Biopharma News
Biopharma news
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News SGS expands testing capabilities at its Glasgow facility
Clients will benefit from a fully comprehensive range of validated biosafety methods to support cell bank and viral vaccine manufacturing and lot release of drug product. -
News TC BioPharm creates allogeneic cell banks for CAR-T cancer therapy products
The first completed bio-banks will be used to develop more cost-effective, safe and efficacious cancer treatments. -
News Alvotech completes US $300 million financing deal
Fuels growth and biosimilar development in a fast-growing market. -
News Sartorius introduces BIOSTAT RM TX single-use bioreactor
Flexsafe RM TX bags enable reliable process performance for optimal cell growth. -
News Univercells introduces breakthrough vaccine manufacturing platform
The automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint. -
News Allergan to establish R&D presence in Cambridge, Massachusetts
The new, strategic presence will allow the company to more easily interact and engage with venture firms and start ups in the area. -
News Expedeon signs supply and license agreement for is Lightning-Link technology
The technology will enable Cell Guidance Systems to manufacture TRIFic detection assays on-demand with highly reproducible and scalable results. -
News BMS and Celgene merge to create premier innovative biopharma company
Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential. -
News Pall opens Center of Excellence in Shanghai
The CoE showcases the latest end-to-end technological solutions for biomanufacturing. -
News New gene therapy manufacturing facility for Orchard Therapeutics
Enhances company's capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells for wide range of diseases on a global scale. -
News Grant winners to investigate continuous manufacturing for gene therapies
Cobra Biologics, Pall, and the Cell and Gene Therapy Catapult share £1.5 million grant from the UK's innovation agency. -
News ADC Bio secures additional equity round investment
Extra funding for strategic move into downstream formulation and fill finish capabilities and full exploitation of Lock-Release as new ADC manufacturing paradigm. -
News SSB and Lonza modify relationship for supply of cell culture media
Sartorius Stedim Biotech will continue to offer Lonza media and buffer products but under a non-exclusive agreement. -
News bioLIVE to merge with BioProduction Congress for 2019 event
BioProduction’s content platform will be added to the bioLIVE exhibition, creating one of the world’s largest event hubs for the bio industry. -
News Sandoz pulls the plug on US biosimilar rituximab
Company will focus on robust biosimilar portfolio for unmet access and sustainability needs. -
News Three-way collaboration to advance gene therapy
Partnership aims to increase the robustness and reduce costs for the manufacturing of AAV vectors. -
News Bioconjugation expertise and increased productivity in bio over next 5 years
Smaller bioreactors and high-density perfusion techniques needed as manufacturing makes significant efficiency improvements. -
News Alvotech receives manufacturing licence for its biopharmaceutical facility
Facility to focus on developing and manufacturing the company's biosimilar portfolio. -
News Complete product lifecycle management in one location
Lonza expansion includes drug substance development, and drug substance and drug product manufacturing. -
News BIA Separations expands with new upstream processing facility
Provides single source of expertise for scaled production of complex biologics for gene therapy and vaccines. -
News Partnership to deliver integrated, off-the-shelf biosimilar manufacturing solutions
Pall and Aetos to advance the market impact of biosimilars and deliver lower-priced, high-quality options to end users. -
News Aptar Pharma to showcase an industry first
PureHale is a new portable drug delivery device designed for upper respiratory care. -
News New SGS biopharmaceutical testing capabilities in Illinois
The new services will focus on quality control analysis and stability testing of biopharmaceuticals. -
News Novartis to divest the Sandoz US dermatology business and generic US oral solids portfolio
The Sandoz US portfolios to be sold to Aurobindo include approximately 300 products, as well as additional development projects. -
News Sartorius and Repligen partner to introduce next-generation perfusion-enabled bioreactors
Customers to benefit from simplified, scalable solutions for intensified cell culture. -
News Plasticell wins military contract to develop regenerative medicines for the battlefield
Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets. -
News Bio processing and manufacturing league table ranks US top and China bottom
US, Germany and Japan revealed as tier one nations in all categories with Sweden ranking the best of the rest. -
News New biopharmaceutical testing laboratory to open in Geneva
SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products. -
News Exosome isolation manufacturing and characterization
New service to reliably and reproducibly isolate exosomes from almost any biofluid. -
News Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines
Company moves away from manual processing in favour of automated, scalable platforms. -
News Extended distribution agreement enables customers to continuously improve their bioprocesses
Agreement includes Pall's next-generation Kaneka KanCapA 3G sorbent for the primary capture of mAbs from clarified cell culture. -
News Amgen breaks ground on next-generation biomanufacturing plant in Rhode Island
The plant will be first-of-its-kind in the US. -
News Partnership struck to aid bio manufacturers
Pall and BioSciencesCorp unite to provide "total solutions" for today's drug manufacturers. -
News WuXi STA and Antengene sign development and manufacturing agreement
WuXi STA chosen for its end-to-end CMC platform for new drug development. -
News New screening company exploits the latest advances in microfluidics and 3D culture
The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity. -
News South Korea's finished drug market growth driven by generics
FDF launches at CPHI Korea as country set to become regional hub. -
News Plasticell leads gene therapy manufacturing consortium
Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies. -
News Ingredients to improve bioprocess manufacturing efficiency
Experts warn bio industry needs to do more to create a sustainable pipeline of talent. -
News CellGenix completes first step of facility expansion
Next expansion step will increase finished product capacity for recombinant proteins by more than tenfold. -
