In an attempt to battle low production volumes of hard-to-manufacture biopharmaceuticals, GE Healthcare announced on January 4, 2017 that it will partner with Synpromics on the development of synthetic promotors. The goal of the collaboration is to identify promoters that will work most effectively with GE’s existing expression system for optimal transcription.
IPEC-Americas published a position paper in response to misconceptions regarding DMFs.
The combined company’s turnover is estimated to reach €8 million ($8.35M) in 2017.
Sun Pharma said a fire that left two dead at the company’s Ahmednagar, India factory did not affect production.
FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.
PF-06410293 met primary endpoints during clinical trials and demonstrated similar efficacy to its reference product.
J&J’s Innovation Global announced the company has entered into 15 new collaborations.
According to a Deloitte report, the industry’s return on its research investment has been steadily slipping for the past six years. The conclusion? Fundamental change may no longer be a given, but a necessity for the industry
Prokarium in the UK and Probiomed in Mexico hope to demonstrate large-scale production of oral vaccines that will reduce cost compared to injections and improve availability.
Top C-suite leaders are already tuning their long-range planning, hiring practices, and business systems for elasticity. Are you ready?
Translating campaign promises to predictions for bio/pharma is difficult, but optimism prevails.
As Europe’s bio/pharma market learns that breaking up is hard to do, it also must address productivity, regulatory, and drug pricing challenges.
The agency has published its refuse-to-receive standards guidance for abbreviated new drug applications.
Equipment and Processing Report
Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.
PTSM: Pharmaceutical Technology Sourcing and Management
Pharma Tech introduced a new high-speed bottling line to its facility in Union, MO.
PTSM: Pharmaceutical Technology Sourcing and Management
AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.
PTSM: Pharmaceutical Technology Sourcing and Management
Novasep’s three facilities located in France and Germany are free of Form 483.
PTSM: Pharmaceutical Technology Sourcing and Management
The company has manufactured double-digit number of batches on the new filling line, for use in early-stage clinical trials.
PTSM: Pharmaceutical Technology Sourcing and Management
The companies entered into a manufacturing agreement for voclosporin active pharmaceutical ingredient.
PTSM: Pharmaceutical Technology Sourcing and Management
The two companies have entered into an agreement to provide Suzeken with access to AmerisourceBergen’s Cubixx inventory solution.
PTSM: Pharmaceutical Technology Sourcing and Management
The $2-billion facility will be located in Clayton, North Carolina.
The contract service provider entered into a contract agreement with the US Army to provide services in the development of treatments of malaria.
Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.
Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.
The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
A pilot project, beginning in 2017, will support the development of biosimilars.
The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.
Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.
The agency announces that 81 medicines overall were recommended in 2016.
Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.