Recon: EMA Discusses Drug Regulation with Chinese Authorities; FDA Raises Concerns on Device Shortages

• Nonpartisan congressional report: Pelosi’s drug pricing bill could be found unconstitutional (STAT)
• 'Patent thicket' bill caught in price reform tug-of-war (Politico)
• FTC staff recommends approval of Roche deal for Spark: report (Reuters) (Endpoints)
• The downside of cheap generics (Axios)
• Biogen's secret campaign to bring its Alzheimer's drug back from the ashes (Reuters)
• FDA investigating whether Zantac causes carcinogens to form in users (Reuters)
• US vaping-related deaths rise to 34, cases of illness to 1,604 (Reuters)
• The Real Cost Of The Opioid Epidemic: An Estimated $179 Billion In Just One Year (NPR)
• Pharma Sells States On ‘Netflix Model’ To Wipe Out Hep C. But At What Price? (KHN)
• Statement on concerns with medical device availability due to certain sterilization facility closures (FDA 1, 2) (Focus)

• China’s $132 Billion Market Pushes Big Pharma Into Uncharted Territory (Bloomberg)
• China's Fountain Medical scores $62M as demand for CRO services surges (Endpoints)
• WuXi Biologics doubles down on Ireland, will build vaccine plant there (Fierce)
• Dialogue with Chinese authorities on medicine regulation (EMA)
• WHO expert panel on digital health meets for first time (WHO)
• Scientists Were Hunting for the Next Ebola. Now the US Has Cut Off Their Funding. (NYTimes)
• NICE considering re-evaluation of quality of life assessment (PMLive)
• Belgian Court Overturns Parallel Export Ban (Pink Sheet-$)
• Xospata bags European Commission approval (PharmaTimes) (Press)
• IGBA Makes Access Pact With WHO (Pink Sheet-$)
• Ghost Viruses And The Taliban Stand In The Way Of Wiping Out Polio (NPR)

• US FDA Plans Rare Disease Center Of Excellence, But Not "That" Kind Of COE (Pink Sheet-$)
• FY2018 FDA Drug Inspection Observations And Trends (FDAZilla)
• Novartis sends second wagon after KRAS gold rush (Endpoints)
• How Much Money Has Your Doctor Received From Drug Companies? (ProPublica)
• Drugmakers Make Significant Headway in Track-and-Trace Compliance (Focus)
• FDA to Withdraw Generic Drug After Company Repeatedly Fails to Resubmit Bioequivalence Data (Focus)
• FDA Revises Guidance on Postmarketing Studies to Reflect ARIA System, SUPPORT Act (Focus)
• FDA Tweaks its Approach to Homeopathic Products (Focus)
• Ethical Reflections on the Recent Critical Shortage of Pediatric Cancer Drug (Harvard Bill of Health)
• An Alzheimer’s patient on what was lost when Biogen shut down its trial, and what may be gained again (STAT)
• Imatinib and the long tail of targeted drug development (Nature)
• Cel-Sci is publicly upbeat about its cancer drug. Privately it’s trying to sell stock (STAT)
• AbbVie doubles down on cystic fibrosis R&D, adding a new drug to the pipeline as Vertex seals its domination of the field with Trikafta OK (Endpoints)
• Gilead execs flag trial failures for Sjögren’s and lupus drugs — while swapping out a favorite HIV program of top analyst (Endpoints) (Fierce)
• A tale of two IPOs (plus one): Cabaletta prices well below range for $75M while Phathom bags $182M (Endpoints)
• Diving deep into AMD, Yale researchers pinpoint cell types drug developers should pay special attention to (Endpoints)

• VISEN Pharmaceuticals announces China Phase 3 clinical study initiation for TransCon human growth hormone, the first unmodified long-acting growth hormone in China (Press)
• Imago BioSciences Preliminary Data from Ongoing Phase 2 Study of IMG-7289 for the Treatment of Myelofibrosis to be Presented at the 61st American Society of Hematology Annual Meeting & Exposition (Press)
• Spectrum Pharmaceuticals Announces Submission to the U.S. Food and Drug Administration of Updated Biologics License Application for ROLONTIS® (Press)
• Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management System Platform in the United States (Press)
• LIPAC Oncology Announces Successful Completion of Phase 1 Bladder Cancer Clinical Study and Initiation of Phase 2A Study (Press)
• Watson Laboratories, Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Oxycodone Hydrochloride and Ibuprofen Tablets; Opportunity for a Hearing (FDA)

• Smaller, lighter, cheaper: A serial entrepreneur wants his portable MRI to transform medicine (STAT)
• J&J reports rising success rate in robotic surgery clinical trial (MedtechDive)
• FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements (Focus)
• FDA clears duodenoscope add-on device aimed at reducing infection (MedtechDive)
• Abiomed touts real-world data on right-side heart failure with Impella RP (MassDevice)
• Integra LifeSciences ticks up on Q3 beats (MassDevice)
• Baxter accounting investigation clouds Q3 results (MedtechDive)
• Fresenius Medical Care wins FDA breakthrough nod for clot-preventing dialysis device (MassDevice)
• Medical Devices: Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid (FDA)
• FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival (Press)
• Flowonix Medical Receives FDA Approval for its Prometra II® 40 mL Programmable Pump System (Press)

• Trump Considers Retreat From Ban of Mint, Menthol Vaping Flavors (Bloomberg)
• Walmart, CVS and Rite Aid pull 22-ounce J&J baby powder off shelves (Reuters)
• Feds owe health insurers $1.6 billion in unpaid subsidies, judge rules (Modern Healthcare-$)
• Legislation Focused on Market Access to Biosimilars (Big Molecule Watch)
• Medicaid: Opioid Use Disorder Services for Pregnant and Postpartum Women, and Children (GAO)
• ACRO hosts Congressional Briefing on clinical research advancements (ACRO)
• Alphabet’s Verily partners with two health systems to experiment with ways to improve patient outcomes (CNBC)
• What the focus on Warren's health plan does (and doesn't) mean (Politico)
• Device Maker, Execs To Pay $6M To End Feds' FCA Claims (Law360-$)
• GSK Loses Bid To End 53 Zofran Birth Defects Cases (Law360-$)
• Case Dismissed: Claims of 149 Plaintiffs Dismissed with Prejudice in Abilify MDL (Drug & Device Law)
• The High Costs of “Weaponizing” Discovery Strategies (FDA Law Blog)

• FDA Advisory Committee Calendar
• Science Advisory Board to the National Center for Toxicological Research Advisory Committee – 3 December 2019

• UK Abuzz With Action On Clinical Trial Transparency (Pink Sheet-$)
• Clinical trials for medicines: apply for authorisation in the UK (MHRA)
• Ranitidine – MHRA drug alerts issued as Perrigo recalls prescription only and over-the-counter products (MHRA)
• Class 2 Medicines recall: Ranitidine 150mg/10ml Oral Solution (EL (19)A/29) (MHRA)
• Class 2 Medicines recall: Zantac 75 Relief Tablets, Zantac 75 Tablets, Galpharm Indigestion Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets, Kirkland Indigestion Relief 75mg Tablets, Morrisons Indigestion & Heartburn Relief 75mg Tablets, Boots Heartburn & Indigestion Relief 75mg Tablets (EL (19)A/30) (MHRA)

• Developing Low-Cost Medical Devices In Bangladesh (Forbes)

• Cipla may raise bar with digital therapeutics push (Economic Times)

• Submissions received: Proposed changes to the classification of active implantable medical devices and their accessories (TGA)
• Therapeutic goods advertising compliance, 2018-19 annual report (TGA)