
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.

FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.

Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics is expected to strengthen its sickle cell disease portfolio.

Sartorius’ £415 million (US$429 million) acquisition of Albumedix is intended to bolster its portfolio with recombinant albumin-based solutions.

Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).

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.

The OMNI Electric Utility Raceway power and data management system is designed to reduce risk and accelerate cleanroom delivery.

La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Ipsen and Marengo Therapeutics will collaborate to advance two precision immuno-oncology candidates.

CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

Promising applications for targeted delivery may be cresting the horizon.

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

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.

GSK has completed its demerger of Haleon and has signed an agreement to help support future pandemic preparedness in Europe.

How can we fix the quality manufacturing issues that come with product shortages?

DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.

The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.

The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis.

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 is opening a new large-scale oligonucleotide and peptide manufacturing facility.