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June 9, 2020
by Michael Mezher

Recon: Royalty Pharma targets $2B IPO; Judge sides with AbbVie in Humira patent thicket suit

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Misled Senators on China’s Role as Vital US Drug Supplier (Bloomberg)
  • Royalty Pharma targets biggest US IPO of the year (Reuters) (STAT) (Endpoints)
  • AstraZeneca wins fresh US backing in race for COVID-19 treatment (Reuters)
  • AbbVie Beats Antitrust Challenge To Humira 'Patent Thicket' (Law360) (STAT)
  • Takeda, Eli Lilly Lose High Court Bid Over Actos RICO Claims (Law360)
  • Corning wins US funding for glass vials output for COVID-19 vaccines (Reuters)
  • Gilead's remdesivir shows promise in COVID-19 study on monkeys (Reuters)
  • Global Blood Therapeutics to seek to expand label for sickle cell treatment (Reuters)
  • Special Report: COVID deepens the other opioid crisis - a shortage of hospital painkillers (Reuters)
  • Pfizer continues recalls of menopause drug Duavee on faulty packaging concerns (Fierce)
In Focus: International
  • WHO says pandemic 'far from over' as daily cases hit record high (Reuters)
  • Bayer, MSD file heart failure drug vericiguat in EU and Japan (PMLive)
  • South Korea's Daewoong Pharmaceutical says anti-parasitic drug effective against coronavirus in animal tests (Reuters)
  • After 11 years, Sanofi kicks backs the rights to unwanted gene therapies to Oxford Biomedica (Fierce) (Endpoints)
  • Roche pens $2B biobucks pact with Innovent Biologics for bispecific and cell therapies (Fierce) (Endpoints)
  • NICE rejects Sanofi's Sarclisa in preliminary guidelines (PharmaTimes)
  • Lundbeck axes staff in revamp of its R&D (PMLive) (Endpoints)
  • Diasorin to appeal Italian court ruling cancelling deal with hospital over COVID test (Reuters)
Coronavirus Pandemic
  • ‘We don’t actually have that answer yet’: WHO clarifies comments on asymptomatic spread of Covid-19 (STAT)
  • Can a Vaccine for Covid-19 Be Developed in Record Time? (NYTimes)
  • COVID-19 vaccines start moving into advanced trials (Nature)
  • COVID-19 mAb supplies could fall short of demand (BioCentury)
  • Explainer: What are antibody therapies and who is developing them for COVID-19? (Reuters)
  • First antibody against COVID-19 spike protein enters phase I (Nature)
  • EU actions to support availability of medicines during COVID-19 pandemic (EMA)
  • Over half of people tested in Italy's Bergamo have COVID-19 antibodies (Reuters)
  • Closing in on all sides: Cuba nears declaring coronavirus victory (Reuters)
  • Delhi coronavirus cases set to explode, hospitals running out of beds (Reuters)
  • China, scientists dismiss Harvard study suggesting COVID-19 was spreading in Wuhan in August (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup June 8, 2020 (FDA)
Pharma & Biotech
  • Females are still routinely left out of biomedical research — and ignored in analyses of data (STAT)
  • Developing blockbuster drugs: both nature and nurture (Nature)
  • New HRSA Data: 340B Program Reached $29.9 Billion in 2019; Now Over 8% of Drug Sales (Drug Channels)
  • Flu shot makers gear up—and get creative—for a critical vaccination season (Fierce)
  • The coronavirus pandemic is reigniting a fierce debate over compounded drugs (STAT)
  • Takeda-partnered Evox signs up to $1.2B pact with Lilly; New liquid biopsy company launches with $12M Series A (Endpoints)
  • Deciphering the Immune Response to Viral Infection (GEN)
  • CSL Behring snaps up a closely-held biotech partner and its IL-6 drug — for transplant rejection (Endpoints)
  • Not Every Label Change is a CBE Label Change (Drug & Device Law)
  • Going where PROTACs can't, Versant unveils $50M bet on Carolyn Bertozzi's LYTAC tech — with a seasoned biotech exec at the helm (Endpoints)
  • Regeneron joins $100M round for DNAnexus and its cloud-computing DNA software (Endpoints)
  • ARCH-backed Autobahn launches with $76M to rebuild myelin and reverse MS (Endpoints)
  • ASCO In Brief: US FDA Looks At Safety Outcomes By Performance Status, Metastasis-Free Survival In Elderly Men (Pink Sheet)
  • US FDA’s Project Facilitate Making Some Improvements To Expanded Access (Pink Sheet)
  • GDUFA III May Be Opportunity For Proactive Pharmacovigilance Discussions (Pink Sheet)
  • Cancer Drug Prices Inconsistent With Value Scores From NCCN Prescribing Tool (Pink Sheet)
  • EU Approves Elanco's $7.6B Bayer Animal Biz Buy (Law360)
  • WuXi Biologics inks lease agreement for 3rd U.S. facility in global expansion push (Fierce)
  • Soleno's drug misses key goal in Prader-Willi trial (PharmaTimes)
  • Nippon Shinyaku’s DMD Drug Gets Orphan Status in Europe (PharmaTimes)
  • India Government may soon allow import of untested drugs under trial (Economic Times)
Medtech
  • Edwards wins approval to introduce Sapien 3 valve in China (MedtechDive)
  • Personalized cancer test maker ArcherDX files $100M IPO (Fierce)
  • GTX Medical wins FDA breakthrough device designation for targeted epidural spinal stimulation (MassDevice)
  • Study: TAVR considered safe treatment for bicuspid valve disease (MassDevice)
  • Dexcom lands CE Mark for G6 glucose monitor (MassDevice)
Government & Regulatory
  • Billions in COVID relief go to biggest hospital chains as smaller rivals await aid (Reuters)
  • Amneal Pharmaceuticals LLC v. Almirall, LLC  (Fed. Cir. 2020) (Patent Docs)
  • Bayer, Merck Beat Dr. Scholl's Buyer's Leg Amputation Suit (Law360)
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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