News Extended co-operation agreement to benefit Sartorius customers
Agreement will enable customers to achieve easier scalability of processes ranging from lab-scale to commercial-scale production of biopharmaceuticals. -
News Thermo invests $50 million to enhance biologics capabilities
With the capacity expansion, Thermo Fisher will have the second largest base of single-use bioproduction capacity at a CDMO in the world. -
News Cost-effective, scalable process development of vaccines in cell culture
Sartorius Stedim Biotech introduces its mini microcarrier bioreactor for culturing adherent cells. -
News Wacker acquisition increases cost-effective pharmaceutical production
The contract manufacturer strengthens its pharmaceutical-protein business with Dutch acquisition -
News Amgen to build first-of-its-kind biomanufacturing plant in the US
Revolutionary, innovative plant offers greater flexibility, speed and efficiency. -
News JXTGE to sell Irvine Scientific to FujiFilm
With the acquisition of Irvine Scientific, FujiFilm will have a full product line supporting customers supplying antibody drugs to assisted reproductive technologies and cell therapy. -
News bioLIVE to introduce global biopharma country ranking
Global analysis will rank each major biomanufacturing country’s market growth potential, innovation and competitiveness. -
News Top marks for Cherwell’s Redipor prepared microbial media products
Extensive range of ready-to-use culture media available in bottles and plates. -
News ProJect Pharmaceutics expands facilities for formulation and lyophilization process development
Expansions to meet safety requirements for GMO S2 and BSL-2 biological products. -
News Revolutionary downstream bioconjugation method under development
New manufacturing paradigm will save 25% of total costs and the need for proteinaceous A & G resins. -
News A powerful new tool for the separation of charged species
A new analytical tool, Electrical Asymmetrical Flow Field-Flow Fractionation (EAF4) is showing much promise in biopharmaceutical and nanoparticle applications. -
News New Pall business unit launches to focus on end-to-end drug manufacturing models
Pall Biotech to focus on enabling drug manufacturers to rapidly transition from pre-clinical to commercial manufacturing. -
News Ablynx - Sanofi's new acquisition
Strengthens Sanofi's R&D strategy with innovative Nanobody technology platform. -
News Sandoz and Biocon to collaborate on next-generation biosimilars
Collaboration will leverage combined strengths of development, manufacturing and commercialization of biosimilars. -
News SSB to equip Abzena's US-based development and manufacturing sites
SSB will provide both facilities with end-to-end process solutions in single-use format. -
News Momenta and Mylan to development proposed biosimilar to Eylea
Targeting the initiation of a pivotal patient clinical trial in the first half of 2018. -
News ANVISA approves Biocon and Mylan's biosimilar Trastuzumab
Libbs will commercialize the product in Brazil under the brand name Zedora. -
News Major changes for bio supply forecast in 2018 by bioLIVE
Integration of supply chain a critical issue as industry globalises, with a resurgence in European manufacturing and biotech markets forecast. -
News Hikma signs licensing agreement with Celltrion for third biosimilar product in MENA region
Truxima is mAb biosimilar to Roche's MabThera (rituximab). -
News CMC Biologics and Harpoon Therapeutics collaborate on exciting new TriTAC molecules
First clinical candidate, HPN424, is in development for the treatment of metastatic prostate cancer and expected to enter Phase I clinical trials in 2018. -
News SGS introduces GMP DNA sequencing service at its Glasgow, UK, laboratory
Service complements existing services for this testing, to provide comprehensive analysis and characterization solutions for clients involved in the production and manufacturing of biopharmaceutical products. -
News SGS launches new large molecule bioanalytical services
Investment builds on company's expertise in small molecule analysis and the use of LC/MS-MS techniques. -
News Expansion of CSL Biotech facility drives advanced manufacturing growth
The development will help meet growing global demand for albumin. -
News Global ADC Bio clients to benefit from new dedicated bioconjugation facility
The design, planning and building work commences immediately and will deliver a purpose-built, dual-stream facility. -
News New clarification platform delivers robust, accelerated performance across multiple mAb processes
The Stax mAx, a single-use harvesting platform, minimizes the impact of process variability between batches. -
News Poor aggregation will see ADC targets fail or face long delays
Experts at ADC Bio warn of impending problems in the ADC pipeline with millions wasted in development costs. -
News Celonic acquires Glycotope’s biomanufacturing facility
Combined technology assets will provides pharmaceutical and biotech customers the unique opportunity to select a tailored expression system. -
News Eurofins creates one of the largest dedicated testing sites of its kind in the UK
£4 million investment will allow the Biopharmaceutical Product Testing business to expand its finished product and raw materials testing and increase capacity to deal with higher volumes. -
News New dedicated biopharma event launches alongside CPHI Worldwide 2018 in Madrid
New event to create unique synergies between the parallel worlds of large, small molecules and contract services. -
News Batavia expands its viral vector and cleanroom facilities to stay on top of demand
Investments will help the company to bring candidate biopharmaceuticals from bench to clinic. -
News Construction starts for Sartorius' new Cell Culture Technology Centre
The 30-million-euro investment will accommodate the growing needs of customers. -
News PnuVax awarded $29.4 million grant to advance innovative vaccine into clinical trials
Use of PnuVax’s unique patented conjugation platform technology to produce the vaccine is expected to speed up biomanufacturing and increase yield for a greatly reduced per-dose cost. -
News 3SBio accelerates expansion of its global biologics platform
The Chinese biopharmaceutical company acquires the Canadian biomanufacturing business of Therapure. -
News Bayer submits BLA in the for BAY94-9027 – a long-acting factor VIII for the treatment of hemophilia A
Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals. -
News Merck successfully closes biosimilars transaction
Step towards strategic alignment of R&D resources to Healthcare priorities. -
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.
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