Sanofi and GSK are keep­ing the R&D en­gine churn­ing for Covid-19 vac­cines.
The part­ners, which have yet to get their first shot on the mar­ket, re­port­ed that their next-gen­er­a­tion boost­er — mod­elled on the Be­ta vari­ant of the SARS-CoV-2 virus and in­cor­po­rat­ing GSK’s ad­ju­vant — kicked up a stronger im­mune re­sponse to adults who re­ceived mR­NA jabs than both its own first-gen­er­a­tion shot and Pfiz­er/BioN­Tech’s Comir­naty.
Cit­ing da­ta from two tri­als, Sanofi first not­ed that in the Phase III COV­I­BOOST VAT02 Co­hort 2 study, the next-gen can­di­date “gen­er­at­ed dou­ble the num­ber of neu­tral­iz­ing an­ti­bod­ies against Omi­cron BA.1 and BA.2 com­pared to the D614-based (orig­i­nal par­ent virus) boost­er.”
Then from the much small­er COV­I­BOOST VAT013 study, which was con­duct­ed by a hos­pi­tal in Paris, in­ves­ti­ga­tors al­so ob­served high­er neu­tral­iz­ing an­ti­body titers — with 76.1% of all par­tic­i­pants see­ing at least a “10-fold in­crease for the wild-type strain.” By com­par­i­son, 63.2% of those who got the Pfiz­er/BioN­Tech boost­er reached that thresh­old, and 55.3% of those who got the first-gen Sanofi/GSK boost­er did.
“Covid-19 keeps evolv­ing and the com­bi­na­tion of emer­gence of vari­ants and wan­ing im­mu­ni­ty is like­ly to lead to the need for ad­di­tion­al boost­er shots, at least in some pop­u­la­tions,” said Thomas Tri­om­phe, ex­ec­u­tive VP, Sanofi vac­cines.
The first-gen­er­a­tion can­di­date is now un­der reg­u­la­to­ry re­views, the com­pa­nies said.
Roughly 24 hours after Canadian regulators gave Amylyx Pharmaceuticals the thumbs-up for its new ALS drug, ICER is out with a new analysis trying to determine whether the drug would be cost effective. And the short answer is no — for now.
Though Amylyx has not disclosed how much it intends to charge for the drug, branded as Albrioza, ICER pegged its estimated cost to an older ALS medicine, edaravone. If Albrioza costs $169,000 per year, as edaravone currently does, the drug would not be cost effective to the US healthcare system, and far from it, ICER says.
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Though the FDA earlier this month told Amylyx Pharmaceuticals the agency would need a little bit longer to review its ALS drug’s application, one country is forging ahead with a green light.
Canada approved Amylyx’s ALS drug AMX0035 early Monday morning, giving the biotech its first green light and ALS patients in the country only the third therapy available to treat the disease. The decision also marks a win for Amylyx, a one-drug biotech that went all-in on ALS — one of the most challenging diseases for drug R&D — and whose fortunes appeared murky after the FDA raised concerns over its data at an advisory committee meeting in March.
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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.
From first-timers to long-timers, marketing creatives and executives can’t wait to get back to the Cannes Lions Festival of Creativity for advertising that begins next week in the south of France. For pharma marketers though, it’s a return to Cannes Lion health with a small “h” this time.
That’s because while Cannes Lions 2022 marks the welcome return to in-person programming and award shows, it’s a new dynamic for health and pharma marketers with no separate Cannes Lions Health conference for the first time.
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Pfizer debuted its first TV commercial for Cibinqo, its next-gen oral JAK inhibitor to treat eczema, with a splashy special effects spot about the “new innovation from Pfizer.” Cibinqo, or abrocitinib, was approved in January for moderate-to-severe atopic dermatitis that’s not responsive to other systemic drugs.
The new “innovation” TV ad reflects Pfizer’s confidence in the steroid-free drug it expects to take in peak sales of $3 billion. Still, Cibinqo’s approval came with serious safety warnings which are also reflected in the ads.
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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.
Pfizer, Concert Pharmaceuticals and Eli Lilly were all gunning to be the first company to bring an alopecia areata drug to market. But Lilly crossed the finish line first Monday.
The Indianapolis-based pharma announced that FDA had approved JAK inhibitor baricitinib, aka Olumiant, for patients with severe forms of the autoimmune disorder alopecia areata (AA), which results in hair loss. The drug, which was approved as a once-daily pill in three dose levels of 1 mg, 2 mg and 4 mg for the indication, had been originally discovered by Incyte before Lilly in-licensed it back in 2009.
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For those tracking the progress of genome editing, the Broad Institute of Harvard and MIT’s David Liu likely needs no introduction (Google him for a refresher), and 2022 might be the year that the editing techniques he and his lab created start to make real strides in the clinic.
Liu’s lab has pioneered two new elegant and precise ways to cut DNA and replace bases with precision, but without making any of the DNA double-stranded breaks that can sometimes lead to off-target effects.
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The latest rival to Alnylam’s drug for hereditary transthyretin-mediated (hATTR) amyloidosis is here — and it comes from Alnylam itself.
Four years after the groundbreaking approval of Onpattro, the world’s first RNAi therapy, the FDA has approved vutrisiran, Alnylam’s next-generation treatment, for polyneuropathy of hATTR in adults. It will be marketed as Amvuttra.
Whereas Onpattro is administered as an intravenous injection every three weeks, Amvuttra is given subcutaneously once every three months.
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