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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.
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.
Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity
Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.
New Guidance on the Use of Real-World Evidence
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
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.
Demerger and the Future
GSK has completed its demerger of Haleon and has signed an agreement to help support future pandemic preparedness in Europe.
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.
European Commission Approves AbbVie Axial Spondyloarthritis Treatment
The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.
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.
Merck and Orion Announce Global Collaboration for Oncology Drug
Merck, known as MSD outside the United States and Canada, and Orion Corporation are collaborating to develop and commercialize a treatment for metastatic castration-resistant prostate cancer.
