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Donald Trump, AP

Fed­er­al judge scut­tles Trump's rule man­dat­ing drug prices in TV ads

The Trump administration has endured a setback after a federal court overturned a ruling — obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Donald Trump. Manuel Balce Ceneta, AP

Ex­ec­u­tive or­der un­der con­struc­tion to peg US drug prices to low­est prices abroad, Trump says

As he mounts his re-election bid for 2020, president Donald Trump unveiled plans that an executive order is being prepared to implement a “favored nations clause” to reduce drug prices in the United States, in conversation with reporters on the south lawn of the White House on Friday.

“We’re working on a favored nations clause, where we pay whatever the lowest nation’s price is,” Trump said. “Why should other nations — like Canada — why should other nations pay less than us?”

Alex­ion's cash cow Soliris just got fat­ter as FDA green­lights an­oth­er block­buster in­di­ca­tion

Alexion has scored an additional FDA OK for its keystone rare therapy Soliris, unlocking what a key analyst calls a significant part of its C5 franchise and elevating that portfolio further up the blockbuster ranks.

The drug is now approved to treat neuromyelitis optica spectrum disorder, a rare autoimmune condition characterized by sudden attacks on the central nervous system. The disease often strikes women in their 30s and 40s, and could be confused with multiple sclerosis. While off-label Rituxan helps most patients — approximately 70% — keep the disease at bay, relapses still threaten to do irreversible harm and cause severe disability to those for whom the standard of care doesn’t work.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Regeneron and their partners at Sanofi have beat the Novartis/Roche team to the punch on another key indication for their blockbuster anti-inflammatory drug Dupixent. The drug team scored an accelerated FDA approval for chronic rhinosinusitis with nasal polyps, making this the first such NDA for the field.

Analysts have been watching this race for a while now, as Sanofi/Regeneron won a snap priority review for what is now their third disease indication for this treatment. And they’re not nearly done, building up hopes for a major franchise.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bristol-Myers Squibb has suffered another painful setback in its years-long quest to expand the reach of Opdivo. The pharma giant this morning noted that their Checkmate-459 study comparing Opdivo with Bayer’s Nexavar in frontline cases of hepatocellular carcinoma — the most common form of liver cancer — failed to hit the primary endpoint on overall survival.

This was a significant milestone in Bristol-Myers’ tally of PD-1 catalysts this year. Nexavar (sorafenib) has been the standard of care in frontline HCC for the past decade, though Opdivo has been making headway in second-line HCC cases, where it’s going toe-to-toe with Bayer’s Stivarga (regorafenib) after recent approvals shook up the market.

FDA spurns hay fever drug from In­di­a's Glen­mark

In its attempt to be transparent about manufacturing machinery, Indian drugmaker Glenmark appears to have shot itself in the foot with the FDA. On Saturday, the Maharashtra-based company disclosed that its hay fever drug, Ryaltris, had been rejected by the US health regulator.

In its complete response letter, the FDA cited deficiencies in the Drug Master File (DMF) related to one of the active pharmaceutical ingredients and a manufacturing plant, Glenmark noted in a statement, adding that it is confident the issue can be resolved in the next 6 to 9 months.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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J&J's Es­ke­t­a­mine, at cur­rent price, is 'low val­ue for mon­ey' — ICER

For Johnson & Johnson’s $JNJ pharmaceutical version of the hallucinogenic anesthetic ketamine — esketamine — to be cost-effective for use in treatment-resistant depression in the long term, its list price must be cut by up to half, ICER concluded in its final report on Thursday.

Cognizant of the myriad of approved antidepressants that often don’t work, the US regulator endorsed J&J’s esketamine, branded as  — Spravato — in March for treatment-resistant depression, conscious that the original cat tranquilizer is frequently used off-label for severe depression.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the moment stop taking notes. You can put down your pens and your pad. I have no slides. I have no substantive data. I have no pitch.”

So began Roger Perlmutter’s brief appearance onstage at Merck’s first investor day in five years, where he dived into the company’s history dating back to 1933. The first employees at Merck Research Laboratories, handpicked by founder George W. Merck, were critical to Merck’s ability to achieve clinical and commercial success.