New Year’s Day price hikes on block­buster drugs set the stage for a big de­bate

Al­ler­gan, Pfiz­er, Bris­tol-My­ers Squibb, Bio­gen and oth­er top drug­mak­ers all cel­e­brat­ed the New Year’s with a tra­di­tion­al boost in the price of their top drugs. 

Bioreg­num Opin­ion Col­umn by John Car­roll

For Al­ler­gan, there was an across-the-board hike of 9.5% for 7 of its top 10 prod­ucts. Bio­gen’s Tec­fidera went up 6%, ac­cord­ing to a ros­ter of new drug prices as­sem­bled Jan­u­ary 1 by Umer Raf­fat from Ever­core ISI. Jar­diance and Trad­jen­ta at Eli Lil­ly went up 6% — af­ter they trig­gered a 2% hike for Al­im­ta just be­fore New Year’s. And so on….

Wel­come to the start of 2019, af­ter on­ly the briefest of hol­i­days from the drug pric­ing de­bate in the US. Just be­fore Christ­mas the con­tro­ver­sy fo­cused on No­var­tis and oth­er gi­ants who were lever­ag­ing up the price on top per­form­ers in the mar­ket. 

Right now, price hikes are a nail, and every­one in Wash­ing­ton DC is look­ing for a ham­mer. You can ex­pect plen­ty of bruis­es and yelps of pain to come in the year ahead as those ham­mers fly.

It won’t mat­ter how much protest­ing these big play­ers do about pro­tect­ing con­sumers from out-of-pock­et costs. Af­ter the ma­jors de­layed their reg­u­lar prices in­creas­es for a few months at the in­sis­tence of the pres­i­dent, the in­dus­try is in for more port­fo­lio “ad­just­ments.” Cue the pres­i­den­tial ac­cu­sa­tions and more ideas like ty­ing Medicare prices to sin­gle-pay­er rates in Eu­rope.

It is this rich top­ic for dis­cus­sion we’ll be tack­ling on the first day at JP­Mor­gan as we as­sem­ble some of the in­dus­try’s top ex­perts on drug pric­ing to see where this de­bate is tak­ing us in 2019. 

I’ll be up front and cen­ter with Pe­ter Bach, an out­spo­ken ad­vo­cate for change at Memo­r­i­al-Sloan Ket­ter­ing, PhRMA chief Stephen Ubl, Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines, Kath­leen Tre­go­ning, the EVP for ex­ter­nal af­fairs at Sanofi and Jeff Mar­raz­zo, the CEO of Spark who’s been spear­head­ing the com­mer­cial­iza­tion of the first gene ther­a­py ap­proved in the US. And we’ll be en­gag­ing in a Q&A with the au­di­ence. Here’s where you can buy a tick­et to the event. 

Me­dia is wel­come to come along as our guest.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.