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

• 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)

• 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)

• 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)

• 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)

• 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)