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UK Outlines Potential Pharma Changes Post-Brexit
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
DHSC Directs Pharma to Stockpile Medicines
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
Experts Reveal Ebola Vaccine Status and Potential
Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
Zika Vaccine Clinical Trial Begins
The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.
First Generic Version of EpiPen Gets Approval
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
Astellas Acquires Gene Therapy Company Quethera
The acquisition will strengthen Astellas Pharma’s position in ophthalmology.
Emergent to Acquire Specialty Vaccines Company PaxVax
The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.
FDA Grants Support Research in Modernizing Pharmaceutical Manufacturing
FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.
Repeat Quality Deviations Found at India Facility
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
Pfizer, BioNTech to Develop mRNA-based Flu Vaccines
The companies entered a multi-year R&D collaboration to develop mRNA-based flu vaccines.
Opioids and Animals
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
Joseph Polli Named AAPS President-Elect
Pharmaceutical scientist association announces upcoming term’s board of directors.
FDA Approves Drug Product Manufacturing for Samsung BioLogics
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
FDA Approves First-of-its-Kind RNA Therapy
The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
FDA Issues Warning Letter to Canadian API Manufacturer
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
North Americans Pegged as Least Informed on Pharma GDPR, GlobalData Reports
Only 54% of North Americans feel informed about the requirements of the general data protection regulation (GDPR), according to a report by GlobalData.
ARM Releases Second-Quarter Report on Regenerative Medicines Sector
The Alliance for Regenerative Medicine’s (ARM) report highlights major trends and metrics from the 2018 second quarter in the regenerative medicines sector.
Ebola Vaccinations Begin in Response to Congo’s Last Outbreak
Ebola vaccinations by the World Health Organization began in North Kivu, Democratic Republic of the Congo, one week after the country’s latest outbreak.
Key Biologics and Astarte Biologics Merge
The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.
EMA Scales Back Activities to Prepare for Brexit
The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.
Avalon GloboCare Partners with Weill Cornell Medical College for CAR-T Production Technologies
Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
EC Approves Pfizer’s Biosimilar to Roche’s Herceptin
The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.
Regeneron, bluebird bio Partner on Cell Therapy Development
The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.
Boehringer Ingelheim Licenses Global Rights to Cystic Fibrosis Gene Therapy
Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.
AuroMedics Pharma Issues Voluntary Recall Due to Glass and Silicone Particulates
AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
MilliporeSigma, InnoCore to Partner on Biodegradable Drug Delivery Platform
The companies will collaborate to bring InnoCore Pharmaceuticals’ proprietary SynBiosys biodegradable polymer platform to market.
Diabetes Drugs Shown to Help Macrophages Control Inflammation
Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.
Takeda Acquires TiGenix
Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical for approximately EUR 520 million (US$604 million).
Amgen Breaks Ground on Next-Generation Biomanufacturing Plant
The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.
GSK, 23andMe to Partner on Genetic Drug Development
GlaxoSmithKline and 23andMe, a personal genomics and biotechnology company, will partner to research and develop new drugs using human genetics.
