President Donald Trump speaks at a Nov. 20 news conference in the briefing room at the White House (Susan Walsh/AP)

With on­ly weeks left in his pres­i­den­cy, Trump makes a fi­nal, long-shot bid to re­make US drug pric­ing

As the cur­tain clos­es on his ad­min­is­tra­tion, Pres­i­dent Don­ald Trump is us­ing his fi­nal weeks in of­fice to push one of his longest-run­ning cam­paign promis­es of low­er­ing pre­scrip­tion drug prices.

Trump an­nounced in a brief Fri­day news con­fer­ence that he would be in­sti­tut­ing the “most fa­vored na­tions” rule ty­ing prices in the US to those in oth­er de­vel­oped coun­tries, as well as end­ing cer­tain re­bates paid to mid­dle­men, al­so known as phar­ma­cy ben­e­fit man­agers, in Medicare. The two rules were part of a se­ries of four ex­ec­u­tive or­ders Trump un­veiled in Ju­ly aimed at tack­ling high pre­scrip­tion costs.

The rule will be­gin to take ef­fect on Jan. 1, Trump said, and is slat­ed to run for the next sev­en years. In the mean­time, Trump said he would al­low state gov­er­nors to pur­chase drugs from Cana­da at low­er prices, though he of­fered no de­tails about how this would take place.

It’s not im­me­di­ate­ly clear how Pres­i­dent-elect Joe Biden’s in­com­ing ad­min­is­tra­tion would han­dle the rule. Biden has said pre­vi­ous­ly that he would con­sid­er es­tab­lish­ing an in­de­pen­dent re­view board to as­sess the val­ues of med­i­cines, ac­cord­ing to Politi­co. Law­suits chal­leng­ing the new rules are like­ly forth­com­ing, fur­ther com­pli­cat­ing their im­ple­men­ta­tion. Trump is al­so con­test­ing the elec­tion re­sults, though in­de­pen­dent ob­servers don’t give him any kind of a re­al chance at suc­ceed­ing.

PhRMA, one of the in­dus­try’s top lob­by­ist groups, ex­pressed its dis­plea­sure with the moves in a state­ment Fri­day af­ter­noon. Pres­i­dent Stephen Ubl said, in part:

It de­fies log­ic that the ad­min­is­tra­tion is blind­ly pro­ceed­ing with a “most fa­vored na­tion” pol­i­cy that gives for­eign gov­ern­ments the up­per hand in de­cid­ing the val­ue of med­i­cines in the Unit­ed States. His­to­ry proves that when gov­ern­ments take uni­lat­er­al ac­tion to set prices, it dis­rupts pa­tient ac­cess to treat­ments, dis­cour­ages in­vest­ment in new med­i­cines and threat­ens jobs and eco­nom­ic growth.

In its cur­rent form, the most fa­vored na­tions rule would ap­ply to 50 cost­ly Medicare Part B med­i­cines, which are ad­min­is­tered in doc­tors’ of­fices, such as ex­pen­sive can­cer and rheuma­toid arthri­tis ther­a­pies. The ad­min­is­tra­tion plans to phase in the low­est price in oth­er coun­tries and “blend” it with the av­er­age sales price, and then add a flat amount per dose for each ap­plic­a­ble drug.

Phar­ma com­pa­nies have staunch­ly op­posed en­act­ing the most fa­vored na­tions clause, and it was a source of much con­tention when Trump ini­tial­ly un­veiled the pro­pos­al four months ago. There were scant de­tails at the time and PhRMA sub­mit­ted a coun­ter­pro­pos­al in Au­gust that would have cut Part B prices by 10%, com­pared to the 30% the White House sought.

The White House re­leased the full text of the ex­ec­u­tive or­der in Sep­tem­ber, di­rect­ing HHS Sec­re­tary Alex Azar to es­tab­lish the clause for both Medicare Part B and Part D, which cov­ers pre­scrip­tion drugs. Ul­ti­mate­ly, a pric­ing deal re­port­ed­ly fell through be­tween the gov­ern­ment and the in­dus­try af­ter White House Chief of Staff Mark Mead­ows asked the com­pa­nies to send a $100 “cash card” to se­niors be­fore No­vem­ber and pin the blame for failed ne­go­ti­a­tions on phar­ma com­pa­nies.

Trump al­so an­nounced Fri­day that he would be end­ing the un­ap­proved drugs ini­tia­tive, in which the FDA re­moves un­ap­proved drugs from the mar­ket for safe­ty rea­sons, al­leg­ing they cre­at­ed sev­er­al price goug­ing op­por­tu­ni­ties for com­pa­nies look­ing to ex­tend their mar­ket ex­clu­siv­i­ty win­dows. Since 2006, the FDA has re­port­ed­ly shelved rough­ly 3,400 med­i­cines and has on­ly 11 left to re­view as part of the pro­gram, per Politi­co.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.

Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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