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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).
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.
Bio-Rad Expands Portfolio of Anti-Idiotypic Antibodies
Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.
Oregon Freeze Dry Opens $7.5 Million Biopharma Facility
The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.
FDA Confirms Ongoing Reliance on Remote Inspection Methods FDA Confirms Ongoing Reliance on Remote Inspection Methods
FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.
DuPont Opens Biopharma Tubing Manufacturing Site in South Carolina
DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.
The US Purchases 66 Million Doses of Moderna’s COVID-19 Vaccine for $1.74 Billion
The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.
PTC Granted Marketing Authorization by European Commission for AADC Deficiency Treatment
The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
Shimadzu’s Nexera XS Inert Chromatography System Enhances Biopharma Analysis
Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis.
Roche Launches Dual Antigen and Antibody Hepatitis C Diagnostic Test
Roche’s new test is the first available immunoassay that allows for simultaneous, independent determination of the hepatitis C virus antigen and antibody status.
WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant
WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.
FDA Continues to Grapple with Accelerated Approval Issues
Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.
Discovery Life Sciences Acquires AllCells
Discovery Life Sciences’ acquisition of AllCells is intended to bolster its cell and gene therapy products and services.
AstraZeneca to Acquire TeneoTwo in Deal Worth Up to $1.26 Billion
AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.
WHO Declares Monkeypox Spread a Global Health Emergency
WHO has determined that monkeypox constitutes a public health emergency of international concern.
EMA Recommends Eleven New Medicines
The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.
EMA Endorses Statement on International Collaboration of Real-World Evidence
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
