Breaking News on Biopharmaceutical Development & Manufacturing

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Biopharmaceuticals becoming big business


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

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.

WuXi to make Prima proteins from new 28,000L single-use facility in China

29-Nov-2016 - WuXi Biologics will make a recombinant soluble LAG-3 protein on behalf of Prima Biomed from its 28,000L single-use facility in China set to open next year.

Pfizer axes parts of $425m Irish expansion after dropping PCSK9 inhibitor

28-Nov-2016 - Plans to build a five-story biomanufacturing plant in Ireland could be shelved following the clinical failure of Pfizer's proposed cholesterol-lowering candidate bococizumab.

BMS biologics-focus trimmed network from 27 to 16 sites since 2007

18-Nov-2016 - Bristol-Myers Squibb has shaped its manufacturing network to support a pipeline consisting of around 75% biological products, the firm says.

uniQure to axe jobs and consolidate operations in cost-saving measures

16-Nov-2016 - Gene therapy firm uniQure will consolidate its global manufacturing and cut up to 60 jobs in a bid to recue operating expenses.

Cell Medica and Baylor extend partnership for off-the-shelf T Cells

15-Nov-2016 - Baylor College of Medicine has extended a partnership to develop off-the-shelf allogeneic cell therapies for Cell Medica.

Selexis and Xencor enter strategic agreement for cell line development

09-Nov-2016 - Selexis and Xencor have entered into a strategic agreement which strengthens an existing relationship for multi-specific antibody cell line development

Sale speculation: We assess German Merck's biosimilar business

04-Nov-2016 - Germany’s Merck has refused to comment on rumours it is looking to sell its biosimilars business, but what would a hypothetical buyer actually get?

Shire closing US plant as it begins to assess post-Baxalta manufacturing footprint

04-Nov-2016 - Shire says it is closing a plasma fractionating facility in Los Angeles, US but remains positive it can successfully manage its post-Baxalta manufacturing network of 17 sites.

FIRM looks to fix blips in Japan’s fast-track regenerative medicine system

14-Oct-2016 - Japan’s early approval process for cell and gene therapies still suffers from clinical recruitment challenges and a solid manufacturing framework, says regenerative medicine group FIRM.

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