Donald Trump holds up a signed executive order in the South Court Auditorium in the White House complex on Friday, July 24, 2020 (AP Photo/Alex Brandon)

Trump looks to ham­mer down drug prices with 4 ex­ec­u­tive or­ders

Pres­i­dent Don­ald Trump signed 4 ex­ec­u­tive or­ders tar­get­ing the phar­ma­ceu­ti­cal in­dus­try Fri­day af­ter­noon, four months be­fore vot­ers head to the polls.

The pres­i­den­tial di­rec­tives are part of Trump’s long-stand­ing goal to re­duce pre­scrip­tion drug prices in the US. As the cal­en­dar turns to­ward No­vem­ber, the pres­i­dent has shift­ed to ex­ec­u­tive ac­tion over work­ing with Con­gress to reach this ob­jec­tive.

Whether or not such ac­tion will re­sult in any mean­ing­ful changes be­fore the elec­tion re­mains to be seen, as the phar­ma in­dus­try con­tin­ues to be a lob­by­ing force on Capi­tol Hill. The ex­ec­u­tive or­ders are al­so like­ly to be chal­lenged in court.

The most con­tro­ver­sial or­der re­port­ed­ly at­tempts to cap some prices Medicare pays to the price in for­eign coun­tries, which are usu­al­ly sig­nif­i­cant­ly low­er. The text wasn’t im­me­di­ate­ly avail­able.

These “most-fa­vored na­tions” claus­es are akin to price con­trols in phar­ma cir­cles, and Trump threat­ened drug com­pa­nies by im­pos­ing this or­der with­in a month if the com­pa­nies didn’t low­er prices on their own. How Trump can en­act the clause with­out Con­gress re­mains un­clear.

One of phar­ma’s most in­flu­en­tial lob­by­ist groups, PhRMA, un­sur­pris­ing­ly re­act­ed neg­a­tive­ly to the de­vel­op­ments. Here’s PhRMA pres­i­dent Stephen Ubl:

In his 2020 State of the Union Ad­dress, Pres­i­dent Trump de­clared that ‘we will nev­er let so­cial­ism de­stroy Amer­i­can health care.’

Yet, in the mid­dle of a glob­al pan­dem­ic, when near­ly 145,000 Amer­i­cans have lost their lives and mil­lions of oth­ers have suf­fered un­told eco­nom­ic hard­ships, this ad­min­is­tra­tion has de­cid­ed to pur­sue a rad­i­cal and dan­ger­ous pol­i­cy to set prices based on rates paid in coun­tries that he has la­beled as so­cial­ist, which will harm pa­tients to­day and in­to the fu­ture.

The re­search-based bio­phar­ma­ceu­ti­cal in­dus­try has been work­ing around the clock to de­vel­op ther­a­peu­tics and vac­cines to treat and pre­vent COVID-19. The ad­min­is­tra­tion’s pro­pos­al to­day is a reck­less dis­trac­tion that im­pedes our abil­i­ty to re­spond to the cur­rent pan­dem­ic – and those we could face in the fu­ture. It jeop­ar­dizes Amer­i­can lead­er­ship that re­wards risk-tak­ing and in­no­va­tion and threat­ens the hope of pa­tients who need bet­ter treat­ments and cures.

The pres­i­dent’s at­tempt to open our coun­try up to so­cial­ized health care sets Amer­i­ca, our eco­nom­ic re­cov­ery and sci­en­tif­ic progress back at a time when we need them most.

BIO’s chief Michelle Mc­Mur­ry-Heath al­so slammed the move, say­ing she was “dumb­found­ed that the Trump ad­min­is­tra­tion would seek to crip­ple the in­dus­try try­ing to end the COVID-19 pan­dem­ic.”

Dur­ing the press con­fer­ence Trump said top phar­ma ex­ec­u­tives will meet with ad­min­is­tra­tion of­fi­cials next week.

A sec­ond or­der is an ex­ten­sion of a plan in­tro­duced late last year that would al­low states, drug whole­salers and phar­ma­cies to re-im­port drugs from Cana­da at a low­er cost. Phar­ma lob­by­ists claim that such plans would not be able to guar­an­tee the safe­ty of the US drug sup­ply chain, a stance that has been met with skep­ti­cism, while Cana­da isn’t par­tic­u­lar­ly in­ter­est­ed in act­ing as a proxy be­tween drug com­pa­nies and states.

The oth­er two or­ders tar­get in­sulin pric­ing and the re­bates drug whole­salers and phar­ma­ceu­ti­cal ben­e­fit man­agers re­ceive when sell­ing to in­sur­ers.

The lob­by­ist group PC­MA has al­ready come out in op­po­si­tion to the lat­ter mea­sure, with pres­i­dent JC Scott say­ing in a state­ment, “This pol­i­cy does noth­ing to ad­dress drug prices, it on­ly serves to cre­ate un­cer­tain­ty and raise pre­mi­ums for se­niors while im­pos­ing near­ly $400 bil­lion in ad­di­tion­al tax­pay­er costs, all at a time when tax­pay­ers are al­ready foot­ing ad­di­tion­al costs to counter the pan­dem­ic and the na­tion­al debt is at record lev­els.”

Drug prices have been a pet is­sue for Trump, and the pres­i­dent re­port­ed­ly ex­pressed his frus­tra­tion with HHS sec­re­tary Alex Azar in Jan­u­ary say­ing the De­mo­c­ra­t­ic Par­ty will “kill us” on the is­sue. The COVID-19 pan­dem­ic has fur­ther com­pli­cat­ed the is­sue, as Trump’s ap­proval re­gard­ing how he’s han­dling the coro­n­avirus is deep in the red, and the White House has been fun­nel­ing cash in­to the in­dus­try to fu­el the re­search and de­vel­op­ment of po­ten­tial vac­cines.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.