Regulatory Recon: NICE Expands Access to Strensiq Stada Execs Step Down as Bain, Cinven Prepare New Bid (5 July 2017)

Posted 05 July 2017 | By Michael Mezher 

Regulatory Recon: NICE Expands Access to Strensiq Stada Execs Step Down as Bain, Cinven Prepare New Bid (5 July 2017)

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

In Focus: US

  • What Has Been Driving Up Costs of Prescription Drugs? (Medpage)
  • A judge orders Martin Shkreli to zip it — after Twitter shuts down his latest online account (Endpoints)
  • Bristol-Myers' tarnished checkpoint star Opdivo beats out Yervoy in surprise PhIII (Endpoints) (Press)
  • Is FDA Too Slow? Researchers Debunk Claims (Focus)
  • In latest setback, another Coherus partner bails out on Amgen biosimilar deal (Endpoints)
  • Congress Moves to Stop IRS From Enforcing Health Law Mandate (NYTimes)
  • Scientists Are Not So Hot At Predicting Which Cancer Studies Will Succeed (NPR)
  • FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy (FDA)
  • AstraZeneca generates $600 million from just two drug sales (Pharmafile)
  • Immunology, one cell at a time (Nature)
  • FDA's Unger On Exondys Approval As Precedent: 'We Hope Not' (Pink Sheet-$)
  • Drugmakers Urge FDA To Phase Out Older Opioids (Law360-$)
  • Drugmakers and distributors face barrage of lawsuits over opioid epidemic (Washington Post)
  • Louisiana considers radical step to counter high drug prices: Federal intervention (Washington Post)
  • Why Neurocrine is charging twice as much for its new drug as it said it would (MarketWatch)

In Focus: International

  • UK Ministers Say They Want to Work With EU on Medicines (Financial Times, Letter) (Focus) (Reuters) (ABPI) (Fierce) (The Guardian) (Pharmafile)
  • Drug agency relocation talks divide old and new EU members (EurActiv)
  • Why Big Pharma Is Targeting China's Deadliest Diseases (WSJ)
  • Europe's next big science-funding programme urged to double its budget (Nature)
  • UK medical chief vows to spread 'genetics dream' (Financial Times) (PharmaTimes)
  • Stada Executives Step Down as Bain and Cinven Eye Fresh Bid (Financial Times) (Pharmafile)
  • EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments (Focus)
  • Merck's Keytruda, Lilly's Lartruvo Available via CDF (PharmaTimes)
  • Drugmaker Shire Faces Blood and Guts Battles on Road to Growth (Reuters)
  • Australian class action suit filed against Johnson & Johnson over pelvic mesh (Reuters)
  • NICE broadens access to Alexion's rare disease drug Strensiq (PMLive) (Pharmafile)
  • NICE Rejects Imbruvica for Untreated Chronic Lymphocytic Leukaemia (NICE)
  • Director-General Dr Tedros takes the helm of WHO: address to WHO staff (WHO)
  • WHO Director-General Dr Tedros will lead WHO delegation at the G20 Summit in Hamburg (WHO)
  • ICH Assembly in Montreal, Canada (May/June 2017) (ICH)
  • Sun Pharmaceutical signs agreement with Samsung BioLogics for psoriasis drug (Economic Times) (Pharmafile)
  • Threat to HIV business spooks GlaxoSmithKline shares (Reuters)
  • Dutch Regulators Plan US FDA-based UDI Requirements for Medical Devices (Emergo)
  • Global Excipient and Drug Manufacturers Weigh Implications of China's New Excipient Dossier and "Bundling Review" Requirements (IPQ)

