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.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.