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Recon: FDA Approves Vertex's CF Combo Symdeko

Posted 13 February 2018 | By Michael Mezher 

Recon: FDA Approves Vertex's CF Combo Symdeko

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Novartis gains US approval for delayed MS drug (Reuters) (Press)
  • On a roll, Vertex grabs FDA OK for CF double shot Symdeko — prices at $292,000 (Endpoints) (PharmaTimes) (Press)
  • He Took a Drug to Prevent AIDS. Then He Couldn't Get Disability Insurance. (NYTimes)
  • Pharma Gets the Worst of Both Drug-Pricing Worlds (Bloomberg) (Politico)
  • The Uniquely American Problem Of High Prescription Drug Costs (KHN)
  • Trump FY 2019 Budget Calls for 180-Day Exclusivity Changes for Generic Drugs (Focus) (Politico) (KHN)
  • New year, new tax rates. How did the world's biggest drugmakers fare? (Endpoints)
  • France's Cellectis wins US patents for gene editing technology (Reuters)
  • Bavarian Nordic CEO Says Likely To Sell Imvamune Priority Review Voucher (SCRIP-$)
  • Opioid makers paid millions to advocacy groups: Senate report (Reuters) (STAT) (NPR) (CFPI) (Report)
  • Cost Of US Opioid Epidemic Since 2001 Is $1 Trillion And Climbing (NPR)
  • Protecting Trade Secrets Disclosed To The FDA (Law360-$)
  • Amazon's Latest Ambition: To Be a Major Hospital Supplier (WSJ)
  • Walgreens Boots Alliance in talks to buy AmerisourceBergen (Financial Times) (Forbes)
  • $100B in NIH-funded research played an important role in all 210 new drugs approved over 7 years (Endpoints) (STAT) (Study)

In Focus: International

  • Bayer's Eylea Wins First Regulatory Approval In China (Reuters)
  • Drug copies ready to take next bite out of Roche's cancer sales (Reuters)
  • Scotland endorses five new therapies for NHS use (PharmaTimes)
  • Plaque psoriasis patients to get NHS access to LEO's Kyntheum (PharmaTimes)
  • NICE deems Batten disease therapy too costly for NHS use (PharmaTimes)
  • Sun Pharma hit with another fire at an Indian plant (InPharmaTechnologist)
  • UK initiative seeks Israeli digital health tech to assist NHS (Reuters)
  • India cuts stent prices by more than 7 percent (Reuters)
  • Sanofi bets on India with portfolio of drugs for diabetes, rare diseases (Economic Times)
  • Can we create a pandemic-free world? (WHO)
  • WHO moves to contain Nigeria's Lassa fever outbreak (WHO)

Pharmaceuticals & Biotechnology

  • Can gene therapy be harnessed to fight AIDS? (STAT)
  • KRAS Targeted Cancer Strategy Shows Early Promise (NIH)
  • Scientists Unearth Hope for New Antibiotics (WSJ)
  • Will Big Drugmakers Mimic Purdue On Opioid Marketing? (Law360-$)
  • AI startup BioXcel Therapeutics shoots for $69M IPO with drugs for Alzheimer's, cancer (Endpoints)
  • Charles River bags a rival CRO player in $800M MPI Research buyout (Endpoints)
  • Briefing Information for the February 14, 2018 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) (FDA)
  • FDA's Strategic Policy Roadmap – Part 2 Addressing Addiction (Eye on FDA)
  • FDA Proposes to Require Electronic Submission of Certain Postmarketing Safety Reports for Approved New Animal Drugs (FDA)
  • What Gilead taught pharma about pricing a cure (BioPharmaDive)
  • Prescription Opioid Use Tied to Higher Pneumonia Risk (Medpage)
  • Teva planned for second generic Copaxone to enter market in 2018 (Reuters)
  • Novartis pushes past manufacturing slowdown to launch second long-acting Copaxone copy (Fierce)
  • Denali signs Lonza to make biologics in first CMO deal (Outsourcing Pharma)
  • Cytobank and the FDA Collaborate to Improve Immunotherapy Development (Press)
  • At US Generic Association Annual Meeting, Worries About Sustainability (Pink Sheet-$)
  • Not Your Typical Response: Oxycodone Sponsor Seeks FDA Hearing On Complete Response Letter (Pink Sheet-$)
  • Staying on Track for Drug Safety (PharmaManufacturing)
  • Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction (FDA)
  • Proposal To Refuse To Approve a New Drug Application for Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity for a Hearing (FDA)
  • Mallinkrodt Pharmaceuticals LLC; Withdrawal of Approval of an Abbreviated New Drug Application for PEMOLINE Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Eli Lilly touts PhIII success for Taltz as rival Novartis stays well out front in crowded immunology race (Endpoints) (Press)
  • Kadmon Announces Positive Topline Results from Phase 2 Study of KD025 in Idiopathic Pulmonary Fibrosis (Press)
  • Chi-Med Completes Enrollment of 527 Patients in Pivotal Phase III FALUCA Trial with Fruquintinib in Lung Cancer (Press)
  • Imara Doses First Patient in Phase 2a Clinical Trial of IMR-687 for Sickle Cell Disease (Press)

Medical Devices

  • Risky tactic, desperate need: Trial to test brain implants for opioid addiction (STAT)
  • NantHealth Submits GPS Cancer Test to FDA, Debuts AI Platform for Tumor ID (GenomeWeb)
  • Canon Medical wins FDA nod for Vantage Galan 3T XGO MRI (MassDevice)
  • How One Top Hospital Is Using Virtual Reality (MDDI)

US: Assorted & Government

  • With a pharma exec running, New Jersey's Senate race becomes a referendum on drug prices (STAT) (Endpoints)
  • Legal Challenges to State Drug Pricing Laws (JAMA)
  • Will FTC Shakeup Impact Pharma? (Pink Sheet-$)
  • E.D. Wash. Rejects Successor Liability in Hip Implant Case (Drug & Device Law)
  • S.2406 - A bill to advance cutting-edge research initiatives of the National Institutes of Health. (Congress)

Upcoming Meetings & Events


  • CAT work plan (EMA)
  • Veterinary medicines: highlights of 2017 (EMA)
  • European Medical Device Regulation: The Compliance Advantage (MDDI)
  • Public can expect 'gold standard' protection against flu next year (NHS England)


  • Malvinder, Shivinder Singh move Supreme Court to challenge High Court ruling in favour of Daiichi Sankyo (Economic Times)


  • Passing of Australia's PBS Amendment Bill welcomed by trade group (PharmaLetter-$)

General Health & Other Interesting Articles

  • Meth, the Forgotten Killer, Is Back. And It's Everywhere. (NYTimes)
  • US progress against sleep-related infant deaths is stalling (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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