Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Lexicon's Xermelo; GRAIL Raises $900M to Develop Cancer Tests (1 Marc

Regulatory Recon: FDA Approves Lexicon's Xermelo GRAIL Raises $900M to Develop Cancer Tests (1 March 2017)

Posted 01 March 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Lexicon's Xermelo GRAIL Raises $900M to Develop Cancer Tests (1 March 2017)

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

In Focus: US

  • Trump Criticizes 'Slow and Burdensome' FDA Approval Process (Focus) (STAT) (Fierce)
  • 'Burdensome' FDA Drug Approval Process Fuels Innovation, Saves Lives (Forbes)
  • Former FDA Commissioners Califf, McClellan Talk Healthcare's Future (Xconomy)
  • A patient with a rare disease will get a private meeting with Trump (STAT)
  • Why the Trump Agenda is Moving Slowly: The Republicans' Wonk Gap (NYTimes)
  • Democrats Revive Canada Drug Import Bill as Safety Questions Linger (Focus)
  • The Future of Precision Medicine: Great Promise, Significant Challenges (Health Affairs Blog)
  • Median cost per patient for orphan drugs is 5.5 times higher, report says (PharmaLetter-$)
  • FDA Approves Lexicon's Xermelo for Carcinoid Syndrome Diarrhea (FDA) (BioCentury) (Reuters) (Press)
  • Genentech v. Amgen: Amgen Seeks Dismissal Under Amgen v. Sandoz (Big Molecule Watch)
  • Longer survival seen with Amgen's Kyprolis vs Velcade in myeloma study (Reuters)
  • Sarepta's Exondys 51 Guidance Well Below Expectations (BioCentury)
  • Ten Years On, FDA Still Has Not Eased The Medical Device Reporting Regulatory Burden As Directed by Congress  (FDA Law Blog)
  • AdvaMed wants HMS to change kickback rules for value-based healthcare (MassDevice) (AdvaMed)
  • Instead Of Trashing A $600 EpiPen, Some Patients Get A Refill (KHN)
  • FDA asks Titan for more info before clinical trial of ropinirole implant (Drug Delivery) (Reuters)
  • Trump's Plan To Sell Insurance Across State Lines Doesn't Mean Lower Costs (Forbes)
  • GOP Divide Widens On Obamacare Repeal (Forbes) (Politico) (NYTimes)
  • Health Care is Front and Center in Democrats' Response to Trump Address (NYTimes)
  • Trump gives nod to Republican tax-credit proposal on Obamacare (Reuters)
  • Obamacare plans' drug spending rose faster than other plans in 2016: Express Scripts (Reuters)
  • GRAIL Raises $900M to Develop Early Blood Tests for Cancer (GEN) (Press)
  • In liquid biopsy race, Freenome lands $65 million, led by Andreessen Horowitz (TechCrunch)

In Focus: International

  • WHO Releases Draft Update of Stability Testing Guidelines (FDANews-$)
  • Hepatitis C drugs re-energize global fight over patents (Nature)
  • Amicus kicks off launch of Galafold in the UK (PharmaTimes) (PharmaLetter-$)
  • Novartis cancer division races to catch up with rivals (Reuters)
  • Japan next target for Novo Nordisk in semaglutide submissions (PharmaLetter-$)
  • NICE knocks back MSD's Keytruda for lung cancer indication (Pharmafile) (PharmaLetter-$) (BioCentury) (Reuters)
  • EFPIA Japan to Compile Policy Proposal on Pricing Reform by Early April: New Chair (PharmaJapanWeb)
  • WHO stresses urgent need for R&D for drug-resistant TB alongside newly-prioritized antibiotic-resistant pathogens (WHO)
  • EC Unveils Revised Guideline on Pharmaceutical Excipients (Focus)
  • EMA Fees to Rise Beginning on 1 April (Focus)
  • Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (Focus)
  • Bayer sells 11 percent of Covestro for 1.46 billion euros (Reuters) (Press)
  • South African launch for breast cancer drug Halaven (PharmaLetter-$)
  • Stada opens its books to private equity bidders (Financial Times)
  • Valeant shares drop 14% as drugmaker cuts guidance (Financial Times) (WSJ)
  • Perrigo slashes 750 jobs, bids farewell to CFO and rolls out ghastly guidance (Fierce)
  • Pharmaceutical industry and patient group collaboration 'absolutely appropriate' (ABPI)
  • New project: success and failure in the development and commercialisation of ATMP products (EFPIA)
  • Malaysia Device Registration: Classify Before You Register (Pacific Bridge Medical)

