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.