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Headlines > Markets & Regulations

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.

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.

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.

update

Kyowa Hakko Kirin subsidiary set up to sell Aranesp biosimilar

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.

Amgen pledges Trump 1,600 US jobs, but how many are in bioproduction?

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.

Sandoz withdraws Neulasta biosimilar application after EMA questions GMP status

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.

Pfizer resubmits US and EU application for withdrawn ADC Mylotarg

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.

Amgen's two-brand strategy? EU thumbs up for Humira biosimilar duo

31-Jan-2017 - The EMA has recommended approval of two versions of AbbVie’s bestselling biologic Humira (adalimumab), both made by Amgen.

News in brief

EDQM and EMA to clarify how Ph. Eur applies to biosimilars at event next week

31-Jan-2017 - The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.

Trump's TPP withdrawal a boon for Asian biosimilar makers?

Trump, TPP and America First threaten US biomanufacturing jobs, says expert

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.

Biosimilars could impact US Remicade sales by 15% in 2017, says J&J

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.”

Wuxi Biologics files IPO prospectus aiming to be gateway to China

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. 

Biopharma business a key driver for Lonza in 2016

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.

Entering the RAT race? FDA issues instructions for new cell therapy designation

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

Boehringer Ingelheim's Humira biosimilar accepted for review in US and Europe

20-Jan-2017 - The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.

Pfenex, Pfizer and Sandoz hail US FDA interchangeability guidelines

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.

AbbVie’s Humira IP strategy having ‘chilling effect on competition,’ UK judge

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...

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