The evolving landscape of value-based care (VBC) in 2024 is witnessing a dynamic shift, driven by nuanced changes that hold the promise of transforming healthcare delivery, quality assessment, and reimbursement methodologies. Here are the key trends that will need to be top of mind for provider organizations that are transitioning to VBC, or looking to improve their performance under value-based contracts.
The FDA said promethazine hydrochloride, a generic drug used to manage allergies and motion sickness, should be administered by intramuscular injection. Intravenous injection can cause chemical irritation and tissue damage, an FDA alert states.
Chief Medical Officer, Dr. Mark Pratt of Altera Digital Health addresses the way technology can be leveraged to improve healthcare in rural communities.
Chiesi Group’s Filsuvez is the second drug to win FDA approval for epidermolysis bullosa and the first for junctional EB, a more severe form of the rare skin disease. The birch tree bark-derived drug is from Chiesi’s $1.25 billion Amryt Pharma acquisition.
The first gene therapies for sickle cell disease are now approved: Casgevy from Vertex Pharmaceuticals Casgevy and Lyfgenia from Bluebird Bio. Despite the same-day approval, key differences give one of these therapies commercialization advantages over the other.
FDA approval of Novartis’s Fabhalta makes the drug the first approved oral therapy for rare blood disorder paroxysmal nocturnal hemoglobinuria. With clinical data showing superiority versus two infused AstraZeneca drugs, Novartis’s pill is well-positioned to take market share from those blockbuster products.
Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.
Life science startups account for just 8% of global startups but are the second largest driver of investment capital, according to a 2022 report. Cell and gene therapies, machine learning technologies and other innovations have spurred the growth of life science companies. But the life science sector gained attention during the Covid-19 pandemic in a way […]
Eli Lilly’s Jaypirca is now approved for treating three types of blood cancers. While Jaypirca blocks a target already addressed by other cancer therapies, the Lilly molecule does it in a way that sets it apart from the rest of its drug class.
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
SpringWorks Therapeutics drug Ogsiveo is now FDA-approved for treating desmoid tumors, a type of tumor affecting connective tissue. The regulatory decision makes the pill the first therapy approved specifically for treating this rare disorder.
The FDA approved AstraZeneca’s Truqap as a new treatment for advanced cases of breast cancer. The drug is the first in a new class of therapies addressing AKT genetic alterations.
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
FDA approval of Bristol Myers Squibb’s Augtyro covers treatment of patients whose non-small cell lung cancer is driven by the rare ROS1 mutation. The molecule comes from BMS’s 2022 acquisition of Turning Point Therapeutics.
We are on the edge of rapid innovation in psychiatry. Now is the time to break out of our silos and take advantage of the promise the future holds.
Takeda Pharmaceutical enzyme replacement drug Adzynma is the first FDA-approved therapy for a rare blood disorder affecting fewer than 1,000 Americans. Our regulatory recap also includes the much-anticipated approval of an Eli Lilly weight loss drug and a crackdown on what the FTC says are improperly listed pharma product patents.
Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less.
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.