Recon: FDA rejects AbbVie eye drug BLA; Novartis, Alcon to pay $347M to settle bribery investigations

• Novartis, Alcon Pay $347 Million to Settle Bribery Probes (WSJ) (STAT) (DOJ)
• FDA Approves Zogenix's Drug for Rare Childhood Epilepsy (Reuters) (STAT) (FDA)
• AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection (Fierce) (Endpoints) (Press)
• DBV lays off employees, scales down programs after receiving no word from FDA (Endpoints)
• Ousted federal vaccine expert alleges health secretary has continued to retaliate (STAT) (Politico)
• States plead for help while White House touts success in curbing virus (Politico)
• Watchdog report finds delays, testing inaccuracies in government response to COVID-19 (The Hill) (GAO)
• US Sets Daily Record For New COVID-19 Cases (NPR)
• CDC says COVID-19 cases in U.S. may be 10 times higher than reported (NBC) (Politico)
• Trump administration asks Supreme Court to overturn Obamacare (Politico)
• ‘Compound King’ Pharmacist Gets 10 Years for $21M Fraud (Bloomberg) (DOJ)

• China to Fast-Track Coronavirus Vaccine Trial Based on Advanced Genetics Technology (WSJ)
• WHO, partners unveil plan to deliver 2B doses of Covid-19 vaccine (STAT)
• Sanofi considers job cuts as CEO seeks to reduce costs – sources (Reuters) (Endpoints)
• AstraZeneca, Daiichi Sankyo working on Japanese supply deal for COVID-19 vaccine hopeful (Fierce)
• India Plans to Impose Strict Rules and Tariffs on Chinese Imports (Bloomberg)
• India's auto and pharma sectors not ready to wean off China (Reuters)
• NICE sticks to Zytiga rejection (PharmaTimes)
• Replacing China as API supplier will be a medium to long term story: Lupin (Economic Times)
• Germany And France Promise New Financial Support To World Health Organization (NPR)

• Fauci hints at new approach to COVID-19 testing (The Hill)
• This Coronavirus Doesn't Change Quickly, And That's Good News For Vaccine Maker (NPR)
• Covid-19 vaccine research must involve Black, Latinx participants (STAT)
• Coronavirus vaccine will not be a cure-all, virologist warns (CNBC)
• Warp Speed May Be Usurping BARDA, Potentially Hurting COVID-19 Vaccine Prospects (Pink Sheet)
• Federal Workforce: Key Considerations for Agencies Returning Employees to Workplaces during Pandemics (GAO)
• The Indian Health Service Wants to Return 1 Million KN95 Masks It Bought From a Former White House Official (ProPublica)
• Drug-Hunter Chases Coronavirus Treatment as Pandemic Spreads (WSJ)
• One Biohacker’s Improbable Bid to Make a DIY Covid-19 Vaccine (Bloomberg)
• Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020 (FDA)

• Bristol Myers says Celgene buyout could supercharge sales to $20B (Fierce)
• CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On (Pink Sheet)
• FDA's on the air: Agency puts coronavirus front and center in podcast debut (Fierce)
• Is it time to replace one of the cornerstones of animal research? (Science)
• CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products (FDA)
• Novartis-backed Poseida is packing in the cash for its next-gen CAR-T work, adding a $110M venture raise on top of its newly-refiled IPO (Endpoints)
• Presented with upbeat Alzheimer's agitation data, FDA sees another 'breakthrough' in Axsome's AXS-05 (Endpoints)
• Inovio adds two to the leadership team; Adrian Woolfson is out at Sangamo (Endpoints)
• Out of jobs, a pair of early cell therapy executives went to Seoul, came back with a new company, $70M and a plan to leapfrog natural killer competitors (Endpoints)
• Hong Kong Cancer Drug Co. Snags $100M Equity Investment (Law360)
• MHLW Revokes Ninlaro’s Sakigake Status for AL Amyloidosis (PharmaJapan)
• J&J scuttles PhIII lupus program on failed data analysis; Novartis pays $345M to resolve bribery charges (Endpoints)

• Clinical Registries Database Mooted As UK Devices Bill Moves To Upper House (MedtechInsight)
• Move to digital mammography failed to improve outcomes, study finds (MedtechDive)
• New Questionnaire Tools Could Help FDA Review Artificial Pancreases (MedtechInsight)
• Roche adds PD-L1-spotting AI to its non-small cell lung cancer pathology platform (Fierce)
• FDA signals support for automated insulin dosing tech, backing new development tool (MedtechDive)
• Compliance Corner: Leverage MDSAP Companion Doc To Master Your Next Audit, Train Staff, Expert Advises (MedtechInsight)
• Abbott touts new data for its minimally invasive structural heart therapies (MassDevice)
• COVID-19: FDA Prods Industry For Better EUA Completion (MedtechInsight)
• FDA clears Masimo respiration sensor (MassDevice)
• FDA OKs Circadia’s radar-powered tool in battle against COVID-19 (MassDevice)

• Death threats, shoves, and throwing blood: Anti-vaxxers’ bullying of public health officials endangers our country (STAT)
• Medicaid Drug Rebate Program Update: CMS Publishes Proposed Rule Addressing Value Based Purchasing Arrangements and Other Topics; D.C. District Court Opposes Base AMP Reset (FDA Law Blog)
• Bayer Ducks Suit Over Birth Control Device Defect Claims (Law360)
• AbbVie, FTC Tussle Over High Court's View On Disgorgement (Law360)