Biopharma News

Keytruda also receives Breakthrough Therapy Designation for second-line treatment.

Rentschler will become the first and only CDMO to have access to Leukocare's patented SPS formulation technologies.

Developments in local manufacturing, regulatory strategies, market entry and harmonisation to be debated by MENA leaders and Government.

Amgen receives positive CHMP opinion for biosimilar adalimumab.

Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates.

Comprehensive validation services for the Chinese market.

If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US.

Expansionincludes the opening of two new process development centers in the US and China.

Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab.

Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic.

Site will use the latest bioprocessing techniques and will employ flexible production strategies to enable it to supply both clinical- and commercial-scale products.

If approved, the product could provide blood cancer patients with access to potentially life-saving medicine.

New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence.

No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks.

New services to enable US biopharmaceutical companies to accelerate development of biosimilars.

Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape.

Potential to be first submission of a proposed biosimilar trastuzumab in the US.

If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma.

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US.

Facilities chosen for their contributions to anti-infectives and vaccines.

Cadence Acoustic Separator system is a novel single-use solution for the clarification of cell culture bioprocess fluids.

Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines.

Will enable manufacturers to reduce costs by eliminating cleaning and validation requirements, as well as hardware infrastructure.

New site expands the company's global operations for small molecule and biologics manufacturing, and marks the company's first manufacturing presence in Asia.

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

Company also in the process of setting up a training collaboration with National Institute for Bioprocessing Research and Training (NIBRT) to develop skills for Ireland’s biologics sector, training 1,500 professionals per year.

Innovative Twin system with two 3,000-L bioreactors and associated downstream processing equipment put into operation. Second significant expansion in one year.

Benralizumab Phase III trials met primary and key secondary endpoints.

Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes.

The CDMO has expanded its capabilities with a new automatic vial filling line to meet increased demand.

Marketing Authorization Application to the EMA currently under review.

The partnership created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody.

Includes scale-up and GMP manufacturing of drugs in late-stage development.

Enzyme developed with CodeEvolver technology for preclinical therapeutics program exceeds agreement requirements.

Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio.

The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe.

Enables explorations of new technologies and solutions to address development and manufacturing challenges.

The plant will manufacture biosimilars and construction is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018.

In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data.

Transaction to expand SSB’s bioprocessing product portfolio with innovative single-use centrifuges.

The partnership covers potential new medicines for atopic dermatitis and psoriasis.

State-of-the-art facility will foster the continued development of the biotechnology industry in China, further supporting national healthcare reforms.

Investments of more than USD 1 billion in state of-the-art biomanufacturing facilities, backed by industry-leading capabilities as part of Novartis, positions Sandoz to deliver biosimilars at unprecedented scale.

New expandable benchtop workstation with unique single-use bioreactor design offers a simple approach to process development for fermentation and cell culture.

Cellca’s cell line and upstream process development services now integrated.

The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade.

Offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials during fermentation.

Total fund size doubled to up to €300 million.

The new facility will significantly increase Alvotech’s production capacity enabling the group to produce higher yields at lower costs.

Company will be one of the first service providers to offer HDX-MS in a cGMP environment.

Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations.

Addition of a Bioreactor 3PACK production facility to its Copenhagen facility provides additional flexible solutions for clients.

Certified leading upstream platform powers China’s biopharmaceutical development.

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.

$280 million project increases workforce, adds new capabilities

Benralizumab first AstraZeneca respiratory biologic to complete Phase III.

Construction now complete on new 62,000 square foot facility.

GE Healthcare delivers world’s first modular manufacturing solution based on single-use bioprocessing technology in just 18 months.

Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication.

200,000 sq ft state-of-the-art biopharmaceutical manufacturing facility supports expanding development pipeline and transition toward commercial stage.

New Lynx CDR connectors facilitate faster and more economic biopharma fluid management.

The commercial launch of the CAS is the first in a series of product launches that enable continuous bioprocessing.

Also offers a powerful state-of-the-art refrigeration system with advanced temperature management.

