Latest Biotechnology, Pharmaceutical and Healthcare News from BioPharma-Reporter

22:51 EDT 20th June 2018 | BioPortfolio

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Showing News Articles 1–25 of 294 from BioPharma-Reporter

Wednesday 20th June 2018

WuXi Biologics kicks off $20m ADC build in China

WuXi Biologics has started building its antibody-drug conjugate (ADC) centre in Wuxi City, China, where it will offer biologics conjugate services for clients.

AbSci aims to tackle the antibody market after raising $12m to scale E. coli-based tech

With $12m in Series C financing, AbSci is looking to tackle the antibody market by accelerating innovation and driving down manufacturing costs using its synthetic biology platform, says CEO.

Tuesday 19th June 2018

Cellectis bakes safety switch into CAR-T to stop runaway responses

Cellectis has built a switch into a chimeric antigen receptor (CAR) T-cell to provide an efficient way to eliminate the therapy if it becomes a threat to patient safety.

Jefferson Institute for Bioprocessing: Site plan and launch update

The Jefferson Institute for Bioprocessing is set to launch in spring 2019, in Jefferson Universityâs new Spring House Innovation Park.

Friday 15th June 2018

IDA Ireland: Low corporate tax rate here to stay, ‘difficult’ to say same for US

The Republic of Irelandâs competitive corporate tax rate represents a âstabilityâ that may not be found in other economies, says IDA Ireland executive.

Two US regulatory wins for Keytruda, a first for cervical cancer

The US FDA has approved Merck & Co.âs bestseller Keytruda for two additional oncology indications â cervical cancer, and relapsed primary mediastinal large B-cell lymphoma.

mAb developer Oncobiologics launches CDMO business

Oncobiologics has launched a CDMO business to provide mAb development and manufacturing capabilities in a small biotech company setting, says CFO.

Wednesday 13th June 2018

Eisai targets dementia drug discovery with US research facility

Eisai says it is creating a research facility for âgenetics-guided dementia discoveryâ in the US and joining a Japanese industry-academia-government collaboration aimed at developing nucleic acid-based drugs.

Biosimilar sales remain small in 'largely untapped' market

Many unanswered questions surrounding the nascent biosimilar market are creating challenges â though less regulated markets may benefit from 'less well defined' definitions, says analyst.

Less-regulated markets a first stop for biosimilar development?

Biosimilar manufacturers marketing biosimilars in 'less regulated' markets, such as Latin America, may benefit from lax definitions, says analyst

Tuesday 12th June 2018

Parker details investment timeline, launches new single-use system

Parker Bioscience outlines its planned investment to meed demand as the industry shifts to traditional processes to biological â for which single-use products are critical, says exec.

End of lengthy legal battle with former CRO draws near, says Cel-Sci

Cel-Sci expects a final resolution this month, more than four years after filing an arbitration suit against its former CRO.

WuXi Biologics to launch in US: Tax reform makes ‘investment thesis much stronger’ says CEO

WuXi Biologics has announced plans to build a $60m manufacturing facility â offering continuous manufacturing options â for clinical and commercial production in the US.

Friday 8th June 2018

ADC Bio: Biotech may 'hold the key' to innovation adoption

CDMOs need to respond to biotech innovation at an R&D level to improve efficiency in antibody-drug conjugate manufacturing, says ADC Bio.

ADC Bio: CDMOs can learn from biotechs to drive manufacturing innovation

CDMOs need to respond to biotech innovation at an R&D level to improve efficiency in antibody-drug conjugate manufacturing, says ADC Bio.

GE grows FlexFactory presence in China with another cell therapy plant deal

GE Healthcare has announced plans to install its second FlexFactory manufacturing platform for cell therapy, this time at Xiangxue Pharmaceuticalâs site in Guangzhou, China.

Gutsy move: Microbiome spin-out seals half-billion-dollar deal with pharma giant

UK-based Microbiotica will collaborate with Roche-owned biotechnology group Genentech in the hunt for new microbiome-based therapeutics and biomarkers for its inflammatory bowel disease (IBD) pipeline.

Wednesday 6th June 2018

US FDA approves Cellectis’ third ‘off-the-shelf’ CAR T-cell candidate for clinical trials

Cellectisâ third gene-edited, âoff-the-shelfâ CAR T-cell candidate is set to enter clinical development after the US FDA approved an IND application for UCART22.

Tuesday 5th June 2018

US FDA rejects another Herceptin biosimilar, Amgen issued CRL

The US FDA has issued a complete response letter to Amgen for its biosimilar version of Rocheâs Herceptin, marking the agencyâs third trastuzumab candidate rejection this year.

Mylan and Biocon win Neulasta race with US FDA-approved biosimilar

The US FDA has approved Mylan and Bioconâs Fulphila, the first biosimilar version of Amgenâs Neulasta to receive regulatory authorisation.

Monday 4th June 2018

EMA recommends Pfizer’s Herceptin biosimilar, EU Commission to assess

The EMA has recommended approval of Pfizerâs Trazimera, a biosimilar version of Rocheâs best-selling monoclonal antibody, Herceptin (trastuzumab).

Friday 1st June 2018

Novartis invests $55m in US gene therapy site, prepares BLA

AveXis â a Novartis company â has added a manufacturing facility in North Carolina to its site network, where it will make investigational therapies for neurological genetic diseases.

US FDA pauses CRISPR gene-edited therapy trial for sickle cell disease

The US FDA has placed CRISPR Technologies and Vertex Pharmaceuticalsâ investigational stem cell treatment on clinical hold.

CMO Rentschler signs Ultragenyx fill/finish deal for US supply

Ultragenyx Pharmaceutical is transferring fill/finish activities for Mepsevvi from Rentschler Biopharmaâs facility in Germany, to Rentschler Fill Solutions in Austria.

Wednesday 30th May 2018

Crescendo Biologics out-licenses 'Humabody' asset to Zai Lab

Zai Lab and Crescendo Biologics have signed a licensing agreement under which Zai Lab will develop protein therapeutics for inflammatory indications.

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