President Biden (AP Images)

Biden sets a 45-day count­down for 'com­pre­hen­sive' plan to tack­le drug pric­ing — while cham­pi­oning some fa­mil­iar poli­cies

Should the phar­ma in­dus­try be brac­ing for new bat­tles on drug pric­ing?

In an ex­ec­u­tive or­der that might serve as a pre­lude for what’s to come, Pres­i­dent Joe Biden spot­light­ed some fa­mil­iar pol­i­cy pro­pos­als while di­rect­ing the HHS to “is­sue a com­pre­hen­sive plan with­in 45 days to com­bat high pre­scrip­tion drug prices and price goug­ing.”

The EO an­nounce­ment comes on the heels of a call by House Speak­er Nan­cy Pelosi to at­tach drug pric­ing re­form to the cur­rent bud­get bill. The cen­tral fig­ure be­hind a sweep­ing bill to tack­le drug prices that’s passed the House, Pelosi pub­licly re­ject­ed the in­dus­try’s ar­gu­ment that low­er­ing prices would harm in­no­va­tion.

Biden’s pre­lim­i­nary plan, re­leased Fri­day af­ter­noon, was paint­ed in much broad­er strokes, and no­tably ex­clud­ed the most rad­i­cal ideas, such as em­pow­er­ing Medicare to di­rect­ly ne­go­ti­ate prices or peg­ging US list prices to an in­ter­na­tion­al in­dex.

Rather, fram­ing the main is­sue as a lack of com­pe­ti­tion, Biden fo­cused on three spe­cif­ic mea­sures en­gag­ing a trio of gov­ern­ment agen­cies: The FDA shall work with states and tribes to safe­ly im­port drugs from Cana­da; the HHS shall in­crease sup­port for gener­ics and biosim­i­lars; and the FTC shall ban “pay for de­lay” or sim­i­lar types of arrange­ments de­signed to sti­fle new mar­ket en­trants.

From the White House:

One strat­e­gy that drug man­u­fac­tur­ers have used to avoid com­pet­ing is ‘pay for de­lay’ agree­ments, in which brand-name drug man­u­fac­tur­ers pay gener­ic man­u­fac­tur­ers to stay out of the mar­ket. That has raised drug prices by $3.5 bil­lion per year, and re­search al­so shows that ‘pay for de­lay’ and sim­i­lar deals be­tween gener­ic and brand name man­u­fac­tur­ers re­duce in­no­va­tion — re­duc­ing new drug tri­als and R&D ex­pen­di­tures.

All three di­rec­tives echo poli­cies or ap­proach­es that have been cham­pi­oned by his pre­de­ces­sor Don­ald Trump or oth­er politi­cians across the aisles.

With the ex­cep­tion of his con­tro­ver­sial en­dorse­ment of a Covid-19 vac­cine IP waiv­er, Biden has been seen as cor­dial to the bio­phar­ma in­dus­try, es­pe­cial­ly in con­trast with Trump’s of­ten con­fronta­tion­al style. The gov­ern­ment spent the past few months main­ly ty­ing ad­min­is­tra­tive loose ends — his HHS with­drew two re­quests for pro­pos­als days ago on the reim­por­ta­tion of in­sulin and per­son­al im­por­ta­tion of pre­scrip­tion drugs, cit­ing a dearth of re­sponse — leav­ing Con­gress to sort out pol­i­cy po­si­tions.

That could well change in 45 days when the HHS lays out its plan. Or not.

The largest phar­ma play­ers, a fact sheet on the new EO states, reaps av­er­age an­nu­al prof­its of 15% to 20%, much high­er than the 4% to 9% re­port­ed by the largest non-drug com­pa­nies.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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