Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017)

Posted 07 November 2017 | By Michael Mezher 

Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017)

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

In Focus: US

  • Lawmakers defend 'unprecedented' Pentagon health panel, which could undermine FDA (Politico) (Endpoints) (The Hill)
  • Mylan's EpiPen sales plummet as pricing scandal bites back (Fierce)
  • Sen. Harris Investigates How Drugmaker Alkermes Pushed Its Opioid-Addiction Treatment (Bloomberg) (Endpoints) (STAT) (The Hill)
  • FDA Approves Roche's Zelboraf to Treat Rare Blood Cancer (Pharmafile) (Reuters) (Press) (FDA)
  • Roche's Alecensa wins wider US approval for lung cancer (PharmaTimes) (Reuters) (Press)
  • US government approves 'killer' mosquitoes to fight disease (Nature)
  • Six Ways Amazon Could Invade the Pharmacy Business (Bloomberg)
  • Jefferies slashes its CVS Health price forecast on Amazon competition risk (CNBC)
  • Voters Confused By Ohio's Ballot Question On Drug Prices (NPR)
  • The Republicans behind Ohio's drug pricing ballot measure (Politico)
  • Kentucky accuses Endo of contributing to opioid epidemic (Reuters)
  • FDA lifts hold on Cellectis' CAR-T trial, adds go-slow caveat (Fierce) (Xconomy) (GEN) (Endpoints) (Press)
  • Big Pharma a Big Winner in Trump's Proposed Tax Plan (Public Citizen)
  • Living Medicines With Curative Intent: Small N's Go Viral (LifeSciVC)
  • For Patients With Heart Failure, Little Guidance as Death Nears (NYTimes)
  • A Quest: Insulin-Releasing Implant For Type-1 Diabetes (NPR)
  • Senators Introduce Bill to Create Public Health Infrastructure to Combat Alzheimer's (Senate Aging)

In Focus: International

  • EMA gets ready for relocation decision (EMA)
  • Brexit with no deal risks chaos in drug supply, report warns (Reuters)
  • Takeda takes on Sanofi with new global dengue vaccine data (Reuters) (Endpoints)
  • China FDA Expands List of Higher-Risk Devices Exempt from Clinical Trial Requirements (Emergo)
  • Roche job cuts mount to 365 as drugmaker rethinks packaging (Fierce) (BioPharma-Reporter)
  • China's Creat suffers setback in Biotest deal on US scrutiny (Reuters)
  • WHO calls for restrictions on use of antibiotics in food animal production (STAT) (WHO)
  • Mallinckrodt slumps as Achtar drug sales disappoint (Reuters)
  • Takeda, Portal Instruments ink $100m deal to combine biologics and needle-free drug delivery (Drug Delivery)
  • Fitch downgrades Teva to junk, citing 'operational stress' (Financial Times)
  • Valeant jumps as contact lens unit helps deliver earnings beat (Financial Times) (CNBC)
  • China's EOC raises $32M to build on crop of harvested cancer drugs (Fierce) (Endpoints)
  • Japanese CMO Fujifilm Diosynth spends extra $28M in US, UK mAb facilities (Endpoints)
  • Summit of Heads of Medicines Regulatory Agencies Symposium Presentations (PMDA)
  • IPEC-Americas and IPEC Europe Publish Co-Processed Excipient Guide for Excipient Makers and Users (IPEC)

