Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (2022)

Table of Contents
Mod­er­na CEO Ban­cel hits the gas with vari­ant-spe­cif­ic boost­ers and a very ear­ly mon­key­pox pro­gram un­der­way Nicole DeFeudis Keep reading Endpoints with a free subscription Will Com­mu­ni­cat­ing with Per­son­al HCPs Get the In­dus­try Clos­er to More Di­verse and Ful­ly En­rolled Clin­i­cal Tri­als? Syneos Health #ESC22: BMS-J&J’s mil­vex­i­an miss­es com­pos­ite end­point, but duo to push drug for­ward with signs of sec­ondary stroke pre­ven­tion and ‘flat bleed­ing curve’ Kyle LaHucik Mod­er­na goes on the patent of­fen­sive; Pablo Legor­re­ta dou­bles down; Is a biotech re­cov­ery on the way?; and more Amber Tong #ESC22: Bay­er's fac­tor XIa in­hibitor miss­es ef­fi­ca­cy marks in 2 PhII stud­ies but drug to move for­ward in some in­di­ca­tions Kyle LaHucik #ESC22: ‘Anx­ious for more ev­i­dence’: As­traZeneca touts DE­LIV­ER da­ta in bid to ex­pand Farx­i­ga’s heart fail­ure la­bel Kyle LaHucik #ESC22: Cin­Cor CMO’s 17-year jour­ney in bring­ing a new hy­per­ten­sion drug to mar­ket con­tin­ues Kyle LaHucik Up­dat­ed: Mod­er­na sues Pfiz­er and BioN­Tech for in­fring­ing on mR­NA vac­cine patents used in block­buster Covid shots Lei Lei Wu Keep reading Endpoints with a free subscription Head of Quality Systems Af­ter wrestling with the San­doz prob­lem for sev­er­al years, Vas Narasimhan set­tles on a spin­out John Carroll Keep reading Endpoints with a free subscription Gilead fights back against BMS Supreme Court pe­ti­tion in patent fight Nicole DeFeudis Keep reading Endpoints with a free subscription Log in to your account e-mail password request magic link email reset password email About You Subscriptions

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (1)

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

August 3, 2022 02:17 PM EDTUpdated 03:52 PM

Pharma

Mod­er­na CEO Ban­cel hits the gas with vari­ant-spe­cif­ic boost­ers and a very ear­ly mon­key­pox pro­gram un­der­way

Nicole DeFeudis

Editor

As Moderna prepares two bivalent variant-specific Covid-19 boosters for delivery in the fall and looks into a potential monkeypox program, CEO Stéphane Bancel stressed on the Q2 call that “now is not the time to slow down.”

The company’s stock $MRNA soared more than 15% Wednesday morning, after Bancel reported a strong quarter and a new $3 billion share buyback plan. Covid sales took a dip compared to last quarter, coming in at $4.5 billion as opposed to $5.9 billion in Q1.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (2)

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Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (3)

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August 22, 2022 06:00 AM EDT

Will Com­mu­ni­cat­ing with Per­son­al HCPs Get the In­dus­try Clos­er to More Di­verse and Ful­ly En­rolled Clin­i­cal Tri­als?

Syneos Health

In 2021, 50 novel medications were approved by the Federal Drug Administration (FDA), the third-highest number of approvals on record and one of many indicators of the extraordinary advancements the medical field has seen in recent decades. But progress within the industry is not equally distributed. When acknowledging the contributions of more than 38,000 patients in its Drug Trials Snapshot of the same year, the FDA noted that “there were many programs where representation from certain racial and ethnic groups was low.” This carefully worded observation describes a long-standing limitation in the clinical trial sector.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (4)

ESC Congress 2022 (Photo by Kyle LaHucik)

August 28, 2022 03:36 AM EDTUpdated 03:53 AM

Pharma

#ESC22: BMS-J&J’s mil­vex­i­an miss­es com­pos­ite end­point, but duo to push drug for­ward with signs of sec­ondary stroke pre­ven­tion and ‘flat bleed­ing curve’

Kyle LaHucik

Associate Editor

BARCELONA — Bristol Myers Squibb and J&J’s Janssen look to move forward with a Phase III of their factor XIa drug in preventing secondary stroke despite missing the goalpost on a composite endpoint, the companies said Sunday morning at the European Society of Cardiology Congress.

During the same session, factor XIa competitor Bayer also announced it had missed the composite endpoint in a mid-stage stroke trial.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (5)

August 27, 2022 06:00 AM EDT

Weekly

Mod­er­na goes on the patent of­fen­sive; Pablo Legor­re­ta dou­bles down; Is a biotech re­cov­ery on the way?; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readerscan visit their reader profileto add Endpoints Weekly. New to Endpoints?Sign up here.

