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EMA Commences Evaluation of RoActemra as COVID-19 Treatment
EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.
FDA User Fees to Rise and Fall as New Fee Agreements Move Forward
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
Paratek Receives Orphan Drug Designation for NUZYRA Antibiotic
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
BMS Elects to In-License AI-Designed, Immune-Modulating Drug Candidate from Exscientia
Bristol Myers Squibb has exercised the option to in-license an immune-modulating drug candidate developed by Exscientia.
Industry Responds to the Latest NICE Methods Review
UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.
Merck KGaA and Telix Partner on Pan-Cancer Clinical Combination Studies
Merck KGaA has partnered with Telix Pharmaceuticals to conduct combination clinical studies for cancer therapy.
Corning’s New Cell and Gene Therapy Platform Demonstrates Large-Scale Bioproduction
Corning’s new Ascent fixed bed reactor (FBR) system is an automated bioproduction platform designed to significantly improve yields and reduce bioproduction costs.
Werewolf Therapeutics Announces Clinical Trial Collaboration with Merck
The collaboration will focus on the interactions between WTX-124 indukine and KEYTRUDA (pembrolizumab).
NIH Scientists Develop Faster COVID-19 Test
A new method developed by the NIH bypasses genetic RNA extraction, simplifying the testing process.
WHO’s Solidarity Plus Trial to Assess Three Drugs for Hospitalized COVID-19 Patients
WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.
Cybersecurity Vulnerabilities Affecting Drug Manufacturing Equipment
BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.
FDA Approves Expanded Label for Lilly’s Lyumjev
Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.
Patent Office Grants BlueAllele Patent for Advanced Gene Editing Technology
BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.
Artiva Biotherapeutics Builds New US Cell Therapy R&D and Manufacturing Facility
Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.
Thermo Fisher Scientific Named IndustryWeek Best Plants Award Winner 2021
Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.
Syngene Expands Microbial and Mammalian Manufacturing Facilities in Bengalaru
Syngene’s additions include a new microbial facility and an expanded mammalian facility.
FDA Grants First of its Kind Indication for Idiopathic Hypersomnia Treatment
FDA has granted its first approval for an idiopathic hypersomnia treatment.
GSK and CureVac’s Second-Generation mRNA COVID-19 Vaccine Candidate Shows Promising Results in Preclinical Study
Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.
Biotage Expands Lipid Capacity with New Facility
Biotage’s new facility in Cardiff, UK, will produce lipids using large-scale flash purification.
FDA Solicits Comments on Drug Products Approved Ahead of Hatch-Waxman Amendments
FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.
Terumo Blood and Cell Technologies and PhotonPharma to Develop Cancer Immunotherapy
Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.
Precision NanoSystems Expands GMP Biomanufacturing Center
PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.
Google and Lumen Bioscience Apply Machine Learning to the Manufacture of Spirulina-Based Biologic Drugs
The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.
Rentschler Biopharma to Begin Construction of New Multi-Product Commercial Manufacturing Facility
Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules.
Lykan Bioscience and Vineti Partner to Advance Cell Therapies from Clinic to Commercialization
Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.
FDA Authorizes Additional COVID-19 Vaccine Dose for Certain Individuals
The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.
Recro Acquires IRISYS for $50 Million
Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.
Biden Highlights Drug Pricing Reforms to Advance Legislative Agenda
The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.
KGI Team Adapts Vaccine Development Work to Address COVID-19
A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.
Aldevron and Ginkgo Bioworks Collaboration Yields mRNA Manufacturing Enhancement
A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.
