Recon: FDA expands use of Pfizer’s Hympavzi for children with hemophilia; J&J to acquire Firefly Bio for $1B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- US FDA approves Pfizer's bleeding disorder drug for children (Reuters)
- In Washington, biotech's China hawks are winning the conversation (Endpoints)
- USDA confirms two more cases of New World screwworm in the US (Reuters)
- Trump’s Medicaid Cuts Keep Getting More Harmful (Bloomberg)
- US FDA Says AI Played Supporting, Summarizing Role In Fast BLA Review (Pink Sheet)
- J&J to buy cancer drug technology developer Firefly Bio for $1 billion (STAT) (Reuters)
In Focus: International
- Germany’s health-spending plan has consequences as Lilly, Boehringer scale back (Endpoints)
- Netherlands Expands Investment Screening Rules for AI, Biotech (Bloomberg)
- Ebola Cases Top 500 in Congo as Patient Escapes Add to Troubles (Bloomberg)
- Industry Urges Dedicated Support For Europe’s €13B IVD Sector (MedTech Insight)
Pharma & Biotech
- Roche enters cancer drug deal worth up to $2.3 billion with Nurix Therapeutics (Reuters) (Endpoints)
- Competition for obesity drugs, clinical blind spots, and more news from ADA (STAT)
- Lilly shares safety, tolerability data on its next-gen obesity drug (STAT)
- Combination of pancreatic cancer drugs from Tango, Revolution leads to high response rate (STAT)
- $2 million gene therapy cures require a financing model (STAT)
- Incyte to buy bleeding disorder biotech Vega Therapeutics in $1.25B upfront deal (Endpoints)
- Novo Nordisk targets turn-of-decade launch for triple-G obesity shot (Endpoints)
- Takeda says it expects to take $2.5B hit after Amitiza antitrust verdict, with plans to appeal (Endpoints)
- Nearly 1 in 5 patients quit Boehringer and Zealand’s obesity shot over side effects (Endpoints)
- Pfizer's good-enough obesity data in a crowded market may force competition on price, dosing (Endpoints)
- Roche’s incretin shot works in mid-stage trial in type 1 diabetes (Endpoints)
Medtech
- Olympus’ Keith Boettiger on robotic GI surgery push (MedTech Dive)
- J&J, Medtronic back CereVasc’s $85M funding round (MedTech Dive)
- More Americans own wearables, connected health devices: survey (MedTech Dive)
- Medtronic seeks clearance for Hugo surgical robot in more indications (MedTech Dive)
Food & Nutrition
- 'They're betting our herd': Texas ranchers question USDA as screwworm returns (Reuters)
- Insight: Screwworm border closure fuels beef boom in Mexico, gloom in Texas (Reuters)
Government, Regulatory & Legal
- Online care is caught in the crossfire as states crack down on corporate medicine (STAT)
- I led the U.S. CDC response to the 2014 Ebola epidemic. The new outbreak needs massive, immediate, meticulous action (STAT)
- Lawmakers promised cancer patients would be protected from Medicaid cuts. Now CMS says otherwise (STAT)
- Bipartisan Bills Seek ‘RESULTS’ On Medicare Rates For Clinical Diagnostic Labs (MedTech Insight)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
