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14th April 2022
by Joanne S. Eglovitch

Recon: GSK acquires Sierra for $1.9B to boost drug pipeline; ICER says $2.1M price for Bluebird’s gene therapy is cost effective

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • McKinsey Opened a Door in Its Firewall Between Pharma Clients and Regulators (NYT) (Endpoints) (House committee report)
  • Pfizer's Bourla: COVID vaccines for new variants possible for Fall (Reuters)
  • U.S. Extends Covid Health Emergency Declaration as Cases Rise (Bloomberg)
  • CDC Panel to Meet April 20 on Covid-19 Boosters, Vote Possible (Bloomberg)
  • US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times (The Pink Sheet)
  • US FDA Grants RMAT Requests At Similar Rate To Breakthrough Designations (The Pink Sheet)
  • Manchin, Warren Push for Over-the-Counter Opioid Reversal Drugs (Bloomberg)
  • Medicare’s Alzheimer’s Drug Plan Falls Short on Diversity Access (Bloomberg)
  • How a pharma company bought 2 accelerated approvals — never ran confirmatory trials — and cashed in until FDA said stop (Endpoints)
  • A $2.1 million price tag for Bluebird Bio’s gene therapy is cost-effective, analysis finds (STAT)
  • Pfizer's new CFO David Denton to get $1.25 mln as annual base salary (Reuters)
  • What happened to all the 'good' drug names? Inside the modern day dilemma of Rx naming (Endpoints)
In Focus: International
  • GSK inks $1.9B Sierra takeover as $3M bet on Gilead castoff turns into blockbuster buyout (Fierce) (STAT) (Endpoints) (Reuters)
  • Bayer, GSK, Novartis and Roche jumpstart biomarker cancer organization to drive tests for all (Endpoints)
  • Repurposing Initiatives Proposed To Unlock ‘Untapped Potential’ In Europe (The Pink Sheet)
  • UK Regulator To Overhaul Conflict Of Interest Rules (The Pink Sheet)
  • Pioneering UK Payment Model For Incentivizing Antibiotic Development Meets Major Milestone (The Pink Sheet)
Coronavirus Pandemic
  • Nearly 86% of US COVID caused by BA.2 Omicron subvariant -CDC (Reuters)
  • No relaxation of COVID measures for China, says President Xi (Reuters)
  • Covid vaccines didn’t work for many cancer patients — but researchers are designing a new shot for them (STAT)
  • New Omicron Sublineages Discovered by S. African Scientists (Bloomberg)
  • STD rates remained high during the first year of the pandemic (Washington Post)
Pharma & Biotech
  • CDR-Life Life Raises $76m To Develop Next-Generation T-Cell Engagers (Scrip)
  • In bid to remake itself after pancreatic cancer flop, Halozyme acquires Antares and its drug delivery tech for $960M (Endpoints)
  • AstraZeneca’s oncology R&D chief Susan Galbraith highlights their next-gen prospects at #AACR22 (Endpoints)
  • Boehringer Ingelheim enters collaboration on hearing loss treatment for up to USD 100m (Medwatch) (Endpoints)
  • Bristol Myers Squibb Foundation unites with Gilead to boost diversity among clinical trial investigators (Fierce)
  • Abzena commits chunk of new $65M investment to build out in hot North Carolina scene (Endpoints)
  • Trying not one, but a three-drug combination to help engineered T cells fight cancer (STAT)
  • Incentives to spur repurposing of existing generics for novel uses would open a new paradigm in drug R&D (STAT)
Medtech
  • FDA approves Boston Scientific’s 3D visualization software to program neurostim devices (Fierce)
  • Abbott, Intuitive and J&J start medtech earnings season against a turbulent backdrop (MedTech Dive)
  • Mirvie mRNA study predicts premature births two months in advance (Fierce)
Government, Regulatory & Legal
  • Fresenius GC Says He Was Canned For Flagging Misconduct (Law360)
  • Seagen’s $42 Million Patent Verdict at Risk With Agency Review (Bloomberg)
  • GSK Zofran Suits Should be Revived, Groups Tell Appeals Court (Bloomberg)
  • Mapping The Top Trials To Know In The Opioid Litigation Wave (Law360)
  • As antitrust case wraps, Martin Shkreli's lawyers say they're owed $2M+ in unpaid legal fees (Endpoints)
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.