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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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