Kim Smith, ViiV head of R&D, at GlaxoSmithKline's Investor Day

FDA ex­pands la­bel for Vi­iV's Cabe­nu­va to cov­er bi-month­ly ad­min­is­tra­tion HIV treat­ment

Adults liv­ing with HIV will now have the op­tion to re­ceive treat­ment just six times a year, as the FDA clears Vi­iV Health­care’s Cabe­nu­va for use every two months.

The la­bel ex­pan­sion comes just a few days af­ter the one-year an­niver­sary of Cabe­nu­va’s ini­tial ap­proval, which marked the his­toric OK for a long-act­ing HIV treat­ment that can be ad­min­is­tered once every month in­stead of dai­ly.

On­ly those who are al­ready vi­ro­log­i­cal­ly sup­pressed, have no his­to­ry of treat­ment fail­ure or sus­pect­ed re­sis­tance to ei­ther of the ac­tive in­gre­di­ents are el­i­gi­ble for this dos­ing reg­i­men.

“In clin­i­cal tri­als, ap­prox­i­mate­ly nine out of every ten tri­al par­tic­i­pants pre­ferred long-act­ing cabote­gravir and rilpivirine dosed every two months com­pared to dai­ly oral cabote­gravir and rilpivirine tak­en as the oral lead-in per tri­al pro­to­col,” said Turn­er Over­ton, pri­ma­ry in­ves­ti­ga­tor of the AT­LAS-2M tri­al and a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Al­aba­ma at Birm­ing­ham.

Cabe­nu­va con­sists of two ex­tend­ed-re­lease in­jecta­bles: cabote­gravir, which is de­vel­oped by Vi­iV, and rilpivirine from J&J’s Janssen (which is al­so mar­ket­ed in­di­vid­u­al­ly un­der the brand names Edu­rant and Rekam­bys.

The dif­fer­ence be­tween the one-month and two-month dos­ing is a big­ger dose, Vi­iV head of R&D Kim Smith pre­vi­ous­ly told End­points News.

How­ev­er, she not­ed, that is the max­i­mum dose al­lowed by those com­pounds — which was why Vi­iV has been look­ing to part­ners for new tech­nolo­gies that can ex­tend the dos­ing in­ter­val to three months, six months or even be­yond.

“We have cre­at­ed the first long-act­ing reg­i­men,” she said. “Our com­peti­tors are fol­low­ing us down on this path, but we are at least five years ahead of them. We want to build on what we’ve al­ready cre­at­ed, the knowl­edge that we’ve gained in de­vel­op­ing Cabe­nu­va, and take it to the next lev­el.”

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.