Biopharma News
Biopharma News
-
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.