Tedros Adhanom Ghebreyesus, Director General of the WHO (Denis Balibouse/Pool Photo via AP Images)

Bavar­i­an Nordic nabs EU ap­proval for mon­key­pox vac­cine as WHO de­clares glob­al health emer­gency

As the WHO de­clared the mon­key­pox out­break to be a glob­al health emer­gency, Bavar­i­an Nordic ob­tained an ex­pand­ed Eu­ro­pean la­bel for its small­pox vac­cine to in­clude the surg­ing virus.

The move comes rough­ly a month af­ter the biotech filed for a la­bel ex­pan­sion, and af­ter sev­er­al coun­tries on the con­ti­nent, and else­where, se­cured their own sup­ply deals for the shot. Bavar­i­an Nordic has said it’s seen “over­whelm­ing” in­ter­est in the vac­cine, and its stock price $BVRNY has fol­lowed in short or­der — shares are up 124% since the first mon­key­pox case was de­tect­ed on May 6.

Mon­day’s ap­proval will like­ly help boost sup­ply of the vac­cine across Eu­rope just a few days af­ter the WHO raised the mon­key­pox alert lev­el to its high­est clas­si­fi­ca­tion Sat­ur­day, of­fi­cial­ly de­clar­ing the out­break a glob­al health emer­gency. There had been more than 17,000 cas­es around the world as of Sat­ur­day, rough­ly a 50% in­crease over the last week, with cas­es in over 75 coun­tries.

“WHO’s as­sess­ment is that the risk of mon­key­pox is mod­er­ate glob­al­ly and in all re­gions, ex­cept in the Eu­ro­pean re­gion where we as­sess the risk as high,” WHO di­rec­tor-gen­er­al Tedros Ad­hanom Ghe­breye­sus said in a state­ment Sat­ur­day. “There is al­so a clear risk of fur­ther in­ter­na­tion­al spread, al­though the risk of in­ter­fer­ence with in­ter­na­tion­al traf­fic re­mains low for the mo­ment.”

The de­c­la­ra­tion was a re­ver­sal from WHO’s pre­vi­ous stance a month ago, when the WHO de­clined to el­e­vate the out­break’s sta­tus.

Last week, Eu­rope se­cured an­oth­er sup­ply deal for Bavar­i­an Nordic’s shot, or­der­ing 54,000 dos­es to bring its to­tal stash to 160,000. An ini­tial or­der of 110,000 shots came in late June, pro­vid­ing more ac­cess to the vac­cine on the con­ti­nent where in­di­vid­u­als had strug­gled to get it.

Oth­er coun­tries, too, have been or­der­ing the jab. Cana­da signed a $56 mil­lion con­tract last month and Bavar­i­an Nordic has pre­vi­ous­ly said it’s been in dis­cus­sions with coun­tries in Asia, Eu­rope, South Amer­i­ca and the Mid­dle East as well.

BAR­DA, mean­while, bought 2.5 mil­lion dos­es for the US na­tion­al stock­pile ear­li­er this month, and has said it ex­pects to de­liv­er 1.6 mil­lion dos­es by the end of the year.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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 readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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