Recon: Biogen delays Alzheimer’s drug submission; NIH COVID-19 treatment guidelines find little evidence for touted drugs

• Senate Approves Aid for Small-Business Loan Program, Hospitals and Testing (NYTimes) (NBC)
• House Plans To Vote This Week On Senate's New Relief Measure (NPR)
• New US Treatment Guidelines for Covid-19 Don’t See Much Progress (NYTimes) (Politico) (NPR) (NIH)
• More deaths, no benefit from malaria drug in VA virus study (AP) (Reuters)
• CDC chief warns second COVID-19 wave may be worse, arriving with flu season (Reuters) (Politico)
• BARDA director leaves role suddenly amid coronavirus pandemic  (STAT) (Reuters)
• US AG Barr won't rule out legal action over state coronavirus measures (Reuters) (NPR)
• United States should allow volunteers to be infected with coronavirus to test vaccines, lawmakers argue (Science Mag) (Letter)
• Biogen delays Alzheimer’s drug filing to FDA, citing Covid-19, complexity of data analysis (STAT)
• Awaiting an FDA decision, Akili rolls out its video game for kids with ADHD under relaxed rules (STAT)
• Gilead, Kite pen natural killer pact with little-known Australian cell therapy player (Fierce) (Endpoints)
• Novartis Kymriah Receives FDA RMAT Designation (Reuters) (Press)
• AbbVie's Imbruvica scoops up 11th FDA approval (Endpoints) (Pharmafile) (Press)

• Global coronavirus cases pass 2.5 million as U.S. tally surpasses 800,000 (Reuters)
• The world needs to change how it trades drugs (Foreign Policy)
• COVID-19 Seen as Tipping Point to Lower Drug Prices, Patent Sharing (Bloomberg Law)
• Spread Of Coronavirus Accelerates Across Africa (NPR)
• Africa Proposes Joint Coronavirus Clinical Trial Reviews (Pink Sheet)
• Sweden resisted a lockdown, and its capital Stockholm is expected to reach ‘herd immunity’ in weeks (CNBC)
• UK Government facing fresh questions over EU equipment scheme (BBC) (Reuters)
• Roche Sees Profit Bump as Drugs and Diagnostics Stay in Demand (Bloomberg) (WSJ) (Fierce)
• UK Watchdog Looking Into Stryker's $4B Plan To Pick Up Rival (Law360)
• Japan to Make Drug Review Time as Short as Possible for COVID-19: Minister (PharmaJapan)
• Astellas Scoops Up UK's Mitochondria-Focused Biotech Nanna (PharmaJapan)
• Germany approves first trial of COVID-19 vaccine candidate (Reuters) (Press)
• It'll be months before coronavirus vaccine is ready: German minister (Reuters)

• Coronavirus Infections May Not Be Uncommon, Tests Suggest (NYTimes)
• Coronavirus cases are likely 10 to 20 times higher in US than reported, former FDA chief Gottlieb says (CNBC)
• Public health experts are now the bad guys (Politico)
• Nearly 25,000 email addresses and passwords allegedly from NIH, WHO, Gates Foundation and others are dumped online (Washington Post)
• 1st Known U.S. COVID-19 Death Was Weeks Earlier Than Previously Thought (NPR)
• FDA Says Smokers May Have Higher Risk of Catching Covid-19 (Bloomberg)
• Alarmed as COVID patients' blood thickened, New York doctors try new treatments (Reuters)
• South Korea finds patients testing positive post-recovery from coronavirus barely infectious (Reuters)
• Recovered, almost: China's early patients unable to shed coronavirus (Reuters)
• Japan's coronavirus mask handout tainted by gripes over mould, stains, insects (Reuters)
• People are dying from coronavirus because we’re not fast enough at clinical research (STAT)
• 'A disaster': Roche CEO's verdict on some COVID-19 antibody tests (Reuters)
• Quest Diagnostics starts antibody testing for coronavirus (Reuters)
• LabCorp to expand availability of antibody tests for COVID-19 (Reuters)
• UK confident of hitting 100,000 COVID-19 daily tests target, Raab says (Reuters)
• India suspends coronavirus antibody tests after questions over reliability (Reuters)
• Israel's OurCrowd leads $12 million investment to develop COVID-19 vaccine (Reuters)
• Watching For Mutations in the Coronavirus (In the Pipeline)
• We can make more ventilators if government ups order, says UK business consortium (Reuters)
• Microsoft hires a former GE exec to work with health companies in the midst of the coronavirus pandemic (CNBC)
• China sees return of coronavirus cases in northwest, warns against overseas travel (Reuters)
• FT analysis sees UK coronavirus death toll at 41,000 (Reuters)

• MilliporeSigma's New CRISPR System Moves Chromatin Out of Way for More Efficient Editing (GenomeWeb)
• FDA Extends Comment Period for Draft Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations Guidance (FDA)
• Biosimilar Competition: How Might FDA Be Convinced To Change Its Naming Policy? (Pink Sheet)
• Export of anti-tuberculosis medicines a worry (Economic Times)
• First NDA in. Regional deal done. Now Myovant has PhIII data to back up relugolix's push to another blockbuster market (Endpoints)
• Early treatment with Novartis' Mayzent stalls secondary progressive MS: study (Fierce)
• COVID-19 lockdown in India hub leaves pharmas scrambling to keep up supply (Fierce)
• Positive Data in Hand, Ono/Takeda to Seek 1st-Line RCC Nod for Opdivo/Cabometyx Combo (PharmaJapan)
• Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency' (Pink Sheet)
• Trial data help small biotech ready its anti-itch drug for approval (BioPharmaDive)
• On a 180-person video chat, biotech executives share the best ways do business amid the coronavirus (STAT)
• Life science companies combine to form COVID-19 research database (Fierce)
• Big Pharma VC firms put $11M in seed funds behind cancer startup with bold vision (Endpoints)

• FDA warns a company selling an insemination kit with parts only intended for use in animals (STAT)
• Is 3D printing ready to fill the gaps in COVID-19 medical equipment needs? (Marketplace)
• FDA grants breakthrough designation to CytoSorb blood purification tech (MassDevice)
• As COVID-19 antibody tests proliferate, analysts see market worth billions for Abbott, Roche and others (MedtechDive)
• ResMed to get biggest bang out of HHS ventilator contracts, analysts predict (MedtechDive)
• India battles supply snags in race to build affordable ventilators (Reuters)
• Thermo Fisher Scientific Q1 Revenues Up 2 Percent (GenomeWeb)
• Tighter Controls, Flood Of Orders Force Chinese Medical Suppliers To Say 'No' To The World (MedtechInsight)

• EudraVigilance User Manual v2 (EMA)
• HHS delays interoperability rules, officially (Politico)
• Lebanon legalizes cannabis farming for medicinal use (Reuters)
• New York charges Mallinckrodt with insurance fraud over opioid claims (Reuters)
• Fed. Circ. Limits Scope Of Biogen's MS Drug Patent Extension (Law360)
• Oral Argument Scheduled for June 3 in Bevacizumab Preliminary Injunction Appeal (Big Molecule Watch)
• Oral Argument Scheduled for June 3 in Bevacizumab Preliminary Injunction Appeal (Big Molecule Watch)
• Edwards Lifesciences Can Appeal Heart Device Patent Ruling (Law360)
• As Zantac Litigation Accelerates, MDL Data Collection Is Key (Law360)
• D. Conn. Sees Through Contact Lens Lawsuit (Drug & Device Law)