A new United Kingdom life-science asset, HIRANI, was launched at a reception at BIO in Philadelphia.
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CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.
ERS Genomics and Bioneer have revealed the signing of a license agreement for access to CRISPR/Cas9 genome editing technology intellectual property.
Gene therapy development company, bluebird bio, has revealed that the European Commission has granted conditional marketing authorization for Zynteglo.
A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.
Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.
The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.
FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.
Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.
The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.
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Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.
Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.
TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.
The European Medicines Agency has issued a vacancy notice for the position of executive director.
FDA is examining and updating its programs for overseeing global operations and international affairs.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).
Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.
EMA has launched a social media campaign aimed at highlighting how the agency and its network maintain safety and efficacy of medicines available in Europe.
It has been confirmed that both Bulgaria and Cyprus will now be able to perform GMP inspections at a level considered equivalent to the United States
The UK government announced during the ABPI’s recent conference that it is making improvements to the Accelerated Access Collaborative.
AbCellera, Niaid Vaccine Research Center, and Ichor Medical Systems have formed a partnership to develop an end-to-end platform capable of developing field-ready, nucleic acid-based countermeasures against a pandemic strain of influenza.
The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
The companies will work together to develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology.
MilliporeSigma event scheduled to recognize biotech challenges and support development potential.
The agency approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus.
The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.
Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.
The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.
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