Pharmaceuticals & Biotechnology

  • Proper tools may help prevent medicine errors at home (Reuters)
  • FDA Panel To Review Intellipharmaceutics' Analgesic (BioCentury)
  • ICER to Work With VA on Drug Price Negotiations (Focus)
  • Allergan, Ironwood's Linzess takes home lone 2017 Effie pharma trophy (Fierce)
  • Janssen Highlights Value of Academic Collaboration in Move to Continuous Manufacturing (IPQ)
  • Delafloxacin, a New Quinolone, is Approved for Skin Infections — But That's Not Where It's Really Needed (NEJM Journal Watch)
  • Merck Foundation created and CEO set in place (Pharmafile)
  • Generic Drugs: First-Cycle Review Times Improve, But Hundreds Of ANDAs Still Pending (Pink Sheet-$)
  • Real world evidence and pharma (PharmaLetter-$)
  • Demystifying Artificial Intelligence For Biopharma (Pink Sheet-$)
  • Antibiotics Pipeline Is Lively, But Sponsors Are Fragile (SCRIP-$)
  • Continuous or batch? A quality question (InPharmaTechnologist)
  • Researchers boost existing antibiotic to tackle drug resistance (Pharmafile)
  • AmpliPhi Biosciences to Present at Bacteriophage Therapy Workshop Sponsored by the FDA and NIH (Press)
  • Amgen medical lead Philippe Legenne on the building blocks of biotech success (PharmaLetter-$)
  • ViraCyte Awarded $3.75M from NIH and FDA to Advance T Cell Immunotherapies (Press)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Array BioPharma Submits New Drug Applications To FDA For Binimetinib And Encorafenib In Advanced Melanoma (Press)
  • US Orphan status for Almac's ovarian cancer drug (PharmaTimes)
  • Cellectis Moves First Off-The-Shelf CAR-T Into US Clinical Trials (SCRIP-$)
  • FDA grants SOBI003 Orphan Drug Designation for the treatment of MPS IIIA (Press)
  • Zydus starts phase II trials of molecule targeting anaemia (Economic Times)

Medical Devices

  • Startling reversal of fortunes as large-cap medtechs soar (EP Vantage)
  • Philips picks up peripheral thrombectomy device maker CardioProlific (MassDevice)
  • DeviceTalks: Big data, virtual reality and the connected brain in medtech (MassDevice)
  • What is and what isn't working when it comes to cybersecurity (MedCityNews)
  • Medtronic's Micra leadless pacer passes space test (MassDevice)
  • Abiomed touts survival benefits in Impella 2.5 cardiogenic shock PCI treatment study (MassDevice)
  • Biotronik touts Pulsar-18 self expanding stent trial data (MassDevice)
  • Varian Medical wins FDA nod for Halcyon radiotherapy cancer treatment system (MassDevice)
  • Smith & Nephew inks wound care collab R&D deal with Univ. of Hull (MassDevice)
  • Edwards' INSPIRIS RESILIA Valve Receives FDA Approval (Press)

US: Assorted & Government

  • Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? "YES" . . . According to a New Bill in the U.S. Senate (FDA Law Blog)
  • New Mexico Wrongful Conduct Rule Shuts Down Opioid Case Against Pharmacist (Drug & Device Law)
  • US prosecutors ask judge to silence Shkreli during trial (Reuters)
  • 'Single-Payer' Healthcare Isn't Necessary -- But Single Pricing Is (Forbes)
  • Medtronic nearing resolution on Infuse suits (MassDevice)
  • J&J's McNeil Gets New Trial After $48M Motrin Reaction Loss (Law360-$)

Upcoming Meetings & Events


  • EU Updates Guidance On Safety Features For Drugs Under Falsified Medicines Directive (Pink Sheet-$)
  • Companies Get 19 EU Paediatric Extensions in 2016, But Many Firms Miss Trial Completion Deadlines (Pink Sheet-$)
  • New Ethical MedTech online portal: a commitment to trust and transparency (MedTechEurope)
  • Blood test by Britain's Angle detects ovarian cancer in study (Reuters) (PharmaTimes)
  • Dates of 2017 SAWP meetings and submission deadlines (EMA)
  • Nasal decongestant to be available to buy from pharmacies (MHRA)
  • Pioneering prostate biopsy device wins NIHR award (PharmaTimes)
  • Figures reflect pharma's role in R&D and training in Spain (PharmaLetter-$)
  • Development of non-substantially manipulated cell-based ATMPs: flexibility introduced via the application of the risk-based approach (EMA)
  • Russian pharma facing barriers abroad and at home (PharmaLetter-$)
  • PBL opens doors at UK bio-development centre (BioPharmaReporter)
  • Immediate-release formulation means fewer pills and more flexibility, says Roche (InPharmaTechnologist)


