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Pelosi drug pric­ing bill promis­es sav­ings, but could gag R&D — CBO analy­sis

The Democrats’ drug pricing bill — unveiled by Speaker Nancy Pelosi last month — could save Medicare spending by $345 billion over a seven-year period, a new analysis suggests. But the venomous climate of impeachment proceedings and the intensifying discord between the Democrat-controlled House and Republican-majority Senate portends the bill will unlikely ever become law.

Technically, both sides of the aisle agree drug prices in the United States need some lowering. The Democrats’ bill, H.R.3 – Lower Drug Costs Now Act of 2019, is engineered to empower the HHS to negotiate prices for the 125 most expensive prescription drugs without at least two competitors — the Trump administration has already backed such a measure for the Veterans Association. Under the bill, prices for this category of medicines are not intended to exceed 120% of the average price in certain other countries (Australia, Canada, France, Germany and the United Kingdom), akin to a proposal floated by Trump earlier this year, which suggested prices be pegged against what other nations were paying as part of an “international pricing index”.

First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Re­searchers find 15% of tri­als could be repli­cat­ed us­ing re­al world da­ta

A study published this week in JAMA Network Open finds that currently available real-world data (RWD) sources can only be used to feasibly replicate 15% of clinical trials.

The aim of the study was to determine whether RWD could be used to power observational studies that answer the same clinical questions as traditional clinical trials.

Randomized controlled trials (RCTs) are considered the gold standard for clinical evidence to support the safety and efficacy of medical products due to high levels of internal consistency and reduced bias.

In re­ver­sal, NICE backs Rubra­ca af­ter Clo­vis agrees to a price cut

NICE has changed its mind, agreeing to cautiously endorse Clovis Oncology’s Rubraca after the drugmaker agreed to cut its price — about two months after the UK cost-effectiveness agency’s initial rejection.

Rubraca, known chemically as rucaparib, is approved for use in the EU as monotherapy for the maintenance treatment of adult patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have relapsed after platinum-based chemotherapy.

Drug price hikes, with­out jus­ti­fi­able new ev­i­dence of ben­e­fit — ICER analy­sis

For patients, policymakers and politicians drug prices in the United States need some lowering, as the sustainability of the US health care system swings from precarious to precipitous. President Trump and every presidential hopeful worth their salt are creating drug price lowering measures to magically cure the ills of the existing system, without curbing innovation or irritating the industry into seeking refuge elsewhere. ICER, the de-facto cost-effectiveness watchdog that is increasingly gaining traction, on Tuesday unveiled an analysis seeking to answer a fundamental question: are these persistent drug price hikes justified?

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Dif­ferin mak­er Gal­der­ma wins FDA ap­proval for a new retinoid for ac­ne

Data suggest that in 2016 the burden of acne vulgaris — the chronic inflammatory skin disease — ballooned to roughly $3 billion in healthcare costs and lost productivity in the United States. Now those pesky blemishes have a new foe in the form of a topical retinoid from Galderma.

Galderma on Friday said it had secured the approval of trifarotene, a topical retinoid cream. Retinoids are a class of medications derived from vitamin A that have long played in key role in acne therapy. Retinoids interact with retinoic acid receptor (RAR) and retinoid X receptor (RXR) — members of a superfamily of ligand-activated transcription factors — to reduce visible lesions as well as inhibit the development of microcomedones and new lesions.

Jim Swanson, Bayer

J&J poach­es Bay­er ex­ec Jim Swan­son as chief in­for­ma­tion of­fi­cer

James Swanson, who helped lead crop sciences at Bayer $BAYN, is joining J&J $JNJ as chief information officer, jumping into a pharmaceutical industry embracing by fits and starts modern digital tools like artificial intelligence.

The move comes a little over a month after Bayer recruited longtime J&J dealmaker Marianne De Backer to lead business development. Swanson replaces Stuart McGuigan, who this year jumped over to the State Department after seven years as J&J CIO.

King Keytru­da: Mer­ck­'s PD-1 star scores #1 po­si­tion and $22B+ pre­dic­tion in an­oth­er top 10 block­buster list for 2025

Predicting which of the current blockbusters will ascend to new heights is anyone’s game, and one that highlights the current dynamics of the industry. On Friday it’s GlobalData’s turn to pick out the therapies that it believes will come out on top in some intensely competitive spaces.

Humira may still top the chart for best-selling drugs in the world, but Keytruda is set to overtake the shrinking franchise in around five years time — with four other drugs set to get ahead of AbbVie’s biggest cash cow.

THE VILLAGES, FLORIDA — President Donald Trump speaks during an event today in central Florida, where he signed an executive order calling for further privatizing of Medicare. (Photo — Joe Raedle/Getty)

Phar­ma to blame for im­peach­ment woes? Yep, Pres­i­dent Trump just sug­gest­ed that about Amer­i­ca's least fa­vorite in­dus­try

President Donald Trump suggested today without evidence that the pharmaceutical industry is behind the new impeachment inquiry from House Democrats.

“I would be very surprised if the hoax didn’t come a little bit from the people that we’re taking on… I wouldn’t be surprised if it was from some of these industries that we take on, like pharma,” Trump said. He was speaking in central Florida at an official White House event on Medicare. HHS secretary Alex Azar, a former president of the US division of Eli Lilly, was in attendance.

Gilead scores PrEP ap­proval for De­scovy — kick­ing off mar­ket­ing push be­fore Tru­va­da gener­ics swarm

The FDA has cleared Gilead’s Descovy — a top pipeline drug it spent a priority review voucher on — for HIV pre-exposure prophylaxis in a broad, but not all-encompassing, population.

Regulators have excluded from the PrEP label anyone at-risk for HIV from receptive vaginal sex. The decision fell in line with both internal reviews and outside expert opinions at the FDA, which concluded that while Descovy showed efficacy for men and transgender women who have sex with men, the data weren’t sufficient to justify giving the drug to cisgender women, a group that makes up a small portion of the overall PrEP group.