ed silverman

FDA scolds Merz over ‘misleading’ Instagram posts featuring interior designer Nate Berkus.. statnews.com/pharmalot/2024…… #pharma #FDA #botox #wrinkles #Instagram

Student group that ranked med schools over industry conflicts votes to accept pharma funding.. statnews.com/pharmalot/2024… #pharma #medicine #MedicalEducation #medschool #conflicts

““The whole purpose of biosimilars was to introduce competition into the marketplace," said study author Ben Rome. "...The fact that it’s so hard to find savings consistently is disappointing." statnews.com/pharmalot/2024… #pharma #biotech #biologics #biosimilars #medicines

“Colombia is planting a flag for global health equity,” said Peter Maybarduk of Public Citizen. “This will inspire new challenges to patent barriers and improve treatment access, towards an AIDS-free generation." statnews.com/pharmalot/2024… #patents #medicines #Colombia #HIV $GSK

“The messages are filled with misinformation that is hard to set straight because it is such a complicated topic and patients are made to feel like their lives are at stake" statnews.com/pharmalot/2024… #pharma #RareDiseases #medicines #drugs #Colorado #Enbrel $AMGN $VRTX

After nearly 30 years covering pharma, you might think I know it all. Here's your chance to find out... you can Ask Me Anything on Thursday, Feb. 15 at 1 pm ET.. click on this STAT+ Connect link to sign up... connect.statnews.com/landing

CMS will use outcomes-based agreements in bid to help Medicaid pay for sickle cell gene therapies.. statnews.com/pharmalot/2024… #pharma #Medicaid #CMS #medicines #sicklecell $VRTX $CRSP $BLUE

Pricey sickle cell treatments raise daunting new challenges for Medicaid programs.. statnews.com/pharmalot/2024… #pharma #sicklecell #Medicaid $VRTX $CRSP $BLUE

When it comes to policing pharma, the FTC says it’s on ‘an incredible winning streak’.. statnews.com/pharmalot/2024… #pharma #FTC #antitrust #monopoly #Biden #rebates #patents #mergers $CVS $AMGN $UNH $CI $GSK $AZN $SNY

Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace.. statnews.com/pharmalot/2023… #pharma #biotech #biosimilar #patents

@DeannaPortero @PearlF @deannaportero yes, i have seen them

@PearlF I really wish that @edsilverman had mentioned whether he saw the FDA communications, or was taking McCarthy's word for it. I'm not skeptical per se, but it would have been powerful to state he saw the records if he saw them. Companies can and do misrepresent FDA communications.

"Last year, the same [FDA] division indicated that data showing the Stealth drug improved heart function could be used to win accelerated approval....But this past June, the division did an about-face and decided the data did not support such an approval."

‘We’ve exhausted all avenues’: A small biotech may give up on its ultra-rare disease drug over frustration with FDA.. statnews.com/pharmalot/2023… #pharma #biotech #FDA #raredisease #orphandrug

Was Amgen less than forthcoming about FDA’s concerns on its cancer drug?.. my latest column.. feedback, suggestions, criticism are welcome.. statnews.com/2023/10/04/amg…… #pharma #biotech #cancer #FDA #transparency #clinicaltrials $AMGN

Colombia set to issue a compulsory license for an HIV medicine sold by GSK’s ViiV.. statnews.com/pharmalot/2023… #pharma #patent #HIV #AIDS #Colombia $GSK $PFE

J&J agrees not to enforce patents on a key tuberculosis drug in dozens of poor countries.. statnews.com/pharmalot/2023… #pharma #patents #TB #tuberculosis #medicine $JNJ

Drug wholesaler owner indicted for alleged role in diverting Gilead and J&J HIV medicines.. read the indictment here.. statnews.com/pharmalot/2023… #pharma #HIV #counterfeit $GILD $JNJ

SEC charges former Pfizer statistician with insider trading over Paxlovid clinical trial results.. statnews.com/pharmalot/2023… #pharma #SEC #insidertrading #Paxlovid $PFE

Gilead defeats federal government in closely watched battle over patents for HIV prevention pills.. statnews.com/pharmalot/2023… #pharma #patents #HIV #AIDS #CDC #HHS $GILD

‘True disruption’: Mark Cuban’s company will sell brand-name diabetes medicines from J&J.. statnews.com/pharmalot/2023… #pharma #diabetes $JNJ

European Union drug pricing proposal for the pandemic treaty generates pushback.. statnews.com/pharmalot/2023… #pharma #pandemic #WHO