Recon: FDA approves Verrica’s Ycanth, first treatment for common skin disorder; Roche inks $2.8B deal with Alnyam
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Verrica's drug gets US nod as first treatment for a type of skin infection (Reuters) (Fierce) (FDA) (Bloomberg)
- Damaged Pfizer plant remains closed as worries mount about shortages of sterile injectables (Endpoints) Bloomberg)
- Emergent’s newest anthrax vaccine is now FDA-approved (Endpoints)
- FDA Greenlights 35 Novel Approvals in H1, Biologics Stand Out (BioSpace)
- US FDA Hiring Data: CBER Exceeds CDER In Progress Toward Goals (Pink Sheet)
- How SCOTUS’ Affirmative Action Decision Could Reduce Diversity in Biopharma (BioSpace)
- Drugmakers Are ‘Throwing the Kitchen Sink’ to Halt Medicare Price Negotiations (NYT)
- Medicare Obesity Coverage Bill Gets Bipartisan, Broad Medical Community Support (FDAnews)
- A new lobby shop looks to remind Congress about NIH’s translational research arm (STAT)
- Gene therapy eyedrops restored a boy’s sight. Similar treatments could help millions (STAT)
- Rise in cancer among younger people worries and puzzles doctors (STAT)
- EMA Says Yes To Janssen’s Talvey & 13 Other Drugs (Pink Sheet)
- Mirati To Challenge EMA’s Rejection Of US-Approved Krazati (Pink Sheet) (Endpoints)
- Roche withdraws EMA expansion application for cancer medicine Gazyvaro after lack of 'robust' trial methods (Endpoints)
- Japan Widens Flu Stockpiles With Shionogi's Xofluza (Pink Sheet)
- WHO Lists Scientific & Ethical Features That All Good Clinical Trials Should Include (Pink Sheet)
- 'Know The Enemy And Know Yourself' Before Entering US, Daewoong Exec Advises (Scrip)
- Vietnam approves commercial use of first African swine fever vaccines (Reuters)
- Roche, Alnylam Ink Potential $2.8B RNAi Partnership for Hypertension (BioSpace) (Endpoints) (Reuters) (MedWatch)
- Roche’s $3 billion Alnylam deal shows drug firms are interested in long-acting heart drugs (STAT)
- Gilead axes PhIII trial for CD47 drug in latest setback for $4.9B buyout (Endpoints) (BioSpace)
- J&J starts share exchange offer for consumer health spin-off Kenvue (Reuters)
- Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop (BioSpace) (Endpoints)
- Lobbying spending dropped for companies that departed PhRMA (STAT)
- Pharma earnings season starts with corporate profits, new CEOs taking center stage (Endpoints)
- Lonza cites biotech funding slowdown as it lowers sales outlook for the year (Endpoints)
- Codexis cuts 25% of staff, slashes drug programs while doubling down on RNAi tech (Endpoints)
- Pfizer drops sickle cell disease collab with Syros inherited from GBT takeover (Fierce)
- Pfizer, Gilead, GSK to Capture Growing Infectious Diseases Market as J&J Pulls Back (BioSpace)
- Kodiak Sciences scraps development of eye drug, shares slump (Reuters) (Fierce)
- Bavarian Nordic ends RSV vaccine programme after poor trial results (Reuters)
- Statins reduce cardiovascular risk in people living with HIV, new global study finds (STAT)
- DOJ Announces Three Medtech-Related Enforcement Actions (MedTech Insight) (Fierce)
- Do Not Use Medical Devices From Texas Firm, FDA Warns (MedTech Insight)
- FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis (MedTech Dive)
- EU Ups Funding For Pandemic R&D, Parliament Backs ‘Strategic Autonomy’ In Medical Product Development (MedTech Insight)
- BD gains FDA clearance to relaunch Alaris infusion pump after recalls (MedTech Dive) (Fierce)
- University of Utah’s Bone Bolt system for complex fractures earns FDA clearance (Fierce)
- Philips shares retreat after fourth straight drop in order intake (Reuters)
- J&J earnings a ‘positive early indicator’ for medtech in Q2: analyst (MedTech Dive)
- AbbVie Must Produce ‘Sham’ Patent Suit Records to Antitrust Foes (Bloomberg)
- J&J to Exchange Most of Kenvue Consumer Stake With Investors (Bloomberg)
- Drug Compounding Appeal Hinges on 2022 Decision, Judge Suggests (Bloomberg)
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