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PathoQuest Achieves GMP Certification for Quality Control Testing Services
PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.
Donaldson Company Acquires Italian Bioprocessing Equipment Specialist
Donaldson Company's acquisition of Solaris Biotechnology is intended to expand their footprint in the life sciences market.
Roche and Genentech Successfully Integrate Flywheel Platform
Flywheel's platform will aid Roche and Genentech in the aggregation and management of medical imaging data.
ACG to Set Up Vast Capsule Manufacturing Plant in Asia
ACG plans to open a capsule manufacturing plant and R&D center in Aurangabad, India.
UCB Announces Positive Top-Line Results from Study Evaluating Bimekizumab
The study found that patients treated with BIMZELX (bimekizumab) achieved 50% or greater improvement in arthritis signs and symptoms relative to those treated with placebo.
MHRA Grants Marketing Authorization for Biogen’s MS Treatment
Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).
Benchling Raises $100 Million in Funding and Continues European Expansion
Benchling raised $100 million to expand in Europe and further develop it's cloud-based R&D platform.
AstraZeneca Unveils State-of-the-Art R&D Facility in Cambridge
AstraZeneca has unveiled its new facility, The Discovery Centre, which will be used to support the company's focus on precision and specialized medicines, and to foster industry collaboration.
Eppendorf Makes Donation to Support Women Working in Science
Eppendorf has donated €20,000 (US$22,400) to the European Molecular Biology Laboratory (EMBL) in support of the “Advancement of Women in Science” project.
EC Grants Marketing Authorization to Gilead’s Trodelvy
The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.
MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio
MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.
Denali Therapeutics and Takeda to Jointly Develop and Commercialize Investigational Treatment for FTD-GRN
Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.
US Government to Pay $1 Billion for GSK and Vir Biotechnology’s Early Treatment of COVID-19
United States government contracts total approximately $1 billion to purchase sotrovimab, an investigational mAb.
CRB Report Investigates Pharma Facility Trends
Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.
Sartorius Offers Redesigned Vacuum Filtration Units with Higher Capacity and Faster Speed
Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.
FDA Authorizes COVID-19 Boosters for All Adults
FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
Novo Nordisk Acquires Dicerna for $3.3 Billion
Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.
Evolution of Aseptic Processing: INTERPHEX Keynote Part 5
Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.
Secarna Pharmaceuticals and Achilles Therapeutics Partner on T Cell Therapy Development
Secarna Pharmaceuticals and Achilles Therapeutics have entered into an agreement to optimize the development of T cell therapies in Achilles’ pipeline.
CGT Catapult and Deep Science Ventures Team Up to Boost Innovation in Advanced Therapies
CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.
GSK Receives European Approval for Three Additional Indications of Nucala
GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.
EC Approves Second Indication for AbbVie’s SKYRIZI
AbbVie's SKYRIZI (risankizumab) has gained approval for the treatment of active psoriatic arthritis in adults, which is the therapy’s second indication in the European Union.
Celltrion Gains Nod from EC for Regdanvimab
EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.
Sterling Pharma Solutions Invests in Process Development and Manufacturing in Dudley, UK
Sterling Pharma Solutions has announced a £10 million (US$13.5 million) investment into process development and manufacturing capacity at its site in Dudley, UK.
EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application
Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.
Lonza Invests in Microbial Development Lab Expansion
Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.
New Cures 2.0 Legislation Advances Biomedical Research and Care
Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.
Evolution of Aseptic Processing: INTERPHEX Keynote Part 4
Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.
Pfizer Submits COVID-19 Oral Antiviral Candidate to FDA for Emergency Use Authorization
Pfizer’s PAXLOVID oral solid-dosage treatment is designed to combat SARS-CoV-2 in high-risk patients at the first sign of infection.
Kala Pharmaceuticals Acquires Combangio
Kala’s acquisition of Combangio expands its clinical-stage biologic pipeline.