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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.

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.

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?

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.

$62m injection in Hungary is latest boost for GSK vaccine production

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.

Biosimilars were ‘plan B,’ says portfolio pumped Merck KGaA

10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.

Opinion

Roche tops biosimilar defence league by a 'country mile'

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.

UK High Court rules against AbbVie in Humira indication patent battle

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.

US FDA lifts hold on Seattle Genetics' blood cancer ADC candidate

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. 

Russia approves first ever biosimilar of Serono’s MS drug Rebif

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).

Synagis maker MedImmune teams with Sanofi Pasteur on mAb RSV drug

03-Mar-2017 - Sanofi Pasteur and MedImmune have partnered to develop a monoclonal antibody (mAb) based treatment for respiratory syncytial virus.

Aska buys option to commercialize Pieris' potential EPO rival in Japan

28-Feb-2017 - Aska Pharmaceutical Co. Ltd has bought an option to commercialize Pieris Pharmaceuticals’ anaemia candidate and EPO rival, PRS-080, in Japan.

Celltrion's MabThera cleared by EC for autoimmune diseases and cancer

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.

Belgian CAR-T biotech enrols first blood cancer patient in new trial

22-Feb-2017 - Celyad SA has enrolled the first multiple myeloma patient in a safety and tolerability trial of its CAR-T therapy.

Opinion

Raging bull' - Vaccines don’t cause autism and saying otherwise costs lives

22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.

Biosimilar group set to lobby new HHS Secretary to reverse reimbursement policy

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.

Lilly rejects reports US tax plan prompted Ireland investment rethink

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.

Symbiosis opens US sales office citing demand from resurgent biotechs

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.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

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.

Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline

10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.

Cellectis gets US ok to test its universal donor derived cancer cell therapy

08-Feb-2017 - US regulators have cleared French biotech Cellectis to trial its “off-the-shelf” blood cancer cell therapy, UCART123.

Trump's travel restrictions will hurt cell therapy sector says ISCT

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).

AUTOLOGUS CELL THERAPY

Opexa 'eliminates major liabilities' by selling Texas facility to KBI

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.

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