President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

Pres­i­dent Don­ald Trump has signed an ex­ec­u­tive or­der de­tail­ing how the fed­er­al gov­ern­ment should help on-shore drug man­u­fac­tur­ing — and the FDA will play a cen­tral role.

The agency now has three months to draw up the list of “es­sen­tial med­i­cines, med­ical coun­ter­mea­sures, and their crit­i­cal in­puts” that the US must have avail­able at all times. Var­i­ous de­part­ments and agen­cies are then di­rect­ed to buy these drugs and their in­gre­di­ents from Amer­i­can man­u­fac­tur­ers.

While lim­it­ed to fed­er­al con­tracts and not pri­vate ones, the ex­ec­u­tive or­der threat­ens to dis­rupt the glob­al sup­ply chain, phar­ma groups warn.

“The ad­min­is­tra­tion is forc­ing bio­phar­ma­ceu­ti­cal com­pa­nies to shift their crit­i­cal at­ten­tion and re­sources away from COVID-19 work to fo­cus on mak­ing sub­stan­tial changes to their busi­ness mod­els nec­es­sary to com­ply with this and oth­er re­cent ex­ec­u­tive or­ders,” PhRMA said in a state­ment. “In­creas­ing U.S. man­u­fac­tur­ing of med­i­cines is a laud­able goal, but it can­not hap­pen overnight and should not come at the ex­pense of in­no­va­tion or Amer­i­cans’ ac­cess to the med­i­cines they need.”

Gil Roth, pres­i­dent of the Phar­ma & Bio­phar­ma Out­sourc­ing As­so­ci­a­tion, said it’s un­clear how ben­e­fi­cial or detri­men­tal the or­der will be to the CD­MOs he rep­re­sents. The sec­tor is strong, he not­ed, and too many ques­tions re­main as to whether new poli­cies will tru­ly ad­dress the bot­tle­becks faced by the in­dus­try.

“Our mem­bers, both on the API and dosage form sides, want a lev­el play­ing field, not a com­mand econ­o­my, and we hope the fed­er­al gov­ern­ment will take in­to ac­count this sec­tor’s ex­ist­ing do­mes­tic ca­pac­i­ty for in­no­v­a­tive and gener­ic drugs be­fore im­ple­ment­ing more man­dates and fund­ing new ca­pac­i­ty at tax­pay­ers’ ex­pense,” he wrote in a state­ment.

Ex­perts have es­ti­mat­ed that as much 90% of the ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in gener­ic drugs sold on US soil is made abroad, al­though there are no of­fi­cial fig­ures.

Un­der the new White House di­rec­tive, gov­ern­ment agen­cies will have to start sub­mit­ting an­nu­al re­ports of where they source their prod­ucts. De­spite the sweep­ing “Buy Amer­i­can” head­line, waivers ap­ply in spe­cif­ic cas­es: when it’s against the pub­lic in­ter­est, the drugs are not pro­duced in the US at a large enough scale, the do­mes­tic prod­ucts would in­crease the cost by more than 25%, or there’s a na­tion­al emer­gency.

Stephen Hahn

FDA com­mis­sion­er Stephen Hahn has sev­er­al more tasks on his list.

Work­ing with HHS Sec­re­tary Alex Azar, he’s charged with ac­cel­er­at­ing FDA ap­proval for do­mes­tic pro­duc­ers of es­sen­tial meds, “in­clud­ing those need­ed for in­fec­tious dis­ease and CBRN threat pre­pared­ness and re­sponse.” In ad­di­tion, he’s al­so ex­pect­ed to is­sue guid­ances for de­vel­op­ing ad­vanced man­u­fac­tur­ing tech­niques, con­duct more site in­spec­tions over­seas and refuse drugs from non-com­pli­ant fa­cil­i­ties.

It re­mains to be seen how the new on-shoring ini­tia­tive will af­fect drug prices, an­oth­er key is­sue Trump is cam­paign­ing on.

For its part, the White House in­sists that low­er­ing the reg­u­la­to­ry bar­ri­er to do­mes­tic phar­ma­ceu­ti­cal man­u­fac­tur­ing (and per­haps rais­ing the bar for for­eign play­ers) and in­vest­ing in new tech would keep drug prices low.

But John and Lau­ra Arnold, who have backed a non-prof­it gener­ic drug man­u­fac­tur­er, are adopt­ing a wait-and-see stance.

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

UP­DAT­ED: 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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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

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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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

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.