Recon: Germany, Italy, France halt AstraZeneca shots; Roche buys GenMark for $1.8B

• US data for AstraZeneca vaccine under review by independent advisers - U.S. official (Reuters)
• Roche buys GenMark for $1.8 million to challenge test rivals (Reuters) (Press)
• Gilead, Merck collaborate to develop long-acting HIV treatment (Reuters) (BioPharmaDive)
• AstraZeneca to seek U.S. authorization for COVID-19 vaccine this month or early next (Reuters)
• Elevate Bio raises $525M to fuel cell, gene therapy expansion (BioPharmaDive) (Endpoints)
• U.S. limits supply of Eli Lilly's COVID-19 antibody therapy in three states (Reuters)
• Moderna doses first patient in study on its COVID-19 booster vaccine (Reuters)
• Biden readies campaign to combat vaccine skeptics (Politico)
• Lilly Alzheimer's drug shows benefit on cognition, function in mid-stage trial (Reuters) (STAT) (Endpoints) (Press)

• EU defends vaccine distribution as nations complain it is uneven (Reuters) (FT) (EC)
• AstraZeneca finds no evidence of increased blood clot risk from vaccine (Reuters)
• WHO examining AstraZeneca vaccine reports, says no evidence of causality (Reuters)
• Germany, Italy, France to halt AstraZeneca shots (Reuters) (AP)
• Netherlands halts use of AstraZeneca COVID-19 vaccine (Reuters)
• Ireland latest country to suspend AstraZeneca COVID-19 vaccine (Reuters)
• The EMA covid-19 data leak, and what it tells us about mRNA instability (The BMJ)
• BioNTech Recruits Rivals to Boost Covid-19 Vaccine Production (WSJ)
• Unthinkable? EU considers getting a vaccine boost from Russia's Sputnik (Reuters)
• China's ambitious COVID-19 vaccination plan to test its production capability (Reuters)
• Malaysian rubber glove group says demand to oustrip supply until 2023 (Reuters)
• Bombshell analysis traces new Ebola outbreak to survivor of West Africa crisis (STAT) (NYTimes)

• Regular booster vaccines are the future in battle with COVID-19 virus, top genome expert says (Reuters)
• EU's Breton says Pfizer can help offset AstraZeneca vaccine delays (Reuters)
• Can the World Learn From South Africa’s Vaccine Trials? (NYTimes)
• Three people in Norway treated for "unusual symptoms" after AstraZeneca COVID-19 shots (Reuters)
• Dane who died from blood clot after AstraZeneca shot had `unusual symptoms', agency says (Reuters)
• Dutch watchdog says 10 reports of possible side effects after Astrazeneca vaccine (Reuters)
• Italy's Piedmont region stops use of AstraZeneca vaccine batch (Reuters)
• Pharma Co. Seeks J&J Virus Vaccine License — Or Else (Law360)
• MHRA response to Irish authorities’ action to temporarily suspend the AstraZeneca COVID-19 vaccine (MHRA)
• After Mesoblast COVID-19 drug flop, Novartis tries again with Molecular Partners (Fierce)
• Takeda and IDT Support Manufacturing of Johnson & Johnson’s COVID-19 Vaccine (Press)

• Money, talent flowing into mRNA sector after COVID-19 success (Reuters)
• DMAP: Focusing on a Fundamental Challenge (Alliance for a Stronger FDA)
• Insitro raises $400M for machine learning-powered drug discovery efforts (Fierce) (FT)
• Sanofi, Regeneron's Libtayo looks for new cervical cancer use with first-in-class survival win (Fierce) (Pharmafile)
• Blown off course, Bluebird shares tick up on positive gene therapy readout (Fierce) (Endpoints)
• Specialty drugmaker ANI to boost CDMO work, generics portfolio with $210M Novitium buyout (Fierce)
• Orphan drug designation and development in Japan: 25 years of experience and assessment (Nature)
• Vivek Ramaswamy's LNP delivery tech play Genevant scores $600M licensing deal from Takeda for nucleic acid therapies (Endpoints)
• Next-gen gene editing upstart is grabbing the brass ring with a $150M crossover play to back its bid on a cure for sickle cell disease (Endpoints)
• Rubius chief lays out the first human data on their lead red cell drug in a comeback play. And the stock skyrockets (Endpoints)
• Backed by Indian biosim giant Biocon, bispecifics player Bicara debuts with $40M and solid tumors on the radar (Endpoints)
• New Zolgensma data demonstrate age-appropriate development when used early, real-world benefit in older children and durability 5+ years post-treatment (Press)
• Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance) (Press)

• 'Painless' glucose monitors are popular but little evidence they help most diabetes patients (NBC)
• Quest eyes $2B DTC testing potential to capitalize on 'breakout' consumer growth (MedtechDive)
• Cardiac wearables, iRhythm, under a cloud as reimbursement questions linger (MedtechDivev)
• Blood Transfusion Kits Used By US Military Subject Of Class I Recall (MedtechInsight)

• Decision Dismissing Claims Against Generic Drug Manufacturer On Implied-Preemption Grounds Also Helpful In Other Contexts (Drug & Device Law)
• The Patent Trial and Appeal Board Returns to the Supreme Court (Harvard Bill of Health)
• Consultation: Electronic media in prescription drug labelling draft guidance document (Health Canada)
• NJ Court Skeptical Of FCA Claims Against Gilead, Shire (Law360)
• Minn. AG's Insulin Suit Against Sanofi, Eli Lilly Gutted (Law360)
• Fed. Circ. Calls Route To PTAB Denial Appeals 'Very Narrow' (Law360)
• Fed. Circ. Affirms Letting J&J Reveal Manufacturer In IP Row (Law360)
• Law Firm Admonished For 'False' Ads In Gilead HIV Drug Suit (Law360)