Regulatory Focus™ > News Articles > 2020 > 6 > Recon: FDA rejects AbbVie eye drug BLA; Novartis, Alcon to pay $347M to settle bribery investigation

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

Posted 26 June 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government & Regulatory
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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