Meditronic has scored a win with the long-anticipated approval of its MiniMed 780G insulin pump by the US Food and Drug Administration (FDA). The pump, which works in concert with the company’s Guardian 4 continuous glucose monitor to allow for automated insulin management, even bolus injections […]
Rob Abbott Appointed as CEO of ISPOR
Earlier this month, ISPOR’s Board of Directors announced they appointed a new CEO to guide the organization, Rob Abbott. Mr. Abbott has over 20 years of executive experience and lead Health Technology Assessment International as CEO and executive director. He took over the new […]
Linda Goler Blount, MPH, to Join ICER Governance Board
Linda Goler Blount, MPH, has been elected to join the governance board of the Institute for Clinical and Economic Review. Blount has worked in health policy and is currently the president of the Black Women’s Health Imperative. She has built a career on addressing health disparities, especially […]
US FDA Still Mulling Over Biogen ALS Treatment Approval Despite Disappointing Phase III Results
Briefing documents from a US Food and Drug Administration (FDA) advisory committee show that Biogen’s ALS drug tofersen is still in the running for approval despite a recent failure in a Phase III trial. The favorable outlook is due, in part, due to its effects on reducing a key protein hallmark of […]
Lilly and Boehringer’s Type II Diabetes Drug Gets Expanded Approval from FDA for Use in Children
Eli Lilly and Boehringer Ingelheim secured approval from the US Food and Drug Administration (FDA) to expand the indications of its diabetes drug Jardience. The new indications include children under 10 with type 2 diabetes, a growing population in recent years. The drug would be the first in its […]
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only […]
Merck’s MMRV Vaccine Gets FDA Approval for Intramuscular Delivery
The US Food and Drug Administration (FDA) has cleared intramuscular administration for measles, mumps, rubella, and varicella (MMRV) vaccines from Merck. This opens up more options for care providers and marks a shift from subcutaneous injections, which were the standard for the shot. The approval […]
Moderna Optimistic About Cancer Vaccine Getting Accelerated Approval
Moderna’s president Stephen Hoge told attendees at Cowen’s Annual Healthcare Conference that the company is optimistic about its chances to snag accelerated approval for its mRNA-based personalized cancer vaccine. Hoge pointed out that data from December may not be enough, but there is enough time […]
EMA Committee Recommends Regeneron’s Libtayo + Chemotherapy Combo for Lung Cancer
Regeneron’s Libtayo (cemplimab-rwlc) has received a recommendation from the European Medicine’s Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) for use in forms of non-small-cell lung cancer (NSCLC) as a combination therapy with a traditional chemotherapy agent. The […]
FDA to Hold Adcomm on Eisai’s Leqembi Alzheimer’s Treatment by July 6th
The US Food and Drug Administration (FDA) will hold an advisory committee (adcomm on Eisai and Biogen’s Alzheimer’s drug Leqembi by July 6th, according to an announcement from Biogen yesterday, March 5th. This comes a year after an adcomm turned down the application for Aduhelm, another […]
