Recon: Takeda Licenses MD Anderson CAR NK Therapies; FDA Offered Divergent Forecasts on Fecal Transplants

• Concerns raised about Giroir at FDA (Politico)
• FDA Approves 24th Biosimilar, 3rd for Neulasta  (Focus) (Reuters) (Endpoints)
• 1 in 2 seriously ill Medicare enrollees struggles with bills (AP) (Axios)
• A New Approach to Gene Therapy—Now In Dogs, Maybe Later In Humans (WSJ)
• Obscure Model Puts a Price on Good Health—and Drives Down Drug Costs (WSJ)
• FDA verdict on Biogen’s Alzheimer’s drug likely to be a ‘political decision,’ analyst says (CNBC)
• With high stakes, eight experts would wield extraordinary influence on fate of Biogen’s Alzheimer’s drug  (STAT)
• After an unprecedented death, FDA is offered divergent forecasts on future of fecal transplants  (STAT) (Endpoints)

• China, US to disclose details of rare cooperation against fentanyl drug scourge (Reuters)
• ATMP Firms Call For Streamlined EU Trial Approvals To Boost Competitiveness (Pink Sheet-$)
• Takeda bags MD Anderson CAR-NKs, plans 2021 pivotal trial (Fierce) (Endpoints) (Press)
• Takeda to Sell Drugs to Stada for $660 Million to Shed Debt (Bloomberg)
• China has become the pharmacy to the world — and a national security risk for the US (STAT)
• Indian Govt may expand essential meds list, cut price of drugs (Economic Times)
• First Netherlands-Based Notified Body Designated Under MDR (Focus)
• ICH Updates: What to Expect Through 2020 (Focus)

• Quarterly Regenerative Medicine Sector Report (AllianceRM)
• OND Reorg Getting Warm Welcome From Review Divisions (Pink Sheet-$)
• US FDA Expands 'Cures' Hiring Authority To Fill Variety Of Open Positions (Pink Sheet-$)
• Fecal transplants work better than antibiotics to treat deadly bacterial infection (NBC)
• Amping up the pharma lab: Drug companies explore the potential of electrochemistry (C&EN)
• Sanofi: FDA OKs flu vaccine for older adults  (MarketWatch) (Press)
• IGBA Calls for Further Regulatory Convergence on Biosimilars (Focus)
• Is FDA Doing Enough to Bring Biosimilars to Market? Experts Discuss (Focus)
• Eli Lilly, Boehringer Ingelheim revise prolific diabetes pact, firing all cylinders for blockbuster Jardiance franchise (Endpoints)
• As CRISPR horizons cloud, a startup focuses on the next big thing with powerhouse potential — the RNA editing platform (Endpoints)
• Gene-Editing Advance Puts More Gene-Based Cures Within Reach (NIH)
• How many rare diseases are there? (Nature)
• Mechanism of RNA splicing modifiers in SMA (Nature)
• Unum drops another program for troubled PhI therapy, moving its eggs to the solid tumor basket (Endpoints)
• Think Mylan's done with M&A after its Pfizer deal? Think again (Fierce)
• First-Ever OTC Inspections Drove Surge Of FDA Warning Letters In FY 2019 (Pink Sheet-$)
• The top 10 highest paid biopharma R&D executives in 2018 (Fierce)
• Statins Tied to Risk of Skin Infections (NYTimes)
• Ipsen grabs new R&D lead as Shire's neuro head leaves amid Takeda takeover (Fierce) (Endpoints)
• Experts are mulling to group antibiotics into categories to combat misuse (Economic Times)
• China and the U.S. are enacting policies that could stymie biomedical innovation (BioCentury)
• Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)

• Revance Completes Enrollment in ASPEN-1 Phase 3 Pivotal Trial for Cervical Dystonia (Press)
• Regeneron Provides Updates on Phase 3 Libtayo® (cemiplimab) Development Program in Advanced Non-small Cell Lung Cancer (Press)
• Aerie Pharmaceuticals Announces Positive Topline Results for Netarsudil Ophthalmic Solution in Phase 2 Study Conducted in Japan (Press)
• Biohaven Completes Enrollment In Pivotal Phase 2/3 Alzheimer's Disease Clinical Trial Of Troriluzole (Press)
• X4 Pharmaceuticals Initiates Phase 1b Clinical Trial of Mavorixafor for the Treatment of Severe Congenital Neutropenia (Press)
• EpicentRx Initiates Dosing in Phase 3 Trial of Immunotherapy RRx-001 for Third-line Small Cell Lung Cancer (Press)
• Palladio Biosciences Announces Presentations of ELiSA Phase 2 Study Results and Phase 3 Lixivaptan Clinical Program Design during the American Society of Nephrology Kidney Week 2019 Meeting (Press)

• FDA classifies Abbott's blood pumping system recall as most serious (Reuters)
• ITC To Investigate Medical Device Imports (Law360-$)
• Adapting To FDA's Proposal For Diagnosis Support Software (Law360-$)
• Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached (FDA)
• Applying human factors engineering to medical device development (Emergo)
• As Essure implant return deadline nears, FDA study enrollment inches up (MedtechDive) (FDA)
• Hips and knees help Zimmer beat Wall Street, amid growing Stryker rivalry (MedtechDive)
• BD beats The Street on Q4 results (MassDevice)
• Myriad shares plunge 40% after missing targets, slashing outlook (MedtechDive)
• FDA clears DiFusion’s spinal implant with new biomaterial (MassDevice)
• Okami Medical wins FDA clearance for vascular occlusion system (MassDevice)
• Spineology touts outcome of U.S. clinical trial for interbody fusion (MassDevice)
• Class 1 Device Recall MMT500, MMT503 (FDA 1, 2)

• Health care outlook on Election Day (Politico)
• The emergence of laboratory benefits managers: PBM déjà vu? (STAT)
• Ex-Theranos CEO Claims FDA Destroyed Key Evidence (Law360-$)
• Daiichi sues Seattle Genetics over tech used in high-profile ADC (Fierce) (Endpoints)
• Federal Circuit Rules On Constitutionality of PTAB Judge Appointments (Big Molecule Watch)
• Health Law Cases in the Upcoming Supreme Court Term (Harvard Bill of Health)
• CVS Health’s Specialty Gain Is McKesson’s Pain (Drug Channels)
• Board Denies CVC Motion to Seal Priority Statement (Patent Docs)
• Illinois Court Applies Mensing/Bartlett to Generic OTC Drug (Drug & Device Law)

• FDA Advisory Committee Calendar

• Class 2 Medicines Recall: M&A Pharmachem Limited Paracetamol 500 mg Tablets, 1 x 1000, PL 04077/0001, (EL(19)A/32) (MHRA)

• Asia Regulatory Roundup: Pakistan Posts Draft Accelerated Approval Guidances (Focus)

• Aurobindo Pharma under USFDA scrutiny (Economic Times)
• Indian government pulling all medical devices under CDSCO regulation (Emergo)
• Gene And Cell Therapies In Asia: Indian Environment Evolving But Multiple Issues Unresolved (Pink Sheet-$)