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FDA Gives Update on Benefit-Risk Assessment Program
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
FDA Grants Priority Review to AstraZeneca’s Leukemia Biologic
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
Pfizer Transfers CAR-T Assets to Allogene
Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.
PPD Expands GMP Biologics Testing Capacity
The contract research organization has added a new analytical laboratory in Middleton, WI, to expand its biologics testing capacity.
INTEGRA Engages Customers to Understand Lab Challenges
The company’s close communication with customers has enabled it to bring advanced pipetting products to market.
Thermo Fisher’s Krios G3i Cryo-Electron Microscope Announced as 2018 Edison Awards Finalist
The company’s Krios G3i cryo-electron microscope is a finalist in the 2018 Edison Awards.
Budget Bill Boosts Funding for Biomedical Research and FDA Programs
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
Celgene, bluebird bio Partner on CAR T Therapy
The companies will co-develop and co-promote a CAR T cell therapy in the United States.
Celgene Completes Juno Acquisition
The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.
Amgen, Allergan Score Positive EMA Opinion on Biosimilar to Roche’s Herceptin
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
Novartis Gets Positive EMA Opinion on Biosimilar to J&J’s Remicade
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
Trutag Technologies Adds New Smart Laminate and Business Unit
The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.
Takeda Confirms Interest in Acquiring Shire
Takeda is considering approaching Shire with a possible offer.
bioLIVE to Launch Global Biopharma Country Ranking
Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.
New Immunoassay Technology Improves Workflow
Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.
New Ultra-Low-Temp Freezer Increases Cold-Storage Performance
Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.
GSK Buys Out Novartis’ Share of OTC Business
In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.
Cesca Licenses CAR-T Cellular Processing Services to China’s Boyalife Group
The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.
Hitachi to Manufacture Regenerative Medicines
Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
EMA Recommends Two Biosimilars, One Orphan Drug, for Approval
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
FDA Publishes Compounding Guidance on the Evaluation of Bulk Drug Substances
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
Helix BioPharma Partners with ProMab on CAR-T Therapies
The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.
Wuxi Biologics to Install Large-Scale Single-Use Bioreactor
The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.
AbbVie, IMF to Partner on Cancer Research
AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.
FDA Program Promises More Transparency in NDA Approvals
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
FDA Warns of the Potential of Contamination at API Facility
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
ISPE Announces Facility of the Year Awards Category Winners
ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.
Thermo Fisher Expands Clinical Distribution in Europe
An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.
FDA Strengthens Postmarketing Safety Reporting Requirements for Combination Products
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
EMA Releases Relocation Tracking Tool
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
