Pfiz­er preps a laun­dry list of drug price hikes for the New Year — let the po­lit­i­cal fire­works be­gin

Pfiz­er is billing this as a re­strained and com­plete­ly rea­son­able move, but the phar­ma gi­ant has just thrown down a gaunt­let beg­ging Pres­i­dent Don­ald Trump to pick it up.

Bioreg­num Opin­ion Col­umn by John Car­roll

On Fri­day af­ter­noon the phar­ma gi­ant $PFE put out a state­ment say­ing that it’s hold­ing the price line on 90% of its drug port­fo­lio come the New Year. But 41 of its drugs have been picked for a price hike on Jan­u­ary 15, av­er­ag­ing 5%. And one of those drugs, which Pfiz­er said has just been ap­proved for 2 new in­di­ca­tions af­ter ex­ten­sive R&D work, is in line for a 9% hike.

Two years ago, that news would have been greet­ed as a sign of re­mark­able mod­er­a­tion. But for ear­ly 2019, af­ter Trump has re­peat­ed­ly ex­co­ri­at­ed the ma­jors for “get­ting away with mur­der” on drug prices, it’s like­ly go­ing to be seen as a call to leg­isla­tive arms.

Just be­fore the elec­tions Trump sug­gest­ed that Medicare Part B move to im­port over­seas drug prices, hop­ing to per­suade com­pa­nies to mus­cle sin­gle pay­er sys­tems to pay more while low­er­ing the cost of ther­a­pies in the US. Ear­li­er, Trump al­so made a high pro­file call to Pfiz­er CEO Ian Read — one of the most re­sis­tant to rein­ing in price hikes — per­suad­ing him to put a planned slate of price in­creas­es on the back burn­er, at least through the end of the year. Oth­er big play­ers al­so quick­ly fol­lowed suit, though Pfiz­er re­cent­ly in­di­cat­ed that they were mov­ing back to busi­ness as usu­al come 2019.

Pfiz­er is al­so promis­ing that con­sumers shouldn’t feel much fi­nan­cial heat. Their state­ment:

These list price in­creas­es are ex­pect­ed to be off­set by high­er re­bates and dis­counts paid to In­sur­ance Com­pa­nies and Phar­ma­cy Ben­e­fit Man­agers and the net ef­fect on rev­enue growth in the U.S. in 2019 is ex­pect­ed to be ze­ro. Giv­en the high­er re­bates and dis­counts, we ex­pect that the health­care sys­tem will share those ben­e­fits with pa­tients so they do not ex­pe­ri­ence high­er costs for their med­i­cines. In 2018 the net im­pact of price in­creas­es on rev­enue growth is pro­ject­ed to be a neg­a­tive 1 per­cent in the U.S com­pared with 2017.

That’s un­like­ly to sat­is­fy the cur­rent res­i­dent in the White House, who is like­ly to view the move as a per­son­al provo­ca­tion.

The Dems, who may wind up as the strangest bed­fel­lows of the Trump ad­min­is­tra­tion on this is­sue, seem to see some op­por­tu­ni­ties here as well.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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