Biopharma News
Biopharma news
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News Biogen’s adalimumab biosimilar referencing Humira, is approved in the EU
Biogen becomes the first company with approved biosimilars for the three most prescribed anti-TNF biologic treatments in Europe. -
News Boehringer Ingelheim receives FDA approval for its Humira biosimilar
Cyltezo approved for the treatment of multiple chronic inflammatory diseases. -
News Biopharma stages a strong recovery over the first half even as M&A deals disappoint
EP Vantage releases half-year reviews of pharma & biotech and medtech performance. -
News Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis
Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate. -
News Boehringer starts clinical study on interchangeability between adalimumab biosimilar candidate and US-formulated Humira
First study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate. -
News Pall introduces proprietary bioreactor control system
The mPath bioreactor control system is the first to be developed and delivered by a technology supplier specifically for their product line, allowing full access to bioreactor capabilities that current commercial solutions cannot provide. -
News Valeant launches Siliq Injection in US
Dermatology unit is rebranded Ortho Dermatologics. -
News Merck launches Remicade biosimilar for all eligible indications, in the US
The biosimilar's list price will represent a 35% discount to the current list price of Remicade. -
News Lilly backs Nektar Therapeutics' novel immunological therapy
NKTR-358 has the potential to treat a number of autoimmune and other chronic inflammatory conditions. -
News GSK delivers double-edged sword
Company announces investments, the sale of several products and a proposal to close a UK manufacturing site. -
News FDA committee recommends approval of Mylan and Biocon's proposed biosimilar trastuzumab
Vote marks first proposed biosimilar trastuzumab to be recommended by the committee. -
News FDA approves Blincyto to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy. -
News Sanofi to acquire Protein Sciences
Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur's portfolio. -
News BIOCAD’s rituximab biosimilar to receive MA in India
First shipment of BIOCAD’s Acellbia to India is scheduled for September 2017. -
News FDA approves Vectibix for use in wild-type RAS metastatic colorectal cancer
First-and-only fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population. -
News Biogen’s Imraldi, an adalimumab biosimilar candidate referencing Humira, granted positive opinion by CHMP
If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe. -
News FDA accepts Amgen's sBLA to expand indication for Xgeva to include multiple myeloma patients
Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US. -
News Sandoz receives approval in Europe for Rixathon to treat blood cancers and immunological diseases
Sandoz now has four biosimilars approved in Europe - more than any other company. -
News FDA Advisory Committee to review Avastin biosimilar candidate
The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC. -
News Sartorius Stedim Biotech launches ambr 15 bioreactor system with Nova BioProfile FLEX2 integration
QbD studies in upstream processing more rapidly performed. -
News Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA
Biosimilar infliximab alone could potentially save the NHS £89 million. -
News Boehringer Ingelheim inaugurates biopharmaceutical manufacturing facility in China
It is the first and only biopharmaceutical manufacturing site established by a multinational active pharmaceutical company in China. -
News Irvine Scientific launches new xeno-free medium for hematopoietic progenitor cell culture
New medium designed for hematopoietic cell culture for cell-based therapies. -
News Sartorius Stedim Biotech partners with Nova Biomedical
Unique tool will allow massive quantities of cell culture data to be collected during upstream processing QbD studies. -
News Merck launches industry's first off-the-shelf cell culture media for perfusion processes
Allows customers to achieve a more optimal output than they would using conventional batch or fed-batch processes. -
News Sartorius Stedim Biotech launches chemistry testing services
This chemistry testing offer complements the company’s existing range of off-the-shelf biological assays for biosimilar products, providing a complete solution from one contract partner. -
News GSK invests $139 million to expand production capacity for Benlysta in Rockville
Site is also expected to house production of a new subcutaneous form of belimumab, which is currently under review with the FDA. -
News Sartorius introduces new BIOSTAT STR bioreactor range and new Flexsafe STR single-use bags
New generation of bioreactors combined with new Flexsafe STR bags offer a fully scalable, single-use system. -
News Fresenius Kabi to strengthen and diversify product portfolio by acquiring Akorn and Merck KGaA’s biosimilars business
Transactions provide access to attractive pharmaceutical growth markets. -
News Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers. -
News Fujifilm increases production capacity and establishes new process development facilities
$130M USD investment to support growing market demand. -
