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Element Acquires JMI Laboratories
Element’s acquisition of JMI Laboratories will increase their North American service offerings.
Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 1
Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.
MHRA Approves COVID-19 Antiviral Drug
The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.
Eli Lilly Withdraws COVID-19 Treatments from EMA Review
EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.
Waters and Sartorius Enter Partnership to Improve Bioprocessing Analysis
The partnership between Waters and Sartorius aims to accelerate speed and increase accuracy in bioprocessing analysis.
TCR² Therapeutics Announces Expansion of US Manufacturing Capacity
TCR² Therapeutics will add a second clean room to their manufacturing operations.
GenScript Opens New Gene Synthesis Center in New Jersey
GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.
Gentronix Expands Lab Facilities, Increases Testing Capacity
Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.
Thermo Fisher Launches New Mass Spectrometry and Chromatography Solutions
Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021.
Will Pharma Accept the Democrats’ Drug Pricing Deal or Continue to Fight Reform?
Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.
Lonza Acquires Exosomics Service Unit and Codiak BioSciences Exosomes Manufacturing Facility
Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.
Novavax COVID-19 Vaccine Receives EUA in Indonesia
Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.
Almac Sciences Collaborates with Irish Manufacturing Research Organization on Flow Chemistry Reactors
The researchers will use 3D printing to design novel flow reactors and static mixers.
Janssen Received the 2021 ISPE Facility of the Year Award
Janssen Sciences Ireland was honored for its project execution of a large-scale expansion of biologics drug substance fed-batch capacity.
GMP/GDP Inspections: Challenges and Opportunities Revealed by the COVID-19 Pandemic
An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.
Takeda Acquires GammaDelta Therapeutics
Takeda’s acquisition of GammaDelta Therapeutics expands their immuno-oncology and innate immune cell therapy portfolio.
Aceragen Acquires Arrevus, Expands Late-Stage Rare Disease Pipeline
Aceragen’s acquisition of Arrevus adds key treatment candidates to its rare disease pipeline.
FDA Approves Novartis’ Scemblix for Treatment of Chronic Myeloid Leukemia
Novartis’ scemblix (asciminib) is designed to provide a single treatment option to patients struggling with chronic myeloid leukemia.
Avantor Completes Acquisition of Masterflex
Following the acquisition, Avantor will have access to Masterflex’s various bioproduction operations.
Great Expectations for Excipients
Can We Agree on Conferences?
Making a Difference in European Bio/Pharma
Manufacturing capacity expansion is high on the agenda for many bio/pharma companies and service providers in Europe.
FDA Approves AbbVie’s Vuity for Presbyopia Treatment
Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.
FDA Grants EUA for Pfizer-BioNTech COVID-19 Vaccine Use in Children
The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.
Sartorius Forms Joint Research Pact with Matica Bio for Advanced Viral Vector Manufacturing Technology
The research collaboration between Sartorius and Matica Biotechnology will aim to optimize PAT technologies, automation software, and single-use platforms for large-scale viral vector production.
Novavax Files for Authorization of its COVID-19 Vaccine in the UK and Australia
Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.
CHMP Recommends Booster Dose Consideration for Moderna COVID-19 Vaccine
EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.
FDA Approves Genentech’s Susvimo for Wet AMD
Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.
BD Launches Plunger Stopper in Partnership with Aptar Pharma
Becton, Dickinson, and Company and partner Aptar’s new plunger stopper will support the injection of biologics into subcutaneous tissue.
Bio-Rad Launches Real-Time PCR Detection Systems for In-Vitro Diagnostics
Bio-Rad will be launching two new real-time PCR detection tools to be used for in-vitro diagnostic testing.