FDA approves BMS’s Opdualag for metastatic or unresectable
WEBMar 23, 2022 · Bristol Myers Squibb (BMS) has announced that Opdualag (nivolumab and relatlimab-rmbw) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult and paediatric patients aged 12 years or older with metastatic melanoma or melanoma which cannot be treated with …
FDA clears first generics of Pfizer/BMS’ anticoagulant Eliquis
WEBDec 24, 2019 · The FDA has approved the first two generics of Pfizer and Bristol-Myers Squibb’s blockbuster anticoagulant drug Eliquis, from Micro Labs and Mylan. FDA approval doesn’t necessarily mean that the generics will be made available anytime soon, as Pfizer and BMS are claiming patent protection for several more years, but …
UDG adds Putnam Associates and Incisive to healthcare comms …
WEBJun 5, 2019 · UDG adds Putnam Associates and Incisive to healthcare comms group. UDG Healthcare is to acquire Putnam Associates, a US-based strategic management healthcare consultancy and Incisive Health, a UK-based healthcare policy and comms consultancy. The twin acquisitions strengthens the breadth of services offered by UDG’s healthcare comms division ...
PMLiVE | Pharmaceutical industry news, articles, jobs, reports, …
WEBWith the flu season rapidly approaching, there is a surge in influenza and vaccine-related studies. These studies often face the significant challenge of a very short recruitment window, which necessitates thorough preparation …
Novartis orphan drug wins 'breakthrough' status from FDA
WEBAug 20, 2013 · Bimagrumab, which was granted orphan drug designation in sIBM in both the US and Europe in 2012, follows Novartis’ lung cancer drug LDK378 and its heart failure candidate serelaxin in winning breakthrough status from the FDA. Timothy Wright, global head of development at Novartis Pharmaceuticals, said: “BYM338 is …
AbbVie’s Rinvoq has ‘marginal clinical benefit’ over ... - PMLiVE
WEBNov 27, 2019 · According to ICER, this evidence demonstrates that Rinvoq provides a small to substantial health benenfit over Humira. The institute found that compared to the TNF blocker, Rinvoq’s value-based price benchmark is between $44,000 to $45,000 per year of treatment. This is a significant change from its initial cost-effectiveness threshold.
Decentralised clinical trials: mapping patient pathways with a focus …
WEBMar 11, 2022 · Decentralised clinical trials: mapping patient pathways with a focus on patient-centricity. It is critical to understand the needs and key drivers of a decentralised clinical trial – considering the target patient population when designing and deploying the trial. This enables the development of effective, highly targeted recruitment and ...
After delay, Merck gets US approval for serious infection drug
WEBOct 24, 2016 · The US FDA approved Merck & Co’s Zinplava as an add-on treatment for Clostridium difficile infections after a three-month delay. The positive verdict comes after the FDA asked for additional information to enable their review of Zinplava (bezlotoxumab; MK 6072), delaying its approval by three months. In June, an FDA advisory committee voted ...
Pfizer, Mylan move ahead with generics merger and spin-out
WEBNov 4, 2020 · Pfizer is planning to spin-out its generic drugs business into a joint venture with Mylan, in a deal that was due to be completed in the middle of the year. Now that the FTC has formally cleared the merger, the new firm, Viatris, will become a generics giant, with Pfizer owning 57% and Mylan owning 43%. “Today’s approval represents the ...
P/S/L appoints new MD for its research business Medefield
WEBJan 10, 2018 · P/S/L Group, a global medicine information organisation, has appointed Niraj Patel to head up its fieldwork services group Medefield as its new managing director. Patel joins the group following 20 years’ industry experience, most recently serving at SHC Universal as its managing director of Europe. He said: “As Medefield continues to ...