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CPHI Report Predicts Significant Shifts in Global Outsourcing Strategies
The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.
EMA Starts Review of Oral Fixed-Dose Combination Treatment for AML
EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.
Grand River Aseptic Manufacturing Completes Phase II of Facility Expansion
Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines.
ProBioGen Executes Master Service Agreement with NextPoint Therapeutics
ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.
Validair Diamond Scientific Installs New Cleanroom
Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training.
Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products
Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer
The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.
UK Approves First Bivalent COVID-19 Booster Vaccine
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
CYTENA Unveils Fully Automated Single-Cell Dispenser for Microorganisms
CYTENA’s B.SIGHT cell dispenser is designed to streamline single-cell isolation in microbiology research.
New England Biolabs Releases Novel Enzymatic mRNA Capping Solution
The Faustovirus Capping Enzyme launched by New England Biolabs is designed to increase capping efficiency and scalability of mRNA manufacturing workflows.
Moderna and European Commission Amend COVID-19 Vaccine Agreement
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.
FDA Approves Roche’s Influenza Treatment for Use in Young Children
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
Merck Enters Alzheimer’s Collaboration with Cerevance
Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.
Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”
Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
FDA to Host Multi-Day Global Access Virtual Conference
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.
Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion
Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics is expected to strengthen its sickle cell disease portfolio.
Sartorius to Acquire Albumedix for £415 Million
Sartorius’ £415 million (US$429 million) acquisition of Albumedix is intended to bolster its portfolio with recombinant albumin-based solutions.
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.
FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Sanofi and Innovent Enter Oncology Collaboration
Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.
Senate Advances Drug Price Negotiations
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
Amgen Will Acquire Chemocentryx in $4 Billion Deal
Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).
EC Approves Additional Indication for Lynparza as Adjuvant Treatment in Breast Cancer
The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.
AES Clean Technology Launches OMNI Electric Utility Raceway
The OMNI Electric Utility Raceway power and data management system is designed to reduce risk and accelerate cleanroom delivery.
La Jolla Institute for Immunology Acquires Carterra LSA Platform
La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.
Synthego Aims to Accelerate Drug Discovery with New Engineered Cell Libraries
Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.
Top Priority for Califf Is Combatting Health Misinformation
Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
Ipsen Strikes Deal Worth Up to $1.59 Billion With Marengo Therapeutics
Ipsen and Marengo Therapeutics will collaborate to advance two precision immuno-oncology candidates.
CRYOPDP Acquires Polar Expres
CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.
