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Headlines > December 2016

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US FDA delays Ocrevus decision date asking Roche for more manufacturing data

23-Dec-2016 - 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.

Humira biosimilar developers: can you find who's taking on AbbVie?

23-Dec-2016 - Over 30 companies are looking to compete against Abbvie in the adalimumab space. Can you find them all in our word search?

Pfizer turns to Charles Stark Draper Laboratory for 'organ-on-a-chip' tech

22-Dec-2016 - 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....

Wacker adding cysteine capacity through Spanish acquisition

21-Dec-2016 - Wacker says it is buying a large-scale fermentation facility in Spain to support growing demand for the amino acid cysteine.

Catalent’s CHO cell lines and Gate’s Foundation to make PATH Malaria vaccine

21-Dec-2016 - 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).

Oxford genetics secures $2m for bioproduction optimisation R&D

21-Dec-2016 - Oxford Genetics hopes to provide improved bioinformatics in order to optimise mammalian bioproduction through a £1.6m grant.

AGC expanding CDMO biz through $500m CMC Biologics buy

21-Dec-2016 - AGC Asahi Glass has signed an agreement to buy CMC Biologics, the second biologics CDMO acquisition for the Japanese chemicals firm in three months.

2016: year of the US biosimilar approval

20-Dec-2016 - With four biosimilars now approved in the US, the sector is growing in confidence says a BMI Research analyst.

BioCity CRO creates new Bioanalysis space with Thermo Scientific

20-Dec-2016 - XenoGesis has upgraded its spectroscopy capabilities in a deal with Thermo Fisher Scientific Inc. 

Repligen adds single-use filtration tech through TangenX acquisition

20-Dec-2016 - Repligen has bought Novasep subsidiary TangenX Technology for $39m, adding single-use tangential flow filtration (TFF) cassettes to its downstream offering.

DuPont gets Gates grant for protein drug production platform

20-Dec-2016 - DuPont has joined a Gates Foundation backed effort to develop low cost production methods for therapeutic proteins.

GSK opens first US vaccine R&D site in Maryland next to non-profit public health unit

16-Dec-2016 - 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).

Univercells part of Gates-backed group trying to cut polio vaccine cost

16-Dec-2016 - The Bill & Melinda Gates Foundation has granted Univercells $12m (€12.5m) to develop a vaccine manufacturing platform that lowers production costs.

'One-stop' CRISPR licensing initiative looks to accelerate the technology's benefits

15-Dec-2016 - As the patent war  over CRISPR gene editing technology continues, experts suggest a “one-stop” licensing alternative could help accelerate advances in new medicines.

apceth Biopharma joins Lonza as bluebird bio cell therapy contractor

15-Dec-2016 - 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.


Sugar lumps? Excipient impurities may be risk to patients says researcher

14-Dec-2016 - 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.

Eurofins Genomics launches EXTREmers

14-Dec-2016 - Eurofins Genomics has launched its EXTREmer oligonucleotides in the US – adding another ‘tool’ to help researchers advance drug discovery.

Sartorius to expand recently acquired cell line business, Cellca

14-Dec-2016 - Sartorius Stedim Cellca has said it will build a laboratory at newly acquired site in Ulm, Germany and hire additional staff.

BMS reshuffles US operations with multiple R&D closures and construction

14-Dec-2016 - Bristol-Myers Squibb has announced plans to pull the plug on some US facilities and streamline construction and investment around “vibrant academic ecosystems”. 

Bayer to be cell therapy player through $225m stem cell JV

13-Dec-2016 - Bayer has launched itself into the cell therapy space through a $225m joint venture focused on developing induced pluripotent stem cells (iPSC).

Avid on track for third plant and to clear $73m biomanufacturing backlog

13-Dec-2016 - 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.

Growth in biologics and vaccines leading injectables business, Aptar Pharma

12-Dec-2016 - 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.

Emergent secures anthrax vaccine extension with US CDC

09-Dec-2016 - Emergent BioSolutions has signed a $911m (€862m) follow-on contract to supply nearly 30 million doses of its anthrax vaccine to the US Government.

Sartorius awarded US patent for single-use biological 3D printer

09-Dec-2016 - 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.

WHO commits to source drugs and vaccines from 'green' suppliers

09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.

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