Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The fight is on: As US pricing reform advances through Congress, pharma gears up for a brawl ( Fierce ) ( Endpoints ) Pediatric Disincentive? Implications Of US Pricing Bill ( Pink Sheet ) Amid Roche and Sanofi's oral SERD setbacks, Menarini gets speedy review at FDA ( Endpoints ) Drugmakers Hunt for One Vaccine to Target All Covid Variants ( Bloomberg ) Monkeyp...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘Litany of false promises’: Pharma bemoans drug pricing bill as patient advocates celebrate ( Fierce ) ( Generics Bulletin ) Haggling With Pharma: Medicare Drug Price Negotiations Explained ( Bloomberg ) With drug pricing almost done, Congress looks to wrap up FDA user fee legislation ( Endpoints ) The GOP blocked an insulin price cap: What it means for diabet...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Analysis: Democrats score big wins on climate, drugs with $430 billion U.S. Senate bill ( Reuters ) ( Endpoints ) ( Pink Sheet ) ( STAT ) White House worked behind the scenes to push Senate toward breakthrough win ( The Hill ) Democrats dramatically narrow their ambitions for lowering insulin costs ( STAT ) Enhertu Goes Into High Gear With HER2-Low Breast Canc...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US   Interchangeable Biosimilar Approved Without Switching Data; Cimerli To Compete With Lucentis ( Pink Sheet ) ( Endpoints ) Clinical Trials, Data Security Among US Federal Enforcement Priorities ( The Pink Sheet ) Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022 ( Endpoints ) Coming Soon: New US FDA O...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023 ( The Pink Sheet ) ( Senate ) US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas ( The Pink Sheet ) FDA greenlights Marius; oral hypogonadism pill; VBL Therapeutics makes cuts to its workforce ( Endpoints ) Biden Names Monkeypox Coordinator as States ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US   U.S. Reaches $1.74 Billion Deal With Moderna for Updated Covid-19 Shots ( Wall Street Journal ) ( The Pink Sheet ) ( Reuters ) Sarepta to seek early FDA approval for gene therapy to treat Duchenne muscular dystrophy ( STAT ) ( Fierce ) FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should ‘move into a ne...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats Manchin, Schumer agree on $430 billion tax, drugs, energy bill ( Reuters ) ( Endpoints ) ( Inside Health Policy ) ( Politico ) Two sides of 'historic' drug pricing bill: Pharma industry blasts 'mistake' while advocates plan for 'first ever' gains ( Endpoints ) Merck CEO concerned about proposed drug pricing bill hurting innovation ( Reuters ) GSK’s B...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ever the optimist, Biogen secures FDA priority review for ALS drug that flunked phase 3 ( Fierce ) ( Reuters ) ( Endpoints ) ( STAT ) Novartis generics arm files for MS biosimilar, challenging Biogen; Pluristem shortens name ( Endpoints ) Incurable Cancer Patients to See Eased Path to Clinical Trials ( Bloomberg ) Out-of-pocket cap will increase the net price ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House to launch effort to develop next generation of Covid vaccines ( STAT ) ( Barrons ) FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals ( Fierce ) Biden administration weighs declaring monkeypox a health emergency ( Washington Post ) ( Reuters ) Monkeypox ‘Can Be Contained” in US, White House Doctor Says ( Bloomberg ) S...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Officials reorganize HHS to boost pandemic response ( Washington Post ) ( Reuters ) ( Politico ) Worried by Supreme Court, U.S. House votes to protect contraception ( Reuters ) Biden picks renowned cancer surgeon Monica Bertagnolli as NCI chief ( STAT ) President Biden tests positive for Covid-19, but has ‘very mild symptoms’ ( STAT ) Biogen agrees to pay $90...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A fourth Covid vaccine is cleared for use in the United States. ( NYT ) ( STAT ) ( Reuters ) ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging ( The Pink Sheet ) FDA carryover funds to pay staff to last until November, Burr says ( Politico ) FDA slaps ImprimisRx with a warning letter over sponsored articles in medic...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The politics of passing a major FDA funding bill just got complicated ( STAT ) FDA approves first at-home therapy for skin repigmentation in vitiligo patients ( STAT ) Biotech employees cash in health care’s largest salaries, while people working at providers sit near the bottom ( STAT ) Dozens of lawmakers urge HHS to fine drugmakers for curtailing discounts ...