The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Amgen and Kyowa Kirin, a Tokyo-based bio/pharmaceutical company, have entered into an agreement to jointly develop and commercialize KHK4083, Kyowa Kirin's investigational monoclonal antibody for treating atopic dermatitis (eczema) and other...
With the industry moving to more personalized medicine and delivering genetic material to patients to treat conditions resulting from genetic mutations, we speak to Sean Canavan, Operations Manager at Almac’s Gene Therapy Centre of Excellence...
President Joe Biden issued the Administration's fiscal year (FY) 2022 budget proposal, which includes higher funding for the US Food and Drug Administration (FDA), support for reforms to lower the cost of prescription drugs, and funding to launch a...
Merck & Co. has completed the spin-off of its women’s health, legacy brands, and biosimilars businesses, into a new separate company, Organon & Co. Merck announced the spin-off last year (February 2020).
“Today [June 3, 2021] marks a...
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has signed a pact with UNICEF to supply up to 500 million doses of its COVID-19 vaccine and has signed separate manufacturing agreements with Lonza and...
The latest on COVID-19 vaccines/drugs from Pfizer, J&J, Sinovac, Biological E., Providence Therapeutics, and the National Institutes of Health.
Manufacturing and supply of COVID-19 vaccines and drugs
EMA OKs More Mfg Capacity for Pfizer’s,...
A roundup of news from Denmark (Novo Nordisk, Heartseed), Switzerland (Biogen), and the US (Bayer, The Discovery Labs, University of Pennsylvania).
Denmark
Novo Nordisk, Heartseed in $598-M Pact for Stem-Cell Therapy Novo Nordisk and Heartseed, a...
To address potential future litigation, Bayer has announced a series of actions it plans to implement following the withdrawal of a motion for preliminary approval of a class-action settlement over its glyphosate-based herbicide, Roundup. Bayer...
Moderna has formed separate manufacturing pacts for its COVID-19 vaccine with Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, and Aldevron, a CDMO of DNA plasmid, protein, and mRNA production. Also, the company...
A roundup of news from Africa (J&J), Germany (Bayer, BioNTech), India (BMS, Syngene), Poland (Moderna), the UK (Clarivate) and the US (Biogen, AbbVie, others).
Africa
J&J Supplies WHO with Vaccine To Prevent Spread of Ebola in West Africa...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, AstraZeneca, GSK, Sanofi, Novavax, SK bioscience, Thermo Fisher, Sharp, and Innova.
Manufacturing and supply of COVID-19 vaccines and drugs
Novavax in Pact with SK...
The US Supreme Court has denied Sandoz’s petition to review a lower court’s decision in July 2020 concerning Sandoz’s biosimilar of Enbrel (etanercept), one of Amgen’s top-selling drugs with 2020 global sales of $4.9 billion.
Sandoz received...
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Pfizer, Sanofi GlaxoSmithKline, Roche, and Lilly.
Manufacturing and supply of COVID-19 vaccines and drugs
Pfizer, BioNTech Formally Announce New EU Pact for COVID Vaccine...
The US government plans to donate 80 million doses of COVID-19 vaccines from the US to assist other countries in address the COVID-19 pandemic.
The US government will send 80 million doses of COVID-19 vaccines to other countries by the end of June...
Sandoz, the generics and biosimilars arm of Novartis, has announced plans to invest EUR 150 million ($183 million) over next three to five years to expand antibiotic production capacity at its sites in Kundl, Austria and in Palafolls, Spain....
