Recon: Abbott beats quarterly profit estimates; UK approves Penlon ventilator for COVID-19

| 16 April 2020 | By Michael Mezher 

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In Focus: US
  • Chaotic search for coronavirus treatments undermines efforts, experts say (Washington Post)
  • House Speaker Pelosi calls Trump WHO decision senseless, dangerous (Reuters)
  • Trump Admin. Officials Warned Against Halting Funding to WHO - Leaked Memo (ProPublica)
  • White House snubs Azar, installs Trump loyalist Michael Caputo as HHS spokesperson (Politico)
  • House Progressives Seek to Bar Vaccine, Treatment Exclusivity (Bloomberg) (Law360)
  • US Senate Democrats seek $30 billion for national coronavirus testing (Reuters)
  • Americans aren't ready to go back to normal after a coronavirus reopening (Axios) (Reuters)
  • Testing Falls Woefully Short as Trump Seeks an End to Stay-at-Home Orders (NYTimes)
  • US races to stock up on dialysis supplies as kidney failure ravages virus patients (Politico)
  • Sanofi teams up with US firm Luminostics on developing COVID-19 testing app (Reuters)
  • FDA Grants Approval of Jelmyto to Urogen Pharma (Bloomberg Law) (Endpoints) (FDA) (Press)
  • Gilead is Said to Hold Arcus Stake Talks, Spurring 54% Rally (Bloomberg) (Endpoints)
  • Biogen joins consortium for building COVID-19 'biobank' (Reuters)
  • Abbott beats quarterly profit, but pulls forecast on coronavirus concerns (Reuters)
  • Half of prescriptions needed for Covid-19 patients on ventilators are going unfilled (STAT)
In Focus: International
  • 'We Alerted The World' To Coronavirus On Jan. 5, WHO Says In Response To US (NPR) (NYTimes)
  • Europe coronavirus cases reach almost 1 million, coming weeks 'critical': WHO (Reuters)
  • Japan, China Vie to Be Global Supplier of Unproven Coronavirus Drug (WSJ)
  • Aurobindo’s regulatory woes cast a shadow on strong fundamentals (Economic Times)
  • Aid groups ask UK gov to stop pharma 'profiteering' from COVID-19 (PharmaTimes)
  • Canadian hospitals prepare to sterilize, re-use N95 masks if supplies dwindle (Reuters)
  • Penlon ventilator receives UK approval in battle against coronavirus (Reuters)
  • Israel retrofits home-use respirators into ventilators to treat coronavirus (Reuters)
  • Gilead Japan to Seek Early Remdesivir Filing If Initial Data Prove Positive: Development Chief (PharmaJapan)
  • PMDA: Novartis’ Flawed, Delayed Responses in Zolgensma Review ‘Extremely Unusual’ (PharmaJapan)
Coronavirus Pandemic
  • Coronavirus Vaccine Prospects (In the Pipeline)
  • Fauci: Coronavirus vaccines could be ready sooner than expected (Axios)
  • Coronavirus: Drugs to be tested on lungs of ICU patients (BBC)
  • Roivant begins giving experimental COVID-19 drug to first US patients (Reuters)
  • Coronavirus pandemic threatens to take crushing toll on rural areas, data show (STAT)
  • Private labs say demand for coronavirus tests is down and they can test more people who aren't as sick (NBC)
  • Here’s What We Know about the Most Touted Drugs Tested for COVID-19 (Scientific American)
  • Scientists tap CRISPR’s search-and-detect skills to create a rapid Covid-19 test (STAT)
  • Blood clots in severe Covid-19 patients leave clinicians with clues about the illness — but no proven treatments (STAT)
  • Simply speaking could transmit coronavirus, new study suggests (STAT) (NEJM)
  • Gay men still unable to donate blood and plasma despite new FDA guidelines. Here's why. (NBC)
  • US coronavirus deaths increase by record amount for second straight day: Reuters tally (Reuters)
  • US coronavirus deaths march higher to over 31,000: Reuters tally (Reuters)
