Recon: Pfizer, J&J Report Success in Prostate Cancer Trials; Array's Melanoma Combo Shows Survival Benefit Against Roche's Zelboraf

Posted 06 February 2018 | By Michael Mezher 

Recon: Pfizer, J&J Report Success in Prostate Cancer Trials; Array's Melanoma Combo Shows Survival Benefit Against Roche's Zelboraf

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

In Focus: US

  • Secret Discounts Kept Soaring Drug Bills Down, Says Middleman (Bloomberg) (CNBC)
  • Array melanoma drugs show significant survival versus Roche drug in study (Reuters) (Endpoints) (Press)
  • Pfizer's Xtandi delays prostate cancer spread in early stage disease (Reuters) (Press)
  • Pfizer vs J&J: Researchers are duking it out for the championship title in nonmetastatic prostate cancer (Endpoints) (Bloomberg) (Fierce) (BioCentury)
  • Allergan smashes earnings estimates, says a trial for its migraine drug succeeds (CNBC) (Reuters) (Endpoints)
  • More Questions Than Answers For Bristol-Myers (Forbes)
  • Looking to grow blockbuster Pomalyst franchise, Celgene declares a win for multiple myeloma triplet in pivotal PhIII (Endpoints) (Press)
  • A compromise 'right-to-try' bill proceeds with help from FDA, but could be a hard sell (STAT)
  • Johnson & Johnson falls on report that lawsuits could expose potentially damaging documents (CNBC)
  • The Endpoints 100: Biotech execs stampede into 2018 with a cheer for the FDA and bullish feelings on public markets, private investors and a 'hot' M&A future (Endpoints)
  • What's in the spending deal (for now) (Politico)
  • Kellyanne Conway's 'opioid cabinet' sidelines drug czar's experts (Politico)
  • Stephen Friend, a well-known health researcher, is out at Apple after less than two years (CNBC)

In Focus: International

  • NICE restricts NHS use of Roche's IPF drug Esbriet (PharmaTimes)
  • China's biotech industry is booming — without drawing the best and brightest 'sea turtles' from the US (STAT)
  • MSF takes Prevnar13 patent battle all the way to Korean Supreme Court (PharmaLetter-$)
  • Brazil's EMS and India's Torrent Pharma vying for Sanofi's generic drugs: sources (Reuters) (PharmaLetter-$)
  • EMA accepts filing for Epidiolex (PharmaLetter-$)
  • Two former Greek PMs implicated in Novartis bribery case (Pharmafile)
  • Desperate for help: prescription drug addicts turn to the web (The Guardian)
  • The winners and losers of the Swedish biotech industry IPO frenzy (Endpoints)
  • Chinese funds plow cash into British VC shops (Fierce)
  • Chinese upstart DL Medicine forges alliance with Pfizer (Fierce)
  • A biotech out of Oxford is developing a vaccine to fight every type of flu (CNBC)
  • At least 33 infected with HIV in India after 'quack' uses tainted syringe: police (Reuters)

Pharmaceuticals & Biotechnology

  • FDA Reviewers Share CMC, GMP Challenges In Last Year's Rush To Approve New Therapies (Pink Sheet-$)
  • Abbott teams up with Angle for metastatic breast cancer study (Pharmafile)
  • A new way of testing tumors may help match patients with cancer immunotherapies (STAT)
  • US FDA Joins Chorus Of Concerns About Results Of GAIN Act (Pink Sheet-$)
  • Academics' Open Letter Opposes Right-To-Try Bill (BioCentury)
  • Mumps booster and new shingles shot are part of new vaccine guidance (NBC)
  • FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders (National Law Review)
  • Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
  • Cities, counties ask Big Pharma to limit opioids production (CBS)
  • Lower-Quality Medical Tx Might Have Skewed Key PCI vs CABG Trials (Medpage)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Zogenix wins inside track at FDA with childhood epilepsy 'breakthrough' (Endpoints)
  • Roche hails another PhIII win on Tecentriq combo, reports promising kidney cancer data (Endpoints) (Press)
  • World-Recognized Experts Join Tenax Therapeutics' Scientific Advisory Board to Guide New Phase 2 Study (Press)

Medical Devices

  • Rapid flu tests only 50 to 70 percent accurate, CDC says (CBS)
  • Exploring the potential of digital therapeutics (McKinsey)
  • Sequencing Human Genome with Pocket-Sized "Nanopore" Device (NIH)
  • Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in Neurology (Press)
  • Compassionate use without an IDE (MassDevice)
  • Teleflex wins FDA nod for next-gen peripheral snares, launches in US (MassDevice)
  • InVivo Therapeutics lifts Toselli to permanent prez, CEO (MassDevice)
  • Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism (FDA)

US: Assorted & Government

  • As lawyers push to limit opioid production in legal deal, Sen. Sanders wants more from Congress (Fierce)
  • Preemption In Pharmaceutical Cases: 2017 In Review (Law360-$)
  • US Teva Worker Can Sue Co.'s Israeli Branch, Judge Says (Law360-$)
  • Long Overdue Generic Dismissal (Drug & Device Law)
  • PTAB Life Sciences Report (Patent Docs)

Upcoming Meetings & Events


  • Extraordinary Management Board meeting: 6 February 2018 (EMA)
  • MHRA expands use of Tillotts' Entocort (PharmaTimes)
  • Bayer Offers Commitments To EU For $63.5B Monsanto Buy (Law360-$)
  • Danish authority takes on CD Pharma for 2,000% 'unfair' price spike (OutsourcingPharma)
  • Human and veterinary medicines: register of licensed manufacturing sites (MHRA)
  • Does GDPR Regulate My Research Studies in the United States? (National Law Review)
  • UK experts urge smokers to switch to e-cigs for big health gains (Reuters) (PHE)
  • Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure (EMA)
  • European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure  (track changes) (EMA)


  • Indonesia declares Papua health crisis under control (Reuters)
  • GenDx Gets South Korean Clearance for HLA Typing Workflow (GenomeWeb)


  • Consumables now costlier than stents in angioplasty (Times of India)
  • Price cap on cardiac stents stifling innovation, harming patients: Manufacturers (Economic Times)


  • Consultation: Remaking of TGO No. 77 – Microbiological Standards for Medicines (TGA)
  • Autologous human platelet-rich plasma and conditioned serum(TGA)
  • Priority review pathway - First registration decision (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.

Categories: Recon

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles