Recon: Moderna Seeks $500M IPO; China Proposes New Laws for Vaccine Management

• Drug prices and IP rights to come up at review of NAFTA (Politico)
• Gottlieb: New drug approval criteria limited to opioids (Axios) (Pharmafile)
• Pharma's grip on the health care economy (Axios)
• Something Happened to US Drug Costs in the 1990s (NYTimes)
• Amarin's Fish-Oil-Derived Drug Shows Great Promise—With Big Caveats (Forbes) (STAT) (Endpoints)
• Did Rep. Chris Collins sell his biotech stock without telling Congress? (STAT)
• Moderna aims to raise $500M in biotech’s largest-ever public offering (STAT) (PMLive)
• Nestle raises stake in food allergy drug developer Aimmune (Reuters) (Endpoints)
• A peek at Congress' lame-duck to-do list (Politico) (Alliance for a Stronger FDA)
• Mylan and Theravance's COPD treatment gets FDA approval (Reuters) (Press)
• Sens. Seek White House Backing for Pay-For-Delay Drug Bill (Law360-$)
• New drug options, risk factors added to U.S. heart guidelines (Reuters) (WSJ)
• Protesters take anger over insulin prices to drug makers, some bearing children’s ashes (STAT)

• With the $62B Shire buyout on track, Takeda plans to debut the newly merged company at JPMorgan (Endpoints) (Financial Times)
• Takeda and Shire to pay almost $1bn in deal fees and expenses (Financial Times)
• Drug firms fear 'wasting' money for a Brexit no-deal outcome (BBC) (BioCentury) (Pharmafile)
• WHO uncovers big national variations in antibiotics consumption (Reuters)
• China proposes new laws on vaccine management (Reuters)
• In China, Desperate Patients Smuggle Drugs. Or Make Their Own. (NYTimes)
• Iranians Fear Medicine Shortages as U.S. Tightens Sanctions (NYTimes)
• AstraZeneca's diabetes drug curbs heart failure, kidney risks (Reuters) (Financial Times)
• Current Ebola outbreak is worst in Congo's history: ministry (Reuters)
• A pivotal day in world’s response to Ebola nears: the launch of a clinical trial (STAT)
• More Women in Poor Countries Use Contraception, Says Report (Bloomberg)
• Vertex and UK agencies are pressured to resolve long-running dispute over pricey cystic fibrosis drug (STAT)
• EU expands label of GSK/Innoviva’s COPD inhaler (PharmaTimes)
• Good News For Australian Sponsors Sourcing APIs From Canada (Pink Sheet-$)
• State Of Vaccine Confidence In The EU 2018 (EC)
• Boehringer backs $33M cancer vaccine play at Switzerland’s AMAL Therapeutics (Endpoints) (Fierce)

• Pharmaceutical Warnings: A Changing Landscape (Law360-$)
• Phage Therapy Could Save People's Lives When Antibiotics Stop Working (BuzzFeed)
• A Timeline of US Biosimilar Adalimumab Launch Dates (Center for Biosimilars)
• An expensive new medication is finally available for her rare disease — but she’s been fighting for two years to get it (Market Watch)
• Novartis builds blockbuster case for Entresto, beating out a cheap ACE inhibitor — or not (Endpoints)
• With drugs, how do we base their medical value vs. out-of-pocket cost? (Washington Post)
• FDA’s BLA Review Sheds Light on Evolution of Biotherapeutic Product Analytical Methods and Their Regulation (IPQ)
• MSD’s Keytruda approved for liver cancer (PharmaTimes)
• Australia is about to eradicate cervical cancer, US is nowhere close. What'll it take? (USA Today)
• U of Missouri becomes first to ship isotope for thyroid cancer in U.S. (Medical Design & Outsourcing)
• Gilead's search for the next great liver drug won't end with its FXR agonist (BioPharmaDive)
• OTC Primatene Mist Returns: Market Future Bright After Cloudy NDA History (Pink Sheet-$)
• 'Slow Money As Bad As No Money' – SMEs Struggle For Superbug Funds (SCRIP-$)
• FDA Opens Door To New Response Criteria For Cancer Immunotherapies (BioCentury)
• Sangamo Slides On Delayed Readout For Hemophilia A Gene Therapy (BioCentury)
• Patients on checkpoint inhibitors sometimes develop severe colitis. Could fecal transplants help? (STAT)
• ‘We ran out of money’: High-profile startup seeking to connect patients with clinical trials shuts down (STAT)
• Harpoon raises $70M to trial solid tumor T-cell engagers (Fierce)
• Generic arthritis drug comes up short against inflammation in heart disease (STAT)

• Acucela Initiates Phase 3 Study of Emixustat Addressing Patients with Stargardt Disease (Press)
• Priority review for AZ/MSD’s Lynparza in first-line maintenance setting (PharmaTimes) (Press)
• Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation (Press)
• Generon Receives Investigative New Drug (IND) Approval from China SFDA for A-319 to Treat Patients with B Cell Malignancies (Press)
• Concert Pharmaceuticals Reports Positive CTP-543 Results from Interim Analysis of Phase 2a Trial in Patients with Alopecia Areata (Press)
• Ophthotech Announces Results from Phase 2a Safety Trial of Zimura® in Combination with Lucentis® in Wet Age-Related Macular Degeneration (Press)
• Transgene - Positive Results from Phase 1 Clinical Trial of TG1050 in Chronic Hepatitis B Presented at the AASLD Liver Meeting 2018 (Press)
• Bristol-Myers and Pfizer present real-world data for Eliquis at AHA meeting (PharmaLetter-$)
• ODYSSEY OUTCOMES investigators highlight at AHA that Praluent® (alirocumab) Injection was associated with fewer deaths from any cause (Press)
• Xeris Pharmaceuticals Releases Additional Phase 3 Clinical Trial Data on Its Ready-to-Use Liquid Glucagon Pen (Press)
• Cardurion Pharmaceuticals Presents Preclinical Data for CRD-733 at the American Heart Association Scientific Sessions and Announces Initiation of Phase 1b Study in Patients with Heart Failure (Press)
• Arrowhead Pharmaceuticals Presents Late-Breaking Clinical Data on ARO-AAT at Liver Meeting® 2018 (Press)

• Ignored As An Election Issue, Deaths From Medical Errors Have Researchers Alarmed (Forbes)
• Pilot trial of Abiomed’s Impella as heart attack treatment meets endpoints, pivotal to follow (MassDevice)
• NuVasive wins FDA nod for Cohere XLIF implant components (MassDevice)

• FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse (FDA)
• FDA Plans to Seek a Ban on Menthol Cigarettes (NYTimes)
• Aetna to pay $25.5 million after denying cancer treatment (Modern Healthcare)
• Biomaterials Access for the 21st Century (Drug & Device Law)
• FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling Regulations (FDA Law Blog)

• FDA Advisory Committee Calendar
• Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI – 11 December 2018

• Mitomycin-C Kyowa: Company-led Drug Alert (MHRA)
• Committee for Medicinal Products for Human Use (CHMP): 12-15 November 2018 (EMA) (Draft Agenda)
• AstraZeneca wants Lynparza re-classified after NICE snub (PharmaLetter-$)

• Eisai launches Lenvima in China (PharmaLetter-$)
• 7 EFPIA Companies Revised R&D Strategies after April Pricing Overhaul: Survey (PharmaJapan)

• Lupin gets EIR from USFDA for its Nagpur facility (Economic Times)
• Zydus Cadila gets USFDA nod for anti-fungal ointment (Economic Times)
• Cipla gets USFDA nod for anti-viral eye infection drug for AIDS patients (Economic Times)