Be­fore the first Covid-19 vac­cines be­came avail­able, coun­tries scram­bled to se­cure ac­cess to the shots, clam­or­ing for sup­ply deals. But as sup­ply now far out­strips de­mand, gov­ern­ments in the Eu­ro­pean Union are push­ing to rene­go­ti­ate those deals.
Ex­ist­ing con­tracts would oblige them to buy vac­cines that will just go to waste, they ar­gue.
EU health min­is­ters are meet­ing to dis­cuss the is­sue, Reuters re­port­ed, cit­ing com­ments French min­is­ter Brigitte Bourgignon made to re­porters.
Most of these pur­chase agree­ments would in­volve Pfiz­er and BioN­Tech, which have al­ready shipped more than a bil­lion dos­es of their part­nered mR­NA vac­cine world­wide.
Poland is the lead­ing coun­try in this at­tempt to re­vise con­tracts and re­duce re­quired or­ders, Reuters added, as it still has more than 30 mil­lion shots in stock and is on the hook to buy an­oth­er 70 mil­lion un­der con­trac­tu­al agree­ments. The coun­try has a pop­u­la­tion of about 38 mil­lion, about 60% of whom are ful­ly vac­ci­nat­ed.
Pfiz­er said it’s made changes to de­liv­ery sched­ules to adapt. But it’s un­clear what so­lu­tion the min­is­ters will be look­ing for — or how they plan to en­force it.
PureTech is throw­ing in the tow­el on ef­forts to de­vel­op its lead drug, LYT-100, for long Covid af­ter a Phase II study sug­gest­ed there was no treat­ment ef­fect.
“Ear­ly in the Covid-19 pan­dem­ic, we iden­ti­fied a po­ten­tial ap­pli­ca­tion for LYT-100 giv­en the hy­poth­e­sis that in­flam­ma­tion and fi­bro­sis may play a role in pro­long­ing res­pi­ra­to­ry symp­toms ex­pe­ri­enced by many pa­tients,” CEO Daphne Zo­har said in a state­ment. “We un­der­took this ex­plorato­ry study, guid­ed by a de­sire to ad­dress this emerg­ing need, while fur­ther ex­pand­ing the safe­ty and tol­er­a­bil­i­ty da­ta for our LYT-100 de­vel­op­ment pro­gram at large.”
What the re­sults do sup­port, ac­cord­ing to the com­pa­ny, is con­tin­ued de­vel­op­ment in oth­er in­di­ca­tions due to its “im­proved tol­er­a­bil­i­ty.”
The tri­al en­rolled 177 pa­tients with the av­er­age age of 55 who con­tin­ued to have res­pi­ra­to­ry com­pli­ca­tions fol­low­ing hos­pi­tal­iza­tion for se­vere acute Covid-19 in­fec­tion.
For the pri­ma­ry ef­fi­ca­cy end­point, in­ves­ti­ga­tors looked at a three-month change from base­line on the six-minute walk test dis­tance, and couldn’t see a dif­fer­ence be­tween drug and place­bo.
LYT-100 is a se­lec­tive­ly deuter­at­ed form of pir­fenidone, an an­ti-in­flam­ma­to­ry drug that’s used to treat id­io­path­ic pul­monary fi­bro­sis. PureTech will be start­ing a reg­is­tra­tion-en­abling pro­gram for the same dis­ease lat­er this month.
The Senate health committee on Tuesday advanced its version of the FDA user fee reauthorization bill, which like its House-passed companion, includes new reforms to the agency’s accelerated approval pathway.
By a vote of 13-9, mostly along party lines, the committee advanced its Food and Drug Administration Safety and Landmark Advancements Act (FDASLA) to the full Senate for a vote that will likely occur before the end of September when the current user fee legislation expires. If the user fee legislation isn’t reauthorized by that deadline, the FDA will have to start laying off staff.
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In its quest to resubmit its Alzheimer’s-induced psychosis drug Nuplazid to the FDA following a CRL, Acadia Pharmaceuticals will have to face an advisory committee later this week. And agency officials released their briefing documents ahead of the hearing Wednesday, revealing a mixed bag of opinions.
FDA statisticians found that the data supporting Acadia’s resubmission, which comprises several post-hoc analyses of its previous pivotal trial, did not appear to conclude the drug is effective in Alzheimer’s patients. But Acadia also repositioned an earlier study as the primary focus of the application, and regulators seemed open to considering this new approach.
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Pfizer’s Covid-19 antiviral may end up hauling in more than $20 billion this year, and help keep many vulnerable people out of the hospital. But new data show the pill doesn’t hold up as well in vaccinated people as the unvaccinated.
Updated data from the company’s Phase II/III trial show the antiviral whiffed on its primary endpoint and offered a non-significant 51% relative risk reduction for hospitalization or death, with five of 576 on the pill in the trial ending up in the hospital or dying, compared to 10 out of 569 on placebo. Meanwhile, a sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe Covid-19 and who were taking the course of Pfizer pills also failed to reach statistical significance.
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While some countries are in the midst of ongoing negotiations with Covid-19 vaccine suppliers now that the supply of pandemic shots is starting to outweigh demand, Moderna is doubling down on production in a European nation  — throwing more than half a billion dollars to start things off.
Moderna is investing 500 million euros into Spain — with the biotech confirming after Spain’s prime minister Pedro Sánchez tweeted out Tuesday.
Public biotechs can still raise money, but it comes with a big caveat: the clinical data must impress.
It appears the market reacted so with Day One Biopharmaceuticals, as the biotech plans to secure $150 million this week in a public offering. The four-year-old company is following a trend of biotechs going straight to the market hours or days after releasing results that outperform expectations and pad the case for a drug’s potential regulatory path.
As the world faces a growing challenge of pathogens resistant to antibiotics, Shionogi and the GARDP have committed to an execution of a license and technology transfer agreement with the Clinton Health Access Initiative (CHAI).
According to Shionogi, the collaboration agreement will aim to increase access to antibiotics for countries around the world, with an emphasis on lower- and middle-income nations. The agreement will focus on cefiderocol, an antibiotic for the treatment of serious Gram-negative bacterial infections.
When Affini-T arrived on the scene a few weeks ago, it had most of the essential elements needed by any biotech upstart.
There were high-profile scientific founders, Phil Greenberg and Aude Chapuis, at the Fred Hutch. A motherlode of cash from ambitious investors like Vida Ventures and Leaps by Bayer. And the building blocks of new drugs to go after oncogenic drivers like KRAS and p53.
And now another piece of the puzzle has snapped into place.
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Ali Raza Khaki is a bladder cancer doctor at Stanford. He’s seen five immune checkpoint inhibitors approved as a second line of treatment, but he really only uses one for that indication — pembrolizumab, marketed as Keytruda, since it’s the only one with randomized controlled trial data.
Two of the other inhibitors, AstraZeneca’s Imfinzi and Roche’s Tecentriq, have since had their accelerated approvals for bladder cancer pulled by the FDA (or rather, the Big Pharmas ‘voluntarily withdrew’ them).
The numbers are somewhat in and biotech diversity looks relatively similar to what it has been for years.
A 2021 sampling paints a very limited picture of the industry, with BIO’s third annual diversity report including only 99 respondent companies. Most questions were not or could not be answered by every single organization, meaning many went unanswered, such as insight on board-level demographics.
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