Regulatory Recon: Merck Buys German Immuno-Oncology Specialist Rigontec; NICE Again Rejects Takeda's Ninlaro for Multiple Myeloma (6 September 2017)

Posted 06 September 2017 By Michael Mezher

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

In Focus: US

  • Merck snaps up a German immuno-oncology upstart in a $603M bolt-on deal (Endpoints) (Fierce) (Press)
  • Novartis charged much more in the US for some drugs than in other countries (STAT)
  • Verastem's blood cancer drug succeeds in late-stage trial (Reuters)  (Endpoints) (Press)
  • IBM pitched its Watson supercomputer as a revolution in cancer care. It's nowhere close (STAT)
  • The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren't Yet Biosimilars in the US (Focus)
  • FDA Warns Drugmaker Over Opioid Marketing Materials (Focus)
  • FDARA, 21st Century Cures And The Era Of Perpetual FDA Reform (Pink Sheet-$)
  • Pharma business on the congressional agenda (Politico)
  • We're Losing the War on Opioids (Bloomberg)
  • Lasker Prizes Go to Planned Parenthood and Developers of HPV Vaccine (NYTimes) (Washington Post) (NIH)
  • Preventing Cancer and Other Diseases Caused by Human Papillomavirus Infection (JAMA) (Cell)
  • Bioverativ, Bicycle in tandem for $424M-plus blood disease R&D pact (Fierce)
  • Sarepta readies FDA pitch after a small study spotlights 1% dystrophin add for golodirsen in Duchenne MD (Endpoints) (STAT) (CNBC)
  • Voyager Therapeutics adds proof its gene therapy for Parkinson's can work, shares soar (Endpoints) (STAT)
  • US judge invalidates Mallinckrodt patents on respiratory treatment (Reuters)
  • Here's the inside account of Gilead's 11-week sprint to its $12B Kite buyout (Endpoints)
  • Secretive Moderna yet to convince on $5bn valuation (Financial Times)
  • US drugmakers chop fewer jobs this year despite headwinds (Fierce)

In Focus: International

  • Roche lung cancer drug Alecensa slashes brain risk in tests (Reuters) (Press)
  • Takeda's Ninlaro knocked back by NICE for second time (Pharmafile)
  • Avoid 'Political Games' Or Risk EMA Losing Most Of Its Staff, Italian Industry Head Warns (Pink Sheet-$)
  • WHO to Launch Pilot to Prequalify Biosimilars (Focus)
  • France's Servier to face trial over Mediator weight-loss drug (Reuters)
  • Drugmaker Vectura warns of destocking hit, shares slide (Reuters)
  • EC approves for Merck's Keytruda for bladder cancer indication (PharmaTimes)
  • Stem cells: Japan's scientific 'moonshot (Financial Times)
  • Real-world data prove efficacy of Eisai and Bial's epilepsy treatment (Pharmafile)
  • Spotlight On TissueGene's Upcoming Korea IPO (SCRIP-$)
  • Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia's Provisional Approval Pathway (Focus)
  • Pharmacovigilance Lawbreakers Could Lose Drug License Under Australia's New Inspection Program (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Shawnee Woman Was Among First In The World To Undergo New FDA-Approved Cancer Therapy (KCUR)
  • Pfizer: The US At The Forefront Of Biopharmaceutical Manufacturing (Forbes)
  • Spotlight – Multiple sclerosis drugs not alone with double-digit price hikes (EP Vantage)
  • Was the big paper about the successful editing of human embryo genes wrong? (Washington Post)
  • Cancer survivors more likely to skip drugs due to cost (Reuters)
  • ISO/IEC 17025 moves to final stage of revision (ISO)
  • Patient Advocates Continue To Push US FDA For Central Office (Pink Sheet-$)
  • Rare obesity disease player Rhythm Pharma sets out in search of a $115M IPO windfall (Endpoints)
  • NuCana plans $115M IPO to test retooled chemotherapies (Fierce)
  • Drug combination reduces risk of HIV infection among teen males (NIH) (Reuters)
  • FDA Commissioner, Dr. Scott Gottlieb, to Address BIO Patient and Health Advocacy Summit (Press)
  • Zika virus selectively infects and kills glioblastoma cells in mice (NIH)
  • Presage Bio Licenses Anti-Cancer Drug to San Diego's MEI Pharma (Xconomy)
  • Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • NeuroRx Awarded FDA Fast Track Designation for First Drug Regimen Targeting Suicide in Bipolar Depression (Press)
  • Actelion Receives FDA Approval Of TRACLEER® (bosentan) For Use In Pediatric Patients With Pulmonary Arterial Hypertension (Press)
  • Lilly to Present New Data for Galcanezumab and Lasmiditan at the 18th Congress of the International Headache Society (IHC) (Press)
  • Aerie Pharmaceuticals Initiates Mercury 3 Clinical Trial of RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% (Press)
  • Poxel to Present Results for Imeglimin Phase 2b Study in Japan for the Treatment of Type 2 Diabetes at the European Association for the Study of Diabetes 53rd Annual Meeting (Press)
  • Symbiomix Therapeutics Announces Publication of Pivotal Phase 3 Data for Investigational Solosec™ for the Treatment of Bacterial Vaginosis (Press)
  • JDRF and vTv Therapeutics Announce Collaboration on Phase 2 Study of Novel Treatment for Type 1 Diabetes (Press)

