officer David Lewis - as part of the 34 staff cull - after several trials using delivery vehicle Ex1 were stopped by the firm.
Long lead times and high barriers to entry will restrict competition in the vaccines market, leaving GSK, Sanofi, Merck & Co. and Pfizer dominant, a Jefferies analyst says.
