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Regeneron

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Regeneron’s fianlimab setback puts melanoma program at a crossroads
business14 days ago

Regeneron’s fianlimab setback puts melanoma program at a crossroads

Regeneron’s phase 3 trial of fianlimab with Libtayo failed to beat Merck’s Keytruda as first-line therapy for unresectable melanoma, missing the primary endpoint of progression-free survival despite a numerical edge at the high dose; analysts say late separation of survival curves drove the non-significant result, signaling renewed pipeline pressure even as Regeneron pursues potential salvage paths (head-to-head vs Opdualag) and continues other programs (Factor XI, cemdisiran-pozelimab) as future catalysts.

via Fierce Biotech|
#business#fianlimab#keytruda
FDA backs first gene therapy to treat a rare genetic deafness (Otarmeni) with free US access
health1 month ago

FDA backs first gene therapy to treat a rare genetic deafness (Otarmeni) with free US access

The FDA approved Otarmeni, Regeneron’s gene therapy for OTOF-related deafness—the first gene therapy for this rare inherited hearing loss—delivered via a single cochlear injection to restore otoferlin production. In a 20-child trial, several participants showed hearing improvements, with five of 12 followed for 11 months reaching near-normal hearing. Regeneron will provide Otarmeni at no cost to US patients, and the therapy was fast-tracked under the Commissioner’s National Priority Voucher program. While promising, effects were generally safe, the condition affects about 50 US babies born each year, and this advance could pave the way for more gene therapies and potentially reduce reliance on cochlear implants.

via New York Post|
#fda-approval#gene-therapy#health
Trump seals first Regeneron drug-pricing deal, pledges more savings ahead
politics1 month ago

Trump seals first Regeneron drug-pricing deal, pledges more savings ahead

President Trump announced the first round of private drug-pricing deals with Regeneron, including Medicaid price reductions, a $225 price for Praluent under TrumpRx, and a $27 billion U.S. investment in drug development; Regeneron also disclosed FDA approval of Otarmeni under a National Priority Voucher program and plans to provide it at no cost to American patients, signaling affordability efforts, though critics say the overall impact has fallen short of promises and the Otarmeni development has faced Deaf-community pushback.

via statnews.com|
#drug-prices#medicaid#politics
Trump unveils Regeneron pact to lower Medicaid drug costs
politics1 month ago

Trump unveils Regeneron pact to lower Medicaid drug costs

President Trump announced a deal with Regeneron to reduce prices on all Regeneron drugs sold on Medicaid, including Praluent at $225 on the TrumpRx site, as part of a broader White House drug-pricing push. Regeneron also pledged about $27 billion in U.S. R&D/manufacturing investments. Details of the contracts remain largely undisclosed, but the administration is promoting the agreements ahead of the midterm elections as part of its effort to reshape U.S. drug pricing.

via PBS|
#drug-pricing#medicaid#politics
FDA approves Otarmeni, first gene therapy for rare OTOF-related infant hearing loss
health1 month ago

FDA approves Otarmeni, first gene therapy for rare OTOF-related infant hearing loss

FDA approves Regeneron's Otarmeni, the first gene therapy for a rare OTOF-mutation–driven hearing loss in infants; in a trial, a single-dose inner-ear injection improved hearing in 16 of 20 children, with some able to detect whispers; the company will provide the drug for free to U.S. patients, while pricing outside the U.S. has not been determined since it is not approved there.

via NBC News|
#fda-approval#gene-therapy#health
Trump Admin Secures Regeneron MFN Deal to Cut Drug Costs and Boost U.S. Manufacturing
policy1 month ago

Trump Admin Secures Regeneron MFN Deal to Cut Drug Costs and Boost U.S. Manufacturing

Trump announced Regeneron’s MFN pricing deal to align U.S. prices with the lowest prices in developed nations, giving Medicaid access to MFN prices on new Regeneron medicines and cutting Praluent’s price from $537 to $225 for direct TrumpRx purchasers; all new Regeneron drugs will carry MFN pricing in the U.S. The pact also includes Otarmeni, a rare-gene therapy, provided at no cost to American families via the FDA's Priority Voucher program. Regeneron pledges $27 billion to U.S. R&D and onshore manufacturing by 2029, part of a broader push that has attracted about $448 billion in domestic pharmaceutical investments in 15 months. The administration has now secured MFN deals with 17 major manufacturers, covering roughly 86% of the branded drug market.

via The White House (.gov)|
#most-favored-nation-pricing#onshoring-manufacturing#otarmeni
Regeneron trims prices for some Americans and pledges free hearing-loss gene therapy after FDA nod
business1 month ago

Regeneron trims prices for some Americans and pledges free hearing-loss gene therapy after FDA nod

Regeneron said it will lower U.S. drug prices for some Americans under President Trump’s pricing plan and will offer its first hearing-loss gene therapy for free to eligible patients after regulatory approval, while also securing a three-year tariff exemption; the therapy Otarmeni targets a rare hearing-loss condition and could reduce reliance on cochlear implants, with analysts signaling potential peak sales around $130 million.

via CNBC|
#business#drug-pricing#gene-therapy
First-in-class Otarmeni gene therapy could restore hearing in rare OTOF-related loss, Regeneron to provide free US access
health1 month ago

First-in-class Otarmeni gene therapy could restore hearing in rare OTOF-related loss, Regeneron to provide free US access

Regeneron’s Otarmeni (lunsotogene parvec-cwha) received FDA accelerated approval as the first in vivo gene therapy for OTOF-related severe-to-profound hearing loss, based on CHORD trial results showing 80% reached a PTA threshold of ≤70 dB HL at 24 weeks and 42% achieved normal hearing (≤25 dB HL) by 48 weeks. The one-time intracochlear infusion is intended for patients with biallelic OTOF variants, preserved outer hair cell function, and no prior cochlear implant in the treated ear, and Regeneron will provide Otarmeni at no cost to eligible U.S. patients. Safety signals include otitis media, dizziness and other procedure-related events; continued approval will depend on confirmatory CHORD data and site-specific eligibility constraints.

via Regeneron|
#fda#gene-therapy#health
Regeneron launches radiopharma push with Telix in a potential $2.1B collaboration
business1 month ago

Regeneron launches radiopharma push with Telix in a potential $2.1B collaboration

Regeneron pays Telix $40 million upfront to co-develop four radiopharmaceutical programs for solid tumors, with an option to add four more. If milestones are met, Telix could earn up to $2.1 billion in biobucks, or opt for milestone-based payments under a cost-sharing model, with shared global commercialization and potential co-promotion. Regeneron will select targets from its antibody portfolio and may pair these agents with Libtayo; the deal also covers diagnostics, with Telix leading commercialization. The collaboration follows Telix’s recent radiopharma expansion and comes amid regulatory headwinds for Telix’s imaging assets.

via Fierce Biotech|
#business#oncology#partnerships
23andMe Reopens Auction Amid Bankruptcy and New Bids
business1 year ago

23andMe Reopens Auction Amid Bankruptcy and New Bids

The sale process of 23andMe has been reopened with new bids after a previous deal with Regeneron was announced. Co-founder Anne Wojcicki, through her nonprofit TTAM Research Institute, has increased her bid to over $305 million, surpassing Regeneron's offer, as the auction heats up with new rules allowing Regeneron to counter with at least $315 million. The sale raises privacy concerns, but both parties have committed to maintaining existing privacy policies.

via Newser|
#23andme#bidding#business