Recon: Pfizer, BioNTech tout response in early COVID-19 vaccine study; Glenmark charged in price-fixing probe

• US risks 100,000 new Covid-19 cases a day, Fauci warns (Politico)
• Covid-19 vaccine from Pfizer and BioNTech shows positive results (STAT) (WSJ)
• Inside Moderna: The Covid Vaccine Front-Runner With No Track Record and an Unsparing CEO (WSJ)
• Trump officials seek to reassure public about safety of a potential coronavirus vaccine (The Hill)
• Ultragenyx wins early approval for rare disease drug (BioPharmaDive)
• DOJ Charges Glenmark With Generic Drug Price-Fixing (Law360) (Politico) (DOJ)
• Drug makers sue to block Minnesota law making it cheaper to get insulin in emergencies (STAT)
• Novartis plots 2nd US factory to meet demand for Lutathera and future cancer radiotherapies (Fierce)
• Indivior ex-chief pleads guilty to US opioid marketing charge (Financial Times) (DOJ)
• Health experts tell Congress decision to cut ties with WHO is ‘tragic,’ ‘unwise’ (CNBC)

• French state, Sanofi face ruling in birth defects case (AFP)
• US buys up world stock of key Covid-19 drug remdesivir (The Guardian) (BBC)
• Specific Vaccine Negotiations with AstraZeneca about to Start: Minister (PharmaJapan)
• India’s customs start clearing API shipments from China (Economic Times)
• UK Competition Watchdog Has Concerns About Stryker/Wright Medical Merger (MedtechInsight) (CMA)
• An experienced biotech is stitched together from transpacific parts, with 265 staffers and a focus on ‘new biology’ (Endpoints)

• In Early February, the Coronavirus Was Moving Through New York (NYTimes)
• Some US government contracts for Covid-19 research could skirt affordable pricing laws (STAT) (BioPharmaDive)
• Five FDA-approved antivirals could target COVID-19: study (Fierce)
• New White House rules restrict use of grant funding to deal with COVID-19 impacts (Science)
• The Justice Department, Department of Health and Human Services, and the Federal Trade Commission Partner to Alert Public of Contact Tracing COVID-19 Fraud Schemes (DOJ)
• Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020 (FDA)

• Experimental HIV drug seems effective at a twice-a-year dose, study finds (STAT)
• Bioprocess 4.0 Approach Will Help Biopharma Achieve Regulators’ Goals (GEN)
• Days after Intercept rejection, Akero surges on ‘unprecedented‘ NASH data (Endpoints)
• How US FDA And Industry Are Looking To Navigate New Supply Chain Data Reporting Requirements (Pink Sheet)
• Covid-19 has roiled clinical trial plans around the world, raising concerns over the industry’s future on new drug approvals (Endpoints) (Fierce)
• Bolt Biotherapeutics nabs $93.5M to push Provenge inventor's new idea deeper in the clinic (Endpoints)
• Regeneron co-founder George Yancopoulos offers a combative defense of the police at a high school commencement. It didn’t go well (Endpoints)
• Armed with positive ALS data, Amylyx scores $30M in fresh funding to complete Alzheimer's PhII (Endpoints)
• Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints (Pink Sheet)
• She Needed Lifesaving Medication, but the Only Hospital in Town Did Not Have It (ProPublica)
• 2 months after launch, QurAlis nabs early ALS compounds from Eli Lilly (Fierce)

• Abbott, Tandem finalize course to integrate diabetes tech (Fierce)
• NIH Spearheads Study To Test At-Home Screening For HPV And Cervical Cancer (KHN)
• AdvaMed, tech groups urge Congress to make eased telehealth rules permanent (MedtechDive)
• Sidekick, Pfizer team on digital therapeutic for chronic disease (MedtechDive)

• Hollowed-Out Public Health System Faces More Cuts Amid Virus (KHN)
• Delaware Court Denies Motion to Consolidate Filgrastim Cases Against Pfizer (Big Molecule Watch)
• Biogen Gets Temporary Halt On Unapproved Mylan MS Drug (Law360)
• Pfizer Calls For Fees On US Merck Pneumonia Vaccine At Trial (Law360)
• Pharmacies Urge 6th Circ. To Boot Opioid MDL Judge (Law360)
• Amputee's Widow Aims To Keep Bayer, Merck On The Hook (Law360)
• SEC Fines Ex-Biotech CEO For Fertility Drug Misstatements (Law360)
• FDA, FTC Financial Penalties Could Be Shackled By SCOTUS Ruling (MedtechInsight)
• Pre-approval no longer required for ads in specified media (TGA)
• Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry (TGA)