Joe Biden on the North Lawn of the White House, April 27, 2020 (Evan Vucci/AP Images)

Opin­ion: Mean­ing­ful drug pric­ing re­forms are head­ed nowhere fast

Pres­i­dent Biden is tak­ing a page out of for­mer Pres­i­dent Trump’s drug pric­ing play­book: of­fer big promis­es around tough ne­go­ti­a­tions with drug­mak­ers, but fail to of­fer a vi­able path for get­ting it done.

Warn­ing signs that drug pric­ing would no longer be a pri­or­i­ty for the pres­i­dent’s mar­quee leg­is­la­tion came over the past week from the Wash­ing­ton Post and Wall Street Jour­nal. To the cha­grin of House Speak­er Nan­cy Pelosi (D-CA) and oth­er De­moc­rats, Pres­i­dent Biden’s mas­sive, $1.8 tril­lion so­cial safe­ty net plan to help Amer­i­can fam­i­lies, de­tails of which were un­veiled Wednes­day morn­ing, does not in­clude a ma­jor push to cur­tail drug prices.

Al­though Biden is sup­posed to of­fer more specifics in his speech to Con­gress tonight, in­clud­ing a de­mand for leg­is­la­tion on price ne­go­ti­a­tions this year, stand­alone leg­is­la­tion on ne­go­ti­a­tions is not like­ly to make head­way in the dead­locked Sen­ate, es­pe­cial­ly if it needs 60 votes for pas­sage.

Biden whiffed on an op­por­tu­ni­ty to spell out what he wants in writ­ing.

“Pres­i­dent Biden has a plan to build on the Af­ford­able Care Act and low­er pre­scrip­tion drug costs for every­one by let­ting Medicare ne­go­ti­ate prices,” the White House said Wednes­day. That was the on­ly men­tion of drug prices in the White House fact sheet on the safe­ty net over­haul.

Se­nior Biden of­fi­cials tried to down­play this gap­ing hole where Biden should ex­plain what he wants on drug prices, telling re­porters on a call on Tues­day evening that Biden “has been very, very clear that he re­mains ful­ly com­mit­ted to ne­go­ti­a­tions to re­duce pre­scrip­tion drug prices — that, you will hear him re­it­er­ate as a very top pri­or­i­ty and some­thing he deems ur­gent.”

But the broad­er nar­ra­tive is that drug pric­ing as a pri­or­i­ty is slip­ping, and no one knows why ex­act­ly, con­sid­er­ing the sup­port from House and Sen­ate De­moc­rats and even some Re­pub­li­cans. Per­haps the phar­ma­ceu­ti­cal lob­by has al­ready got­ten to Biden? Per­haps the Biden team doesn’t want to pun­ish drug­mak­ers af­ter how quick­ly they were able to de­vel­op Covid vac­cines?

What­ev­er the rea­son, those as­sur­ances from se­nior staffers mean very lit­tle as the House and Sen­ate re­main di­vid­ed on how to pur­sue drug prices. House De­moc­rats last week rein­tro­duced their land­mark (or dead in the wa­ter, de­pend­ing on which par­ty you lis­ten to) drug pric­ing bill, HR 3, which passed along par­ty lines in the House in De­cem­ber 2019 but was nev­er con­sid­ered by the Sen­ate.

At­tempts to re­vive that bill and oth­ers will be­gin in earnest next week at a House En­er­gy & Com­merce Com­mit­tee hear­ing. But if drug pric­ing leg­is­la­tion is re­al­ly go­ing to make head­way, the Sen­ate will need to weigh in.

Some Sen­ate Re­pub­li­cans have al­ready raised red flags about gov­ern­ment price ne­go­ti­a­tions (even as the US is the on­ly coun­try in the world to not ne­go­ti­ate) and fo­cused their plans in­stead on low­er­ing out-of-pock­et costs.

How the leg­is­la­tion makes it across the fin­ish line re­mains murky, but the need for such leg­is­la­tion is as clear as ever.

A new GAO analy­sis on Wednes­day found that for 20 brand-name drugs in 2020, es­ti­mat­ed US prices paid at the re­tail lev­el by con­sumers and oth­er pay­ers (such as in­sur­ers) were more than two to four times high­er than prices in Aus­tralia, Cana­da and France.

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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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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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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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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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.

(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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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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Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.