Recon: Pfizer, BioNTech coronavirus vaccines get fast track designation; FDA refuses CytoDyn’s HIV drug application

• Pfizer, BioNTech’s coronavirus vaccines get FDA’s ‘fast track’ status (Reuters) (Press)
• FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility (STAT)
• US National Security Panel Examining Chinese Investors’ Purchase of Pharma Firm (WSJ)
• Opioid Distributors Are Asked to Boost Offer to End Litigation (Bloomberg)
• From Houston to Miami, hospitals running short of remdesivir for Covid-19 patients (STAT)
• Moderna's COVID-19 vaccine could cruise to $5B in sales—or more, analysts say (Fierce)
• Senate Democrats call for $25B for vaccine production, distribution in next package (The Hill)

• Big Pharma snubs request to appear before European Parliament (Politico)
• WHO officials say coronavirus antibodies may wane after several months (CNBC)
• India clears a psoriasis drug for COVID-19, and a tiny US biotech's shares soar (BioPharmaDive) (Economic Times)
• Thailand to Begin Its Covid-19 Vaccine Human Trials in September (Bloomberg)
• Beigene, already flush with cash, raising $2B from investors (BioPharmaDive) (Press)

• Bottleneck for U.S. Coronavirus Response: The Fax Machine (NYTimes)
• Trump Wears Mask In Public For First Time During Walter Reed Visit (NPR)
• New Study Says 'Silent Spreaders' May Be Responsible For Half Of US COVID-19 Cases (NPR)
• Study of Coronavirus in Pregnant Women Finds Striking Racial Differences (NYTimes)
• Coronavirus (COVID-19) Update: Daily Roundup July 10, 2020 (FDA)

• Royalty Pharma’s Dazzling Debut Leads to Tepid Street Views (Bloomberg)
• Spark, chasing BioMarin, plans 2021 start for key hemophilia gene therapy study (BioPharmaDive)
• Tecentriq misses the mark in advanced ovarian cancer (PMLive)
• New data reinforces safety profile of Roche’s Hemlibra (PMLive)
• Angelini lands EU rights to Ovid's phase 3 rare disease drug (Fierce)
• Applied Therapeutics amends investor deck, bolstering accusations made by anonymous critic (STAT)
• Virtual Adcom Vet Says In-Person Events May Be Better For Product Approval Recommendations (Pink Sheet)
• How can cancer drug prices better match their benefits? Germany offers a cost-saving model (STAT)
• Multinational drugmakers seek to form new trade union (Korea Biomedical Review)
• Biologicals Join List Of EU Medicines Requiring Nitrosamine Evaluation (Pink Sheet)
• Improved EU Patient Access & Reimbursement On The Cards For Translarna (Pink Sheet)
• In Astounding Test, Scientists Revive Damaged Lungs for Transplant (NYTimes)

• FDA Schedules Advisory Panel To Review Neovasc’s Angina Treatment (MedtechInsight)
• FDA clears ivWatch's IV safety monitoring sensor patch (Fierce)
• IVDR implementation by 2022 'highly doubtful,' trade group warns (MedtechDive)
• Philips taps BioIntelliSense's symptom-tracking sticker for COVID-19, other chronic diseases (Fierce)
• Lab groups ask Trump admin for more transparency into COVID-19 testing supply allocation (MedtechDive)

• AbbVie Faces Suit Over Delays In Generic Blood Pressure Med (Law360)
• Zimmer Must Face Hip Implant Suit (Law360)
• New Pharma Co. Defenses For 'Innovator Liability' Claims (Law360)