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AuroMedics Pharma Issues Recall Due to Glass Particulates in Vials
The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
IPEC-Americas Acquires Global Excipient Event
ExcipientFest has been acquired by IPEC and rebranded as Excipient World.
GE Increases Cell Culture Media Production Capacity
The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.
Catalent to Develop Biosimilars for Valerius Biopharma
Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.
Lilly to Acquire ARMO BioSciences for $1.6 Billion
Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.
BIA Proposes New Biotech Fund Structure to UK Government
The BioIndustry Association has called on the British government to introduce a new venture capital fund structure that will enable the public to invest in the United Kingdom’s biotech revolution.
Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
CGMP Violations Found at India Facility
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
GlobalData Reports on Barriers Impeding Biosimilar Entry into US Market
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
Precision Medicines Speed Development and Reduce Healthcare Costs
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
Lonza, Proteon Therapeutics Extend API Manufacturing Partnership
The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
Inventory Management Software Designed for Biopharma
InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.
Merck, Moderna Expand mRNA Cancer Vaccines Partnership
The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.
J&J’s Janssen to Acquire BeneVir for $1 Billion
Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.
Takeda to Acquire Shire for $62 Billion
Takeda expands its global and therapy base with announced acquisition of Shire.
Novartis’ Sandoz Receives CRL for Biosimilar to Roche’s Rituximab
The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
FDA Moves to Overhaul New Drug Review Process
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
GlobalData Reports on Humira Biosimilars Uptake in EU
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
Lonza to Invest in Mid-Scale Biologics, Cell Therapy Manufacturing
Lonza announces addition of mid-scale biologics manufacturing capacity and cell-therapy suites at Portsmouth, NH site.
New Processing System Streamlines Cell Therapy Manufacturing
GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.
Avid Bioservices Expands Process-Development Capabilities
The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.
WuXi Biologics to Invest $389 Million in New Biomanufacturing Facility
The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.
Haselmeier, Common Sensing to Partner on Injectable Solutions
The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.
Pandemic Fears Stoke Calls for New Vaccines and Global Health Initiatives
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
Fresenius Terminates $4.3-Billion Merger with Akron
Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.
Biogen, Ionis Expand $1-Billion Neurological Disease Alliance
The companies plan to advance programs for dementia and other neurological conditions.
Astellas Sells Research Facilities to Gilead’s Kite Pharma
As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.
Wyatt Technology Announces Executive Team Changes
Geofrey Wyatt has been named CEO and Clifford Wyatt named president of Wyatt Technology.
Data Integrity Failures and Other CGMP Violations Found at China Facility
FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