Pharmaceuticals & Biotechnology

  • IQVIA is the new Quintiles and IMS Health (Endpoints) (Press)
  • C&EN's 10 Startups to Watch (C&EN)
  • Top 7 tech hurdles to human germline CRISPR (The Niche)
  • Could You Be Allergic to Additives in Food or Drugs? (NYTimes)
  • Mylan Insists Complex Generics Strategy Is Poised To Deliver (SCRIP-$)
  • The Dilemma of Two Innovative Therapies for Spinal Muscular Atrophy (NEJM)
  • Single-Dose Gene-Replacement Therapy for Spinal Muscular Atrophy (NEJM)
  • Nusinersen versus Sham Control in Infantile-Onset Spinal Muscular Atrophy (NEJM)
  • Tezacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del (NEJM)
  • Phase III data will support Otsuka's FDA resubmission (PharmaLetter)
  • J&J's next potential frontier for Stelara? Lupus, thanks to positive phase 2 data (Fierce)
  • The future of drug discovery? New tech, a focus on human biology, and partnerships, says Charles River (Outsourcing Pharma)
  • FDA Study: Continuing Education Programs Can Meet REMS Requirements (FDANews-$)
  • Right to Know: Why the FDA Should Not Be Cut Out of Expanded Access Requests (Health Care Blog)
  • Higher brain glucose levels may mean more severe Alzheimer's (NIH)
  • Versant, NEA help fund eye disease biotech Oyster Point (Fierce) (Endpoints)
  • In conversation with: Jeremy Levin, CEO of Ovid Therapeutics (Fierce)
  • After a strong few years, Aimmune CEO Dilly to step down in 2018 (Fierce)
  • Haemonetics to cut 11% of workforce (MassDevice)
  • Could AstraZeneca's ovarian cancer drug also treat glioblastoma? (Fierce)
  • ACE Inhibitors and Statins in Adolescents with Type 1 Diabetes (NEJM)
  • Tolvaptan and Autosomal Dominant Polycystic Kidney Disease (NEJM)
  • Targeting the roots of Sjögren's syndrome (Novartis)
  • FDA Announces Withdrawal of Draft Guidance for Industry #230 Regarding Animal Drug Compounding (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Alnylam Initiates ENVISION Phase 3 Clinical Study with Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (AHPs) (Press)
  • Novartis' Cosentyx shown to inhibit joint damage in PsA (PharmaTimes)
  • NanOlogy™ Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Mucinous Cysts of the Pancreas (Press)
  • Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Press)
  • FDA Issues 483 to Texas Compounder (FDA)
  • Bedford Pharmacy Responds to FDA 483 (FDA)

Medical Devices

  • PMA Monthly approvals from 10/1/2017 to 10/31/2017 (FDA)
  • FDA clears common blood cell count test that offers faster results for patients and providers (FDA)
  • Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action - Incorrect Artwork on Packaging (FDA)
  • Boston Scientific recalls certain sizes of Eluvia, Innova stents  (Drug Delivery)
  • Three Steps Toward a Successful Clinical Trial for a Combination Product (MDDI)
  • Spotlight – Luck, strategy and FDA device approvals (EP Vantage)
  • J&J's Ethicon wins $39m DoD contract for surgical supplies (MassDevice)
  • Mazor Robotics crushes expectations with Q3 results (MassDevice)
  • Grifols wins FDA nod for fibrin sealant (MassDevice)
  • Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels that Feed Cancer (Press)
  • Axonics® Receives IDE Clearance from U.S. FDA to Conduct a Pivotal Study with its Sacral Neuromodulation System for the Treatment of Urinary Dysfunction (Press)
  • Cerus Corporation Receives IDE Approval to Initiate Phase III ReCePI Study (Press)

US: Assorted & Government

  • ACA sign-ups spike at open enrollment's start (Washington Post) (CBS)
  • Insurers step up pitch for Obamacare as government slashes its effort (Reuters)
  • Rx Opioids: Medicare Needs to Expand Oversight Efforts to Reduce the Risk of Harm (GAO)
  • Owner of Florida Pharmacy Pleads Guilty in $100 Million Compounding Pharmacy Fraud Scheme; Real Properties, Cars and a 50-Foot Boat Will Be Forfeited (DoJ)
  • Employer Pharmacy Benefits in 2017: More Cost-Shifting to Patients As Tiers and Coinsurance Expand (Drug Channels)
  • FTC Releases FY 2015 Staff Report on Drug Patent Settlement Agreements; Competitive DRUGS Act of 2017 Introduced in House (FDA Law Blog)
  • PTAB Life Sciences Report (Patent Docs)
  • Turning A Lemon Into Lemonade (Drug & Device Law)

Upcoming Meetings & Events


  • Redx restarts trading on return from administration (Financial Times)
  • EU's Innovative Medical Technology and EMA's Measures (EMA)
  • SME Office Newsletter (EMA)
  • Medtronic wins CE Mark for Intellis SCS, PNS systems (MasDevice) (MDDI)


  • Japan clears Abbott's Mitraclip (MassDevice)
  • Data from Phase III study to support 2018 filing for Edirol in China (PharmaLetter)


  • Lupin gets warning letter from USFDA for Goa, Indore units (Economic Times)
  • Pfizer gets favourable ruling from DoP on refixing ceiling price of Oxytocin injection 10IU/ml (PharmaBiz)
  • Intermediates the answer to China API dependence, says Indian export delegate (InPharma)


  • One Drop launches its diabetes tech in Canada after regulatory nod (Drug Delivery)


  • Infant/Child reduced energy defibrillation electrodes (TGA)

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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