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EMA Reviews Products from Pharmaceutics International
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
EMA Recommends Suspension of Riluzole Alkem
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.
Next Steps Uncertain for the UK Pharma Industry Post Brexit Vote
In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.
FDA Provides Quality Metrics Technical Conformance Guide
The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.
Thermo Fisher and NIBRT Link Up for Characterization Project
Thermo will provide access to its instruments to NIBRT so that the Dublin-based group can generate helpful characterization data.
China Approves Drug Marketing Authorization Holder Pilot Plan
China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.
Study: HIV-1 Neutralizing Antibodies in Infants May Impact Vaccine Development
Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.
Kalytera Appoints Robert Langer to Scientific Advisory Board
Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.
Adaptimmune and Thermo Fisher Collaborate on Manufacture of Cell Therapies
The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.
Pharmacopeias Continue Harmonization Program
The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.
Clinical Supply Facility Warned by FDA
The agency cited the company for sterile manufacturing violations.
CPhI Accepting Applications for 2016 Pharma Awards
The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.
EMA and FDA Collaborate on Patient Engagement
The two agencies have set up a working group on involving patients in drug development.
MedPAC Recommends Changes to Medicare Drug Coverage
Pressure is mounting to reduce costs and spending on prescription drugs.
CAR-T Optimized to Target Solid Tumors in Animal Models
A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.
Sandoz Plans to Launch Five Biosimilars by 2020
Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.
FDA Approves Use of Zika Virus Assay
The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.
FDA Accepts Emergent’s sBLA for Manufacturing of its Anthrax Vaccine
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
Janssen Alleges HyClone Lab Infringed its Cell-Culture Media Patent
In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.
Gene Editing through CRISPR Considered in Human Models
The first-ever use of CRISPR in humans will be evaluated by the National Institutes of Health during a meeting from June 21–22, 2016.
Anthrax Vaccine Nabs Orphan Drug Status
A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.
Keytruda Proves Superior to Chemotherapy in Phase III Trials
Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.
Pfizer Builds Biologics Clinical Manufacturing Facility in Massachusetts
Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.
Study: Patients Who Have Reactive Responses to Infliximab Should Not Switch to Biosimilar Versions
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
Sartorius Stedim Biotech Introduces New Benchtop Bioreactor System
The ambr 250 is a mini bioreactor system for parallel fermentation or cell culture.
Lonza Sponsors Horseshoe Crab Conservation Initiatives
Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.
FDA Issues Warning Letter to Austin Biotechnology Inc.
The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.
Compounding Pharmacy Warned for Sterile Manufacturing Violations
FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.
FDA Issues Warning Letter to Drug Compounder
The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.
Compounding Pharmacy Gets Warning Letter
FDA cited a Las Vegas compounding pharmacy for sterility violations.