US: Pharmaceuticals & Biotechnology

  • Novo Nordisk's Head of North America resigns (Pharmafile)
  • FDA Finally Addresses Interchangeable Biosimilars (Law360-$)
  • Why Biosimilar Drug Names Contain Unhelpful Gibberish (Forbes)
  • BioMarin building CA plant to support Factor VIII gene therapy candidate (BioPharmaReporter)
  • PhRMA Sets In Motion Massive Campaign Launching New Era In Medicine (Forbes)
  • Complying With Expanded Access Policy Drug Laws (Law360-$)
  • First Generic Approvals Decline For Fourth Straight Year At US FDA (Pink Sheet-$)
  • Good Review Practices MaPP Recertification (Lachman Consultants)
  • Why drug importation threatens patient safety (PhRMA)
  • CDC review finds acceptable air quality supplied by air hoses in laboratories (CDC)
  • Former Teva CEO leads 'field of dreams' strategy at Ovid Therapeutics (PharmaLetter-$)
  • Asthma drugs may have alternative function as pneumonia treatment (Pharmafile)
  • Promising anti-cocaine treatment aims for human trials within a year (Pharmafile)
  • Bio CDMO space: Fujifilm looking to challenge Lonza and B-I (BioPharmaReporter) (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Sangamo Therapeutics Receives Orphan Drug Designation from the FDA for SB-913 Genome Editing Treatment for MPS II (Press)
  • Exelixis links with BMS to test potential cancer combo (PharmaTimes)
  • Serelaxin as a potential treatment for renal dysfunction in cirrhosis: Preclinical evaluation and results of a randomized phase 2 trial (PLOS)
  • Aerie Pharmaceuticals Announces Resubmission of NDA for RhopressaTM (netarsudil ophthalmic solution) 0.02% (Press)
  • Celgene, Agios gain FDA speedy review for AML med enasidenib (Fierce) (Press)
  • Lilly to Present New Data for Taltz (ixekizumab) in Psoriasis and Psoriatic Arthritis at the American Academy of Dermatology (AAD) Annual Meeting (Press)
  • Perrigo Announces FDA Final Approval For The Generic Version Of Axiron Topical Solution, 30 mg/1.5 mL (Press)
  • Viamet Announces RENOVATE Phase 2b Onychomycosis Results to be Presented at the American Academy of Dermatology 2017 Annual Meeting (Press)
  • New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name (FDA)

US: Medical Devices

  • Q&A: Labceutics' Jordan Clark on Industry, FDA Gap on Rx/Dx Codevelopment Principles (GenomeWeb)
  • 5 mistakes found in cloud-connected medical devices (MassDevice)
  • CeloNova Biosciences Receives FDA Approval of COBRA PzF™ Stent System (Press)
  • Elixir Medical's DeSyne stent tops Medtronic's Endeavor after 5 years (Drug Delivery)
  • Surgical Nav group Scopis wins FDA, Health Canada nod for ENT nav system (MassDevice)
  • Insulet slides on Q4 earnings miss (MassDevice)
  • Integer Holdings shares dip on Q4 (MassDevice)
  • Globus shares dip on mixed-bag Q4, FY2016 earnings (MassDevice)
  • Gamida Cell touts first patient treated in Phase III NiCord trial (MassDevice)

US: Assorted & Government

  • Pfizer Sues Ex-Marketing Director Over Trade Secret Theft (Law360-$)
  • President Trump And I Take The Same Drugs — Except One (KHN)
  • Open Science Prize announces epidemic tracking tool as grand prize winner (NIH)
  • Moderate Dems send letter pleading with Trump: "we implore you to begin focusing" (Vox)
  • How The Courts Review Executive Orders (Law360-$)
  • The trials and tribulations of pharmaceutical IP management (Law360-$)
  • Litigation Tourism Ended In Missouri (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Explanatory note
  • Clinical Trial on medicinal products ‐ Vigilance Data Reporting (ANSM)
  • Alnylam Receives European Medicines Agency PRIME Designation for Accelerated Assessment of Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (Press)
  • Licensing procedure for electronic cigarettes and other nicotine-containing products (NCPs) as medicines (MHRA)

Asia

  • WuXi AppTec Lab Testing Division's Bioanalytical Service Unit Passed FDA Inspection (Press)
  • China Struggling to Sustain Digital Health Initiatives (Medpage)
  • As H.I.V. Soars in Philippines, Conservatives Kill School Condom Plan (NYTimes)

India

  • Sanofi, Boehringer Ingelheim close business swap in India (Economic Times)
  • CDSCO Issues Notice on Phase IV Studies for Fixed-Dose Combiantion Drugs (CDSCO)
  • NPPA to look into diabetes drug price-fixing allegations (Economic Times)
  • MicroPort, undaunted by price caps, enters India's stent market (MassDevice)
  • Pharma heads say no compromise on quality in Indian mfg plants in response to US FDA concerns (PharmaBiz)
  • Maha FDA orders hospital pharmacies without pharmacists in Wardha, Nagpur to shut (PharmaBiz)
  • Health ministry revokes ban on drug letrozole, for induction of ovulation in anovulatory infertility (PharmaBiz)
  • Lupin launches cream in US to treat skin inflammation (Economic Times)
  • India issues fresh antibiotic guidelines to tackle superbug menace (Economic Times)

Australia

  • Medical Devices Safety Update, Volume 5, Number 2, March 2017 (TGA)

Canada

  • Acerus Files a New Drug Submission for GYNOFLOR™ in Canada (Press)
  • Elekta wins Health Canada nod for Leksell Gamma Knife Icon SRS system (MassDevice)
  • Regulatory decision summary for CUVITRU (Health Canada)

Other International

  • WHO says bird flu outbreaks raise alarm, but human risks still low (Reuters) (STAT)
  • The potential benefit of scaling up malaria prevention to reduce low birth weight in Africa (PLOS) (Study)
  • Hope for HIV control in southern Africa: The continued quest for a vaccine (PLOS)

General Health & Other Interesting Articles

  • Colon and Rectal Cancers Rising in Young People (NYTimes)
  • Renewing PLOS Medicine's editorial board in times of global distraction (PLOS)
  • Youth with type 2 diabetes develop complications more often than type 1 peers (NIH)
  • Breast cancer costs low-income women more jobs (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 news@raps.org.

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


Categories: Recon, Regulatory News

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