News Millipore Express high area filters ideal for processing feed streams with high particulate levels
Greater filtration capacity with a smaller footprint than conventional filters, improving economics for biopharmaceutical manufacturing. -
News Amgen submits applications in the US and Europe to expand current indication for Xgeva
Applications include data from the largest international trial conducted in multiple myeloma. -
News Analytical protein aggregate separation without a column
System can achieve separations with higher resolution, reproducibility and recovery then has previously been possible. -
News $100 billion of revenues up for grabs for drug manufacturers as patents for key biologics expire
For success in the biosimilars sector, manufacturers must adopt QbD, DoE and PAT initiatives. -
News Proclara Biosciences Australia awarded grant to help develop new biotherapy with blockbuster potential
Work on a second-generation fusion protein due to start in 2017 at Patheon's manufacturing facility in Brisbane. -
News Horizon Discovery enters into R&D and licensing partnership for bioproduction cell line optimisation
Partnership formed to evaluate the impact of Amplycell’s novel cell fitness technology on expression capacity of Horizon’s bioproduction cell line. -
News Apotex to invest $184 million to grow US manufacturing presence
Expansion plan comprises company's largest investment in the US. -
News Sandoz proposed biosimilar adalimumab demonstrates equivalent efficacy as Humira
Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. -
News First ever biosimilar of interferon beta-1a approved in Russia
Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis. -
News Allergopharma opens new biopharmaceutical production in Reinbek
Merck's €42 million investment expands the allergies business on a global scale. -
News Sanofi Pasteur and MedImmune collaborate on monoclonal antibody to prevent illnesses associated with RSV
MEDI8897 has been engineered to have a long half-life so that only one dose would be needed for the entire RSV season. -
News Roquette commits to bioharma market with new products
Reinforces position as a supplier of excipients and raw materials for the pharmaceutical and biopharmaceutical industries. -
News FDA accepts BLA for avelumab for the treatment of metastatic urothelial carcinoma for Priority Review
Second Biologics License Application accepted by the FDA for avelumab. -
News Sanofi and Lonza join hands to establish large-scale biologics production facility
Partnership leverages Lonza's expertise in large-scale mammalian cell culture facilities alongside Sanofi's strength in developing and launching biologics based treatments. -
News Valeant's treatment for plaque psoriasis gets FDA thumbs up for Siliq
More than 50% of patients in three clinical studies who used Siliq achieved total skin clearance within a year. -
News Austrian Centre of Industrial Biotechnology and GE Healthcare establish a cell line engineering collaboration
Partnership to explore and identify new tools and methods to modify and optimize the CHO cell line performance. -
News FDA accepts two sBLAs for Merck's Keytruda for metastatic urothelial cancer
Keytruda also receives Breakthrough Therapy Designation for second-line treatment. -
News Leukocare signs up to become Rentschler's specialized tech partner and formulation developer
Rentschler will become the first and only CDMO to have access to Leukocare's patented SPS formulation technologies. -
News Rapid emergence of MENA biologics industry sees first ever Biopharma Conference and new venue at CPHI Istanbul 2017
Developments in local manufacturing, regulatory strategies, market entry and harmonisation to be debated by MENA leaders and Government. -
News First adalimumab biosimilar candidate recommended for EMA approval
Amgen receives positive CHMP opinion for biosimilar adalimumab. -
News Zymeworks opens state-of-the-art lab facility
Provides the company with increased control over discovery research, antibody generation, medicinal chemistry and bioconjugation for generating antibody drug conjugates. -
News Sartorius Stedim Biotech opens a new validation service laboratory at its Shanghai site
Comprehensive validation services for the Chinese market. -
News FDA accepts BLA for Mylan and Biocon's proposed biosimilar trastuzumab
If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the US. -
News Merck expands end-to-end biodevelopment centers
Expansionincludes the opening of two new process development centers in the US and China. -
News JAMA publishes Mylan and Biocon's proposed biosimilar trastuzumab Phase III data
Published study results showed an overall response rate of 69.6% for MYL-1401O compared to 64% for branded trastuzumab. -
News FDA extends review of application for Ocrevus
Extension is the result of the submission of additional data regarding the commercial manufacturing process of the biologic. -
News Planning permission granted for new Shire manufacturing site in Ireland
Site will use the latest bioprocessing techniques and will employ flexible production strategies to enable it to supply both clinical- and commercial-scale products. -
News Interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product
If approved, the product could provide blood cancer patients with access to potentially life-saving medicine. -
