Stéphane Bancel, Moderna CEO (Markus Schreiber/AP Images)

Mod­er­na promis­es to pro­vide vac­cines at no out-of-pock­et cost

Mod­er­na said Wednes­day that peo­ple won’t need to pay out-of-pock­et for its Covid vac­cine, re­gard­less of their in­sur­ance sta­tus, once the US gov­ern­ment stops cov­er­ing the cost of the shots.

Last week, the De­part­ment of Health and Hu­man Ser­vices con­firmed plans to on May 11 end the fed­er­al Covid-19 pub­lic health emer­gency. Since Con­gress hasn’t signed off on ad­di­tion­al funds for vac­cines and treat­ments, the gov­ern­ment will halt its free shot pro­vi­sion this year.

The ad­min­is­tra­tion reaf­firmed its com­mit­ment to “en­sur­ing that Covid-19 vac­cines and treat­ments will be wide­ly ac­ces­si­ble to all who need them,” and added that Covid vac­cines will con­tin­ue to be cov­ered by Medicare Part B and most pri­vate in­sur­ance plans with no cost-shar­ing.

On Wednes­day, Mod­er­na an­nounced that those who are unin­sured or un­der­in­sured will al­so be able to re­ceive the com­pa­ny’s shots at no cost through a pa­tient as­sis­tance pro­gram launch­ing af­ter the pub­lic health emer­gency ex­pires.

“Every­one in the Unit­ed States will have ac­cess to Mod­er­na’s Covid-19 vac­cine re­gard­less of their abil­i­ty to pay,” the com­pa­ny said in a news re­lease.

Sen. Bernie Sanders (I-VT), chair­man of the Sen­ate Com­mit­tee on Health, Ed­u­ca­tion, La­bor and Pen­sions, con­demned Mod­er­na’s re­port­ed plans to quadru­ple the price of its Covid-19 vac­cine in a let­ter to CEO Stéphane Ban­cel last month. Ban­cel told the Wall Street Jour­nal that Mod­er­na is con­sid­er­ing pric­ing its vac­cine be­tween $110 and $130 per dose in the US, the same range Pfiz­er sug­gest­ed last fall, ac­cord­ing to mul­ti­ple re­ports. Mod­er­na de­clined fur­ther com­ment.

“The huge in­crease in price that you have pro­posed will have a sig­nif­i­cant­ly neg­a­tive im­pact on the bud­gets of Med­ic­aid, Medicare and oth­er gov­ern­ment pro­grams that will con­tin­ue cov­er­ing the vac­cine with­out cost-shar­ing for pa­tients,” Sanders wrote. “Your de­ci­sion will cost tax­pay­ers bil­lions of dol­lars. Your out­ra­geous price boost will al­so in­crease pri­vate health in­sur­ance pre­mi­ums.”

Ban­cel has agreed to ap­pear be­fore HELP on March 22, ac­cord­ing to Sanders.

Boost­er shots

US boost­er up­take con­tin­ues to crawl, with just 15.8% of Amer­i­cans hav­ing rolled up their sleeves for the up­dat­ed vac­cine, ac­cord­ing to the CDC’s lat­est da­ta. For com­par­i­son, more than 80% of el­i­gi­ble Amer­i­cans have re­ceived at least one dose of a Covid vac­cine.

Last month, the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee vot­ed unan­i­mous­ly in fa­vor of “har­mo­niz­ing” Covid vac­cine com­po­si­tions, mean­ing all cur­rent vac­cine re­cip­i­ents would re­ceive a bi­va­lent vac­cine, re­gard­less of whether they’ve got­ten their pri­ma­ry se­ries, in an ef­fort to clear up con­fu­sion and “get clos­er to the strains that are cir­cu­lat­ing,” one mem­ber said.

De­spite slow up­take, Ban­cel ex­pects at least $5 bil­lion in 2023 vac­cine sales from al­ready con­firmed ad­vance pur­chase agree­ments and 2022 con­tract de­fer­rals.

Pfiz­er has pre­vi­ous­ly com­mit­ted to of­fer­ing unin­sured US res­i­dents free ac­cess to its vac­cine through the com­pa­ny’s pa­tient as­sis­tance pro­gram.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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