Pharmaceutical Technology
NOVEMBER 30, 2022
Each month, Pharmaceutical Technology takes a look at recent decisions taken by regulatory and reimbursement agencies and identifies the key manufacturing players that can be impacted by them. The monoclonal antibody (mAb) is already approved for treating paroxysmal nocturnal haemoglobinuria in children and adolescents. NICE decisions.
Roots Analysis
APRIL 15, 2024
These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.
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Pharmaceutical Technology
JULY 29, 2022
Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.
Pharmaceutical Technology
NOVEMBER 22, 2022
It is therefore to be expected that there are a far greater number of Chinese sites for API manufacturing for FDA and EMA innovator and biosimilar drugs than for dose manufacturing and packaging. The majority of FDA and EMA innovator and biosimilar marketed drugs produced by Chinese sites are small molecules.
The Pharma Data
NOVEMBER 5, 2020
Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Evinacumab , an antibody to ANGPTL3.
Pfizer
DECEMBER 13, 2021
The teams started changing existing filling lines, building formulations booths and new filling lines, constructing packaging lines and a “freezer farm,” while recruiting and training new colleagues. All those were investments at risk, that’s the bet we took,” says Van Steenwinkel. Adding flexibility and increasing volume has been key.
Drug Discovery World
FEBRUARY 22, 2023
Biopharma drug development will outpace traditional small molecule drug development In 1993 a collaboration between BASF and Cambridge Antibody Technology developed a compound initially named D2E7 that was the first fully human monoclonal antibody approved by the FDA.
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