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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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