Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Sen­ate last week vot­ed along par­ty lines, 51-50, with Vice Pres­i­dent Ka­mala Har­ris cast­ing the tie-break­er, to make Pres­i­dent Biden ap­pointee Al­varo Bedoya the de­cid­ing vote on a split 2-2 Fed­er­al Trade Com­mis­sion.

Al­varo Bedoya

The ad­di­tion of Bedoya to the FTC could not on­ly spell more trou­ble for bio­phar­ma M&A ac­tiv­i­ty, as he may align with his De­mo­c­rat part­ners to break the FTC ties, but it may al­so mean that FTC Chair Lina Khan has what she needs to move for­ward on a study around the phar­ma mid­dle­men known as phar­ma­cy ben­e­fit man­agers.

The FTC was pre­vi­ous­ly dead­locked, with a 2-2 vote from last Feb­ru­ary, re­gard­ing the need for such a study (mean­ing it did not move for­ward), al­though many in and around the phar­ma­cy world raised con­cerns at that meet­ing.

Na­tion­al Com­mu­ni­ty Phar­ma­cists As­so­ci­a­tion CEO B. Dou­glas Hoey praised Bedoya’s con­fir­ma­tion in a state­ment, adding, “We be­lieve that he shares the com­mit­ment to in­ves­ti­gat­ing phar­ma­cy ben­e­fit man­agers and em­pow­er­ing con­sumer choice by pre­serv­ing small busi­ness com­pe­ti­tion.”

The top three PBMs — CVS Care­mark, Ex­press Scripts and Op­tum­RX — con­trol 80% of the PBM mar­ket, in­clude three of the four largest US phar­ma­cies by pre­scrip­tion drug rev­enue, and are ei­ther owned by or own in­sur­ance com­pa­nies.

A clos­er look in­to some of these PBM pric­ing games shows how they can con­trol mar­kets, and use an­ti-com­pet­i­tive tac­tics, like fa­vor­ing brand-name drugs when gener­ics are avail­able, to boost their own bot­tom lines.

But it re­mains un­known if Khan will push for­ward with her cur­rent plan for a PBM study, with just the three De­mo­c­rat votes, or try to win over the two oth­er FTC com­mis­sion­ers with a new PBM study plan.

Pre­vi­ous­ly, FTC com­mis­sion­ers Noah Phillips and Chris­tine Wil­son, who vot­ed against con­duct­ing the FTC study on PBMs but re­mained open to such a study, claimed that that cur­rent plan un­der Khan to study PBMs was not de­signed to in­ves­ti­gate their com­pet­i­tive ef­fects, and it’s not clear this study would re­veal any­thing about pa­tients’ out-of-pock­et costs.

Pri­or to join­ing the FTC, Bedoya was the found­ing di­rec­tor of the Cen­ter on Pri­va­cy & Tech­nol­o­gy at George­town Uni­ver­si­ty Law Cen­ter, where he is cur­rent­ly a vis­it­ing pro­fes­sor of law.

Ac­cord­ing to the FTC, he has been in­flu­en­tial in re­search and pol­i­cy in the ar­eas of pri­va­cy and tech­nol­o­gy. He pre­vi­ous­ly served as chief coun­sel to the Sen­ate Ju­di­cia­ry sub­com­mit­tee on Pri­va­cy, Tech­nol­o­gy and the Law, and Coun­sel and as chief coun­sel to for­mer Sen. Al Franken (D-MN).

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.

Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”