Recon: FDA nods for Ultragenyx, Epizyme; Roche posts mixed results in late-stage prostate cancer trial

• Ultragenyx's Crysvita scores FDA nod in 2nd ultra-rare bone disorder (Fierce) (FDA)
• Epizyme wins second OK for Tazverik, in follicular lymphoma (Endpoints) (FDA)
• US biotech group to trial Covid-19 pill for use at home (Financial Times)
• Rush for Generic Go-Ahead on Novel Drugs Roils Pharma Industry (Bloomberg)
• Coronavirus Attacks the Lungs. A Federal Agency Just Halted Funding for New Lung Treatments. (NYTimes)
• General Tapped To Lead 'Operation Warp Speed' Vaccine Drive Faces Skeptical Senators (NPR)
• Hours after patent win, Mylan asks FDA to speed OK for generic to Biogen’s Tecfidera (Endpoints)
• Wall Street, bribery and an opioid epidemic: the inside story of a disgraced drugmaker (Financial Times)
• Too Many Vaccine Trials May Exclude Older Adults (NYTimes)
• Big Tech Zeros In on the Virus-Testing Market (NYTimes)

• Chinese biotech to test GSK, Dynavax adjuvants in coronavirus vaccine study (BioPharmaDive)
• Vertex and Canada hold talks over cystic fibrosis drug, but a deal for newer medicine remains out of reach (STAT)
• Roche prostate cancer hopeful has mixed results in late-stage trial (Reuters) (Endpoints)
• Blood type, genes tied to risk of severe COVID-19: European study (Reuters)
• Osteoporosis drug shows promise against coronavirus (Politico)
• WHO says coronavirus enters ‘new and dangerous phase’ as daily cases hit record high (CNBC)

• Ex-Trump FDA chief says requiring coronavirus masks is not ‘denying people their liberty’ (CNBC)
• Insurers May Only Pay For Coronavirus Tests When They're 'Medically Necessary' (NPR)
• Public Health Experts Warn The U.S. Lacks Resources To Contain The Coronavirus (NPR)
• You May Have Antibodies After Coronavirus Infection. But Not for Long. (NYTimes)
• Scientists Take Aim at Another Coronavirus Study in a Major Journal (NYTimes)
• New UK COVID-19 Guide To Help Ensure Medicines Research ‘Is Done Well’ (Pink Sheet)
• Coronavirus (COVID-19) Update: Daily Roundup June 18, 2020 (FDA)

• Clinical trial costs to develop a new drug may actually be rather modest — or so one study suggests (STAT)
• The biotech IPOs keep coming at chart-topping levels — with no slowdown in sight (Endpoints)
• US FDA Shies Away From Zoom Meetings Because Of Security Concerns (Pink Sheet)
• Finch touts positive results for its microbiome pill for C. diff infections (STAT) (Endpoints)
• GlaxoSmithKline recalls children's Robitussin, Dimetapp with faulty dosing cups (Fierce) (FDA)
• Ignoring cancer care now may trade one public health crisis — Covid-19 — for another, NCI chief warns (STAT)
• FDA Opens Useful Dialogue On Orange Book Patent Listings (Law360                )
• Boehringer Ingelheim nabs new US president and CEO; AstraZeneca vet hops aboard Novavax as CMO (Endpoints)
• GSK announces FDA Advisory Committee meeting to review belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma (Press)
• Regarding a Warning Letter from the U.S. Food and Drug Administration (Takeda)
• Ipsen scores FDA fast-track for Onivyde in first-line pancreatic cancer (PMLive)
• Amid Allergan buyout, AbbVie dumps unwanted Assembly microbiome pact (Fierce) (Endpoints)
• Waldenström’s macroglobulinemia drug Brukinsa accepted for EU review (PharmaTimes)
• EU filing for CPP's familial adenomatous polyposis drug (PharmaTimes)
• Top US FDA Official Says New 'Playbook' Needed For CMC Reviews Of Gene Therapy Products (Pink Sheet)
• DCGI grants permission to manufacture and sell Glenmark pharmaceuticals’ Favipiravir for Covid-19 (Economic Times)
• Indian government lifts export ban on anti-malarial drug hydroxychloroquine (Economic Times)

• Lack of data encryption for Baxter devices flagged in barrage of DHS alerts (MedtechDive)
• Edwards Can't Fully Launch Heart Device Amid Patent Appeal (Law360)
• ADA 2020: Tandem Wins FDA Nod For T:Slim Pump Technology In Children; Positive Feedback on Studies (MedtechInsight)
• GE Healthcare taps Lunit's AI for its new chest X-ray suite (Fierce)

• Senators back sustaining telehealth momentum post pandemic (MedtechDive)
• Moody's: US healthcare system rebounds from COVID-19 in May, but a bumpy road lies ahead (HealthcareDive)
• 3M settles N95 price-gouging suit (MassDevice)
• Mylan Faces Fight To Bar Generic Sleep Aid As Launch Nears (Law360)
• Justices Told Suboxone Ruling Lets PTAB 'Do As It Pleases' (Law360)
• DOJ Wants To Keep Generic-Drug Exec's Case In Pa. (Law360)
• D.C. Circuit Whacks CMS’ Wacky WAC Disclosure Rule (FDA Law Blog)