Deals
Ken Song's T Cell Engager Bet Gets Picked Up
Ken Song has done it again.
Latest — Page 9
FDA
FDA Clears Pfizer-Arvinas Veppanu as First PROTAC
FDA cleared Veppanu on Friday as the first-ever PROTAC therapy, a new drug class that actively degrades disease-causing proteins rather than just blocking them.
Deals
Bought Candid for $2B, UCB Challenges Gilead on TCE
UCB bought Candid Therapeutics for $2 billion upfront, plus up to $200 million in development milestones, cutting off a planned reverse merger with…
FDA
Celcuity Beats Piqray in Phase 3, Shares Jump 15%
Pfizer sold gedatolisib to Celcuity for $10 million upfront in 2021.
Legal
Defender Pulls DigiCert Root Certs in False-Positive Hit
Microsoft's Defender antivirus flagged legitimate DigiCert root certificates as Trojan:Win32/Cerdigent.
Legal
Instructure Hit by Second Breach in Eight Months
A criminal threat actor hit Instructure, the company behind the Canvas learning management system, in a cyberattack disclosed this week.
FDA
FDA Clears Arvinas' Veppanu, First PROTAC Drug
FDA cleared Veppanu (vepdegestrant) on Friday, a month ahead of its June 5 PDUFA date, making the Pfizer-Arvinas collaboration the first to take a PROTAC…
Deals
Novartis Seals $23B US Build With NC API Plant
Novartis has committed $23 billion to build seven U.S. facilities, and the final piece just landed in Morrisville, North Carolina: a 56,200-square-foot…
FDA
FDA Approves Axsome's Auvelity for Alzheimer's Agitation
FDA approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's disease patients.
FDA
Moderna Pushes FDA on Covid Vaccine Access with Post-Marketing Data
Moderna told FDA it will provide post-marketing data on its Covid-19 vaccines to restore access to a broader population, the company confirmed May 1.
AI
Restrict AI Agent Access: Six Agencies Warn
Six government cybersecurity agencies from the US, UK, Australia, Canada, and New Zealand just told every operator running agentic AI in production: your…
AI
Passed: Minnesota's Ban on AI Nude Apps
Minnesota's new nudification law applies to any company that makes AI tools capable of generating fake intimate images — and it targets the moment of…
SEC
CFPB Cuts Lender Data Rule: 2,500 to 280
$166 million in annual compliance savings sounds like a win.
Legal
SFO Secures Ultra Electronics DPA, £4.8M in Probe Costs
The UK Serious Fraud Office secured a court-approved Deferred Prosecution Agreement with Ultra Electronics Holdings Ltd, a British manufacturer of…
Legal
Tightens KYC, FCC Cuts 1999 Foreign Carrier Loophole
The FCC voted unanimously Wednesday to tighten Know Your Customer rules for U.S. telecoms, closing a loophole dating to 1999 that let foreign companies…
