Industry News
Report Shows Bioscience Industry Has $2-Trillion Economic Impact
A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.
ISPE Field-Tests Quality Program
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
AAPS Announces 2018 Slate of Candidates
The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
Gottlieb Proposes Modernization of Drug Review Office
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
Hospira Recalls Naloxone Hydrochloride
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
New Research Hub Tackles Access to Vaccines
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.
Merged Microscope Illuminates Biological Processes In Vivo
National Institutes of Health (NIH) researchers combine two microscope technologies to create sharper, faster images.
Amgen and Harvard Partner on Digital Biology Educational Platform
The Amgen Foundation and Harvard University will develop LabXchange, a free online science education platform that will provide digital instruction and virtual lab experiences.
Ingenza in Collaboration to Recycle CO2 from Bioprocessing Plants
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
FDA Releases REMS Guidance
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
FDA Publishes Guidance on the Effects of Drugs on Blood Pressure
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
Data Integrity Failures Found at China Facility
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
WHO Vaccinates Against Ebola with Merck & Co.'s Experimental Vaccine
World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
European and Indian Pharmacopoeias Coordinate on Quality Standards
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
FDA Commissioner Puts Branded Companies on Notice
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
China’s Pharma Growth Potential to Drive Attendance at CPhI China
Internationalization and regulatory reform are driving growth and investment China.
Apotex Recalls Product Due to Elevated Levels of Impurities
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
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.
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.
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.
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.
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.
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.
USP Drops Biologics Naming Proposal
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