This new service offers a number of advantages compared with current analytical techniques.

How providing comprehensive data can accelerate drug development.

Neuraminidase, which is not currently the main target antigen in traditional flu vaccines, enables newly formed flu viruses to exit the host cell and cause further viral replication in the body.

Novel enzymatic, 1-step site-specific protein conjugation technology for ADC production.

Ascenion unveils technology highlights: New approaches for the treatment of neurodegenerative disorders and glioblastoma.

Exciting lectures and discussions on therapeutic fusion proteins.

New company to develop novel cell-based cancer immunotherapies in China.

The combined offering is aimed at helping biopharmaceutical manufacturers increase productivity, improve efficiency and reduce costs.

New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype.

New ready-to-use assays enable quick and simple generation of precise biosimilar comparability data.

Thermo Scientific Sorvall BIOS 16 centrifuge designed to provide simplified, flexible bioprocessing.

Scientists can meet with BioPharmaSpec experts at BioPharma Asia to discuss characterization strategies for accelerating their biosimilar development.

ModiQuest will screen their high class in-house phage display libraries, ModiPhage.

GBI Research says pipeline consists of 29% monoclonal antibodies.

The packaging has been specifically designed for the processing of small batches such as clinical and technical lots, orphan drugs or personalized medicines.

The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020.

Facility being operated by Avid Bioservices subsidiary with capacity to potentially generate additional $40 million in annual revenue.

Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells.

Certified quality of analytical services for developers of biologics and biosimilars .

£22 million investment in Liverpool by global biopharma company.

BalanCD CHO Feed 4 is a chemically-defined, animal component-free powder feed for large-scale bioproduction in a variety of high performing CHO cells.

Designed for use in biotechnological applications, especially for membrane screening and small-volume process development.

Symbiosis Pharmaceutical Services has picked-up several new clients in North America, which has primarily been driven by companies looking for small-scale aseptic manufacturing capabilities to support clinical trials.

First biotech company in Greater China region to receive European approval.

Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab.

The first biosimilar monoclonal antibody reviewed, for all eligible indications.

Positive opinion based on reduction in the risk of disease progression or death with Empliciti in combination with standard of care regimen for multiple myeloma demonstrated in ELOQUENT-2 study.

Gary Zieziula to head biopharma business in North America and Marc Horn to lead biopharma business in China.

Redipor prepared media to be supplied directly to customers.

FDA grants Priority Review with target action date of 23 July 23 2016.

Transparency Market Research has announced the publication of a new report, titled "Biological Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020".

New website will support clients in developing and implementing entire single-use bioprocesses.

Albumedix strengthens its leading position in albumin-based drug delivery through acquisition of Eleven's Supermin albumin technology.

The new stand-alone company Albumedix will continue to develop albumin-based products and technologies for the pharmaceutical industry.

The ideal solution for scaling studies and low volume ultra- and diafiltration operations.

Lonza adds two 1000-L single-use bioreactor systems to its current mammalian manufacturing capacity.

Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis

The assets will broaden AmpliPhi's IP portfolio and speed the development of its phage therapies

Takeda intends to use the facility primarily for the manufacture of Entyvio (vedolizumab) and other biologic products.

The total investment is around a half billion euro.

Facility will manufacture biologics for clinical trials.

New offering incorporates clinical, commercial and regulatory insight to improve the probability of an asset’s commercial success.

The PnuBioVax vaccine contains heat shock proteins and multiple antigens produced by a modified form of S. pneumoniae, leading to a mechanism of action which is expected to be strain-independent.

Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck

The company showcases the innovative Syrina 2.25 auto-injector that brings the flexibility to design a unique form factor and also the full Syrina platform accommodating multiple primary containers and high viscous, high volume injections.

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

The projected FDA action date is 16 March 2016.

Coated stoppers for sensitive and high-value injectables.

First completed Phase III study of adalimumab biosimilar in the treatment of patients with moderate-to-severe RA.

The system offers parallel processing and walk-away control of 24 micro bioreactors.

Trastuzumab development and transfer for first Indonesian on-site production.