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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 - Sartorius reported a 22% year-on-year growth in sales in its bioprocessing division, driven by continued demand for single-use systems.
31-Jan-2017 - GE Healthcare says a new inflatable bioreactor bag configured in perfusion mode can achieve a cell density over four times that of the current industry standard.
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 - Shark antibodies are an attractive way to deliver biologics to the brain, says Ossianix which is using its blood-brain barrier (BBB) crossing technology in collaboration with Lundbeck.
27-Jan-2017 - Capacity upgrades and US FDA discussions delayed the filing of Sandoz’ Humira biosimilar, the company has confirmed.
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.
26-Jan-2017 - Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
25-Jan-2017 - Porton Biopharma says it is undergoing a manufacturing review to address US FDA concerns about the production of Jazz Pharmaceuticals’s orphan drug Erwinaze.
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 - ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.
24-Jan-2017 - An unnamed San Diego-based firm has signed a licensing agreement for Abzena Plc’s ThioBridge antibody drug conjugate (ADC) linker technology.
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
23-Jan-2017 - Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
20-Jan-2017 - With increased interest in cell and gene therapies, BioLife Solutons has reported a 28% year-on-year growth in sales of biopreservation media, while Cryoport has struck another logistics deal.
20-Jan-2017 - The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.
20-Jan-2017 - Industry is struggling to find and develop skilled bioprocessing workers according to respondents to NIBRT’s biopharma trends survey.
18-Jan-2017 - Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.
18-Jan-2017 - Irvine Scientific has launched what it says is the first available chemically-defined, animal component-free medium for T cell culture.
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...
17-Jan-2017 - The majority of biomanufacturers use single-use systems at least in the development stage says Entegris’ Eric Isberg, but scaling-up will always be a challenge.
17-Jan-2017 - Siemens and GEA have developed a continuous manufacturing platform for pharmaceuticals that integrates the former’s quality control software.
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