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Jim Miller Presents Contract Services Keynote at CPhI North America 2018
Industry analyst Jim Miller will provide insight into the past, present, and future of the contract services market at the CPhI North America conference on Wednesday, April 25, 2018 in Philadelphia, PA.
ReAgent Opens New Eco-Friendly Factory
The new premises have been built-to-spec to offer efficient, high quality, and environmentally friendly service to customers.
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 Completes Juno Acquisition
The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.
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.
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.
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).
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.
Natoli Engineering Enters Encapsulation Machine Replacement Parts Market
Natoli acquired Carlisle Precision Machining, which supplies replacement parts for encapsulation equipment.
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.
Service Aids Design and Installation of Cleanroom Systems
Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.
MedPharm Receives Investment from Ampersand Capital Partners
MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.
Hitachi to Manufacture Regenerative Medicines
Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
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.
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.
Helsinn to Acquire Rights to Skin Cancer Drug
Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine), a topical skin-cancer drug, from Actelion Pharmaceuticals.
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.