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Headlines > March 2017

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Agenus trimming 50 jobs as it focuses on cancer vaccines and antibodies

31-Mar-2017 - Immuno-oncology antibody and vaccine firm Agenus Inc will close a site in Basel and axe 50 jobs as part of a reorganisation.

UK biotech inks stem cell engineering deal with Singapore researchers

31-Mar-2017 - Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.

Lonza confirms drug firm was biggest customer in 2016

31-Mar-2017 - Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013

Emisphere set to benefit as Novo Nordisk pushes oral diabetes pipeline

30-Mar-2017 - Novo Nordisk’s focus on developing oral versions of semaglutide and four other diabetes drugs could net drug delivery firm Emisphere over $200m.

Regeneron and Sanofi's $37,000 per year eczema mAb given US FDA nod

29-Mar-2017 - The US FDA has approved the first systematic treatment for eczema: Sanofi and Regeneron’ monoclonal antibody Dupixent (dupilumab).

UK biopharma industry looks to Switzerland ahead of impending Brexit

28-Mar-2017 - The UK BioIndustry Association will visit Switzerland ahead of Brexit negotiations to learn how to work in Europe without being in the EU.

News in brief

Permira to buy Lyophilization Services of New England

28-Mar-2017 - Private equity fund Permira has announced its intention to buy freeze drying firm Lyophilization Services of New England Inc (LSNE) 

Eleven Biotherapeutics: Taking on ADCs with targeted protein therapeutics

28-Mar-2017 - A two-step manufacturing process makes antibody-drug conjugate production expensive and causes stability issues, says Eleven Biotherapeutics which is fusing antibody fragments to cytotoxic proteins.

Lilly: Tax reforms would release $150m to further support US manufacturing

27-Mar-2017 - Eli Lilly will invest $850m in its US operations this year but warns the country’s antiquated tax system leaves the firm at a competitive disadvantage.

'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'

Industry needs new bioreactor and monitoring tech for stem cell scale-up, expert

24-Mar-2017 - Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

Eurofins pumping $5m into a UK biopharmaceutical testing site

24-Mar-2017 - Eurofins will expand its UK biopharmaceutical testing offering through a £4m ($5m) facility in Livingston, Scotland.

US FDA fast-track designation for Humacyte's tissue-based hemodialysis product

22-Mar-2017 - Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.

Amgen targets Roche in Europe with Herceptin biosimilar submission

22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.

Goodwin Biotech to work on opioid addiction vaccines project

22-Mar-2017 - Contract manufacturer Goodwin Biotechnology will work with Minneapolis Medical Research Foundation (MMRF) to develop vaccines to treat opioid addiction.

GSK breaks ground on $175m German Bexsero vaccine facility

21-Mar-2017 - GlaxoSmithKline has broken ground on a €162m ($175m) meningococcal B vaccine production plant in Germany.

Infographic

Biosimilar interchangeability: Do you know your switching from your substitution?

21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.

EC says separate GMP for cell and gene therapies is necessary

21-Mar-2017 - The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.

PIC/S raises concerns about EC plan for advanced therapy GMP

20-Mar-2017 - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.

Roquette aims to up its biologic reagent presence

17-Mar-2017 - Roquette says investments in packaging, documentation and testing requirements have helped the firm move into the biologics excipient and reagent space.

Lonza launches liver cells for biopharma research

17-Mar-2017 - Lonza has launched a new range of cryopreserved liver cells for biopharmaceutical companies that want to assess the toxicity of their drugs.

Patheon: Biologics seeds to bloom in 2018 as products shift to commercial

17-Mar-2017 - Patheon says it expects to see a surge in biologics revenue in 2018 as products shift from development stage to commercial.

Reader's poll

American-made biosimilars a differentiator in US market, Coherus

15-Mar-2017 - US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?

GE Healthcare installs purification tech at FujiFilm Diosynth site

15-Mar-2017 - GE Healthcare has completed another tech installation at FujiFilm Diosynth’s biopharmaceuticals facility in Billingham, UK, integrating a single-use purification system with bioreactors it provided in 2014.

FDA grants industry requests for interchangeability guidance comment extension

15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.

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