Regulatory Recon: David Hung Steps in as Axovant CEO; Stada to Support €4.1B Takeover Offer from Bain Capital and Cinven (10 April 2017)

Posted 10 April 2017 By Michael Mezher

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

In Focus: US

  • FDA Moving Biosimilar Substitution Guidance Forward Robustly (Bloomberg)
  • Critics worry faster FDA drug reviews could compromise safety (Boston Globe)
  • The Breakdown in Biomedical Research (WSJ)
  • Medivation Founder David Hung Becomes CEO Of Axovant Sciences (Forbes) (Endpoints) (Press)
  • Pharma investors put less skin in the game as risk appetite wanes (Financial Times)
  • Fresenius Says It's in Talks to Buy Generic Drugmaker Akorn (Bloomberg) (Pharmafile)
  • Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists (KHN)
  • Can SPRINT Be Used To Inform Hypertension Treatment? (CardioBrief)
  • How Washington's favorite cancer fighter helps himself (Politico)
  • FDA Delays eCTD Requirements for Master Files (Focus)
  • Scott Gottlieb's FDA Commissioner Confirmation Hearing: Remarkably Unremarkable (Health Affairs Blog)
  • Congress and FDA nominee heap love on 'adaptive trials' (Science)
  • Value-based payment finds friend in a high place (EP Vantage)
  • No 'Death Spiral': Insurers May Soon Profit From Obamacare Plans, Analysis Finds (NYTimes)
  • The Trump administration is ill-prepared for a global pandemic (Washington Post)
  • PhRMA And Trump: 'Go Boldly,' Or Tread Carefully? (Pink Sheet-$)
  • How Trump and the FDA Can Create a Pharmaceutical Manufacturing Renaissance (Modern Healthcare)
  • PRISM Identifies Vaccine Safety Issues (FDAVoice)
  • The Blame Game on Drug Prices Is Getting Dangerous (WSJ)
  • Drugs That Work In Mice Often Fail When Tried In People (NPR)
  • Giving Terminally Ill Patients the 'Right-to-Try'—Will it really help from a medical and ethical standpoint? (Medpage)

In Focus: International

  • Top 10 European MDR Questions (Emergo)
  • Bain and Cinven win €4.1bn bidding war for German drugmaker (Financial Times) (NYTimes)
  • Twenty-one countries vie to host EU drug agency after Brexit (Reuters)
  • Brexit: Scenario Planning Well Under Way At EMA (Pink Sheet-$)
  • Brazil Prepares To Make Its Own Sovaldi As Regulator Opposes Patent Application (Pink Sheet-$)
  • US FDA sounds alert on quality issues in Indian pharma (Business Standard)
  • EFPIA opinion on the Country Reports 2017 (EFPIA)
  • China Emerges as Powerhouse for Biotech Drugs (WSJ)
  • Chinese Investor Drops $1.4B For German Drugmaker (Law360-$)
  • Political and Ethical Dilemmas Facing Bio/Pharma Companies in a Global Marketplace (PharmTech)
  • Debt-laden Teva, looking for cash, weighs $2B women's health sale: report (Fierce)
  • CAR T-Cells, Helping US Firms & An "Ambitious" Plan For Advanced Therapies In The EU (Pink Sheet-$)
  • A Baby With 3 Genetic Parents Seems Healthy, But Questions Remain (NPR)

US: Pharmaceuticals & Biotechnology

  • Boehringer awaits Jardiance lift-off (EP Vantage)
  • The FDA is keeping its partial hold on Repros' Proellex (Endpoints)
  • How Many Pills Are Too Many? (NYTimes)
  • OncoMed sinks as cancer drug fails; Bayer opts against licensing drugs (Reuters)
  • RESPECT: find out what it means to ADCs, says Eisai subsidiary (BioPharmaReporter)
  • Enbrel's First Outcomes Contract Is With Harvard Pilgrim; Others May Follow (Pink Sheet-$)
  • Biohaven seeks IPO cash to fund trials of AZ, BMS castoffs (Fierce)
  • Final ICER report finds lack of evidence on RA drug value vs prices (PharmaLetter-$) (Pink Sheet-$)
  • Modern Drug Development (Policy & Medicine)
  • Google still scrambling for solutions after J&J, others depart YouTube advertising (Fierce)
  • Stem cells: Single-use bioreactors and microcarriers can overcome scale-up issues, experts (BioPharmaReporter)
  • Selling cell thawing: Medcision launches early adopter scheme to push tech (BioPharmaReporter)

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

  • Roche's Alecensa notches trial win against Pfizer's Xalkori (Reuters) (Press)
  • Medivir posts lymphoma data, guns to get into phase 3 (Fierce)
  • Phase III Study Shows Genentech's Alecensa Was Superior to Crizotinib in a Specific Type of Lung Cancer (Press)
  • Alexo Therapeutics Announces Initiation of Phase 1 Clinical Trial of ALX148 for the Treatment of Advanced Solid Tumors and Lymphoma (Press)
  • NantCell Announces FDA Grant of Orphan Drug Designation for the Company's Ganitumab Monoclonal Antibody Therapy in Ewing Sarcoma (Press)
  • Syros Announces FDA Acceptance of IND to Advance SY-1365, Its First-in-Class Selective CDK7 Inhibitor, into Phase 1 Clinical Trial in Patients with Advanced Solid Tumors (Press)
  • FDA Grants New Clearance for Verax PGD® Test for Individual WBD Platelet Units (Press)

