Recon: FDA rejects BioMarin gene therapy, Gilead arthritis drug; J&J to acquire Momenta for $6.5B

• FDA’s Emergency Approval of Blood Plasma Is Now on Hold (NYTimes)
• J&J strikes $6.5 billion deal for autoimmune disease specialist Momenta (Reuters) (STAT)
• Gilead shares slide after FDA knocks back rheumatoid arthritis drug (Reuters) (STAT)
• FDA rejects BioMarin hemophilia A gene therapy, shares dive (Reuters) (STAT)
• Drug costs for COVID-19 patients plunge at U.S. hospitals, but may rise (Reuters)
• Mylan's Tecfidera generic launch jolts Biogen, putting billions at stake (Fierce)

• Germany, France want more funding, power for WHO as part of sweeping reforms (Reuters)
• Regeneron Enlists Swiss Rival Roche to Help Make Covid-19 Drug (WSJ) (Reuters) (Press)
• Takeda to sell OTC drug unit to Blackstone for $2.3bn (Nikkei) (FT)
• Reliance buys majority stake in online pharmacy Netmeds for $83 million (Reuters)
• World Health Assembly adopts global strategy to accelerate cervical cancer elimination (WHO)
• World Health Organization's struggle for a global COVID-19 vaccine plan (Reuters)

• FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic (MedtechDive)
• 1.5 Million Antibody Tests Show What Parts of N.Y.C. Were Hit Hardest (NYTimes)
• Will Covid-19 vaccines be safe for children and pregnant women? The data, so far, are lacking (STAT)
• Why Pooled Testing for the Coronavirus Isn’t Working in America (NYTimes)
• Dr Reddy's launches antiviral drug Avigan in India, to launch remdesivir in September (Economic Times)
• Coronavirus (COVID-19) Update: Daily Roundup August 18, 2020 (FDA)

• Trump Ethics Panel Urges Rejection of Fetal Tissue Research (NYTimes)
• Turning Point releases positive data for targeted cancer drug, points to more rapid FDA filing (STAT) (Endpoints)
• Lilly doubles down on Innovent cancer drug in immunotherapy push (BioPharmaDive)
• Gilead expands Tango alliance, continuing a busy year of cancer deals (BioPharmaDive)
• GSK doses first patients in phase 3 meningitis vaccine trial (PMLive)
• A cure for hemophilia is closer than ever. For many patients, it could be just out of reach. (BioPharmaDive)
• US FDA Accepts Myovant’s Relugolix Triple Combo for Review in Uterine Fibroids (PharmaJapan)
• EU Fast-Track Loss For GSK's Dostarlimab (Pink Sheet)
• Zolgensma First To Be Subject To New German Data Collection Rules (Pink Sheet)
• UK Identifies Critical Failures In Cross-Contamination Control Strategies (Pink Sheet)
• Bushu plans $100 million expansion for pharmaceutical inspection facility; RUCDR breaks away from Rutgers University, relaunches as IBX (Endpoints)
• Sorrento ousts CFO as long-running Covid-19 drama continues (Endpoints)
• Another blow to NASH, disappointing trial results spell end for darkhorse player Albireo (Endpoints)
• Informing single-arm clinical trials with external controls (Nature)

• WHO Looks At Speeding Up National Registration Of Prequalified IVDs (MedtechInsight)
• Contact Lenses May Slow Nearsightedness in Children (NYTimes)
• Mum’s the Word on Hearing Aids (FDA Law Blog)
• Fujifilm Medical Targets IVD Market With Business Reshuffle (MedtechInsight)
• FDA Plans Remote Workshop On Orthopedic Device-Related Infections (MedtechInsight)
• 23andMe's consumer pharmacogenetics report no longer requires follow-up testing for certain medications (Mobihealthnews)
• Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior (FDA)

• Key Lawmakers Press US Trade Commissioner On Barriers To Device Supply Chain (MedtechInsight)
• Martin Shkreli fails to end FTC, New York lawsuit over Daraprim price hikes (Reuters)
• Boehringer Strikes Deal To End DOL Pay Bias Probe (Law360)
• Mallinckrodt Must Face Infant Drug Pricing Claims (Law360)
• West Virginia sues CVS, Walmart for aiding opioid epidemic (The Hill)
• Legislators Seek US FDA Input On Teva Proposed Opioid Settlement (Pink Sheet)