Durbin push­es for Sen­ate vote on bill to in­clude drug prices in ads

Sen­a­tor Richard Durbin (D-IL) took to the Sen­ate floor on Wednes­day to push for a vote on a bi­par­ti­san bill that would re­quire phar­ma­ceu­ti­cal com­pa­nies to list the prices of their pre­scrip­tion drugs in di­rect-to-con­sumer (DTC) ad­ver­tise­ments.

Ac­cord­ing to Durbin, the av­er­age Amer­i­can sees nine DTC drug ads each day and the phar­ma­ceu­ti­cal in­dus­try spends more than $6 bil­lion per year on DTC ads.

Durbin and Sen­a­tor Chuck Grass­ley (R-IA) passed a sim­i­lar ver­sion of this bill unan­i­mous­ly in the Sen­ate in Au­gust 2018, but it was re­moved in an ap­pro­pri­a­tions con­fer­ence with the House of Rep­re­sen­ta­tives.
Now, how­ev­er, Grass­ley notes that the De­moc­rats con­trol the House and if the Sen­ate acts on the bill, which is al­so co-spon­sored by Sen­a­tors An­gus King (I-ME), and Lamar Alexan­der (R-TN), it could be­come law.

The lat­est push for such dis­clo­sures comes as US Dis­trict Court Judge Amit Mehta in Ju­ly ruled that the US De­part­ment of Health and Hu­man Ser­vices (HHS) lacks the au­thor­i­ty to re­quire drug­mak­ers to post list prices in phar­ma­ceu­ti­cal DTC tele­vi­sion ad­ver­tise­ments.

Pre­vi­ous­ly in June, Am­gen, Mer­ck, Eli Lil­ly and the As­so­ci­a­tion of Na­tion­al Ad­ver­tis­ers sued HHS over its pend­ing rule that would have es­tab­lished such dis­clo­sures, claim­ing that the list prices are not what pa­tients pay and that the agency does not have the au­thor­i­ty for such a rule­mak­ing.

Mean­while, a re­search let­ter in JA­MA from Sep­tem­ber, shows how states are con­tin­u­ing to push for fur­ther drug price trans­paren­cy but with lit­tle suc­cess. Of 166 drug pric­ing laws iden­ti­fied in the study, 35 laws passed in 22 states and in­clud­ed a trans­paren­cy com­po­nent, but on­ly sev­en laws passed in six states were deemed in­for­ma­tive.

“De­spite many re­cent state laws about price trans­paren­cy, we found that most of them were in­suf­fi­cient to re­veal true trans­ac­tion prices, and no state passed leg­is­la­tion that pro­vid­ed ef­fec­tive trans­paren­cy across the en­tire sup­ply chain. To en­sure drug price leg­is­la­tion is use­ful, pol­i­cy mak­ers should re­quire that re­al price in­for­ma­tion, in­clud­ing dis­counts and re­bates, is re­port­ed by all sup­ply chain par­tic­i­pants,” the au­thors from the Uni­ver­si­ty of South­ern Cal­i­for­nia wrote.


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So­cial im­age: Richard Durbin via durbin.sen­ate.gov

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

UP­DAT­ED: 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.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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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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