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 - 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 - 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.
03-Feb-2017 - Kyowa Hakko Kirin has set up Kyowa Kirin Frontier Co Ltd to sell a version of Aranesp (darbepoetin alfa) it is developing with Amgen.
03-Feb-2017 - The promised jobs were always part of Amgen’s 2017 plans says CEO Robert Bradway, but a reduced US footprint means hiring more biomanufacturing staff is unlikely.
01-Feb-2017 - Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
01-Feb-2017 - Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
31-Jan-2017 - The EMA has recommended approval of two versions of AbbVie’s bestselling biologic Humira (adalimumab), both made by Amgen.
31-Jan-2017 - The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.
27-Jan-2017 - Donald Trump’s withdrawal from the Trans-Pacific Partnership (TPP) could end up benefitting Asian biosimilar makers and reducing US jobs, says an IP lawyer.
25-Jan-2017 - Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
25-Jan-2017 - Wuxi Biologics has confirmed its intention to go public in an IPO application that reveals the contracter has seen revenue double and profits increase three-fold since 2014.
25-Jan-2017 - Lonza has cited demand for mammalian cell culture manufacturing and contracts signed with cell and gene therapy as key drivers in 2016.
24-Jan-2017 - Drugmakers have been invited to submit preliminary clinical evidence for cell and gene therapies under the new US FDA Regenerative Advanced Therapy designation
20-Jan-2017 - The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.
18-Jan-2017 - A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
18-Jan-2017 - A UK judge says a vexatious litigation strategy is staving off Humira biosimilars, but AbbVie is “playing by the rules and incurring the costs of doing so,” according to an...