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Headlines > January 2017

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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.

Single-use once again growth engine for Sartorius

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.

Patented GE bioreactor bag boasts of 214m CHO cells/mL in perfusion mode

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.

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.

Lundbeck banks on shark antibody delivery tech to cross blood-brain barrier

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.

Sandoz awaiting facility inspections before filing Humira biosimilar in US

27-Jan-2017 - Capacity upgrades and US FDA discussions delayed the filing of Sandoz’ Humira biosimilar, the company has confirmed.

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.

Biocon wins $68m Malaysian contract for biosimilar insulin and pen supply

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.

FDA hits UK state-owned CDMO with warning over leukemia drug production

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.

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.

ADMA to buy US Biotest plant and fix problems that derailed RI-002

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.

News in brief

Mystery San Diego party inks $300m deal with Abzena for antibody linking tech

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.

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

Amatsigroup buys French Pyrofree manufacturing specialist Disposable-Lab

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.

Cell preservation prosperity: BioLife and Cryoport up on personalised meds

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.

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.

Biopharma survey: Shortage of bioprocessing talent key threat to sector

20-Jan-2017 - Industry is struggling to find and develop skilled bioprocessing workers according to respondents to NIBRT’s biopharma trends survey.

UPDATED: UCART19

Servier universal CAR-T therapy outsourced to Belgian CDMO

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.

Irvine Scientific introduces xeno-free T cell growth medium

18-Jan-2017 - Irvine Scientific has launched what it says is the first available chemically-defined, animal component-free medium for T cell culture.

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...

Exclusive interview

Single-use bioreactors: 2,000L a ceiling, says new BPSA board member

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.

GEA and Siemens team on continuous processing tech

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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