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Biopharmaceuticals becoming big business

Pipelines

As pharmas evolve into biopharmas drug company pipelines fill with biopharmaceutical products. Here we will track the latest developments, discoveries and products.

'One-litre bioreactor scale currently the maximal for stem cell expansion and differentiation'

Industry needs new bioreactor and monitoring tech for stem cell scale-up, expert

24-Mar-2017 - Stem cell therapy developers are lacking production scale-up technologies, says the chair of an upcoming conference bringing industry and academia together to address the problem.

Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT'

24-Mar-2017 - Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

US FDA fast-track designation for Humacyte's tissue-based hemodialysis product

22-Mar-2017 - Humacyte has received one of the first US FDA regenerative medicine designations for its investigational human acellular vessels (HAVs) candidate Humacyl.

$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.

Kite public offering looks to raise $350m for CAR T cell therapy support

07-Mar-2017 - Kite Pharma has announced a public offering to support commercialisation of its lead CAR-based therapy, axicabtagene ciloleucel.

Vaxess granted $6m to develop sustained release vaccine patches

07-Mar-2017 - Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.

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.

BioMarin building CA plant to support Factor VIII gene therapy candidate

28-Feb-2017 - A Californian manufacturing facility to support clinical development of a haemophilia A gene therapy will be completed this year, says BioMarin.

Strategic CRO takes $100m hit from Pfizer's shelved PCSK9 candidate

17-Feb-2017 - Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.

Bio-outsourcing share to drop as Big Pharma invests heavily in-house, analyst

15-Feb-2017 - CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.

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.

Dutch Biopharma launches Phase III trial of Leukemia donor cell therapy

14-Feb-2017 - Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.

Catalent running its biologics business at over 90% capacity

08-Feb-2017 - Catalent is struggling to keep up with demand for its biomanufacturing services, but a third production train will open up more capacity from October.

Roche: 'Largest biomanufacturing capacity across the industry' to get bigger

07-Feb-2017 - Roche says it will continue to expand its biologics manufacturing capacity while reducing its small molecule network.

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

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.

Kite inks Chinese JV and Japanese partnership for lead T Cell candidate

10-Jan-2017 - Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.

Orchard picks PharmaCell to make its autologous cell therapies

09-Jan-2017 - Orchard Therapeutics has selected Dutch CMO PharmaCell to manufacture products from its gene therapy pipeline.

Shire selling Baxalta site in Austria once earmarked to make hemophilia drug

06-Jan-2017 - Shire has confirmed it is selling a former Baxalta manufacturing site in Austria once earmarked for a €138m ($145m) expansion and modernisation.

Prokarium and Probiomed team to scale-up thermostable oral vaccine

04-Jan-2017 - The project funded by the UK and Mexican governments will look to prove the scalability of Prokarium’s oral vaccine platform, the firm says.

Humira biosimilar developers: can you find who's taking on AbbVie?

23-Dec-2016 - Over 30 companies are looking to compete against Abbvie in the adalimumab space. Can you find them all in our word search?

GSK extends single-use purification tech R&D deal with Puridify

06-Dec-2016 - The development partnership has been extended as GlaxoSmithKline looks to make clinical trial scale batches using Puridify’s Protein A alternative to packed bed chromatography columns.

Thermo Fisher buys MTI-GlobalStem upping stem cell and reagent offering

30-Nov-2016 - Thermo Fisher has bolstered its stem cell technology and reagent business through the acquisition of MTI-GlobalStem.

Cook and Asymptote to launch water-free automated cell thawing tech

30-Nov-2016 - An automated system co-developed with Cook Regenetec offers a more controlled and repeatable method of thawing cell and gene therapies than traditional techniques, says Asymptote.

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