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June 8, 2020
by Michael Mezher

Recon: AZ reportedly approached Gilead on merger; Aimmune touts 2-year data for peanut allergy drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Coronavirus drugmakers' latest tactics: Science by press release (Politico)
  • The $7,000 Covid test: Why states are stepping in to shield consumers (Politico)
  • Despite Big Promises, US Has Delivered Limited Aid in Global Virus Response (NYTimes)
  • Scientists Are Questioning Past Research By The Founder of Surgisphere (BuzzFeed) (STAT)
  • Sarepta’s gene therapy for limb-girdle disease shows improved muscle function after one year (STAT) (BioPharmaDive) (Endpoints)
  • Aimmune says peanut allergy drug shows benefit after two years (Reuters)
  • Biopharma IPO boom yields buoyant biotech public debuts (Endpoints)
  • Will the ‘patent dance’ cause Amgen to temporarily pull a biosimilar off the market? (STAT)
  • People are paying as much as $10,000 for an unlicensed remdesivir variant for their cats, in a thriving black market linked to Facebook groups (Business Insider)
  • The US government's supply of the only proven Covid-19 drug runs out at the end of the month (CNN)
In Focus: International
  • Astrazeneca ‘drops interest’ in Gilead Sciences (The Times) (Bloomberg) (Endpoints)
  • Oxford Biomedica eyes UK supply boost of AstraZeneca's COVID-19 vaccine (Reuters)
  • Europe wants to make its own drugs, but it needs American blood plasma (Reuters)
  • UK Lab to Sidestep Drug Industry to Sell Potential Virus Vaccine (NYTimes)
  • EU antitrust regulators reinforce case against Teva pay-for-delay deals (Reuters)
  • Fujifilm says COVID-19 drug research may drag on into July (Reuters)
  • Shanghai Junshi Biosciences in human tests for coronavirus antibody drug (Reuters)
  • Peter Thiel’s Palantir Is Given Access to UK Health Data on Covid-19 Patients (Bloomberg)
  • WHO Finally Endorses Masks to Prevent Coronavirus Transmission (NYTimes)
  • AstraZeneca blood cancer drug shows signs of helping COVID-19 patients (Reuters)
  • Two fewer Notified Bodies for European CE Mark certifications (Emergo)
  • Up to 12 infected in Congo's new Ebola outbreak: WHO (Reuters)
Coronavirus Pandemic
  • New Coronavirus Hot Spots Emerge Across South And In California, As Northeast Slows (NPR)
  • Nearly 600 — And Counting — US Health Workers Have Died Of COVID-19 (KHN)
  • Japan to adopt selective, rather than blanket, approach in coronavirus tests (Reuters)
  • Study: Shutdowns prevented 60 milllion coronavirus cases in US (The Hill)
  • Lockdowns may have averted 3 million deaths in Europe by curbing COVID-19: study (Reuters)
  • New Zealand on course to eliminate coronavirus with zero active cases (Reuters)
  • Bolsonaro threatens WHO exit as COVID-19 kills 'a Brazilian per minute' (Reuters)
  • Brazil stops publishing its coronavirus death toll (Politico)
  • Lilly Announces Start of a Phase 1 Study for its Second Potential COVID-19 Antibody Treatment (Press)
  • Coronavirus (COVID-19) Update: Daily Roundup June 5, 2020 (FDA)
  • False Negative Tests for SARS-CoV-2 Infection — Challenges and Implications (NEJM)
  • Waiting for Certainty on Covid-19 Antibody Tests — At What Cost? (NEJM)
  • Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015) (MHRA)
  • 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic (MHRA)
Pharma & Biotech
  • China’s biggest-ever Nasdaq biotech IPO comes at an awkward time (STAT)
  • Alnylam sets up 3rd potential RNAi approval with a showcase of positive lumasiran data (Endpoints)
  • As US calls for stateside manufacturing, antibiotic maker Paratek gambles on 'onshoring' effort (Fierce)
  • Add ear gene therapy company Akouos to the ever-growing list of IPOs amid Covid-19 (Endpoints)
  • Nimbus picks 4 preclinical targets for the next chapter of its pioneering computational drug discovery work (Endpoints)
  • NIH — and some familiar players — back a PhII Alzheimer’s gamble in another stab at the amyloid hypothesis (Endpoints)
  • When times got tough, the biopharma industry hit the Zoom button and kept things moving at a multibillion-dollar clip (Endpoints)
  • Blood pressure drugs linked to lower death risk; more sensitive test recommended for blood clot risk (Reuters)
  • Insmed's anti-inflammatory drug wins breakthrough status; Kyowa Kirin backs new fund from 4BIO Capital (Endpoints)
  • Japan Pharma Trade Group Nudges Govt to Postpone Off-Year Re-Pricing (PharmaJapan)
  • AbbVie Presents Data Showing RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA (abatacept) in Rheumatoid Arthritis Patients (Press)
  • New Data from the Phase 3 HELP Study Open-Label Extension Evaluate the Long-Term Safety and Efficacy of TAKHZYRO® (lanadelumab) in Reducing Hereditary Angioedema Attacks (Press)
Medtech
  • FDA authorizes COVID-19 saliva test by Phosphorus Diagnostics (Reuters)
  • Surmodics wins CE Mark for drug-coated balloon (MassDevice)
  • Boston Scientific secures CMS pass-through nod for single-use endoscopes (MedtechDive)
  • Insulet's pivotal study back on track, setting up Horizon launch in early 2021 (MedtechDive)
Government & Regulatory
  • Attorney General Morrisey releases results on DEA opioid investigation (The Journal)
  • Four Florida Men Charged for Their Roles in a $54 Million Compound Pharmacy Kickback Scheme (DOJ)
  • EMED Technologies Corp. v. Repro-Med Systems, Inc. (Fed. Cir. 2020) (Patent Docs)
  • 3M Says Ex-Marine Faked Bill Gates Ties In Massive N95 Scam (Law360)
  • Teva Invalidates Opiant Patents In Narcan 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.
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