Breaking News on Biopharmaceutical Development & Manufacturing

Headlines > July 2017

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Cancer-fighting combo: mRNA and antibody-focused treatment wins EU patent

21-Jul-2017 - Regulators have granted CureVac a European patent for its mRNA vaccine and anti-PD-1 antibody technology designed to prevent and treat cancers and infectious diseases.

Sanofi signs nanobody drug and tech deal that could earn Ablynx billions

21-Jul-2017 - Sanofi has licensed access to Ablynx NV’s nanobody platform as well as candidate drugs in a deal that could earn the Belgian firm billions of euros.

update - comment from Unite

GSK says UK manufacturing cuts not Brexit related

20-Jul-2017 - GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and...

Update - comments from EMA and EFPIA

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

19-Jul-2017 - Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation 

Proliant BSA in Asia: China opens door to NZ bovine blood

19-Jul-2017 - Following months of importation restrictions, Proliant Biologicals has announced it is eligible to export bovine serum albumin (BSA) from its Feilding, New Zealand-based facility to China.

Recreated pox virus may yield vaccines and expression systems say scientists

18-Jul-2017 - Researchers at the University of Alberta, Canada say a synthetic version of the extinct horsepox virus could yield more efficient protein expression systems and better vaccines. 

BiondVax leases site for universal flu vaccine plant in Israel

18-Jul-2017 - BiondVax Pharmaceuticals Ltd has leased space for a manufacturing plant with capacity to make tens of millions of doses of its flu vaccine, M-001.

US FDA to decide on Spark's vision loss gene therapy Luxturna in January

18-Jul-2017 - The US FDA has promised to review Spark Therapeutics’ candidate vision loss gene therapy Luxturna by next January.

Emergent to buy Sanofi smallpox vaccine and take on CDC contract

18-Jul-2017 - Emergent BioSolutions will pay up to $125m (€108m) for Sanofi’s smallpox vaccine ACAM2000 in a deal that includes a plant and 10-year supply contract with the US Government.

Hair-raising R&D: RepliCel developing autologous cell therapy for baldness

12-Jul-2017 - Vancouver, Canada-based RepliCel is developing an autologous cell therapy to treat patients with baldness due to androgenetic alopecia. 

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 - Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

ABEC breaks the 2,000L ‘plastic ceiling’ with 4,900L single-use bioreactor

12-Jul-2017 - ABEC says its latest offering has twice the working volume of the 2,000L bioreactor systems generally deemed to be the upper limit in single-use bioprocessing.

Sanofi shells out $650m for non-egg based vaccine maker Protein Sciences

11-Jul-2017 - Sanofi will add the recombinant protein-based influenza vaccine Flublok to its products, along with a manufacturing facility in Pearl River, New York.

Biosimilar break-up: Daiichi Sankyo halts Coherus development in Japan

11-Jul-2017 - Daiichi Sankyo Japan has announced it is discontinuing the development of Coherus’ Etanercept biosimilar, CHS-0214.

Shire focusing on biotechnology and R&D hubs in MA operations shake up

11-Jul-2017 - Shire will consolidate both R&D and biomanufacturing facilities in Massachusetts to establish a rare diseases hub in Cambridge and a ‘Technology Center of Excellence’ in Lexington.

Vaccine booster for France, big pharma prepared

10-Jul-2017 - The French government has announced it will make more vaccines mandatory from 2018 onwards.

Mylan's EU biosimilar ambition hit by GMP issues at Biocon plant

10-Jul-2017 - Three biosimilar products submitted to the EU for approval have suffered a setback after regulators found 35 GMP deficiencies at Biocon’s fill/finish facility in Bangalore, India.

Spheryx awarded Ph II grant to modify tech for biologics industry

07-Jul-2017 - Spheryx, Inc. has been awarded a $1.5m grant over two years to support modifications to the company’s propriety protein aggregation detection and monitoring technology.

EC says Merck and Sigma-Aldrich broke M&A procedures and could face $170m fine

06-Jul-2017 - German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission

News in brief

French venture fund bets on Japanese microbiome firm with €11.6 m investment

05-Jul-2017 - Seventure’s Health for Life Capital fund has announced a €11.6 million ($13.2m) financing of Tokyo-based microbiome firm Anaeropharma Science.

Vaccine manufacturing deviation reports up by 19% in 2016, US FDA

05-Jul-2017 - An increase of quality, process control and specification issues contributed to a rise in reported vaccine manufacturing deviations last year, a US FDA report finds.

PBL opens doors at UK bio-development centre

04-Jul-2017 - Porton Biopharma has opened a biologics characterisation and development facility at its site in the UK.

Sun shines on CMO Samsung Biologics to make its psoriasis mAb candidate

04-Jul-2017 - Samsung Biologics will make Sun Pharma’s psoriasis monoclonal antibody candidate Tildrakizumab in a deal worth $55.5m.

Pump up the volume: Cellnovo adding insulin device line in Romania

04-Jul-2017 - French technology firm Cellnovo has selected Flex Ltd to build a production line in Romania, to manufacture insulin cartridges for its diabetes management system.

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