With drug pric­ing re­form po­ten­tial­ly clos­er than ever, Pub­lic Cit­i­zen pens new let­ter call­ing for change

Af­ter pen­ning a let­ter to Speak­er of the House Nan­cy Pelosi and Sen­ate Ma­jor­i­ty Leader Chuck Schumer in June call­ing for drug pric­ing re­form and Medicare im­prove­ment, Pub­lic Cit­i­zen has mount­ed pres­sure with a let­ter thank­ing two mem­bers of Con­gress and a Sen­a­tor for the pre­vi­ous work, and call­ing for more re­lief to pa­tients and con­sumers.

The let­ter ad­dressed to Sen. Ron Wyden (D-OR), Rep. Richard Neal (D-MA), and Rep. Frank Pal­lone (D-NJ) reads:

Bold drug pric­ing re­form that meets the lev­el of am­bi­tion Amer­i­cans de­mand would ful­fill promis­es made con­sis­tent­ly and re­peat­ed­ly by Pres­i­dent Biden, Ma­jor­i­ty Leader Schumer, Speak­er Pelosi and a vast ar­ray of elect­ed Sen­a­tors and mem­bers of Con­gress. In­deed, the Eli­jah E. Cum­mings Low­er Drug Costs Now Act was the most sig­nif­i­cant and im­pact­ful leg­is­la­tion ad­vanced out of the House to low­er drug prices and ex­pand ac­cess to med­i­cines in the Unit­ed States in a gen­er­a­tion, per­haps ever.

Pub­lic Cit­i­zen claims that drug pric­ing re­form would save $450 bil­lion over 10 years and that adding den­tal, hear­ing and vi­sion care to Medicare would cost less than $360 bil­lion over 10 years. A June 16 let­ter ad­dressed to Pelosi and Schumer called to ex­pand Medicare to Amer­i­cans ages 50 and old­er, cit­ing a 10.5% unin­sured rate of adults be­tween the ages of 50 and 64, large­ly thanks to pan­dem­ic-dri­ven job loss.

Drug price re­form would ex­ist in the form of low­ered pre­mi­ums and out-of-pock­et costs, and pro­tect pa­tients against drug price spikes and elim­i­nate the prac­tice of pa­tients ra­tioning treat­ment, which can lead to death.

“The Unit­ed States spends far more than any oth­er coun­try on phar­ma­ceu­ti­cals, and the largest pur­chas­er in the world is the Medicare Part D pro­gram,” the let­ter says.

The or­ga­ni­za­tion’s voice has been loud through­out the past few months. In June, Pub­lic Cit­i­zen penned a let­ter call­ing for the top three FDA of­fi­cials, in­clud­ing act­ing com­mis­sion­er Janet Wood­cock, to re­sign, fol­low­ing the ap­proval of Bio­gen’s Alzheimer’s treat­ment Aduhelm. In the let­ter writ­ten to Health and Hu­man Ser­vices Sec­re­tary Xavier Be­cer­ra, the or­ga­ni­za­tion’s di­rec­tor Michael Car­ome said that new lead­er­ship was “a pre­req­ui­site” for restor­ing the agency’s cred­i­bil­i­ty.

In Jan­u­ary, the or­ga­ni­za­tion al­so called for Wood­cock’s re­moval af­ter her de­fense of the 1995 ap­proval of Oxy­Con­tin, and al­low­ing opi­oid man­u­fac­tur­ers to share false claims about the risks and ben­e­fits of the drugs, which has led to a cri­sis across Amer­i­ca.

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.

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.

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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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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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.

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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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.