Medical Devices

  • FDA Finalizes Guidance on Interoperable Devices (Focus) (FDA Voice)
  • Could Targeted Medical Information Help Develop Better Devices? (MDDI)
  • How medical device risk management is connected with design controls (MDDI)
  • This is why pre-design research is essential for the IVD industry (MedCityNews)
  • Mobile apps for diabetes patients need careful review (Reuters)
  • Class 1 Device Recall for IntraAortic Balloon Pumps (FDA 1, 2, 3)
  • Medtronic launches long-term PLF, TLIF Infuse bone protein study (MassDevice)
  • Janssen's respiratory panel wins 510(k) clearance (Drug Delivery)
  • NuVasive Receives FDA 510(k) Clearance For Leading EOS Innovation (Press)
  • C4 Imaging Announces an Additional FDA 510(k) Clearance for its Positive-Signal MRI Marker - Sirius™ (Press)

US: Assorted & Government

  • Trump must prevent the next biological attack before it strikes (The Hill)
  • GHTC Calls on Trump Administration to Sustain Global Health, R&D Funding in 2019 Budget (GHTC)
  • Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2014 Average Sales Prices (HHS OIG)
  • Hatch Announces Hearing to Review Issues Impacting Healthcare Costs and Coverage (Senate Finance)
  • Outside experts assess Ohio's ballot issue on prescription-drug prices (Columbus Dispatch)
  • Biotech Leaders Sign Open Letter Asking Trump To Reconsider Rescinding DACA (BioCentury)
  • Medical Device "Fraud on the FDA" Theory Might Be Viable in Minnesota, if Properly Pled (FDA Law Blog)
  • There'll Always Be Posner: An Appreciation (Drug & Device Law)
  • What's next for health care as Congress returns (Politico)
  • Antidepressants Found In The Great Lakes And Fish (Forbes)

Upcoming Meetings & Events

Europe

  • EMA Updates Advice on Pursuing CHMP Opinions for Products for Non-EU Countries (FDANews-$)
  • Look out for people at risk of having ADHD diagnosis missed, says NICE (NICE)
  • Roche to increase level of local production in Russia (PharmaLetter-$)
  • Prices for drugs in Russia could increase by 15%-20% next month (PharmaLetter-$)

Asia

  • Thousands hit by malaria, dengue as South Asia's worst floods in a decade recede (Reuters)
  • Call for 2020 Chinese Pharmacopoeia to radically raise standards (PharmaLetter-$)

India

  • Delhi HC reserves decision on Daiichi's Rs 2,500 crore award against Fortis promoters (Economic Times)
  • Health ministry soon to launch country's first mini drug testing lab at Ahmedabad airport (PharmaBiz)
  • Health ministry once again invites suggestions from stakeholders on proposal to replace gelatin capsules with cellulose-based capsules (PharmaBiz)
  • India cannot be ignored for global clinical trials; new regulations restore clarity & confidence: Tim Regan (PharmaBiz)
  • Strides Shasun Expands Australia Base With Amneal Deal (SCRIP-$)

Australia

  • Medical Devices Sponsor Information Day – 2017 (TGA)
  • Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017 (TGA)

General Health & Other Interesting Articles

  • Vaginal estrogen not tied to cancer or heart disease risks (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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