Biden HHS seeks to dis­miss PhRMA’s law­suit to stop Cana­di­an drug im­ports

As the FDA has yet to au­tho­rize any state plans to im­port pre­scrip­tion drugs from Cana­da, the Biden ad­min­is­tra­tion called on the US Dis­trict Court for DC late last week to dis­miss a PhRMA law­suit over the im­ports be­cause any po­ten­tial harms re­main spec­u­la­tive.

Biden’s HHS said PhRMA’s “whole­sale at­tack” on the rule that al­lows states to sub­mit such plans to the FDA has not yet af­fect­ed their mem­ber com­pa­nies “in any con­crete way and per­haps nev­er will.”

The call to dis­miss the suit, which aligns the Biden ad­min­is­tra­tion with the Trump pol­i­cy, notes that two pro­pos­als from Flori­da and New Mex­i­co have been sub­mit­ted to FDA, but the agency has not of­fered a time­line for when it will de­cide on ei­ther one.

Law firm Cov­ing­ton & Burl­ing, on be­half of PhRMA, filed a cit­i­zen pe­ti­tion with the FDA in Jan­u­ary to de­ny Flori­da’s ap­pli­ca­tion, and it filed an­oth­er cit­i­zen pe­ti­tion in March call­ing to de­ny New Mex­i­co’s too.

For Flori­da, PhRMA crit­i­cized the pro­pos­al be­cause it does not in­clude the name of a Cana­di­an whole­saler that would be nec­es­sary for the plan to work, and it del­e­gates sig­nif­i­cant re­spon­si­bil­i­ties to a pri­vate sec­tor ven­dor to work out the de­tails. For New Mex­i­co, PhRMA took is­sue be­cause the state did not pro­vide a for­eign sell­er, im­porter, or FDA-reg­is­tered repack­ager or re­la­bel­er, and it pro­vides on­ly the first it­er­a­tion of the list of drugs to be im­port­ed.

But Biden’s HHS ex­plains how the rule al­low­ing the sub­mis­sion of these state pro­pos­als asks noth­ing of PhRMA’s mem­ber com­pa­nies. And be­cause the rule and state pro­pos­al process has on­ly been in the works for a few months, FDA needs time to eval­u­ate whether to ac­cept or de­ny the ap­pli­ca­tions, Biden’s HHS main­tains.

“To even be el­i­gi­ble for au­tho­riza­tion, a pro­gram must sat­is­fy up­front (and con­tin­ue to demon­strate there­after) a host of strin­gent reg­u­la­to­ry re­quire­ments re­lat­ed to pa­tient safe­ty and drug sup­ply chain se­cu­ri­ty, as well as show sig­nif­i­cant cost sav­ings to Amer­i­can con­sumers,” the Biden ad­min­is­tra­tion’s mo­tion to dis­miss says. “FDA pos­sess­es dis­cre­tion to de­ny any pro­pos­al that does not fa­cial­ly meet the reg­u­la­to­ry re­quire­ments. Even if a pro­pos­al is fa­cial­ly com­plete, the agency still may with­hold au­tho­riza­tion.”

Fol­low­ing the court fil­ing, Flori­da Gov. Ron De­San­tis (R) on Fri­day as­sert­ed that it “puts the Biden Ad­min­is­tra­tion on the record in sup­port of the FDA rule,” which he said could po­ten­tial­ly save the state be­tween $80 mil­lion and $150 mil­lion in the first year alone. He al­so pushed the FDA to act quick­ly in de­cid­ing on the pro­pos­al, say­ing, “Florid­i­ans have been wait­ing long enough for low­er drug prices, and there is no good rea­son to keep them wait­ing.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales.

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With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

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Jon Cole, emergency doc at Minneapolis' Hennepin County Medical Center

FDA warns Min­neso­ta doc for run­ning two ke­t­a­mine tri­als with­out INDs, and with chil­dren and a preg­nant woman

The FDA on Tuesday released a warning letter sent to a Minnesota physician who failed to exclude vulnerable populations from two clinical trials comparing the anesthetic ketamine with haloperidol and midazolam as potential severe agitation treatments.

The letter makes clear that not only did Jon Cole, emergency doc at Minneapolis’ Hennepin County Medical Center, never file INDs for the trials with the FDA, as required by law, he also didn’t write appropriate protocols to ensure that children and pregnant women weren’t enrolled, and didn’t exclude those who were under the influence of intoxicants, in whom the use of ketamine is cautioned.