J&J hikes US prices for a bas­ket of drugs, in­clud­ing cer­tain top-sell­ers — Reuters

As De­mo­c­ra­t­ic mem­bers of Con­gress pro­posed leg­is­la­tion to curb soar­ing drug prices on Thurs­day, the world’s biggest drug­mak­er by rev­enue John­son & John­son $JNJ raised prices for about two dozen of its pre­scrip­tion med­i­cines, adding to the hun­dreds of price hikes al­ready ini­ti­at­ed by var­i­ous drug­mak­ers in 2019.

Most of the in­creas­es on J&J’s drugs — in­clud­ing top-sell­ers pso­ri­a­sis drug Ste­lara, can­cer drug Zyti­ga and blood thin­ner Xarel­to — were be­tween 6% and 7%, ac­cord­ing to a re­port by Reuters, cit­ing da­ta from Rx Sav­ings So­lu­tions, which helps health plans, em­ploy­ers and em­ploy­ees seek cheap­er pre­scrip­tion med­i­cines.

The Band-Aid mak­er is not plan­ning to raise the prices on any more of its drugs this year, J&J told Reuters. Among large bio­phar­ma com­pa­nies, J&J is one of the least de­pen­dent on drug price hikes for growth, ac­cord­ing to a re­cent analy­sis pub­lished by Leerink.

Al­ler­gan $AGN, Pfiz­er $PFE, Bris­tol-My­ers Squibb $BMY, Bio­gen $BI­IB, Sanofi $SNY, No­vo Nordisk $NVO and oth­er top drug­mak­ers all greet­ed 2019 with price hikes, al­though da­ta sug­gest that in gen­er­al, drug­mak­ers are slow­ing the size and fre­quen­cy of price hikes as po­lit­i­cal, me­dia and pub­lic scruti­ny in­to pric­ing in­ten­si­fies.

Be­tween Jan­u­ary 2 and Jan­u­ary 10, the num­ber of drugs whose prices had been raised rose from more than 250 med­i­cines to close to 490, ac­cord­ing to Rx Sav­ings, as cit­ed by Reuters.

The Unit­ed States is by far the most lu­cra­tive mar­ket for drug­mak­ers — un­like many oth­er high-in­come na­tions — where the gov­ern­ment does not di­rect­ly in­flu­ence pric­ing pol­i­cy, re­ly­ing in­stead on com­pe­ti­tion.

In the UK for in­stance, NICE de­ter­mines whether a med­i­cine is cost-ef­fec­tive — if that thresh­old is not met, the drug is usu­al­ly not in­tro­duced in­to the na­tion­al health ser­vice. The phar­ma­ceu­ti­cal in­dus­try in the Unit­ed States is crit­i­cal of the UK mod­el, as­sert­ing the prac­tice sti­fles the pace of med­ical in­no­va­tion and pa­tients are robbed of ac­cess to im­por­tant med­i­cines. Aside from the high risk and cost of R&D, US drug­mak­ers al­so jus­ti­fy their pol­i­cy of high­er US prices be­cause they have to ne­go­ti­ate with mid­dle­men in the form of phar­ma­cy ben­e­fit man­agers.

In re­cent years, the spot­light on phar­ma­ceu­ti­cal price goug­ing has in­spired a num­ber of US law­mak­ers, as well as the cur­rent Trump ad­min­is­tra­tion to pro­pose leg­is­la­tion to tem­per hikes, and in­crease the gov­ern­ment’s abil­i­ty to in­flu­ence drug prices.

Rep­re­sen­ta­tive Eli­jah Cum­mings, chair­man of the Con­gres­sion­al com­mit­tee on over­sight and re­form, who rein­tro­duced some of bills tak­ing aim at “sky­rock­et­ing” drug prices as part of a leg­isla­tive pack­age on Thurs­day, an­nounced that a hear­ing on pre­scrip­tion drug prices was sched­uled to take place on Jan­u­ary 29.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.