Biopharma News
Biopharma news
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News Zenith Technologies and GE Healthcare Life Sciences strike biopharma alliance
The combined offering is aimed at helping biopharmaceutical manufacturers increase productivity, improve efficiency and reduce costs. -
News FDA approves Teva's Cinqair (reslizumab) Injection
New biologic for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype. -
News Sartorius Stedim BioOutsource introduces assays for testing biosimilarity of three leading biologics
New ready-to-use assays enable quick and simple generation of precise biosimilar comparability data. -
News New large-capacity bioprocessing centrifuge enhances productivity and reliability
Thermo Scientific Sorvall BIOS 16 centrifuge designed to provide simplified, flexible bioprocessing. -
News BioPharmaSpec expanding into Asia with new business development teams
Scientists can meet with BioPharmaSpec experts at BioPharma Asia to discuss characterization strategies for accelerating their biosimilar development. -
News ModiQuest Research and Sobi to continue their collaboration on antibody generation
ModiQuest will screen their high class in-house phage display libraries, ModiPhage. -
News Monoclonal antibodies headline innovation in gastric cancer treatment pipeline
GBI Research says pipeline consists of 29% monoclonal antibodies. -
News Pall launches pyrofree sterile, ready-to-use glass vials
The packaging has been specifically designed for the processing of small batches such as clinical and technical lots, orphan drugs or personalized medicines. -
News FDA issues a draft guidance for industry on Implementation of the ‘Deemed to be a License’ Provision of the BPCI Act of 2009
The draft guidance explains that FDA will not approve any pending or tentatively approved application for a biological product under the FD&C Act after 23 March 2020. -
News Peregrine Pharmaceuticals announces formal commissioning of new, state-of-the-art commercial manufacturing facility
Facility being operated by Avid Bioservices subsidiary with capacity to potentially generate additional $40 million in annual revenue. -
News FDA accepts sBLA for Keytruda (pembrolizumab) in advanced NSCLC
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. -
News Sartorius Stedim BioOutsource contract testing facility in Glasgow successfully passes FDA inspection
Certified quality of analytical services for developers of biologics and biosimilars . -
News World’s second biggest influenza vaccine manufacturer expands operations at Speke site
£22 million investment in Liverpool by global biopharma company. -
News Irvine Scientific launches new feed media to maximize productivity in large-scale bioproduction
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. -
News Sartocon Slice 50: Sartorius Stedim Biotech presents a new small-scale crossflow device
Designed for use in biotechnological applications, especially for membrane screening and small-volume process development. -
News US biotechs driving growth at Scottish CMO
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. -
News JHL Biotech receives approval From European authorities to begin biosimilar clinical trial
First biotech company in Greater China region to receive European approval. -
News Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA
Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab. -
News Pfizer commends FDA Advisory Committee’s vote to approve proposed biosimilar infliximab
The first biosimilar monoclonal antibody reviewed, for all eligible indications. -
News BMS and AbbVie receive positive CHMP opinion for investigational antibody, Empliciti, for the treatment of multiple myeloma
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. -
News Merck announces new biopharma heads for North America and China
Gary Zieziula to head biopharma business in North America and Marc Horn to lead biopharma business in China. -
News Cherwell improves support for pharmaceutical microbiology in Republic of Ireland
Redipor prepared media to be supplied directly to customers. -
News Merck announces FDA acceptance of BLA for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile infection recurrence
FDA grants Priority Review with target action date of 23 July 23 2016. -
News Biological drugs market set to grow at a CAGR of 10.10% to reach US$287.1 billion by 2020
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". -
News Sartorius Stedim Biotech launches Integrated Solutions online resource center
New website will support clients in developing and implementing entire single-use bioprocesses. -
News Albumedix and Eleven Biotherapeutics announce albumin variant technology agreement
Albumedix strengthens its leading position in albumin-based drug delivery through acquisition of Eleven's Supermin albumin technology. -
News Novozymes separates its biopharma activities to form independent company
The new stand-alone company Albumedix will continue to develop albumin-based products and technologies for the pharmaceutical industry. -
News Sartorius Stedim Biotech presents new crossflow filtration system for process development
