Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover

ReconRecon | 23 August 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer's COVID Vaccine Gets Full Approval From The FDA (NPR) (NYT) (NBC)
  • Biden calls on companies to mandate vaccines following FDA full approval (The Hill)
  • Pentagon set to make Pfizer vaccine mandatory after FDA approval (Reuters)
  • New York City, The Country's Largest School System, Mandates Teacher Vaccinations (NPR)
  • The U.S. Is Getting a Crash Course in Scientific Uncertainty (NYT)
  • Health Officials Warn Against Using Ivermectin for COVID-19 Amid Rise in Poisonings (Slate)
  • Abbott Goes on the Defensive after a Scathing New York Times report (MD+DI)
  • ‘It’s not really price transparency’: Pharmacies push back on Surescripts, GoodRx deal (MedCity News)
In Focus: International
  • Rising numbers of European orphan approvals (BIoCentury)
  • European Commission Doubles Down on Illumina/Grail Merger (MD+DI)
  • ZyCoV-D becomes world’s first plasmid DNA vaccine for COVID-19 (EPR)
  • Philippines approves emergency use of Russia's Sputnik Light vaccine (Reuters)
  • Valneva begins UK rolling submission for COVID-19 vaccine (Pharmaletter)
  • Xeljanz receives EU marketing authorization for juvenile arthritis (EPR)
  • Will Production Bottlenecks For BMS’s Abecma Pose Problems After EU Approval? (Scrip)
  • NICE recommends Novartis’ Rydapt for advanced systemic mastocytosis treatment (PMLive)
  • China’s NMPA accepts sBLA for tislelizumab in nasopharyngeal cancer (Pharmaletter)
Coronavirus Pandemic
  • Don't Use Pfizer's COVID Vax Off-Label in Kids, Experts Warn (MPT)
  • WHO chief calling for two-month halt on vaccine boosters (The Hill)
  • Accelerated By The Delta Variant, New COVID-19 Cases Are Rising in US (NPR)
  • For first time since July, China reports no new local COVID-19 cases (Reuters)
  • New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection (NPR)
  • A lucky few seem ‘resistant’ to Covid-19. Scientists want to know why (STAT)
Pharma & Biotech
  • Pfizer swallows CD47 biotech Trillium in $2.3B takeover (Fierce) (STAT)
  • Sabatini, biotech founder and mTOR pioneer, ousted after sexual harassment investigation (Fierce)
  • Anti-aging foundation SENS fires de Grey after allegations he interfered with investigation into his conduct (Fierce)
  • ESC: Amarin touts Vascepa's ability to reduce repeat heart problems as it fights generic with 'skinny label' claim (Fierce)
  • Axsome sees depression drug decision delayed as FDA kicks expected CRL can down the road (Fierce)
  • Bristol Myers Squibb nabs priority review tag for $3.15B arthritis drug Orencia to prevent transplant rejection (Fierce)
  • CRISPR pinpoints new leukemia target and a 'pocket' that could make it druggable (Fierce)
  • Genevant pens $303M biobucks pact with Takeda, aiming at rare liver diseases using gene therapy (Fierce)
  • Tyra Biosciences wants to bank $100M for an IPO (Fierce)
  • Flagship, Orbimed, ARCH, Alta top list of high-performing biotech venture capital firms (STAT)
  • RA Capital aims to take preclinical biotech to Nasdaq as Tyra files S-1 during summer lull (Endpoints)
  • Datavant, Real Chemistry form precision medicine partnership (Outsourcing Pharma)
  • CG Oncology CEO highlights biotech’s oncolytic immunotherapy for bladder cancer (MedCity News)
  • MGH team shows how injured muscles might be repaired with patients' own skin cells (Fierce)
  • Next-generation multiple sclerosis therapies look beyond B cells (BioCentury)
  • Gilead, Regeneron, AstraZeneca and more encourage FDA to expand patient reported outcome guidance (Endpoints)
  • Perspective: In the shadows (LifeSci VC)
  • Forbes China Healthcare Summit: FDA, MSK, Novartis, Kevin Rudd (Forbes)
  • Early-stage approval for Opdivo in third cancer type (Pharmaletter)
  • SPAC slashes value of LumiraDx merger by $2B on falling COVID-19 testing forecast (MedTech Dive)
  • Cardiac Dimensions Looks at HF Patients with FMR in Pivotal Study (MD+DI)
  • Class I recall for Cardinal Health’s Monoject saline flush prefilled syringes (FDA)
  • Robotic mastectomy's safety and effectiveness unproven, FDA warns (MedTech Dive)
Government, Regulatory & Legal
  • Holmes Can't Stop Ex-Theranos Lab Director From Testifying (Law360)
  • Opinion: FDA’s kratom ban would harm the public and damage the agency’s credibility (STAT)
  • The Myth of “Pre-Approval” Warning Claims (Drug & Device Law Blog)
  • NPA Files Citizen Petition with FDA over NAC (WholeFoods Magazine)
  • When the tables turn: Investigating the FDA (Pharmaletter)
  • Novartis Seeks To Block Alleged Infringer Of Votrient Patent In India (Scrip)
  • Tasigna Lawsuits Federal Court MDL Order Issued in August 2021 (Drug Injury Watch)
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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