  • Indian pharma cos secure 138 ANDA approvals from US FDA during first half ended June 2017 (PharmaBiz)
  • Gloomier outlook for generics but Indian biotech more confident (PharmaLetter-$)
  • Plan to implement devices park at Gujarat under discussion at Inter-ministerial level (PharmaBiz)
  • Desi pharma companies need not fear Amazon in US (Economic Times)
  • Sun Evaluating Plant-Based Candidates To Treat Zika (SCRIP-$)
  • Lupin launches generic conjunctivitis treatment medicine in US (Economic Times)
  • Zydus Cadila's anti-diabetic drug gets USFDA marketing nod (Economic Times)
  • Sun Pharma inks $55.5-mn deal for anti-psoriasis drug (Economic Times)
  • Alembic gets tentative USFDA nod for erectile dysfunction drug (Economic Times)
  • Fortis promoters to reply to Daiichi Sankyo's contempt application (Economic Times)
  • NPPA fixes/revises ceiling prices/retail prices of 814 scheduled formulations subsequent to GST implementation (PharmaBiz)
  • Biocad expects Indian approval of rituximab biosimilar soon (PharmaLetter-$)
  • BSE Healthcare index remained under pressure in first half of 2017 (PharmaBiz)


  • CFDA Vice Minister Sun Xianze meets CEO of the GAVI Alliance (CFDA)
  • Daiichi Sankyo stops work on RA drug biosimilar for Japan (PharmaLetter-$)
  • Sinobioway Counters Sinovac Buyout Offer (BioCentury)
  • Sirnaomics Bets On RNAi In China With First IND Approval (SCRIP-$)
  • Ipsen wins MHLW approval for gastroenteropancreatic neuroendocrine tumor drug (Drug Delivery)
  • New combination therapy for type 2 diabetes approved in Japan (PharmaLetter-$)'
  • Olumiant gains marketing approval in Japan for RA (PharmaLetter-$)


  • New multiple myeloma therapies approved by Health Canada, but not being funded (PharmaLetter-$)
  • Did Free Trade with U.S. Undermine Canada's Public Health? (Medpage)
  • What is the DPD Data Extract? - Drug Product Database (DPD) Data Extract (Health Canada)
  • Abbott wins Health Canada nod for FreeStyle Libre glucose monitor (Health Canada)


  • Restoration of skilled occupation visas welcomed across Australian med/pharma sectors (PharmaLetter-$)
  • Cost recovery implementation statement (TGA)
  • Electronic signatures to replace 'wet ink' signatures (TGA)
  • Special access scheme rules (TGA)
  • Draft list of permitted indications (TGA)
  • Australia Announces A "Fairer" Orphan Drugs Program, With New Eligibility And Validity Criteria (Pink Sheet-$)

Other International

  • First generic magnesium injection prequalified (WHO)
  • Brazil's Anvisa Enjoys Industry Support Despite Regulatory Changes, Low Funding (Pink Sheet-$)
  • Emergency polio vaccinations considered in Raqqa following new report of paralysis (STAT)
  • Haiti could stem cholera epidemic by end 2018: health officials (Reuters)

General Health & Other Interesting Articles

  • Jurassic Park screening, featuring a conversation with George Church (Wyss Institute)
  • As new and lethal opioids flood U.S. streets, crime labs race to identify them (STAT)
  • Is Alcohol Good for You? An Industry-Backed Study Seeks Answers (NYTimes)
  • Shingles may up risk of heart attack, stroke (Reuters)
  • This wooden toe could be one of the oldest prosthetics in the world (Medical Design & Outsourcing)

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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