Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal

ReconRecon | 09 August 2022 |  By 

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 diabetics (Washington Post)
  • After addressing FDA’s concerns, Reata’s wait for ataxia drug decision extended by 3 months (Fierce) (Endpoints)
  • FDA's vaccine adcomm to review first fecal transplant to treat C. difficile infections (Endpoints)
  • Verona’s shares jump as COPD drug hits goal in phase 3, teeing up FDA filing (Fierce)
  • FDA slaps CorMedix with a second manufacturing-related drug rejection (Fierce) (Endpoints)
  • US Moves to Stretch Out Monkeypox Vaccine Supply (NYT) (Washington Post)
  • Will low-dose vaccination stretch the monkeypox vaccine supply, or backfire? (STAT)
  • US to buy Siga's IV drug worth $26 million to fight monkeypox outbreak (Reuters)
  • US to stop supplying Lilly's mAb for Covid-19 this month as commercial market awaits (Endpoints)
  • America has a maternal mortality crisis. Biden push aims to change that (Washington Post)
In Focus: International
  • EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot (Reuters)
  • COVID-19 vaccines: Commission and Moderna adapt delivery schedules for late summer and winter (European Commission)
  • Anger and anxiety stalk EU’s monkeypox vaccine lottery (Politico)
  • Advanz bags EU rights to Polypid’s prolonged-release antibiotic (Fierce)
  • Agency donates breathing devices for premature babies to Ukraine (Reuters)
  • Pfizer manufacturing workers walk out after similar pay disputes at GSK, Novo Nordisk (Fierce)
  • Mixed Results For China’s First Home-Grown COVID Antiviral (Scrip)
  • New Graft Probes Cast Shadow Over China's Drug Pricing, Reimbursement Systems (Pink Sheet)
Pharma & Biotech
  • GSK Ups Ante in ADC Discovery Game with $1.4B Mersana Option Deal (Biospace) (Endpoints) (Pharmalive)
  • Merck is back in Alzheimer’s saddle with $1B+ Cerevance pact, years after dropping the BACE (Fierce)
  • Biopharma Industry Shows Signs of Life in Ever-Changing Economic Landscape (Biospace)
  • Kodiak manages to score a win for its Eylea rival — but the major test is still ahead (Endpoints)
  • BeiGene and Novartis Make Late-Stage Progress against Liver Cancer (Biospace)
  • AstraZeneca ADC barrels forward as Keytruda combo data make case for lung cancer use (Fierce)
  • Verona, Daiichi Sankyo, AstraZeneca and Kodiak Score Big Wins in Key Diseases  (Biospace)
  • Aptar takes up option on Orbital high dose dry powder inhaler in pursuit of halcyon drug delivery days (Fierce)
  • For the second time, Pfizer tries a warranty in response to concerns over high drug costs (STAT)
  • Struggling Novavax halves its sales forecast as COVID shot launch sputters (Fierce) (Endpoints)
  • Teva bullish ahead of 2-step biosimilar attack on Abbvie’s blockbuster Humira (Biopharma Reporter)
  • Q&A: Astellas' retiring head of development reflects on gene therapy deaths (Endpoints)
  • Why non-opioid pain drugs keep failing — and what's next for the field (Endpoints)
  • Phillips In Talks With DOJ Over Breathing Machine Recalls (MedTech Insight)
  • Call for EU reference laboratories sent to Member States (EC)
  • The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures (Fierce)
  • Hyris T-Cell Test Gains CE-IVD Mark (FDAnews)
  • FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for retail sales approval (MedTech Dive)
  • BD begins tender offers for up to $500M in debt to advance repayment strategy (Medtech Dive)
Government, Regulatory & Legal
  • Eight Indicted In Alleged Genetic Testing Fraud (MedTech Insight)
  • Medtronic Settles Man’s Suit Over Alleged Pacemaker Defect (Bloomberg)
  • Viatris Must Face Novo Nordisk Ozempic Patent Claims in Delaware (Bloomberg)
  • Karyopharm’a Win Over Investors on Cancer Drug Data Affirmed (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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