Regulatory Focus™ > News Articles > 11 > Recon: Moderna Seeks $500M IPO; China Proposes New Laws for Vaccine Management

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

Posted 12 November 2018 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
 
Sponsored Content: RCRI – Regulatory & Clinical
 
FDA is maintaining scrutiny of in vitro diagnostic and genetic tests. Earlier this month, the FDA issued safety communications related to genetic tests and direct to consumer diagnostics. While the in vitro diagnostics field is a rapidly evolving science, the FDA is working hard to stay on top of the primary safety concerns. The safety alerts were provided to help educate the public on FDA’s role in regulating these products and describing the potential limitations.
 
In Focus: International
  • 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 $33M cancer vaccine play at Switzerland’s AMAL Therapeutics (Endpoints) (Fierce)
Pharmaceuticals & Biotechnology
  • Pharmaceutical Warnings: A Changing Landscape (Law360-$)
  • 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 $70M to trial solid tumor T-cell engagers (Fierce)
  • Generic arthritis drug comes up short against inflammation in heart disease (STAT)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Acucela Initiates Phase 3 Study of Emixustat Addressing Patients with Stargardt Disease (Press)
  • Priority review for AZ/MSD’s Lynparza in first-line maintenance setting (PharmaTimes) (Press)
  • Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation (Press)
  • Generon Receives Investigative New Drug (IND) Approval from China SFDA for A-319 to Treat Patients with B Cell Malignancies (Press)
  • Concert Pharmaceuticals Reports Positive CTP-543 Results from Interim Analysis of Phase 2a Trial in Patients with Alopecia Areata (Press)
  • Ophthotech Announces Results from Phase 2a Safety Trial of Zimura® in Combination with Lucentis® in Wet Age-Related Macular Degeneration (Press)
  • Transgene - Positive Results from Phase 1 Clinical Trial of TG1050 in Chronic Hepatitis B Presented at the AASLD Liver Meeting 2018 (Press)
  • Bristol-Myers and Pfizer present real-world data for Eliquis at AHA meeting (PharmaLetter-$)
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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 $25.5 million after denying cancer treatment (Modern Healthcare)
  • Biomaterials Access for the 21st Century (Drug & Device Law)
  • FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling Regulations (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Mitomycin-C Kyowa: Company-led Drug Alert (MHRA)
  • Committee for Medicinal Products for Human Use (CHMP): 12-15 November 2018 (EMA) (Draft Agenda)
  • AstraZeneca wants Lynparza re-classified after NICE snub (PharmaLetter-$)
Asia
  • Eisai launches Lenvima in China (PharmaLetter-$)
  • 7 EFPIA Companies Revised R&D Strategies after April Pricing Overhaul: Survey (PharmaJapan)
India
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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