FDA com­mis­sion­er Scott Got­tlieb sets some goals: Find ways to low­er drug prices, use new tech to speed de­vel­op­ment

Scott Got­tlieb start­ed his first full week as FDA com­mis­sion­er by lay­ing out some goals and guide­lines for the agency now un­der his di­rec­tion, hop­ing to al­le­vi­ate some con­cerns he’s been hear­ing about the fu­ture. In an all-hands speech to staff on Mon­day, Got­tlieb re­it­er­at­ed some now fa­mil­iar themes on what he hopes to ac­com­plish, and how every­one at the FDA is now ex­pect­ed to lend a hand.

Aside from some health ini­tia­tives on smok­ing and com­bat­ing the opi­oid ad­dic­tion cri­sis in the coun­try, Got­tlieb pledged to find new ways to low­er drug prices, push­ing through com­plex gener­ics and biosim­i­lars while lay­ing the ground­work to pre­vent any more sweet­heart deals to de­lay the ar­rival of low-cost knock­offs, im­ply­ing that he’s prepar­ing to take ac­tion on that front.

He not­ed:

We al­so need to take steps to make sure the gener­ic drug process isn’t be­ing in­ap­pro­pri­ate­ly gamed to de­lay com­pe­ti­tion and dis­ad­van­tage con­sumers. I hope to have much more to say on this top­ic in the com­ing weeks.

In the area of new drug de­vel­op­ment:

Con­gress gave us a clear man­date to be for­ward-lean­ing when it comes to how we’ll eval­u­ate safe­ty and ef­fi­ca­cy in view of emerg­ing sci­en­tif­ic in­sight and bet­ter an­a­lyt­i­cal tools. Im­ple­ment­ing the 21st Cen­tu­ry Cures Act is a key pri­or­i­ty. We need to make sure we’re tak­ing steps to fos­ter in­no­va­tion and reg­u­lat­ing ar­eas of promis­ing new tech­nol­o­gy in ways that don’t raise the cost of de­vel­op­ment or re­duce in­no­va­tion….

We need to be pa­tient-cen­tric and sci­ence-based in every­thing we do. And, we must make sure that in all our ef­forts, we main­tain the gold stan­dard for reg­u­la­to­ry sci­ence and in­de­pen­dent, sci­ence-led de­ci­sion-mak­ing, all led by a strong ca­reer work­force.

Got­tlieb al­so high­light­ed a change­up in the Of­fice of Reg­u­la­to­ry Af­fairs. As Bloomberg re­port­ed ear­li­er Mon­day, Got­tlieb is fo­cus­ing work­ers on spe­cif­ic ar­eas like drugs and de­vices in or­der to achieve greater ex­per­tise as they in­spect fa­cil­i­ties and probe con­sumer com­plaints, aban­don­ing the old re­gion­al fo­cus with shared re­spon­si­bil­i­ties.

“As ORA’s man­date be­comes more com­plex and more glob­al, we look for­ward to achiev­ing op­er­a­tional ef­fi­cien­cies that can im­prove our abil­i­ty to ful­fill our pub­lic health mis­sion and pro­tect con­sumers,” not­ed Got­tlieb.

None of this is a dra­mat­ic de­par­ture for the FDA. But Got­tlieb is al­so send­ing the mes­sage that busi­ness as usu­al won’t be the theme for his tenure as head of the FDA. His im­me­di­ate pre­de­ces­sor, Robert Califf, of­fered a quick thumbs up for get­ting start­ed ear­ly with a re­or­ga­ni­za­tion.

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.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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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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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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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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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.