News Smaller companies could carve out a sizeable niche in future influenza vaccines space
New entrants, as well as smaller companies, will expand the use of cell culture-based manufacturing methods to increase their presence. -
News Study confirms Sandoz biosimilar etanercept has equivalent efficacy to originator
No clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks. -
News Sartorius Stedim Biotech opens new bioanalytical testing laboratory in Boston
New services to enable US biopharmaceutical companies to accelerate development of biosimilars. -
News Increased development of highly-targeted biologics set to change composition of asthma therapeutics market
Biologics and monoclonal antibodies to become a bigger presence within the small-molecule-dominated landscape. -
News Mylan and Biocon announce FDA submission for proposed biosimilar trastuzumab
Potential to be first submission of a proposed biosimilar trastuzumab in the US. -
News EMA validates the MAA for avelumab for the treatment of metastatic Merkel cell carcinoma
If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma. -
News Boehringer Ingelheim's adalimumab biosimilar candidate shows promise
Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis. -
News Pfizer announces US availability of biosimilar Inflectra
Inflectra will be the first biosimilar monoclonal antibody (mAb) to be available in the US. -
News Merck Research Laboratories facilities designated as “Milestones in Microbiology” sites
Facilities chosen for their contributions to anti-infectives and vaccines. -
News Pall Life Sciences wins BPI 2016 Best Downstream Application Award
Cadence Acoustic Separator system is a novel single-use solution for the clarification of cell culture bioprocess fluids. -
News SSB launches two single-use Sartocon loop assemblies with integrated polyethersulfone membrane
Assemblies save up to 60% on processing time and offer a safe approach to ultrafiltration of biologics and vaccines. -
News Pall Life Sciences to introduce continuous bioprocessing with single-use technologies
Will enable manufacturers to reduce costs by eliminating cleaning and validation requirements, as well as hardware infrastructure. -
News AbbVie opens first phase of its global manufacturing facility in Singapore
New site expands the company's global operations for small molecule and biologics manufacturing, and marks the company's first manufacturing presence in Asia. -
News FDA approves Amgen's new biosimilar for multiple inflammatory diseases
Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases. -
News GE to invest €150 million in biopharmaceutical manufacturing campus in Ireland
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. -
News Rentschler doubles manufacturing capacity to address growing demand for biopharmaceuticals
Innovative Twin system with two 3,000-L bioreactors and associated downstream processing equipment put into operation. Second significant expansion in one year. -
News AstraZeneca's first biologic respiratory medicine shows positive results in severe asthma
Benralizumab Phase III trials met primary and key secondary endpoints. -
News Sartorius Stedim Biotech presents the first fully integrated upstream platform
Unique product and service portfolio extensively covers all steps from cell line development to commercial manufacturing processes. -
News Vibalogics set for live biological filling boost
The CDMO has expanded its capabilities with a new automatic vial filling line to meet increased demand. -
News Merck announces FDA filing acceptance of NDA for MK-1293, an investigational follow-on biologic insulin glargine
Marketing Authorization Application to the EMA currently under review. -
News Catalent Biologics and Zumutor collaborate to develop antibodies with enhanced ADCC Activity
The partnership created a fucose knockout GPEx cell line expressing high levels of an anti-HER2 antibody. -
News Merck to provide Provantage End-to-End development and manufacturing services to Y-mAbs for lead antibody compound
Includes scale-up and GMP manufacturing of drugs in late-stage development. -
News Codexis completes obligations under R&D agreement with leading biopharmaceutical company
Enzyme developed with CodeEvolver technology for preclinical therapeutics program exceeds agreement requirements. -
News GSK announces significant new investment in UK manufacturing network
Investment in advanced manufacturing of new respiratory and biopharmaceuticals portfolio. -
News SB5, an adalimumab biosimilar referencing Humira, accepted for review by EMA
The approval of SB5 could make Biogen the first company to commercialize three anti-TNF biosimilar therapies in Europe. -
News Merck relaunches customer collaboration centers with new concept and M Lab name
Enables explorations of new technologies and solutions to address development and manufacturing challenges. -
News Cipla to launch South Africa’s first biotech manufacturing facility
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. -
News Sartorius Stedim BioOutsource introduces new Released N-Glycan Assay
In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data. -
News Sartorius Stedim Biotech acquires US start-up kSep Systems
Transaction to expand SSB’s bioprocessing product portfolio with innovative single-use centrifuges. -
News LEO Pharma enters biologics through strategic partnership with AstraZeneca
