Roche has tak­en the Trump pledge, join­ing Pfiz­er, No­var­tis and Mer­ck in promis­ing to hold the line on drug prices

You can add yet an­oth­er Big Phar­ma to the grow­ing list of gi­ants swear­ing off US price hikes.

Roche tells me this morn­ing that they told HHS on Ju­ly 11 — the day af­ter Pfiz­er CEO Ian Read agreed to roll back a price hike in a call with the pres­i­dent — that “we will not be tak­ing any price in­creas­es for the re­main­der of the year.”

Roche’s move comes as Pfiz­er, No­var­tis and Mer­ck have all pledged to hold the line on drug prices for the rest of the year — which comes amid con­sid­er­able skep­ti­cism over just how mean­ing­ful this is. And Reuters is re­port­ing that Bay­er and Mer­ck KGaA are al­so falling in­to line.

Roche, though, al­most im­me­di­ate­ly was called out for freez­ing prices af­ter they had al­ready com­plet­ed two rounds of price hikes this year. Bloomberg re­ports that the phar­ma gi­ant raised prices on its big three can­cer drugs — Avastin, Per­cep­tion and Rit­ux­an — and oth­ers just days ago, fol­low­ing in­creas­es in Jan­u­ary.

Based on pre­vi­ous years, Roche may well have been fin­ished rais­ing prices any­way.

The move will sure­ly lead to plen­ty of new hoots from crit­ics, who have been call­ing out Mer­ck for slash­ing the price of a hep C ther­a­py that was all but dead any­way, along with oth­er drugs that had lost patent pro­tec­tion.

Im­pact­ful or not, from the per­spec­tive of the Trump ad­min­is­tra­tion, this is an­oth­er big win. The op­tics on these price freezes are just what Don­ald Trump was look­ing for when he called up Pfiz­er CEO Ian Read fol­low­ing the com­pa­ny’s move to raise prices on dozens of prod­ucts.

Now it looks like we’ll soon have a ma­jor­i­ty of the top 10 promis­ing to hold the line, at least for the rest of this year.

Here’s the rest of the state­ment from Roche:

We take de­ci­sions re­lat­ed to the prices of our med­i­cines very se­ri­ous­ly and our com­mit­ment to pa­tient ac­cess and in­vest­ment in fu­ture break­throughs are re­flect­ed in our ac­tions. This ap­plies to the way we price new med­i­cines and how we change the price of those med­i­cines over time.

For ex­am­ple, our last sev­en new med­i­cines were priced less than oth­er ap­proved med­i­cines used to treat a sim­i­lar dis­ease. We re­cent­ly priced Ocre­vus, an in­no­v­a­tive treat­ment for mul­ti­ple scle­ro­sis, 25% low­er than the med­i­cine it sur­passed in clin­i­cal tri­als, and Hem­li­bra at less than half the cost of the stan­dard treat­ment for he­mo­phil­ia A with in­hibitors.

Al­so, over the past sev­er­al years, Genen­tech’s an­nu­al av­er­age net price in­crease, weight­ed by sales, was ap­prox­i­mate­ly 3% – in line with the med­ical con­sumer price in­dex (CPI).

But for pa­tients and the health­care sys­tem to ben­e­fit ful­ly from re­spon­si­ble pric­ing ac­tions, we must al­so fo­cus on im­ple­ment­ing long-term, sys­tem-wide so­lu­tions that low­er costs, while sus­tain­ing sci­en­tif­ic in­no­va­tion and ac­cess to life-chang­ing med­i­cines.

To that end, we are en­gag­ing with HHS and oth­ers to pro­pose and dis­cuss ideas and rec­om­men­da­tions that can bring about pos­i­tive, last­ing change. These in­clude en­abling the Cen­ters for Medicare & Med­ic­aid Ser­vices to ben­e­fit more di­rect­ly from pri­vate sec­tor com­pe­ti­tion for Part B med­i­cines; re­form­ing the 340B pro­gram; and im­ple­ment­ing nov­el pric­ing and re­im­burse­ment mod­els.

We’re com­mit­ted to be­ing part of the so­lu­tion and look for­ward to con­tin­u­ing these dis­cus­sions.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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