Latest news on patient death in n-of-1 CRISPR trial; Good news for RSV; Vaccine R&D revolution; and more – Endpoints News

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.
This is the rare week where Endpoints News is making news. If you haven’t heard, Drew Armstrong will be joining us from Bloomberg to become our new executive editor. We are thrilled to have him on board. Read founder and editor John Carroll’s note about our big announcement — and what that means for Endpoints.
Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it’s free.
The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.
CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.
In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.
Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it’s free.
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.
Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.
Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it’s free.
A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.
The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.
Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.
In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”
Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it’s free.
The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.
This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.
Long-time biotech venture firms Versant and New Enterprise Associates are backing a new startup run by former C4 Therapeutics chief executive Andrew Phillips.
The fledgling biotech has raised at least $30 million so far, according to paperwork filed with the SEC this week. The round could balloon to $60 million.
Phillips, who left protein degradation startup C4 in 2020 to be a managing director at Cormorant Asset Management, is running the show of the new venture as president, the SEC filing outlines. He also served as interim CEO of Cormorant-backed and Hansoh Pharmaceutical-partnered Blossom Bioscience last year.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.
Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.
Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.
Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.
Unlock this story instantly and join 154,100+ biopharma pros reading Endpoints daily — and it’s free.
Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.
The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source

Leave a Comment

Ads Blocker Image Powered by Code Help Pro

Ads Blocker Detected!!!

Welcome to FactsPrime

Sorry, We have detected that you have activated Ad-Blocker. Please Consider supporting us by disabling your Ad Blocker, It helps us in maintaining this website. To View the content, Please disable adblocker and refresh the page.

Thank You !!!