All
CPhI India Marks 10th Anniversary
Pharma industry event in Mumbai will host 40,000 visitors on Nov. 17-23.
FDA Advises Limited Clinical Testing for Biosimilars
The biosimilar pathway permits licensure based on less than full clinical data.
GE Healthcare to Expand Westborough Facility
The company announce its plans to invest $7 million in the expansion of the Westborough, MA facility.
Astellas to Acquire Ganymed
Astellas will acquire Ganymed and its portfolio of ideal monoclonal antibody candidates.
Bellicum Collaborates on CAR-T Therapies
Bellicum and Ospedale Pediatrico Bambino Gesù will collaborate on preclinical and clinical development of CAR-T and TCR therapeutics.
Keeping an Eye on the Ultimate Prize
CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.
USP and Chinese Pharmacopeia Extend Partnership
US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.
Oxford Genetics Secures GBP1 Million Investment for Gene Therapy Technologies
Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.
ICE Launches New Guide on Pharmaceutical Coding Options
Interactive Coding Equipment has produced a detailed guide to help pharmaceutical manufacturers make informed choices in the selection of suitable coding equipment for their applications.
TraceLink Launches Early Access Program for Life Sciences Cloud
TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.
Teva and IBM Expand Partnership
Teva and IBM expanded their partnership to focus on drug development and chronic disease management.
Sanofi Pasteur Collaborates with WRAIR, Fiocruz on Zika Vaccine Development
The collaboration follows the signing of a cooperative research agreement between Sanofi Pasteur, Fiocruz, and WRAIR.
Caribou Biosciences and the Jackson Laboratory Enter into License Agreement for CRISPR-Cas9
Caribou and JAX entered into a license agreement for Caribou’s CRISPR-Cas9 gene editing technology.
Interpharm Praha A.S Receives FDA Warning Letter
The Czech Republic drug manufacturer was cited for data integrity and quality issues.
Heat Biologics and University of Miami Collaborate on Zika Vaccine Development
Heat Biologics will collaborate with the University of Miami on the development of a Zika vaccine using the company’s gp96 platform.
Multi-Tenant Warehouse Option Aids Healthcare Companies
GENCO, a FedEx Company, introduces a multi-tenant warehouse model in Milton, Ontario, and Memphis, Tennessee.
FDA Tackles Cellular, Gene Therapies
FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.
BARDA Contracts IDT Biologika for Live Virus Fill/Finish Services
IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.
Catalent Breaks Ground for Expanded Biologics Facility
Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.
Horizon Discovery Signs Subscription-Based Licensing Agreement for Biomanufacturing Cell Lines
Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.
Researchers Propose a Flexible Method for Gene Therapy Manufacture
Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.
Adding Insulin Improves Viral Yield in Vaccine Production
Insulin has been shown to improve the production of viruses and viral vectors.
FDA Highlights Flexibility in Approving Rare Disease Therapies
FDA leaders insist that the decision to approve Sarepta’s Exondys (eteplirsen) should not be considered a model for future development of orphan drugs.
Catalent to Provide Fill and Finish Services for Samsung Bioepis’ Biosimilar
Prefilled syringes for commercial supply of the etanercept biosimilar will be produced at Catalent’s Brussels facility in Belgium.
Oxford Genetics Opens New Facility to Support R&D in Cell and Gene Therapy
Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.
ICH Introduces Two New Guidelines
The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.
Pfizer to Begin Shipping Inflectra in US
The company announced plans to begin shipping Inflectra to the US market in late November 2016.
Merck KGaA Expands Biotech Production Capacity in Spain
A €15-million investment will be made over 2014-2016 in a biotech facility located in Tres Cantos, Spain
FDA Awards Grants for Treatments of Rare Diseases
The agency awarded 21 new clinical trial research grants to boost the development of treatments for rare diseases.
US and Europe Collaborate on Patient Treatments
FDA is working with EMA to treat rare diseases and keep patients involved in healthcare.
