Recon: China First to Approve AZ, FibroGen Anemia Drug; Sanofi Signs Massive Lease for Cambridge Hub

• Sanofi signs megalease at Cambridge Crossing (Boston Globe) (Endpoints) (WBUR)
• Did Merck circumvent its duty to warn on ‘Fosamax fractures’? (STAT)
• Sen. Alexander, a leading Republican on health legislation, will not seek reelection (STAT) (NYTimes)
• Why Trump still needs Obamacare (Politico)
• Abiomed Sells $600 Million Worth Of Its Pencil-Size Heart Pump. But Some Doctors Have Big Questions About It. (Forbes)
• Shire bags US approval for constipation drug Motegrity (PMLive) (Press)
• Evofem shares surge as contraceptive gel meets late-stage trial goal (Reuters)
• Amazon’s vision for the future of health care is becoming clear (CNBC)
• States Ask Judge to Declare Health Law Still in Effect While Ruling Is Appealed (NYTimes)
• Set It and Forget It: How Better Contraception Could Be a Key to Reducing Poverty (NYTimes)
• Sen. Cory Booker Calls For More Transparency In Medicaid Drug Decisions (NPR)
• J&J moves to limit impact of Reuters report on asbestos in Baby Powder (Reuters)
• J&J announces $5 billion share buyback after shares extend losses (Reuters)
• Orphan Drugs in the United States (IQVIA)

• China first to approve AstraZeneca, FibroGen anaemia drug (Reuters) (BioCentury) (Endpoints)
• Novartis braces for a battle over the cost effectiveness of a gene therapy (STAT)
• WHO confirms case of yellow fever in Netherlands, says risk low (Reuters)
• Astellas, Sunovion and Shield breach ABPI Code (PharmaTimes)
• Indivior to launch cheaper opioid addiction drug; maintains forecast (Reuters)
• Reimagining medicine? Novartis wraps pharma’s first big global pot deal (Endpoints)
• Bristol-Myers Squibb nears $1.6B sale of OTC unit Upsa to Taisho: report (Fierce)
• Indivior rallies after drugmaker confirms full-year sales guidance (Financial Times)
• India: 3.36% of about 82,600 drugs samples found to be substandard (Economic Times)
• Indian regulator says Reuters report on J&J baby powder 'under consideration' (Reuters)
• An Island Nation Starts an Experiment: Vaccines Delivered by Drone (NYTimes)
• China Approves Junshi’s Tuoyi, First Domestic Anti-PD-1 mAb (BioCentury)
• China Outlines Adjuvant Drug List (BioCentury)

• Our Door Is Open: FDA Puts Patients First (FDA)
• Sales of antibiotics used in food-producing livestock dropped last year (STAT) (FDA)
• With $42M, Ex-Ignyta CEO Aims At Cancer Again With Startup, Erasca (Xconomy) (Endpoints)
• Bristol-Myers Squibb, Boston Medical Center Partner to Study Immuno-Oncology Response, Resistance (GenomeWeb) (Press)
• Entrada Therapeutics Nabs $59M for Drugs that Gain “Entry” to Cells (Xconomy) (Fierce) (Endpoints)
• FDA Looks To Strengthen, Speed Drug Reviews With Flow Of Quality Data (Scrip-$)
• Novartis CAR-T chief drops out of Big Pharma, joins the great migration to a favorite biotech destination (Endpoints)
• Lilly's Taltz beats out AbbVie's megadrug Humira in psoriatic arthritis showdown (Fierce)
• FDA’s Revised Draft For Compounding Pharmacies Opens Door To Compounding For Office Use (Pink Sheet-$)
• San Antonio Develops “Action Plan” to Draw Life Sciences Businesses (Xconomy)
• Kineta Gets $15M in New Cancer Drug Partnership with Pfizer (Xconomy)
• Targeting underlying cause of PAH, Cambridge spinout Morphogen-IX raises about $23M in Series B (Endpoints)
• Sophiris, Stock Sliding After Cancer Drug Data, Still Plans Phase 3 (Xconomy) (Endpoints)

• Alkermes and Biogen announce new MS drug application for FDA (PharmaTimes)
• Teva Announces Positive Topline Phase IIIb Results with Fremanezumab in Adults with Migraine Who Did Not Respond to Multiple Classes of Preventive Treatments (Press)
• Puma Biotechnology Announces Top Line Results of the Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer (Press)
• Vertex Announces Positive Phase 2 Data in Third Proof-of-Concept Study with the NaV1.8 Inhibitor VX-150 (Press)
• ArTara Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA on Choline Chloride for Injection for Intestinal Failure Associated Liver Disease (IFALD) (Press)
• Palladio Biosciences Announces Dosing of First Patients with Lixivaptan in ELiSA, a Phase 2 Clinical Study in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) (Press)
• Trinity Partners Announces Findings from FDA-Approved Drug Performance Index (Press)
• Ayala Pharmaceuticals Announces First Patient Enrolled in Phase 2 Study of Lead Product Candidate AL101 for Adenoid Cystic Carcinoma with Notch Activated Mutations (Press)
• Lexicon pain drug advances after clearing early clinical test (Fierce)
• Idorsia's selatogrel hits goals in phase 2 cardiovascular trials (Fierce)

• Medical device industry regulation is changing: What you need to know (Medical Design & Outsourcing)
• Bill Of The Month: $43,208 For Repeat Surgery To Replace Broken Medical Device (NPR)
• How Boston Scientific Reinvented Itself in 2018 (MDDI)
• FDA clears EhmetDX’s 3D CBCT positioning software (MassDevice)
• Investigators hit pause on trials following concerns over paclitaxel-coated devices (Drug Delivery)
• Apollo Endosurgery deals Lap-Band to ReShape Lifesciences for up to $17m (MassDevice)
• Inspire Medical Systems closes $75m offering (MassDevice)
• Merit Medical puts $60m on the table for Vascular Insights (MassDevice)
• Cardiva Medical Announces FDA Approval of the VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure Following Electrophysiology Procedures (Press)
• Aortica touts FDA clearance to use Medtronic’s Valiant Navion in AAA IDE study (MassDevice)
• Pulse Biosciences closes $45m round (MassDevice)

• Insights On Right To Try Act And 'Expanded Access' Concerns (Law360-$)
• Coming Soon: FDA Over-The-Counter Drug Approval Overhaul (Law360-$)
• Issue of First Impression – You Can’t Redirect Remand (Drug & Device Law)
• National Academies of Sciences Releases Report on Science of Patient Input, Citing Input from HP&M’s James Valentine (FDA Law Blog)
• 'Bad drug' lawsuit ads hurt doc-patient relationships and need regulation, says industry coalition (Fierce)
• Why Regulation Alone May Not Solve For Unsafe Supplements In The Supply Chain (Forbes)

• FDA Advisory Committee Calendar

• Russia to organize 10 state tenders for drugs against orphan diseases (PharmaLetter-$)
• Emollients: new information about risk of severe and fatal burns with paraffin-containing and paraffin-free emollients (MHRA)
• Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetes (MHRA)
• Hydrocortisone muco-adhesive buccal tablets: should not be used off-label for adrenal insufficiency in children due to serious risks (MHRA)

• Glenmark Pharma gets USFDA nod for ear drops (Economic Times)
• Free pharma samples come under GST lens (Economic Times)
• Madras HC bars e-sale of drugs from Thursday (Economic Times)

• Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance (TGA)
• Medicines Safety Update, Volume 9, Number 4, December 2018 (TGA)