The partnership covers potential new medicines for atopic dermatitis and psoriasis. -
News Pfizer invests in a new world-class global biotechnology center in China
State-of-the-art facility will foster the continued development of the biotechnology industry in China, further supporting national healthcare reforms. -
News Sandoz announces plans for five major global biosimilar launches by 2020
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. -
News Sartorius Stedim Biotech launches innovative ambr 250 modular bioreactor system
New expandable benchtop workstation with unique single-use bioreactor design offers a simple approach to process development for fermentation and cell culture. -
News New Sartorius Stedim BioOutsource microsite goes live
Cellca’s cell line and upstream process development services now integrated. -
News Health Canada approves Inflectra (biosimilar infliximab) for three additional indications
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. -
News Sartorius Stedim Biotech presents Virosart Media
Offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials during fermentation. -
News Merck expands its Investment Fund Merck Ventures
Total fund size doubled to up to €300 million. -
News Alvotech opens state-of-the-art biosimilar facility in Iceland
The new facility will significantly increase Alvotech’s production capacity enabling the group to produce higher yields at lower costs. -
News SGS introduces new hydrogen deuterium exchange capabilities for protein characterisation and biopharmaceutical development
Company will be one of the first service providers to offer HDX-MS in a cGMP environment. -
News Fujifilm Diosynth collaborates with MSD on a new 20,000-L microbial biologics facility
Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations. -
News CMC Biologics expands GMP manufacturing capacity in Europe
Addition of a Bioreactor 3PACK production facility to its Copenhagen facility provides additional flexible solutions for clients. -
News WuXi Biologics and Sartorius Stedim Biotech open joint laboratory in Shanghai
Certified leading upstream platform powers China’s biopharmaceutical development. -
News Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU
Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU. -
News BioPharma Services USA awarded a 5 Year, $20 million contract with the FDA
The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021. -
News BMS opens expanded biologics facility
$280 million project increases workforce, adds new capabilities -
News AstraZeneca announces positive results from benralizumab Phase III programme in severe asthma
Benralizumab first AstraZeneca respiratory biologic to complete Phase III. -
News Fujifilm Diosynth Biotechnologies opens new laboratory facility in Research Triangle Park, NC
Construction now complete on new 62,000 square foot facility. -
News JHL Biotech opens innovative biosimilars manufacturing facility in China
GE Healthcare delivers world’s first modular manufacturing solution based on single-use bioprocessing technology in just 18 months. -
News FDA grants Priority Review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
Lilly has received additional designations for olaratumab from the FDA, including Breakthrough Therapy, Fast Track and Orphan Drug, for this indication. -
News Alnylam breaks ground on new manufacturing facility in Norton, Massachusetts
200,000 sq ft state-of-the-art biopharmaceutical manufacturing facility supports expanding development pipeline and transition toward commercial stage. -
News Merck introduces first multi-use disposable sterile connectors for biopharma
New Lynx CDR connectors facilitate faster and more economic biopharma fluid management. -
News Pall Life Sciences launches commercial Cadence Acoustic Separator for intensified bioprocess clarification and purification applications
The commercial launch of the CAS is the first in a series of product launches that enable continuous bioprocessing. -
News Eppendorf Centrifuge 5920 R: the new benchmark in capacity and performance
Also offers a powerful state-of-the-art refrigeration system with advanced temperature management. -
News SGS introduces new bio-layer interferometry analysis for biopharmaceutical development
This new service offers a number of advantages compared with current analytical techniques. -
News New webinar: optimizing analytics for biosimilars
How providing comprehensive data can accelerate drug development. -
News NIH study finds factors that may influence influenza vaccine effectiveness
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. -
News ProBioGen and Eucodis sign agreement to commercialize C-LiNK, a novel ADC technology
Novel enzymatic, 1-step site-specific protein conjugation technology for ADC production. -
News Tech Transfer: 9th BioVaria to take place in Munich on 17 May 2016
Ascenion unveils technology highlights: New approaches for the treatment of neurodegenerative disorders and glioblastoma. -
News Rentschler: 4th Laupheim Biotech Days to take place 13–14 June 2016
Exciting lectures and discussions on therapeutic fusion proteins. -
News Juno Therapeutics and WuXi AppTec announce new company
New company to develop novel cell-based cancer immunotherapies in China.
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