Recon: FDA Declines to Ban Textured Breast Implants Linked to Rare Cancer

• FDA Won’t Ban Sales of Textured Breast Implants Linked to Cancer (NYTimes) (AP) (MassDevice) (FDA)
• Biotech runs on venture capital. But not all VC models are created equal (STAT)
• Budget office: $177B in added costs from Trump drug plan (AP) (Bloomberg)
• Gilead tops earnings forecast as cancer drug drives sales (Financial Times)
• Gilead unveils plan to separate Kite cell therapy unit (PMLive) (Yahoo)
• Insys Therapeutics founder, former executives found guilty in criminal fentanyl bribery case (CNBC) (NYTimes) (Reuters)
• FDA rejects Acacia’s lead drug — again — due to the same manufacturing issue (Endpoints)
• Can a small drug maker make amends with the FDA after giving its inspectors the bum’s rush? (STAT)
• First US use of CRISPR to directly target cancer will seek go-ahead from regulators (STAT)
• Insiders describe aggressive growth tactics at uBiome, the health start-up raided by the FBI last week (CNBC)
• FDA To Propose Mandatory Recall Authority For Drug-Like Supplements (IHP)
• The search for the kryptonite that can stop CRISPR (MIT Technology Review)

• EMA annual report 2018 published (EMA)
• GSK's 3-in-1 inhalable drug shows promise in asthma study (Reuters)
• Congo Ebola death toll nears 1,000, new vaccine planned: WHO (Reuters)
• Monstrous rumors stoke hostility to Pakistan's anti-polio drive (Reuters)
• Cholera outbreak declared in cyclone-hit northern Mozambique (Reuters)
• Novartis and Sanofi heads take on UK pharma leadership roles (PMLive)
• NICE recommends Roche’s Tecentriq for metastatic NSCLC (PharmaTimes)
• Fresenius Kabi Launches Biosimilar Adalimumab Idacio in Germany (Press)
• US FDA seeks voluntary action on Dadra plant in relief for Sun (ET)
• South Korea Invossa Incident Raises Suspicions About Regulators, Sponsor At Local Forum (Pink Sheet-$)
• How South Korea Can Win In The Global Clinical Trial Arena (Scrip-$)

• Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future (Focus)
• FDA nearing ‘holy grail’ of drug review, Gottlieb says (BioCentury)
• Gottlieb: How a cultural shift is transforming FDA’s drug reviews (BioCentury)
• Woodcock Details Upcoming Changes to NDA and BLA Review Process (Focus)
• AIDS drugs prevent sexual transmission of HIV in gay men, study finds (NBC)
• Final Bids for Sentinel System Due in Weeks, Woodcock Says (FDANews-$)
• FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation (FDA)
• J&J eyes prostate cancer boost as FDA accepts Erleada for real-time review (Fierce)
• Alnylam posts strong Onpattro sales as competition heats up (BioPharmaDive)
• Genkyotex picks out silver linings from failed PhII, braces for pivotal study in primary biliary cholangitis (Endpoints)
• Celgene reports 'durable' responses to multiple myeloma CAR-T in early trial despite relapses (Fierce)
• The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results (Harvard Bill of Health)
• New FDA Boss Details Wide-Ranging Enforcement Plan (Law360-$)
• At Big Neuro Meeting, Migraine Drug Competitors to Make Oral Arguments (Xconomy)
• AstraZeneca-led team uses a struggling cancer drug to gain insight into treatment resistance (Fierce)
• Dan O’Day’s to-do list for Gilead: Recruit a Kite CEO, press the pedal on next-gen cell therapies and start buying stuff (Endpoints)
• Did a disaster crush your stock in 2018? These biotechs were happy to come up with some rich compensation deals for the CEO anyway (Endpoints)
• Amgen taps Syapse to infuse real-world data into its cancer clinical trial designs (Fierce)
• As backlash mounts in the wake of a disastrous PhIII flop, Eisai goes deeper with 2 new hires (Endpoints)
• Tessa showcases preclinical promise of ‘all-in-one’ add-on to its cancer cell therapy, in march to the clinic (Endpoints)
• Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance (FDA)

• Microcap biotech VistaGen turned to pennystock after PhII results show its depression drug doesn’t work solo (Endpoints)
• New England Journal of Medicine Publishes Positive Phase 3 PREVENT Data for SOLIRIS® (eculizumab) in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) (Press)
• Phase III CAPTAIN Study of Trelegy Ellipta in Patients with Asthma Meets Primary Endpoint (Press)
• Ligand Completes Enrollment of Phase 1 Clinical Trial of Captisol-enabled Iohexol (Press)
• Biohaven Announces Late-Breaking Oral Presentation Of Rimegepant Zydis® ODT Phase 3 Results At American Academy Of Neurology (AAN) 2019 Annual Meeting And New Data Release At Investor Event (Press)

• FDA’s Device Inspections Program Sets FY19 Performance Goals (Focus)
• FDA Publishes List of Priority Patient Preference Areas for Medical Devices (Focus)
• Staar Surgical shares drop on FDA request for more data on EVO/EVO+ Visian lenses PMA bid (MassDevice)
• ResMed shares up after posting Street-beating Q3 (MassDevice)
• FDA clears Biofourmis' software for ECG-based arrhythmia detection (mobihealthnews)
• Caris Life Sciences Receives FDA Breakthrough Device Designation for MI Transcriptome™ Companion Diagnostic Test (Press)

• CBO: 7 million more uninsured after ObamaCare mandate repeal (The Hill)
• US health agency finalizes conscience and religious freedom rule (Reuters)
• San Francisco sues HHS over conscience-rights rule (Politico)
• H.R. 938, Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (CBO)
• H.R. 965, CREATES Act of 2019 (CBO)
• H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 (CBO)
• Fed Circuit: FDCA violations are not a private matter until the FDA speaks (BioWorld)
• As measles returns, U.S. states look to cut vaccine exemptions (Reuters)
• Eisai Wants Aurobindo's Generic Weight Loss Drug Blocked (Law360-$)
• Merck Sues To Nix Mylan's Plans For Diabetes Generic (Law360-$)
• States Say They Can Show Conspiracy In Generic Drug MDL (Law360-$)
• Deadline Won't Stop Med Mal Suit Against Quest Diagnostics (Law360-$)
• Ex-NECC Pharmacists Guilty Of Role In Fake Shipments (Law360-$)
• Court Blesses FDA’s Rarely Used Administrative Search Warrant Authority (FDA Law Blog)
• Bio-Rad Laboratories, Inc. v. 10X Genomics, Inc. (D. Del. 2019) (Patent Docs)
• Washington Blocks Attempt to Dodge Generic Preemption Rules (Drug & Device Law)
• Employees Start To Feel The Squeeze Of High-Deductible Health Plans (NPR)

• FDA Advisory Committee Calendar

• Withdrawal of vaginal mesh (Danish Medicines Agency)
• EU Regulatory Roundup: MHRA Accused of Appalling Treatment of Families in Pregnancy Test Review (Focus)

• DoP rejects Biocon's review petitions against ceiling price fixation on Blistro Trio 1 and Blistro Trio 2 (Pharmabiz)
• Industry seeks retrieval of unregistered Chinese APIs circulated in domestic market to protect citizens’ health (Pharmabiz)
• New WHO Public Inspection Report (WHOPIR) published – Mylan Laboratories LTD (WHO)

• Summary Safety Review - Cellex Photopheresis System (Health Canada)

• Scientology cruise ship leaves St. Lucia after measles quarantine (Reuters)