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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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FDA ap­proves GSK's BC­MA drug, mark­ing a rocky re­turn to can­cer for the British gi­ant

Despite concerns on both safety and efficacy, the FDA approved GlaxoSmithKline’s multiple myeloma drug belantamab mafodotin, deciding that for the sickest patients the benefits outweighed the risk.  It will be marketed as Blenrep and sold for $23,900 per month.

The approval is notable both for the multiple myeloma field and for GSK itself. It’s the first approval for a drug that targets BCMA, a protein overexpressed on multiple myeloma cells that researchers have been trying to target for over a decade. A flurry of other BCMA drugs, having already shown promise in early trials, are likely to follow in the next few years.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.