Attorney General Merrick Garland (Nicholas Kamm, Pool via AP)

Ex­clu­sive: Bi­par­ti­san let­ter to Mer­rick Gar­land warns of opi­oid over­dose drug short­ages

De­mo­c­rat Mar­cy Kap­tur of Ohio joined with Re­pub­li­can Andy Har­ris of Mary­land in pen­ning a new let­ter to At­tor­ney Gen­er­al Mer­rick Gar­land rais­ing fresh con­cerns about the most re­cent opi­oid set­tle­ments that re­quire Te­va Phar­ma­ceu­ti­cals to pro­vide more than $200 mil­lion worth of nalox­one sup­plies to just three states over 10 years, and which might cre­ate short­ages else­where.

Mar­cy Kap­tur

The let­ter, first ob­tained by End­points News, ques­tions what Gar­land’s plans are mov­ing for­ward, es­pe­cial­ly con­sid­er­ing Con­gress pre­vi­ous­ly raised warn­ings in Au­gust 2020 that man­u­fac­tur­ers sup­ply­ing MAT drugs to states at no cost in lieu of pay­ing out their set­tle­ments could cre­ate bot­tle­necks in sup­plies.

“At that time, con­cerns cen­tered on the im­pact of glob­al opi­oid set­tle­ment and FDA re­spond­ed that this would be bet­ter posed to the De­part­ment of Jus­tice (DOJ). These same con­cerns have es­ca­lat­ed in light of re­cent an­nounce­ments that mul­ti­ple states — Flori­da, Rhode Is­land and Texas — are al­low­ing the drug man­u­fac­tur­er to not on­ly pro­vide MAT treat­ment drugs but al­so opi­oid re­ver­sal agents, like nalox­one,” Kap­tur and Har­ris wrote.

Most re­cent­ly, Te­va agreed to pay part of its set­tle­ment with the state of Flori­da by pro­vid­ing gener­ic Nar­can (nalox­one hy­drochlo­ride nasal spray) val­ued at $84 mil­lion (whole­sale ac­qui­si­tion cost) over 10 years. Rhode Is­land’s AG sim­i­lar­ly agreed to a deal where Te­va will sup­ply 50,000 kits of Nalox­one (100,000 nasal sprays) per year for 10 years, val­ued at $62.5 mil­lion, as well as opi­oid treat­ment Sub­ox­one val­ued at $16 mil­lion over 10 years.  And in Texas, the state will get $75 mil­lion worth of Nar­can from Te­va over 10 years.

Andy Har­ris

“The un­in­tend­ed con­se­quences that could re­sult from these mis­guid­ed set­tle­ments are even more con­cern­ing,” the rep­re­sen­ta­tives wrote. “Al­low­ing one com­pa­ny to pro­vide free drugs to en­tire pa­tient pop­u­la­tions is tak­ing a vi­tal­ly im­por­tant choice away from physi­cians and pa­tients. These set­tle­ments span 10 or 15 years, de­pend­ing on the agree­ment, fun­da­men­tal­ly al­ter­ing the mar­ket and sti­fling in­no­va­tion in that space.”

And Kap­tur and Har­ris are ask­ing whether the DOJ has the au­thor­i­ty it needs to as­sess the im­pact that these set­tle­ments will have on the MAT and nalox­one mar­kets.

Mean­while, the FDA may need more con­gres­sion­al au­thor­i­ty to en­sure that opi­oids com­ing to mar­ket are bet­ter than what’s cur­rent­ly avail­able, com­mis­sion­er Rob Califf said at a hear­ing last week.

Sen. Mike Braun (R-IN) agreed that the FDA could use this ad­di­tion­al au­thor­i­ty to rein in opi­oid ap­provals as the cri­sis led to more than 100,000 over­dose deaths in 2021, ac­cord­ing to the CDC.

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.

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.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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