Roche un­veils three new mon­key­pox tests as cas­es rise

Health ex­perts main­tain that the cur­rent mon­key­pox sit­u­a­tion is a stark con­trast to Covid. Even so, a hand­ful of biotechs have sprung to ac­tion, in­clud­ing Roche, who quick­ly de­vel­oped a set of three tests to de­tect the virus.

Roche and sub­sidiary TIB Mol­bi­ol un­veiled their Light­mix Mod­u­lar Virus test kits on Wednes­day — three unique test kits that can help track the spread of mon­key­pox.

The first kit de­tects or­thopoxvirus­es, in­clud­ing all mon­key­pox virus­es orig­i­nat­ing from the West African and Cen­tral African forms of the virus. The sec­ond kit is a spe­cif­ic test that de­tects mon­key­pox virus­es on­ly, while the third si­mul­ta­ne­ous­ly tests for both or­thopoxvirus­es and mon­key­pox virus­es.

Thomas Schi­neck­er

“Di­ag­nos­tic tools are cru­cial for re­spond­ing to and ul­ti­mate­ly con­trol­ling emerg­ing pub­lic health chal­lenges as they ad­vance re­sponse mea­sures such as trac­ing ef­forts and treat­ment strate­gies,” Roche Di­ag­nos­tics CEO Thomas Schi­neck­er said in a state­ment.

The test kits are now avail­able for re­search use in most coun­tries around the world, ac­cord­ing to Roche.

Mon­key­pox has been around since 1958 when two out­breaks oc­curred in colonies of re­search mon­keys. Around 20 coun­tries have re­port­ed re­cent out­breaks, with cas­es pil­ing up main­ly in Eu­rope, ac­cord­ing to a Reuters re­port. The US con­firmed its first case in Mass­a­chu­setts just last week, and the CDC is in­ves­ti­gat­ing sev­er­al oth­er po­ten­tial cas­es.

BAR­DA said last week it would shell out $119 mil­lion in an agree­ment with Bavar­i­an Nordic to ex­er­cise op­tions for a freeze-dried stock­pile of Jyn­neos, which cov­ers both mon­key­pox and small­pox. And to­day, the com­pa­ny an­nounced it se­cured an­oth­er vac­cine deal with an undis­closed coun­try.

The Dan­ish com­pa­ny’s stock $BVN­RY was up more than 10% on Wednes­day af­ter­noon, pric­ing in at $9.65 per share.

Mean­while, Emer­gent snagged the rights to Tem­bexa, Chimerix’s small­pox treat­ment for all ages that was ap­proved in 2021. And Mod­er­na is test­ing its own vac­cine can­di­date in pre­clin­i­cal stud­ies, ac­cord­ing to Reuters.

Nor­man Bay­lor

Ear­li­er this week, Bel­gium be­came the first coun­try to in­sti­tute a manda­to­ry quar­an­tine pe­ri­od of 21 days for con­firmed mon­key­pox pa­tients.

This wouldn’t be the first time that the US has faced a mon­key­pox out­break. Cas­es cropped up in 2003 af­ter the US re­ceived a ship­ment of an­i­mals from Ghana. That out­break was con­tained with test­ing and vac­ci­na­tion, ac­cord­ing to the CDC.

Nor­man Bay­lor, who once di­rect­ed the FDA’s Of­fice of Vac­cines Re­search and Re­view and now serves as a con­sul­tant, told End­points News that he doubts the US will need to roll out wide­spread vac­cines. And he em­pha­sized that the sit­u­a­tion now is much dif­fer­ent than when Covid-19 ar­rived in the US back in 2020.

“The good news is we have a vac­cine. Re­mem­ber with Covid, we had noth­ing. We were start­ing from scratch,” he said.

In the US, mon­key­pox cas­es are con­firmed by or­thopoxvirus test­ing, which re­quires a dry le­sion swab spec­i­men ac­cord­ing to the CDC. Sam­ples are col­lect­ed by vig­or­ous­ly brush­ing a pa­tient’s le­sions, which are then sent to a net­work of lab­o­ra­to­ries for test­ing.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”