Recon: FDA approves first interchangeable biosimilar for Lucentis eye drug; Amgen to acquire ChemoCentryx for $4 billion

ReconRecon | 04 August 2022 |  By 

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 Opioid Plan (Pink Sheet)
  • Don’t Look Up? Congress Can’t Ignore Risk To Small Molecule Drugs In Pricing Bill, Investors Warn (Pink Sheet)
  • Monkeypox: US Gov’t Leaders Say Tpoxx Needs Randomized Control Trial Before Treatment For All (The Pink Sheet) (Endpoints)
  • HHS Lays Out ‘Long Covid’ Research Plan; Provider Support (InsideHealthPolicy)
  • Yes, Moderna is feeling the pressure to address monkeypox, R&D chief confirms (Fierce)
  • Eli Lilly to make COVID-19 antibody drug commercially available from August (Reuters)
  • Senators Decry ‘Incompetence’ in US Organ Transplant System  (Bloomberg)
In Focus: International
  • Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib (Pink Sheet)
  • AstraZeneca says Lynparza gets EU nod to treat early-stage breast cancer (Reuters)
  • Advanced Therapy Developers Urged To Monitor Major EU Proposal On Using Blood, Tissues & Cells (Pink Sheet)
  • China Cool On Nasal Vaccines, Backs Antivirals In Latest COVID Guidance (The Pink Sheet)
  • Ukraine health crisis worsens as medics work amid shelling – WHO (Reuters)
  • African monkeypox cases not concentrated among gay men, experts say (Reuters)
Pharma & Biotech
  • Amgen adds potential blockbuster drug with $3.7bln ChemoCentryx deal  (Reuters) (WSJ) (Biospace) (STAT)
  • Thinning its $11B Array of options, Pfizer drops cardiology drug after phase 3 fails futility check (Fierce) (Biospace)
  • Moderna CEO Bancel hits the gas with variant-specific boosters and a very early monkeypox program underway (Endpoints)
  • Travere fails to convince regulators to consider accelerated approval for a rare kidney disease – again (Endpoints)
  • Merck’s Keytruda Takes Another Hit with Phase III Prostate Cancer Fail  (Biospace)
  • Amgen hits pause on $400M eczema bet to tweak phase 3 study (Fierce)
  • Late to the CAR-T game, AstraZeneca quietly works on its own off-the-shelf therapies (Fierce)
  • Roche, Genentech place a $100M bet on fibrosis, nabbing PhII program from Kiniksa (Endpoints)
  • Sales of Boehringer Ingelheim's diabetes, pulmonary drugs jump within $11B+ first-half total (Endpoints)
  • After a bust with knee pain drug and 3 Covid-19 flops, Ampio lays off staff; Antibody startup nabs second deal in two weeks (Endpoints)
  • Horizon lowers expectations for Tepezza and adjusts its strategy for the year ahead (Endpoints)
  • As a handful of companies spin out health businesses, Germany's Schott glassmaker looks to get in on the action (Endpoints)
  • Monoclonal antibody treatment for malaria shows encouraging results (STAT)
  • Latest Italian Designation Means Germany And Italy Are Home To Half EU’s MDR Notified Bodies (MedTech Insight)
  • US Agencies Publish Guidance To Ensure Telehealth Access Equality (MedTech Insight)
  • 6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time (Medtech Dive)
  • CDRH Soliciting Proposals for Experiential Learning Program (FDA)
  • Despite slipping sales, Siemens passes COVID testing revenue goal a quarter early (Fierce)
  • Exact Sciences hands over Oncotype prostate cancer test to MDxHealth for $30M upfront (Fierce)
  • Thermo Fisher, plugging ahead on $650M bioprocessing upgrade, unveils $75M expansion at US site (Fierce)
  • Stryker opens 3D printing facility in Ireland, promising 600 new jobs (Fierce)
Government, Regulatory & Legal
  • How Innovators Can Combat Patent Infringement Using Litigation Funding (Bloomberg)
  • In GSK trade secrets case, appeals court backs short sentences against prosecutors’ wishes (Fierce)
  • Regeneron Sues Viatris to Halt Biosimilar of Earnings Star Eylea (Bloomberg)
  • Abbvie Win on Humira Patent Portfolio Thwarts Antitrust Attacks (Bloomberg)
  • Tennessee sues Walgreens pharmacy chain over opioid distribution (Reuters)
  • New US Abortion Landscape Raises Worst Digital Privacy Fears  (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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