Joe Biden (AP Photo/Patrick Semansky)

$35 month­ly in­sulin cap: Re­pub­li­cans de­cry how White House, Dems plan to pay for it

As the House preps to vote on a $35 month­ly in­sulin cap lat­er to­day (the Sen­ate has plans for a vote next month too), there re­main sev­er­al out­stand­ing ques­tions on how the unin­sured will be cov­ered, how De­moc­rats plan to pay for the cap and what the af­ter-ef­fects might be (i.e. will this cap be off­set by pre­mi­um in­creas­es?).

Kick­ing off dis­cus­sion on the White House-backed cap Wednes­day, the House Rules Com­mit­tee split al­most even­ly along par­ty lines. De­moc­rats called for some­thing to be done to stop peo­ple from ra­tioning their life­sav­ing in­sulin due to price, while Re­pub­li­cans have sought oth­er plans to low­er in­sulin costs, in­clud­ing mar­ket-based so­lu­tions like biosim­i­lars, which have strug­gled to take off so far, or pro­vid­ing PBM re­bates di­rect­ly to pa­tients.

Un­der the bill pro­posed, Medicare ben­e­fi­cia­ries and those in­sured through pri­vate plans would pay no more than $35 for a 30-day in­sulin pre­scrip­tion, or the less­er of $35 or 25% of the plan’s ne­go­ti­at­ed price for a 30-day pre­scrip­tion.

Frank Pal­lone

House En­er­gy & Com­merce Chair Frank Pal­lone (D-NJ) tes­ti­fied Wednes­day on be­half of the bill, ex­plain­ing how most who re­ly on in­sulin to save their lives pay more than dou­ble this $35 cap, and the rea­son that these prices have con­tin­ued to rise is be­cause three drug­mak­ers con­trol the more than $20 bil­lion in­sulin mar­ket — Eli Lil­ly, No­vo Nordisk, and Sanofi — and keep the price high.

“We have so many peo­ple with di­a­betes who are de­pen­dent on in­sulin and whose costs are sky­rock­et­ing,” Pal­lone said, while al­so open­ly mus­ing about whether the Sen­ate could see some Re­pub­li­can de­fec­tions on this, and nab the 60 votes nec­es­sary to pass the bill.

The bi­par­ti­san duo of Sens. Su­san Collins (R-ME) and Jeanne Sha­heen (D-NH), who pre­vi­ous­ly worked on in­sulin in 2019, will lead the Sen­ate’s ef­forts. The is­sue of in­sulin prices in the US has been lin­ger­ing for years with no so­lu­tion. The cur­rent price of in­sulin in the US is more than 10 times that of 33 oth­er com­pa­ra­ble coun­tries, even as the net price of in­sulin has de­clined in re­cent years.

Rep. Cathy Mc­Mor­ris Rodgers (R-WA) tes­ti­fied against the House in­sulin bill on Wednes­day, rais­ing ques­tions about the CBO’s score of it, which said it would cost the gov­ern­ment about $11 bil­lion over 10 years.

Rep. Michael Burgess (R-TX) al­so raised con­cerns about where the De­moc­rats were seek­ing to pay for this in­sulin price cap, ques­tion­ing Pal­lone about why the plan was to cap in­sulin at $35 per month and not $10.

“You’re pay­ing for it with mon­ey that doesn’t ex­ist in the re­bate rule, so why not,” he said.

What Burgess re­ferred to is the way the in­sulin bill al­so would de­lay, for one year, the im­ple­men­ta­tion of a Trump-era rule af­fect­ing cer­tain phar­ma re­bates in Medicare Part D. The Biden ad­min­is­tra­tion like­ly has no in­ten­tion of ever im­ple­ment­ing that rule, as it would end up cost­ing the fed­er­al gov­ern­ment al­most $200 bil­lion over 10 years. De­moc­rats have pre­vi­ous­ly sought to use de­lays in the rule, which is tech­ni­cal­ly still on the books as tak­ing ef­fect, as a way to pay for oth­er drug pric­ing ini­tia­tives.

Mean­while, the com­mit­tee on Wednes­day al­so did not take up an amend­ment to this bill, co-spon­sored by Lloyd Doggett (D-TX) and oth­er De­moc­rats, that would’ve al­so ex­tend­ed this in­sulin price cap to those who are unin­sured, and which would’ve cost an­oth­er $9 bil­lion, ac­cord­ing to the amend­ment text.

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:

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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?”

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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.

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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.

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(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.

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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.”