Latest Biotechnology, Pharmaceutical and Healthcare News from BioPharma-Reporter

01:35 EST 13th November 2018 | BioPortfolio

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Showing News Articles 1–25 of 330 from BioPharma-Reporter

Monday 12th November 2018

Medicon Valley: How Denmark and Sweden are ‘bridging’ the biotech gap

The Nordic life science cluster aspires to become the most prominent in northern Europe, says Medicon Valley Alliance executive.

Friday 9th November 2018

GE Healthcare strengthens single-use manufacturing in China

GE Healthcare will manufacture single-use consumables for bioprocessing through a collaboration with Wego.

Coherus receives US FDA approval for Neulasta biosimilar, pricing 33% lower

The company will launch Udenyca onto the US market on January 3, 2019, to compete with Amgenâs originator product and Mylanâs rival biosimilar.

Thursday 8th November 2018

#BIOEurope: ‘Deal making is off the charts and the IPO window is open’

Denmark played host to its first BIO Europe this week, welcoming 4,500 attendees from across the globe â including growing numbers from China and South Korea.

Wednesday 7th November 2018

Astellas invests $256m in cell therapy manufacturing buildout

The company will construct two facilities in Japan and relocate its regenerative medicine facility in the US.

The changing biosimilar landscape: Lesser-known firms, blockbuster molecules

As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.

Sandoz bows out of US Rituxan biosimilar race

After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.

Tuesday 6th November 2018

Gene editing partnership to provide custom cells for drug discovery

Ncardia and Horizon Discovery have partnered to provide custom, genetically- modified and differentiated human cells for drug discovery and preclinical models.

EU Humira biosimilar discounts at ‘higher end’ of scale, says AbbVie

In Europe, biosimilar rivals have undercut Humiraâs list price from 10% to 80%, says AbbVie CEO.

Monday 5th November 2018

CAR-T manufacture ‘where mAbs were in the early 1990s’, says bluebird CTMO

With cell and gene therapies developing at a rapid pace, it leaves significant questions as to how manufacturing processes are keeping up.

Friday 2nd November 2018

Novo Nordisk cuts 3% of staff to ‘transform biological and technological innovation’

The Danish drugmaker announced that job losses at the company will number 1,300 before the end of the year, with the majority of those already having left their roles.

Gene therapy de-coded: Utilizing mRNA ‘programming language’ for therapy production

A study published by graduate students at MIT showed that a synthetic mRNA-based âprogramming languageâ can control protein expression in gene therapy.

Hyrimoz approval prepares US for a September 2023 launch

The US FDA approval, coupled with a Humira licensing agreement, will see Sandozâ biosimilar enter the market as of September 30, 2023.

Thursday 1st November 2018

Hired and Retired: Transitions at the top

In a significant move at the larger end of the biopharma world, AstraZenecaâs global VP of cardiovascular, renal and metabolism made the move to Novo Nordisk to head up its biopharm unit.

Wednesday 31st October 2018

WuXi Biologics breaks ground on $240m manufacturing site near Beijing

Construction has started at WuXi Biologicsâ eighth drug substance manufacturing facility, which CEO Chris Chen says will enable the CDMO to âdevelop and manufacture biologics more cost effectivelyâ.

Lonza invests in ‘game-changer’ automated cell therapy manufacture

After a three-year partnership, Lonza pulled the trigger on acquiring a controlling stake of Octane Biotech and their jointly developed Cocoon system.

Tuesday 30th October 2018

US FDA vetoes Regeneron’s Eylea syringe in CRL

The US FDA has rejected Regeneron Pharmaceuticalsâ prior-approval supplement for Elyea pre-filled syringe, requesting additional clinical data and manufacturing information.

Johnson & Johnson boost vaccine production at Dutch facility

Johnson & Johnson has unveiled a vaccine facility in Leiden, the Netherlands, which will focus on R&D, technological development, and large-scale production of vaccines for late-stage clinical trials.

Samsung Bioepis targets Soliris market, with ‘many more candidates’ in pipeline

Within days of Samsung Bioepis sending its Soliris candidate to the clinic, the firm details its development process, novel biologics ambitions, and plans to become âthe single dominant player in biosimilarsâ.

Friday 26th October 2018

Shire requests US approval to make Flexbumin at plasma plant

Shire has filed a US FDA submission to manufacture plasma-volume replacement therapy, Flexbumin, at its new plant in Stanton Springs, Georgia.

EMA gives positive opinion on Keytruda as adjuvant therapy

MSD announced that the EMAâs CHMP has adopted a positive opinion recommending approval of Keytruda as an adjuvant therapy for the treatment of patients with melanoma.

Roche predicts US competition: MabThera, followed by Herceptin and Avastin

The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.

Samsung BioLogics on future expansion: Novel biologics and new JVs, says CEO

The company is considering an expansion beyond biosimilars into novel biologics development, says CEO TH Kim.

Thursday 25th October 2018

Avid expansion to triple process development capacity, says CEO

Avid continues its transition to a fully-fledged CDMO by transforming its process development capabilities with new lab space.

Wednesday 24th October 2018

MilliporeSigma adds first non-mammalian cell line to portfolio

MilliporeSigma collaborated with GylcoBac to provide an Sf-9 insect cell line for vaccine and gene therapy development.

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