Endpoints News
FTC's fight against PBMs is paused Read in browser
Endpoints News
Thank you for reading, dupa dupackia!
basic
UPGRADE
M T Wed Th F
2 April, 2025
Uncertainty is inevitable. Commercialize with confidence and adaptability.
Create flexible, actionable roadmaps, budgets, and hiring plans in a fraction of the time.
sponsored by Corval
top stories
1. Day after mass FDA firings, new commissioner addresses remaining staff, focusing on 'MAHA' vision
2. FDA cuts stir buyer’s remorse for some biopharma leaders, once excited by Trump
3. FTC's fight against PBMs is paused
4. Eli Lilly adds obesity startup knownwell to its direct-to-consumer service
5.
news briefing
Roche says Ocrevus failed Phase 3 study; Sanofi licenses autoimmune asset from Nurix
6. New CDMO emerges, acquires cell and gene manufacturer Landmark Bio
7. Exclusive: Mikael Dolsten shares his post-Pfizer plans, including advising an AI unicorn with pharma dreams
8. Q&A: John Crowley warns biotech is 'dangerously close' to breaking, as tariff threat, markets batter industry
more stories
 
Alexis Kramer
.

President Donald Trump is expected to announce sweeping new tariffs at 4 p.m. ET, a move that has the pharma industry on edge. The details have been scarce so far, but a recent survey from BIO found that tariffs on products from the EU would increase manufacturing costs for most of the companies polled. Stay tuned for more shortly.

.
Alexis Kramer
Editor, Endpoints News
1
by Zachary Brennan

New FDA Com­mis­sion­er Mar­ty Makary took to the stage at the reg­u­la­tor's Mary­land head­quar­ters on Wednes­day, in his first pub­lic com­mu­ni­ca­tion to much of the agency since Tues­day's mass fir­ings.

Ac­knowl­edg­ing the fir­ings, which were tar­get­ed at 3,500 FDA em­ploy­ees — or 19% of staff — he called the changes dif­fi­cult but nec­es­sary to reach the goal of "Mak­ing Amer­i­ca Healthy Again," re­fer­ring to the slo­gan of new HHS Sec­re­tary Robert F. Kennedy Jr. Sim­i­lar job cuts by Kennedy took place Tues­day across gov­ern­ment health func­tions.

Makary's re­marks were de­scribed by three peo­ple who at­tend­ed the ses­sion. Makary took no ques­tions, two of the peo­ple said, but ac­knowl­edged the dif­fi­cult na­ture of the past sev­er­al days, and said he would sup­port staff who were vi­tal to the agen­cy's op­er­a­tions.

Click here to continue reading
2
by Andrew Dunn, Max Bayer

This week’s sweep­ing lay­offs at the FDA have caused some bio­phar­ma lead­ers to change their tune on the Trump ad­min­is­tra­tion.

Af­ter Pres­i­dent Don­ald Trump’s vic­to­ry in No­vem­ber, many bio­phar­ma CEOs ranged from cau­tious op­ti­mism to en­thu­si­asm about more deals, ris­ing mar­kets and few­er reg­u­la­tions. But the first few months have been de­fined by in­dus­try lead­ers who ei­ther stayed silent or tried to find com­mon ground, even as long­time vac­cine skep­tic Robert F. Kennedy Jr. was con­firmed to lead HHS, and the Elon Musk-led DOGE ini­tia­tive draft­ed mass work­force re­duc­tion plans in­side of HHS.

Tues­day’s fed­er­al cuts, which gut­ted di­vi­sions of the FDA and forced out many se­nior lead­ers with decades of in­sti­tu­tion­al knowl­edge, prompt­ed the be­gin­nings of crit­i­cism from some of bio­phar­ma’s Trump back­ers.

Click here to continue reading
3
by Nicole DeFeudis

The FTC’s le­gal fight against three ma­jor phar­ma­cy ben­e­fit man­agers is on hold af­ter two agency com­mis­sion­ers have been re­moved by the Trump Ad­min­is­tra­tion.

The com­mis­sion­ers, Re­bec­ca Slaugh­ter and Al­varo Bedoya, is­sued two of three votes in fa­vor of bring­ing an ad­min­is­tra­tive com­plaint against the PBMs last year, which al­leged that “an­ti­com­pet­i­tive and un­fair re­bat­ing prac­tices” by the com­pa­nies led to in­flat­ed list prices for in­sulin prod­ucts. Care­mark, Ex­press Scripts, Op­tum Rx and af­fil­i­at­ed com­pa­nies known as group pur­chas­ing or­ga­ni­za­tions were named in the com­plaint.

Slaugh­ter and Bedoya were ter­mi­nat­ed by the Trump ad­min­is­tra­tion on March 18, ac­cord­ing to a mo­tion filed on Mon­day. As “there are cur­rent­ly no sit­ting Com­mis­sion­ers able to par­tic­i­pate in this mat­ter,” the case has been stayed for at least 105 days, a Tues­day or­der states. The stay can be lift­ed “up­on mo­tion by one or more of the par­ties in the pro­ceed­ing."

Click here to continue reading
US PHARMA AND BIOTECH SUMMIT
Join top executives, investors, and policymakers at the US Pharma & Biotech Summit for exclusive insights and discussions on the biggest trends impacting the industry. Reserve your spot today.
4
by Shelby Livingston

Eli Lil­ly’s di­rect-to-con­sumer ser­vice has added an­oth­er tele­health start­up to its line-up of providers who can pre­scribe its med­ica­tions, as it pre­pares to see more de­mand for obe­si­ty drugs fol­low­ing the end of the tirzepatide short­age.

The drug­mak­er has list­ed Boston-based known­well, a pri­ma­ry care and obe­si­ty med­i­cine start­up, on the Lil­ly­Di­rect site, along­side two ex­ist­ing weight loss part­ners, Form Health and 9amHealth. Ac­cord­ing to the site, known­well will pro­vide vir­tu­al care na­tion­wide.

Lil­ly has been ex­pand­ing Lil­ly­Di­rect, which launched in Jan­u­ary 2024 to con­nect pa­tients to providers treat­ing obe­si­ty, mi­graines and di­a­betes and ship pre­scrip­tions straight to pa­tients’ homes. In re­cent months, Lil­ly al­lowed vir­tu­al care com­pa­nies in­clud­ing Ro, Sesame and Noom to in­te­grate their tech­nol­o­gy with its plat­form so pa­tients could more seam­less­ly ac­cess cash-on­ly vials of Zep­bound, the brand name for the obe­si­ty drug tirzepatide. Last week, the drug­mak­er al­so part­nered with Synap­ti­c­ure to con­nect pa­tients to Alzheimer’s treat­ment.

Click here to continue reading
News Briefing: Quick hits from the biopharma web
5
by ENDPOINTS

Plus, news about Sum­it­o­mo Phar­ma, Gilead, Roche, De­sen­tum, In­hi