The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end […]
Samsung and Pfizer Expand Collaboration to Accelerate Biosimilar Production
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira […]
US Senator Bernie Sanders Looks to Cap Prices on Publicly Funded Drugs
US Senator Bernie Sanders (I – VT) is looking to include price caps on drugs developed with federal funding into a reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act. The proposal would place a ceiling price that matches the lowest price for a given drug in France, Germany, Japan, […]
ICER to Perform Value-Assessment for KarXT Schizophrenia Treatment
The Institute for Clinical and Economic Review (ICER) will perform a value-assessment on KarXT (xanomeline tartrate/trospium chloride), Karuna Therapeutics’ experimental therapeutic for schizophrenia. Public discussion of the assessment will take place next February at the 2024 New England CEPAC […]
Amicus Therapeutics Gets EU Approval for Pompe Disease Drug
Amicus Therapeutics has received approval from the European Commission (EC) for Opfolda (miglustat), its treatment for Pompe disease, a rare disorder that causes progressive muscle weakness. The approval specifically covers the drug in combination with Pombiliti (cipaglucosidase alfa). Results from […]
A Wave of Humira Biosimilars Hit the US Market
Several new biosimilars to AbbVie’s Humira (adalimumab) have just hit the US market in the past week, bringing a new wave of competition for the expensive top-selling therapeutic of all time. The copycats come from companies like Organon, Samsung Bioepsis, Sandoz, and Boehringer Ingelheim. Hadlima, […]
CMS Publishes Revised Guidance for Medicare Drug Pricing Negotiations
As the upcoming Medicare drug pricing negotiations approach, the US Centers for Medicare and Medicaid Services (CMS) have released a revised guidance that better outlines the process. Pharma companies and industry groups have been anxiously awaiting such clarification, but the new information has […]
CMS Makes Changes to Upcoming Medicare Drug Pricing Negotiations
In response to a series of lawsuits from the pharma industry, the US Centers for Medicare and Medicaid Services (CMS) have announced changes to upcoming Medicare drug pricing negotiations. The agency dialed back a confidentiality policy associated with the negotiations, a sticking point for some […]
The Next US Presidency Doesn’t Look Friendly to Pharma
No matter who wins the next US presidency, it doesn’t look that there will be a friend to the pharma and biotech industries in the White House, according to a new Axios article. Donald Trump, the current Republican front-runner has already repeated his previous campaign promise of not letting the US […]
ICER Founder and President to Leave Position This Year
The Institute for Clinical and Economic Review (ICER) has announced that its founder, Steve Pearson, MD, will step down from his role as president later this year. ICER’s COO Sarah Edmond will take over the position as president, while Pearson will move to an advisory position for the organization, […]