US: Medical Devices

  • More prostate cancer patients get radiation when doctors own the equipment (Reuters)
  • Medical Device Compliance: Taking the Easier Literature Search Route (MDDI)
  • Deep brain stimulation may reduce severe Tourette's syndrome (Washington Post)
  • Class 1 Device Recall StrataMR Adjustable Valves & Shunts (FDA 1, 2)
  • Tip-separation issues prompt recall of Merit Medical's Prelude sheath introducer (MassDevice)
  • Commercializing the first da Vinci surgical robot: Lessons you need to know (MassDevice)
  • Hologic wins $721m fixed-price DoD contract (MassDevice)

US: Assorted & Government

  • Ex-NY assemblyman, doctors charged in illegal opioid prescription scheme: officials (Reuters)
  • Healthcare creates 13,500 jobs in March as ACA repeal scare slowed growth (Modern Healthcare)
  • Wyden Expands Request to HHS to Ensure Verma Complies with Ethics Agreements (Wyden)
  • Big Generic Drugmakers Must Defend Propranolol Antitrust Claims (Bloomberg) (Law360-$)
  • Griffith Bill Proposes Legislative Fix to "Route-of-Abuse" Exclusivity Block (FDA Law Blog)
  • Paul Ryan Could Lose Another Trumpcare Vote Tuesday In Kansas (Forbes)
  • The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017) (Patent Docs)
  • Plaintiffs' Causation Expert Renounces His Own Conclusions – and Withdraws – in Mirena IIH Litigation (Drug & Device Law)
  • Amneal Infringed Truvada Patents, Gilead Says (Law360-$)
  • Patent Office Upholds Shire's Patent for Hunter Syndrome Enzyme Replacement Therapy (FDA News-$)
  • Investors Sue AbbVie Over $1.6B Fee, Say More Loss Looms (Law360-$)
  • GlaxoSmithKline Asks Justices To Rule On Paxil Jurisdiction (Law360-$)
  • Texas expands Zika recommendations ahead of 2017 mosquito season (Reuters)

Upcoming Meetings & Events

Europe

  • Greek official: 'Thousands' of people implicated in Novartis bribery probe (Fierce)
  • EMA Completes Postmarket Safety Review of Uptravi (Focus)
  • Sobi's UK & Ireland chief on Bioverativ and the next generation of hemophilia treatments (PharmaLetter-$)
  • Finland's pharma industry investments rose to 227 million euros last year (PharmaLetter-$)
  • Losing GSI – MHRA emails are changing (MHRA)
  • Marketing authorisations granted in March 2017 (MHRA)
  • Parallel import licences granted in March 2017 (MHRA)
  • Guest commentary: The UK as a leading global life sciences cluster (ABPI)

Asia

  • CFDA adjusts some administrative approval procedures for drugs and medical devices (CFDA)
  • Biocad's Asian Biosimilars Play Undaunted By Roche (SCRIP-$)
  • Dalian Wanda to invest $10 billion in China healthcare hub (Reuters)

India

  • ​US regulator makes 2 observations at Neuland Labs' facility (Economic Times)
  • USFDA completes inspection of Dahej unit: Ajanta Pharma (Economic Times)
  • Bayer cancer drug faces new patent problems in India (PharmaLetter-$)
  • AICDF complaints to 5 state govts against leading pharma co and its CFA in Kolkata for not recalling expired & NSQ drugs (PharmaBiz)
  • MoHFW notifies inclusion of BCS in D&C Rules, industry sees easier facilitation of application review (PharmaBiz)
  • Centre's move to shift DoP, NPPA under health ministry viewed game changer for Indian pharma (PharmaBiz)
  • NPPA identifies 613 cases of non-compliance of its notified prices of various medicines by pharma cos (PharmaBiz)

Australia

  • Mesoblast takes off as cell therapy for heart failure passes interim test (Fierce)
  • Medicines Advisory Statements Specification updates (TGA)
  • Codeine-containing medicines: Harms and changes to patient access (TGA)
  • New biologicals based on a parent biological (TGA)
  • Varying biological entries on the ARTG (TGA)

Other International

  • Nationwide immunization campaign protects 5 million children against polio in war-torn Yemen (WHO)

General Health & Other Interesting Articles

  • Sperm Loaded with Drugs Could Target Gynecological Cancers (MIT Technology Review)
  • Kidney transplant vouchers could address timing issues (Reuters)
  • Lots of sleep tied to worse breast cancer survival odds (Reuters)
  • California women have banned flame retardants in their bloodstreams (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.

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