Another round of major medical conferences is upon us, and Kyle LaHucik is in Barcelona, bringing us live coverage from the European Society of Cardiology Congress. We’ll be posting updates on our website throughout the weekend.

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Lonza

Geleen, Netherland

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Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (6)

August 28, 2022 03:36 AM EDT

Pharma

#ESC22: Bay­er's fac­tor XIa in­hibitor miss­es ef­fi­ca­cy marks in 2 PhII stud­ies but drug to move for­ward in some in­di­ca­tions

Kyle LaHucik

Associate Editor

BARCELONA — Bayer’s factor XIa inhibitor didn’t clear the hurdle in certain primary efficacy marks in two Phase II clinical studies, trial investigators said Sunday morning at the European Society of Cardiology Congress.

Bristol Myers Squibb and Johnson & Johnson’s factor XIa inhibitor also flopped on a composite primary endpoint in their own Phase II study, presented shortly after Bayer on Sunday morning.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (7)

August 27, 2022 11:03 AM EDTUpdated 16 hours ago

Pharma

#ESC22: ‘Anx­ious for more ev­i­dence’: As­traZeneca touts DE­LIV­ER da­ta in bid to ex­pand Farx­i­ga’s heart fail­ure la­bel

Kyle LaHucik

Associate Editor

BARCELONA — Three and a half months after teasing a topline win for its heart failure and type 2 diabetes med Farxiga, AstraZeneca laid out the details of the drug’s performance in another heart failure patient population to a crowd at the European Society of Cardiology Congress.

The UK Big Pharma said its drug led to an 18% reduction in a composite endpoint comprising cardiovascular death or worsening heart failure, good for a p-value less than 0.001, over a median follow up of 2.3 years. Broken down, the relative risk reduction was: 21% for worsening HF, 23% for HF hospitalizations and 12% for CV death.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (8)

ESC Congress 2022 (Photo by Kyle LaHucik)

August 28, 2022 09:15 AM EDT

#ESC22: Cin­Cor CMO’s 17-year jour­ney in bring­ing a new hy­per­ten­sion drug to mar­ket con­tin­ues

Kyle LaHucik

Associate Editor

BARCELONA — Sixteen years ago, Mason Freeman was “very disappointed.” A first-in-human study of an aldosterone synthase inhibitor, or ASI, had done what it was supposed to do: block aldosterone production. But it also blocked cortisol.

So, his managers at Novartis scrapped the program that the decades-long Harvard/Mass General physician and a French professor had drummed up just a year earlier.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (9)

Stéphane Bancel, Moderna CEO (AP Photo/Charles Krupa)

August 26, 2022 11:21 AM EDTUpdated 02:59 PM

Law

Up­dat­ed: Mod­er­na sues Pfiz­er and BioN­Tech for in­fring­ing on mR­NA vac­cine patents used in block­buster Covid shots

Lei Lei Wu

News Reporter

Following its announcement in March that it would begin enforcing its Covid-19 vaccine patents in wealthy countries, Moderna says it is suing Pfizer and BioNTech over their mRNA shot.

Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (10)

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ENDPOINTS CAREERS

Head of Quality Systems

Lonza

Lexington, MA, USA

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Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (11)

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

August 25, 2022 04:55 AM EDTUpdated 07:20 AM

Deals

Af­ter wrestling with the San­doz prob­lem for sev­er­al years, Vas Narasimhan set­tles on a spin­out

John Carroll

Editor & Founder

Novartis CEO Vas Narasimhan has finally figured out how he can get Sandoz off his list of major headaches. He’s going to spin the generics giant out as a separate company.

The pharma giant says it will set up Sandoz as an independent company in H2 2023 after navigating the separation through regulators. The spinout will create a lumbering giant with a home on the SIX Swiss Exchange, an American Depositary Receipt program in the US, a pipeline of 15 biosimilars and a rep for mediocre performance.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (12)

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August 26, 2022 02:29 PM EDT

Pharma

Law

Gilead fights back against BMS Supreme Court pe­ti­tion in patent fight

Nicole DeFeudis

Editor

A couple months after Bristol Myers Squibb brought its patent fight with Gilead’s Kite unit to the Supreme Court, Gilead is now making the argument that the petition should be denied because it challenges more than 50 years of precedent.

Juno – which was acquired by Celgene and then Bristol Myers Squibb — sued Gilead’s Kite unit back in 2017, alleging that the company’s CAR-T therapy Yescarta infringed on patents that were licensed to Juno by Memorial Sloan Kettering Cancer Center.

Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (13)

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