Regulatory Recon: UK Supreme Court Rules in Favor of Lilly Patents; HHS OIG Probes Alexion (7 July 2017)

Posted 07 July 2017 By Zachary Brennan

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

In Focus: US

  • Sophie’s Choice for Oncologists: Who Gets New Life-Saving Drug (Bloomberg)
  • Alexion Says U.S. Health Inspector General Is Part of DOJ Probe (Bloomberg)
  • Dr Rob Califf on His Short-Lived Tenure as FDA Commissioner (Medscape)
  • Dr. Brenda Fitzgerald expected to be named CDC director (Stat) (HHS)
  • A proposal would limit prices on meds developed with Defense Department dollars (Stat)
  • Endo Pulls Opioid From US Market at FDA's Request (Focus)
  • Generic Industry Group Sues Maryland Over Price Gouging Law (Focus)

In Focus: International

  • UK Supreme Court Rules In Lilly's Favor On Alimta Patents (Press) (Reuters)
  • WHO: Gonorrhea Resistance on the Rise (MedPage Today) (Reuters) (Stat) (WHO)
  • 10 Years in, EU Pediatric-Use Marketing Authorization Called a 'Disappointment' (Focus)
  • European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (Focus)
  • EC says Merck and Sigma-Aldrich broke M&A procedures and could face fine (InPharma)
  • EMA Defers U.S. GMP Inspections Pending November Activation of Mutual Agreement (FDANews-$)
  • Canada’s Supreme Court boosts protection for pharma patent holders (C&EN)
  • Time for full transparency on pharmaceutical money (Toronto Star)
  • India’s Hetero to produce cancer and AIDS drugs in Russia (PharmaLetter-$)
  • Fosun stock tumbles over rumors of chairman disappearance—again (Fierce)
  • Konica Minolta To Buy Ambry Genetics In Deal Worth $1B (Law360-$) (Reuters)

Pharmaceuticals & Biotechnology

  • O’Connor resigns as CEO of Advaxis with immediate effect (Fierce)
  • Batch Manufacturing or Continuous Manufacturing? – That is the Question (FDA Law Blog)
  • Rare-Disease Drugmakers Join in Worries Over GOP Health Overhaul (Bloomberg)
  • Bio Roundup: BCRA Fireworks, Shkreli Muzzled, Endo Pulls Drug & More (Xconomy)
  • Big cap biopharma ends the half year on a high note (EP Vantage)
  • Seven questions CTL019 adcom should consider (and two it won’t) (EP Vantage)
  • Channeling cell and gene therapies through the cold chain (Pharma IQ)
  • Pacira to stop making DepoCyt due to long-term production problems (InPharma-Technologist)
  • Martin Shkreli's lawyer and 'cowboy' venture capitalist duel over what horses and investments are worth (CNBC)
  • Patheon investing $45 million in multisite service expansion (C&EN)
  • Novartis turns to Oxford BioMedica for a major CAR-T supply deal (Endpoints)
  • Innovative therapies require innovative thinking on access and cost (Stat)
  • Sanofi partner Zealand files for IPO to fund drug approvals (Fierce)
  • Opportunities and challenges in phenotypic drug discovery: an industry perspective (Nature Reviews Drug Discovery-$)
  • What is the right amount to spend on biopharma R&D? (Nature Reviews Drug Discovery-$)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Biotech's IPO Uptick Is Nothing to Fear (Bloomberg)
  • Upcoming events – Puma’s FDA decider and semaglutide’s head-to-head battle (EP Vantage)
  • Sanofi and Alnylam plunge into PhIII with a rival to Roche’s top hemophilia drug (Endpoints)
  • J&J turns its back on Capricor and its failed stem cell tech, taking its money and rep with it (Endpoints)
  • Market watch: Strategies for biosimilars in emerging markets (Nature Reviews Drug Discovery-$)
  • Eli Lilly Pledges $52M to Life Sciences Partnership with Purdue (Xconomy)

Medical Devices

  • Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers (FDA)
  • 8th Circ. Upholds DePuy Quick Win In Hip Implant Suit (Law360-$)
  • Cardiologs wins FDA 510(k) for ECG analysis platform (Mass Device)
  • Creavo Medical raises $15m (Mass Device)

US: Assorted & Government

  • Specifications for eCTD validation criteria (FDA)
  • Transmitting electronic submissions using eCTD specs (FDA)
  • Technical Rejection Criteria for Study Data (FDA)
  • Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for
  • Comments (Federal Register)

Upcoming Meetings & Events

Europe

  • Germany determines Cinqaero gives 'minor additional benefit' in severe asthma (PharmaLetter-$)
  • Suspended and revoked licences for manufacturers and wholesalers of medicines (MHRA Update)

General Health & Other Interesting Articles

  • Outbreak of hantavirus infections kills three in Washington state (Reuters)
  • Opioid prescriptions down since 2010, but big differences seen among counties (Stat)
  • How Canadian researchers reconstituted an extinct poxvirus for $100,000 using mail-order DNA (Science)

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.

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