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Every briefing, headline, and filing we've published, newest first.
The WeekSTAT News ↗
An FDA advisory panel recommended use of an experimental Replimune treatment for advanced melanoma that the ag…
The WeekPharmaVoice ↗
Researchers have pinpointed genes linked to dangerous CAR-T cell therapy side effects, and a predictions marke…
The WeekPharmaceutical Technology ↗
Sublingual semaglutide, which does not hold marketing authorisation, is touted to minimise gastric issues.…
The WeekFiercePharma ↗
Shionogi's "Got the Call, Make the Call" campaign for COVID antiviral Xocova kicks off with a TV ad depicting …
The WeekFierceBiotech ↗
Apnimed has raised $192 million for its upsized IPO, with the proceeds earmarked to fund the launch of its sle…
The WeekBriefing
FDA’s July 30 notice sets FY 2027 PDUFA fees below FY 2026 levels for clinical-data applications, non-clinical…
The WeekDrug Channels ↗
Today's guest post comes from Jen Norton, President, Market Access & Value at EVERSANA. Jen examines why fragm…
The WeekPharmaceutical Technology ↗
Wider patient access to CGTs hinges on further infrastructure developments and the movement of therapies into …
The WeekPharmaceutical Technology ↗
US efforts to scrutinise overseas drug manufacturing could expose Europe's role in supplying FDA-approved inno…
The WeekSTAT News ↗
"The ADA is no longer what we'd call a profile in courage," write Adam Marcus and Ivan Oransky of Retraction W…
The WeekBioPharma Dive ↗
The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce bac…
The WeekBioPharma Dive ↗
The RNA-focused biotech shed 30% of its market value - or close to $12 billion - amid growing investor concern…
The WeekBioPharma Dive ↗
Regulators say the telehealth company illegally shared patients' health data with advertisers and misled its c…
The WeekPharmaVoice ↗
Regeneron tapped the Aussie biotech to enter the radiopharma market with a multi-pronged agreement. …
The WeekFiercePharma ↗
With increased sales of its newer drugs compensating for declining revenues from its multiple sclerosis portfo…
The WeekFierceBiotech ↗
Johnson & Johnson is cruising deeper into in vivo CAR-T waters, paying $785 million upfront to strike a de…
The WeekBriefing
CMS’s proposed 2027 OPPS rule would cut 340B drug reimbursement from ASP plus 6% to ASP minus 33.4%. The savin…
The WeekSTAT News ↗
STAT is live-blogging a meeting of FDA experts to review Replimune's experimental melanoma drug, RP1.…
The WeekBioPharma Dive ↗
At a contentious meeting with possible implications for other rare disease drugmakers, outside experts ultimat…
The WeekPharmaVoice ↗
Rather than going head-to-head with approved CAR-T cell therapies, biotechs like Caribou Biosciences are posit…
The WeekFiercePharma ↗
The Considered+AI is an AI-native agency that's been rooted in generative AI tools since its start in 2021.…
The WeekFierceBiotech ↗
Flush with GLP-1 cash and pipeline success, Eli Lilly rose from 16th to first over five years in Norstella's i…
The WeekBriefing
Freenome’s blood-based colorectal cancer test won FDA approval, and Abbott will exclusively market it in the U…
The WeekSTAT News ↗
STAT is live-blogging an FDA meeting on Capricor Therapeutics' treatment for Duchenne muscular dystrophy, whic…
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