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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.

CEO scouts top E&W Coast scientific talent to secure Merck & Co.'s future

‘Don’t underestimate Merck's vaccine business,’ says CEO

07-Jun-2017 - CEO Ken Frazier has told investors investments and partnerships, such as collaboration with messenger RNA firm Moderna Therapeutics, have bolstered Merck & Co.’s vaccine division.

Merck & Co. €280m spend in latest commitment to Irish biomanufacturing

31-May-2017 - Global demand for its biologics and vaccines has driven expansion plans and 300 jobs across two Irish facilities says MSD.

Amgen: Bioprocess intensification and integration key for next-generation manufacturing

23-May-2017 - Its new Singapore single-use plant is a fraction of the size of a conventional commercial facility but next-generation biomanufacturing at Amgen points to even smaller, more integrated sites.

Novartis in Switzerland: Biologics job boost but 500 'traditional' jobs to go

19-May-2017 - Novartis will add around 350 Swiss jobs to support its innovative biologics pipeline as it looks to cut 500 more “traditional” development and manufacturing roles.

Norgine increases portfolio in Merus acquisition

16-May-2017 - European Norgine B.V. has agreed to acquire all issued and outstanding shares of Merus Labs International in cash for $342m (€309.6).

Seven-year switch? Formycon bets on third wave biosimilars with Stelara candidate

12-May-2017 - Formycon says it is aiming to bring the first biosimilar of J&J’s immunology best-seller Stelara (ustekinumab) to market as early as 2023 in the US.

Correction

Glenmark eyes up 1,000L production line expansion at Swiss plant

09-May-2017 - A second single-use production line could offer commercial-scale capacity for bispecific antibodies but Glenmark says it would need to scale-up further to support more traditional biologics.

BPI Europe 2017

Cost-cutting oral vaccine tech will make Vaxart less reliant on CMO

04-May-2017 - Vaxart says its tablet delivery platform has simplified vaccine production so significantly it may bring manufacturing currently contracted to Lonza back in-house.

DISPATCHES FROM BPI EUROPE 2017

CHO stopper? Biogen looks to alternative cell lines for future of bioproduction

28-Apr-2017 - The Chinese hamster ovary (CHO) cell line is not the future for biomanufacturing says Biogen, which will publish results from a study of alternative hosts later this year.

DISPATCHES FROM BPI EUROPE 2017

Boehringer Ingelheim upping capacity with €700m mammalian cell culture plant

27-Apr-2017 - Boehringer Ingelheim has broken ground on a €700m stainless steel bioproduction facility set to house 135,000L of mammalian cell culture capacity.

DISPATCHES FROM BPI EUROPE 2017

Messenger RNA a ‘game-changer’ for vaccine industry, Sanofi Pasteur

26-Apr-2017 - Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.

Sanfilippo syndrome gene therapy could be filed in US next year, Abeona

11-Apr-2017 - Abeona Therapeutics says it plans to file its single injection adeno-associated virus (AAV) gene therapy for Sanfilippo syndrome in the US in late 2018.

1st Stem Cell Community Day - Hamburg, Germany

Stem cells: Single-use bioreactors and microcarriers can overcome scale-up issues, experts

07-Apr-2017 - The only practical way to scale-up volumes of mesenchymal stem cells (MSCs) is by using microcarriers in single-use bioreactors, say scientists from A*STAR and Instituto Superior Técnico.

Shire success will support polysialic acid drug delivery platform, says Xenetic

06-Apr-2017 - Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.

Dispatches from the 1st Stem Cell Community Day, Hamburg

UK Catapult: QbD and process automation key for making commercial cell therapies

05-Apr-2017 - Process automation should be incorporated early when developing large scale cell therapy manufacturing platforms, according to a lead scientist from the UK Catapult.

US FDA submissions pit Novartis and Kite head-to-head in CAR race

04-Apr-2017 - Novartis and Kite Pharma have both submitted autologous leukemia candidates for review, paving the road for the first available chimeric antigen receptor (CAR) T cell therapy.

UK biotech inks stem cell engineering deal with Singapore researchers

31-Mar-2017 - Plasticell has partnered with Singapore’s Agency for Science, Technology and Research (A*STAR) and the Nanyang Technological University (NTU) to advance its stem cell pipeline.

Regeneron and Sanofi's $37,000 per year eczema mAb given US FDA nod

29-Mar-2017 - The US FDA has approved the first systematic treatment for eczema: Sanofi and Regeneron’ monoclonal antibody Dupixent (dupilumab).

'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.

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