  • The CDC and WHO Have Already Said Mosquitoes Don’t Spread Coronavirus. Now USDA Will Study It, Too. (ProPublica)
  • Australia to retain coronavirus curbs for at least another four weeks (Reuters)
  • Germany plans partial reopening of shops and schools: sources (Reuters)
  • Britain probably reaching virus peak, says England's Chief Medical Officer (Reuters)
  • French coronavirus toll jumps by record 1,438 deaths (Reuters)
  • Australia to keep coronavirus restrictions for four more weeks despite success (Reuters)
  • As Brazil's COVID-19 testing lags, available labs go unused (Reuters)
  • Supplies for coronavirus field hospital held up at US-Mexico border (Reuters)
  • Mexico president says UN slow in ensuring access to medical gear amid coronavirus (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup April 15, 2020 (FDA)
Pharma & Biotech
  • Is It Safe to Take That Medication While Breastfeeding? (NYTimes)
  • Remarks by Dr. Hahn to the 2020 Rx Drug Abuse and Heroin Summit (FDA)
  • Leo Pharma licenses global rights from two Asian biotechs (PMLive)
  • Sumitomo subsidiary flashes new way of treating schizophrenia in PhII trial (Endpoints) (Science Mag)
  • Evidence from Pragmatic Trials during Routine Care — Slouching toward a Learning Health System (NEJM)
  • Amneal yanks ulcer drug off US shelves on fears of carcinogen contamination (Fierce)
  • Delayed Advisory Committees Need Not Worry Sponsors Too Much (Pink Sheet)
  • Regeneron gets FDA priority review for Ebola sibling of COVID-19 prospect (Fierce)
  • Covid medicine: Dr Reddy’s Laboratories begins work on Gilead drug clone (Economic Times)
  • Novo Nordisk expands 90-day free insulin program to workers affected by COVID-19 (Fierce)
  • CARES Act Will Accelerate OTC Drug Development (Law360)
  • Drug Cos. May Find Real-World Evidence Cuts Both Ways (Law360)
  • Abundant funding, sparse data: San Francisco startup backs 'real world' model for rare disease drug development (Endpoints)
  • Interim data on Vir's Alnylam-partnered RNAi hep B drug suggest efficacy is broadly on par with J&J, Arrowhead rival — analysts (Endpoints)
  • Pascal Soriot, lamenter of low pay, faces investor revolt for being overcompensated (Endpoints)
  • Galapagos finds Polish partner for inflammation drugs; Zai Lab's Zejula app gets speedy review in China (Endpoints)
  • Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic Impurities (IPQ)
  • The European research-based pharmaceutical industry’s commitment to tackling the coronavirus pandemic (EFPIA)
  • Boston Scientific to begin selling cheaper ventilator alternative (MedtechDive)
  • Philips launches scaled-down ventilator, inks production deals to boost output (MedtechDive)
  • Dexcom gets FDA permission to use continuous glucose monitors on hospitalized COVID-19 patients (San Diego Union-Tribune)
  • CMS doubles Medicare payment for coronavirus diagnostic lab tests (MedtechDive)
Government & Regulatory
  • Pharmacy chains gain a ‘solid’ victory in opioid litigation, but aren’t off the hook yet (STAT)
  • Utah bill would clear the way for experimental drugs to treat COVID-19 (Salt Lake Tribune)
  • Pandemic will delay blockbuster trial of ex-Theranos CEO Elizabeth Holmes (STAT) (CNBC)
  • PTAB Axes University Of Chicago Cancer Treatment Patent (Law360)
  • Federal Court of Australia grants interim injunction to prevent advertising by Evolution Supplements Australia (TGA)
  • Medical device labelling obligations (TGA)
  • Regulation of Personal Protective Equipment and COVID-19 (TGA)
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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