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.
21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.
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.
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.
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?
15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.
14-Mar-2017 - The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.
08-Mar-2017 - Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.
07-Mar-2017 - Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
07-Mar-2017 - The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths.
03-Mar-2017 - Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).
03-Mar-2017 - Sanofi Pasteur and MedImmune have partnered to develop a monoclonal antibody (mAb) based treatment for respiratory syncytial virus.
28-Feb-2017 - Aska Pharmaceutical Co. Ltd has bought an option to commercialize Pieris Pharmaceuticals’ anaemia candidate and EPO rival, PRS-080, in Japan.
22-Feb-2017 - The European Commission has approved Celltrion Healthcare’s rituximab biosimilar – Truxima (CT-P10) – for the same autoimmune disease and cancer indications as the reference product.
22-Feb-2017 - Celyad SA has enrolled the first multiple myeloma patient in a safety and tolerability trial of its CAR-T therapy.
22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.
15-Feb-2017 - Industry group the Biosimilars Forum has welcomed President Trump’s pick of Representative Tom Price as Secretary of Health and Human Services.
14-Feb-2017 - Rumours of an Irish expansion freeze have been greatly exaggerated according to Eli Lilly, which says it remains committed to its Kinsale biomanufacturing site.
13-Feb-2017 - Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.
10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.
08-Feb-2017 - US regulators have cleared French biotech Cellectis to trial its “off-the-shelf” blood cancer cell therapy, UCART123.
06-Feb-2017 - If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
06-Feb-2017 - CDMO KBI Biopharma, Inc. has acquired the lease and assets of Opexa Therapeutics’ facility in Texas after the firm’s lead MS candidate failed Ph IIb.