Pharmaceutical Supply, Pharmaceutical Manufacturing, Contract …
The US manufacturer NorthStar Medical Radioisotopes has unveiled a Contract Development & Manufacturing (CDMO) facility dedicated to the production and development of medical radioisotopes. EMA accepts Alvotech and Advanz Pharma’s Marketing Authorization Application for biosimilar of J&J’s Simponi. Synaffix and BigHat Biosciences ...
The rise of the integrated research organization: A conversation …
Sep 11, 2019 · Behind the term is NC-based Javara, which made its official debut in June 2018 . The company’s CEO Jennifer Byrne told us the name ‘integrated research organization,’ or IRO, emerged as the descriptor for the new clinical research model following discussions with Wake Forest Baptist Health.
ICON to acquire PRA Health Sciences in $12b deal
Feb 25, 2021 · ICON, a Dublin-based contract research organization (CRO) has entered into an agreement to acquire PRA Health Sciences, another CRO currently sited in Raleigh, North Carolina. The arrangement comprises a cash and stock transaction valued at approximately $12bn USD. According to company leaders, the transaction stands to benefit pharmaceutical ...
McKesson completes RxCrossroads acquisition
Jan 8, 2018 · McKesson Corporation has completed its acquisition of RxCrossroads to support customer needs beyond channel distribution as the industry faces increasing challenges. The supply chain management solutions company purchased RxCrossroads – a Kentucky-based specialty solutions provider – from CVS Health Corporation in a deal valued at $735m ...
AbbVie reports positive phase 3 results for Parkinson's drug
Sep 26, 2024 · AbbVie announces positive phase 3 results for Parkinson’s drug. The oral, specific dopamine agonist met its primary endpoint in the trial, which is the second of three phase 3 trials testing tavapadon for treatment of Parkinson’s disease. AbbVie acquired Cerevel Therapeutics earlier this year and tavapadon is the company’s lead candidate ...
Clinical trial cost is a fraction of the drug development bill
Sep 26, 2018 · News and analysis on clinical trial services and contract research and development. Clinical trial cost is a fraction of the drug development bill, with an average price tag of $19m. The price of running a clinical trial to obtain FDA approval is a fraction of the total drug development cost – challenging traditionally held beliefs about the ...
$680M deal with CBC and Mubadala shifts UCB's strategy
Aug 29, 2024 · The $680 million transaction, announced on August 26, involves the sale of established brands such as Keppra, Vimpat, Neupro, Zyrtec, and Xyzal, along with UCB's Zhuhai manufacturing site, to CBC Group and Mubadala Investment Company. This deal marks a pivotal moment in UCB’s evolution, as the company shifts its focus towards innovation and ...
Work on Novo Nordisk's 56-acre site has begun with $4.1BN …
Jul 12, 2024 · Novo Nordisk announces $4.1BN investment to expand US manufacturing capacity. Novo Nordisk has revealed plans for a $4.1 billion investment in a new manufacturing facility in Clayton, North Carolina. This significant expansion aims to enhance the production of injectable treatments for obesity and chronic diseases.
FDA publishes QbD example to help generics firms file ANDAs
Jan 19, 2012 · The FDA has published a QbD approach to modified release tablet development to help generic companies meet its 2013 deadline. After January 2013 the Office of Generic Drugs (OGD) expects abbreviated new drug applications (ANDAs) to implement QbD (Quality-by-Design). To help generics manufacturers make the transition the US Food and Drug ...
FDA clearance to start clinical trials with new obesity drug
Oct 10, 2024 · Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug. The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity. Antag Therapeutics has announced that the FDA has accepted the investigational new drug (IND) application ...