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Aadi Bioscience and Aerpio Pharmaceuticals Close Merger and $155 Million Private Placement
Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.
Avantor Makes Multi-Year Investment in Hydration Capabilities for Biologics Production
Avantor plans to address rising global demand for biologics with their investment in hydration capabilities.
Quotient Sciences Makes Multi-Million Dollar Investment to Expand Drug Substance Manufacturing Facility
Quotient Sciences is investing £6.3 million ($8.68 million) into their drug substance manufacturing capabilities.
USAntibiotics Reopens Facility, Returning Antibiotic Production to the United States
USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.
Catalent Acquires Nutraceutical for $1 Billion
Catalent’s acquisition of Bettera paves the way for growth in the softgel and oral dose formulation and manufacturing market for nutraceuticals.
FDA and Industry Map New R&D Initiatives under Next User Fee Program
FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.
Two Dead After Receiving Contaminated Moderna COVID-19 Vaccines & Japan Pulls Another 1-Million Doses From Circulation
After receiving the COVID-19 vaccine from a batch of Moderna vaccines that were suspected to have contaminants, two people in Japan died. Meanwhile, another one million doses have been temporarily suspended in Japan.
Insilico Biotechnology Joins Inno4vac Project
Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.
FSD Pharma to Acquire Lucid Psycheceuticals
FSD Pharma has entered a definitive agreement to acquire all of the issued and outstanding shares of Lucid Psycheceuticals for approximately US$9 million (CAD$11.3 million) in FSD Pharma stock.
Investigational Radiopharmaceutical for the Treatment of Bone Cancer Receives FDA Clearance of IND
FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).
Contaminant in Moderna Vaccines in Japan Suspected to be Metallic Particles
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
Amgen, USC, and Thermo Fisher Partner on Cryo-EM Biotechnology Research
The University of Southern California and Amgen have teamed up to provide researchers access to two of Thermo Fisher Scientific’s cryo-EM instruments.
Biotium’s New Staining Kit Aims to Optimize Exosome Detection
A new membrane staining kit, ExoBrite, launched by Biotium aims to enhance the detection of exosomes through flow cytometry.
Next-Gen Automation Lab Aims to Speed Up Drug Discovery Process
Eli Lilly and Company and industry partners, including Ziath, are focused on speeding up the drug discovery process with a fully automated lab.
BioMed X and Janssen Start Up Research Programs in Autoimmunity and Drug Delivery
BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.
Promega to Showcase Applications of Bioluminescent Research Tools at Global Seminar Series
Promega will demonstrate applications of bioluminescence tools at Discover Glo 2021.
BioAgilytix Acquires Australian-Based CRO 360biolabs
BioAgilytix, a US-based contract research laboratory focused on large-molecule drug development, has agreed to purchase 360biolabs, an Australia-based contract research organization specializing in virology and immunology.
AGC Biologics Breaks Ground on New Multipurpose Facility in Denmark
AGC Biologics has broken ground on a new multipurpose facility in Copenhagen, Denmark, that will increase capacity.
NGM Bio Pinpoints Fourth Antibody Drug Candidate for Oncology Therapy Development
NGM Biopharmaceuticals has disclosed a fourth antibody drug candidate, NGM831, for development into an oncology therapeutic.
Todos Medical to Launch New Antibody Blood Test for COVID-19
Todos Medical has completed validation of its cPass neutralizing antibody blood test to monitor COVID-19 immunity.
Pfizer to Acquire Trillium Therapeutics in $2.26-Billion Deal
Pfizer’s proposed $2.26-billion acquisition of Trillium Therapeutics will add next-generation hematology-targeted immuno-therapeutics to its oncology pipeline.
Lonza Invests in Drug Product Manufacturing Services in China
Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.
Pfizer Vaccine Approval Key to Boosting Vaccination Rates
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA Offers Guidance on How to Include Bioequivalence Info in ANDAs
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
HHS Public Health Makes Statement on COVID-19 Booster Shots
HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.
FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
WHO Head Reiterates Call for Two-Month COVID-19 Booster Moratorium
Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.
UK Regulator MHRA Approves Moderna COVID-19 Jab for Adolescents
MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
Novartis Secures Chinese Approval for Pediatric Indication of Cosentyx
Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.
ICMRA Sets Out Recommendations on Regulation of Future Therapies Using AI
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.