FDA
Supreme Court Restores Mifepristone Mail Access
Mail-order mifepristone is back after the Supreme Court reversed an appeals stay, but the litigation that created the disruption is still running.
Latest — Page 26
Deals
Amgen Adds $300M to Puerto Rico Biologics Site
Amgen drops another $300M into its Puerto Rico biologics site, bringing Juncos to nearly $1B total and U.S. manufacturing pledges close to $2B.
Deals
Bid $55.5B for eBay: GameStop Can't Cover It
GameStop offered $55.5B for eBay at $125 a share, a 46% premium, but CNBC's math found a $16 billion gap Ryan Cohen couldn't explain.
FDA
ODAC Rejects AstraZeneca Camizestrant 6-3 After 9 Months
FDA ended nine adcomm-free months on April 30 with split votes on two AstraZeneca cancer drugs, but consultants warn it's a narrow restart.
Legal
ShinyHunters Steals 275M Instructure Canvas Records
ShinyHunters claims 275 million student and teacher records stolen from Instructure's Canvas platform, hitting nearly 9,000 schools worldwide.
Deals
Windward Bio Raises $165M for Late-Stage Trial
Swiss biotech Windward Bio raised $165M to advance a China-derived drug into late-stage testing. What investors get from this bet is the real question.
Deals
Ken Song's T Cell Engager Bet Gets Picked Up
Ken Song has done it again.
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.
