Recon: FDA approves Heron’s non-opioid anesthetic; Poll suggests low public trust in US health institutions

• CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 (NYTimes) (Reuters) (STAT)
• US CDC finds more clotting cases after J&J vaccine, sees causal link (Reuters) (NBC) (NYTimes)
• Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. (NBC)
• Poll Finds Public Health Has A Trust Problem (NPR) (RWJF)
• Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef (Endpoints)
• Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review (Endpoints)

• Top scientists question the need for COVID-19 booster shots (Reuters)
• China backs talks on intellectual property waiver for COVID vaccines (Reuters)
• Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice (Reuters)
• UK trial points to mixed vaccines raising risk of side-effects (FT)
• Japan vaccine chief blames drug approval system for slow inoculation drive (Reuters)
• Brazil’s Supreme Court rules that patent extension rules are unconstitutional (STAT)

• Delaying second COVID-19 vaccine doses can help reduce deaths – study (Reuters)
• Vaccine waiver talks can make drug firms the heroes, US trade chief says (Reuters) (Law360)
• Roche chief compares waiving vaccine patents to East German nationalization (FT)
• Brazilian Covid variant in Illinois leads to a pause in shipments of Lilly’s mAb combo (Endpoints)
• Provisional determination granted to Pfizer in relation to COVID 19 vaccine, COMIRNATY - for use in individuals 12 years of age and older (TGA)

• ‘More Amazon and less pharmacy’: one exec on the company’s strategy for prescription drugs (STAT)
• Pfizer calls proposed IP waiver for Covid vaccines a 'distraction' from finding real solutions on access (Endpoints)
• Biogen licenses a stroke drug from Japanese drugmaker TMS (BioPharmaDive)
• 'Dude, you're getting a Dell' — as a new deep-pocket biotech investor (Endpoints)
• ICER, Accelerated Approval And The Payer Voice At The US FDA (Pink Sheet)
• ‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively (Pink Sheet)
• US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III (Pink Sheet)
• Sanofi, Cellectis team up to pair Lemtrada with allogeneic CAR-Ts; Bristol Myers joins Evotec's drive to advance UK science (Endpoints)
• Sanofi’s Libtayo shows positive Phase III results in advanced cervical cancer (Pharmafile)
• A non-opioid pain startup believes it can top the bupivacaine market — and it's thinking in terms of weeks, not days (Endpoints)
• A Third Rock-backed player charts a new course against transcription factors. Do 'switch sites' hold the magic sauce? (Endpoints) (BioPharmaDive)
• Feds charge another CRO staffer with faking data in a GlaxoSmithKline pediatric asthma study (Endpoints)
• Incyte’s PD-(L)1 inhibitor headed for an ODAC showdown next month (Endpoints)
• Exelixis' Cabometyx scores backing from Ipsen in thyroid cancer, with full data release set for ASCO (Fierce)
• Regulator seeks views on reclassification of pain medication (MHRA 1, 2)
• Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection (FDA)

• Medical devices reforms: Reclassification of certain medical devices (TGA)
• Medtronic hit with another Class I recall regarding HeartWare HVAD system (MedtechDive)
• Communication, Cooperation, Harmonization: Experts Generate New EU Regulatory Momentum (MedtechInsight)
• J&J Vision sets sights on childhood myopia with new FDA contact lens clearance (Fierce)
• BD scores European approval for at-home HPV testing, as COVID lockdowns dent cervical cancer screening rates (Fierce)
• Thermo Fisher, Quest step up K-12 COVID-19 testing as school districts look to safely reopen (MedtechDive)
• Medtronic issues 3rd Class I recall of the year related to HeartWare blood pump (Fierce)

• 37 Lawmakers Urge Acting Medicare Chief To Pull Trigger On MCIT Breakthrough Rule (MedtechInsight) (MedtechDive)
• Purdue's Ch. 11 Confirmation Hearing Set For August (Law360)
• Attys 'Wasting Time' In Sluggish Opioid Trial: Calif. Judge (Law360)
• 2nd Circ. Won't Revive Suit Against Pfizer Over Lipitor (Law360)