Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump ad­min­is­tra­tion is not giv­ing up just yet. On Wednes­day, the HHS filed an ap­peal against a judge’s de­ci­sion in Ju­ly to over­turn a rul­ing oblig­at­ing drug man­u­fac­tur­ers to dis­close the list price of their ther­a­pies in tele­vi­sion ad­verts — hours be­fore it was stip­u­lat­ed to go in­to ef­fect.

In May, the HHS pub­lished a fi­nal rul­ing re­quir­ing drug­mak­ers to di­vulge the whole­sale ac­qui­si­tion cost— of a 30-day sup­ply of the drug — in tv ads in a bid to en­hance price trans­paren­cy in the Unit­ed States. The phar­ma­ceu­ti­cal in­dus­try has ve­he­ment­ly op­posed the rule, as­sert­ing that list prices are not what a typ­i­cal pa­tient in the Unit­ed States pays for treat­ment — that num­ber is typ­i­cal­ly de­ter­mined by the type of (or lack there­of) in­sur­ance cov­er­age, de­ductibles and out-of-pock­et costs. Al­though there is truth to that claim, the move was con­sid­ered sym­bol­ic in the Trump ad­min­is­tra­tion’s health­care agen­da to hold drug­mak­ers ac­count­able in a cli­mate where sky­rock­et­ing drug prices have in­censed Amer­i­cans on both sides of the aisle.

A DC fed­er­al judge in ear­ly Ju­ly quashed the rul­ing at the be­hest of a tri­fec­ta of drug­mak­ers: Mer­ck $MRK, Eli Lil­ly $LLY and Am­gen $AMGN, in ad­di­tion to the Na­tion­al As­so­ci­a­tion of Ad­ver­tis­ers, a trade as­so­ci­a­tion. They ar­gued that the rule eclipsed HHS’s au­thor­i­ty be­cause Con­gress “nei­ther ex­press­ly nor im­plied­ly grant­ed HHS the pow­er un­der the So­cial Se­cu­ri­ty Act to reg­u­late drug mar­ket­ing” and con­tend­ed that com­pelled speech vi­o­lat­ed the First Amend­ment.

The court agreed that the HHS does not have the statu­to­ry au­thor­i­ty to im­ple­ment the drug price dis­clo­sure rul­ing. Al­though the court does not take “any view on the wis­dom of re­quir­ing drug com­pa­nies to dis­close prices. That pol­i­cy very well could be an ef­fec­tive tool in halt­ing the ris­ing cost of pre­scrip­tion drugs. But no mat­ter how vex­ing the prob­lem of spi­ral­ing drug costs may be, HHS can­not do more than what Con­gress has au­tho­rized,” it con­clud­ed.

Trump has long lam­bast­ed the phar­ma­ceu­ti­cal in­dus­try for its pric­ing poli­cies. Af­ter cap­tur­ing the pres­i­den­cy, Trump pro­claimed drug­mak­ers were “get­ting away with mur­der.” His ad­min­is­tra­tion has since un­veiled a string of pro­pos­als to tem­per pric­ing, in­clud­ing one last year en­gi­neered to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries.

As he mounts his re-elec­tion bid for 2020, Trump has sug­gest­ed that an ex­ec­u­tive or­der is be­ing pre­pared to im­ple­ment a “fa­vored na­tions clause” to re­duce drug prices in the Unit­ed States. US law­mak­ers are al­so push­ing to im­port drugs from Cana­da, but a Reuters re­port re­vealed Cana­di­an of­fi­cials aren’t ex­act­ly re­cep­tive to the idea, sug­gest­ing the move might threat­en the coun­try’s drug sup­ply or raise costs for its own cit­i­zens.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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