The ideal solution for scaling studies and low volume ultra- and diafiltration operations. -
News Lonza expands single-use manufacturing capacity in Slough facility to meet customer demand
Lonza adds two 1000-L single-use bioreactor systems to its current mammalian manufacturing capacity. -
News Regeneron and Sanofi announce sarilumab BLA Accepted for review by FDA
Sarilumab is an investigational, human monoclonal antibody intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis -
News AmpliPhi acquires key bacteriophage assets from UK-based Novolytics
The assets will broaden AmpliPhi's IP portfolio and speed the development of its phage therapies -
News Takeda acquires US biologics manufacturing facility
Takeda intends to use the facility primarily for the manufacture of Entyvio (vedolizumab) and other biologic products. -
News Boehringer Ingelheim invests in Europe: pharma company expands biopharmaceutical production at Vienna site
The total investment is around a half billion euro. -
News BeiGene selects GE’s FlexFactory biomanufacturing platform for pilot cGMP production facility in China
Facility will manufacture biologics for clinical trials. -
News Quintiles launches suite of services to integrate asset development planning
New offering incorporates clinical, commercial and regulatory insight to improve the probability of an asset’s commercial success. -
News ImmBio initiates First-in-Human studies of its novel pneumococcal vaccine, PnuBioVax
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. -
News Merck Announces Samsung Bioepis receives approval of Renfelxis (infliximab), a biosimilar of Remicade, in Korea
Samsung Bioepis’ second immunology biosimilar approved, to be commercialized under partnership with Merck -
News Bespak addresses India’s biopharmaceutical drive for high value drug delivery products that differentiate generics, biobetters and biosimilars at CPHI India 2015
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. -
News Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA
Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. -
News FDA accepts for priority review the sBLA for Opdivo in patients with advanced renal cell carcinoma
The projected FDA action date is 16 March 2016. -
News Aptar Stelmi to feature PremiumCoat at CPHI India
Coated stoppers for sensitive and high-value injectables. -
News Amgen presents detailed results from Phase III study demonstrating clinical equivalence of biosimilar candidate ABP 501 with adalimumab
First completed Phase III study of adalimumab biosimilar in the treatment of patients with moderate-to-severe RA. -
News New ambr 15 fermentation micro-scale bioreactor system provides enhanced microbial strain screening
The system offers parallel processing and walk-away control of 24 micro bioreactors. -
News ProBioGen in biosimilar deal with Bio Farma Indonesia
Trastuzumab development and transfer for first Indonesian on-site production. -
News Regeneron announces an additional $350 million investment and 200 new jobs in Limerick by end-2017
Raheen site will be largest capacity biopharmaceutical production facility in Ireland. -
News Sartorius Stedim Biotech launches Flexsafe 3D Pre-Designed Solutions for storage and shipping applications
New S80 film features consistent cell growth, robustness and high quality. -
News Merck Millipore adds protein pegylation to portfolio of services
Services include feasibility studies, process and analytical development and scale-up. -
News ShangPharma and Qidong Biopharma Industrial Zone sign an agreement for a $60-million investment in China
The plans include a multifunctional preclinical research facility and a state-of-the-art biologics manufacturing facility. -
News Sandoz inaugurates BioInject — a new biopharmaceutical manufacturing facility in Schaftenau, Austria
BioInject is a state-of-the-art facility that will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics. -
News Horizon Discovery Group enters bioproduction cell line licensing agreement with LakePharma
The terms of the license cover commercial use of a genetically-engineered Chinese Hamster Ovary (CHO) cell line, developed by Horizon and adapted to manufacturing conditions by LakePharma. -
News AstraZeneca purchases US biologics manufacturing facility to support growing pipeline
The LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the company’s extensive portfolio of biologics medicines. -
News SGS Life Sciences Services to host 4th Antwerp Biopharm Seminar on clinical trial solutions
The one-day conference, entitled “Safety and Efficacy — Clinical Trials Solutions”, will bring together experts from SGS Life Services and the wider pharmaceutical industry, to discuss advances in biopharmaceutical research and development and combine ... -
News Aragen Bioscience announces licensing agreement for protein production technology from ProteoNic Biotechnology
Under the terms of the agreement, Aragen gains the rights to apply this technology to the development of recombinant cell lines with significantly enhanced commercial production levels compared to current methods.
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