Regulatory Recon: Alexion Cutting 600 Jobs in Boston HQ Move; Teva Sells Paragard Contraceptive Business for $1.1B (12 September 2017)

Posted 12 September 2017 By Michael Mezher

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

In Focus: US

  • Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies (Focus, Video)
  • What Does It Cost to Create a Cancer Drug? Less Than You'd Think (NYTimes) (NPR) (Medpage)
  • Vertex shuts down study of long-acting Kalydeco but insists development still on track (STAT)
  • Alexion cutting 600 jobs and moving headquarters in major shakeup (Endpoints) (New Haven Register)
  • Regeneron, Sanofi post good PhIII asthma data for Dupixent — but it's losing its halo (Endpoints) (Reuters)
  • CardioBrief: Is Cardiology Flatlining? (Medpage)
  • US tribal patent deal could have big impact on generic drug market (Reuters)
  • "Continuous Manufacturing" – Common Guiding Principles Can Help Ensure Progress (FDAVoice)
  • AbbVie says deaths in arthritis trial not linked to drug (Reuters) (Endpoints)
  • Sage's epilepsy drug fails to do better than placebo in key clinical trial (STAT) (Endpoints)
  • FDA panel says risk of opioid use in kids' cough medicines outweighs benefits (STAT)
  • Struggling in R&D, GSK lines up an FDA pitch on COPD with mixed data (Endpoints)
  • Shire says trial shows new HAE drug significantly reduces attacks (Reuters) (Fierce)
  • Suicide Data Incorrectly Reported in Drug Trials, Suit Claimed (NYTimes)
  • Novartis says biosimilar rituximab accepted for review by FDA (Reuters)
  • Apple is working with Stanford and American Well to test whether its watch can detect heart problems (CNBC)

In Focus: International

  • South Africa's Adcock Ingram to acquire Genop Holdings (Reuters)
  • Annual performance statistics report: July 2016 to June 2017 (TGA)
  • Australian Pharma Under Pressure To Provide Full Documentation For GMP Clearance (Pink Sheet-$)
  • MDSAP Update: Canada's 2019 Deadline Still on Track (Focus)
  • New Teva chief must tackle 'tough decisions' on jobs (Financial Times)
  • Teva sells Paragard contraceptive business for $1.1bn (Financial Times) (Fierce)
  • NICE: We're the institute of 'yes' (PMLive)
  • Bayer Names New CFO (Press)
  • Singapore HSA Clarifies Telehealth and Mobile Medical App Guidelines (Emergo)
  • Supply chain and economic operator regulation under the MDR and IVDR (MedicalDevicesLegal)
  • Pharmaceutical companies gave $12m to doctors, nurses and pharmacists (The Guardian)
  • ESMO: Merck's Keytruda-chemo combo spurs big response in new stomach cancer patients across the PD-L1 board (Fierce)

Pharmaceuticals & Biotechnology

  • Onxeo shares blitzed after PhIII liver cancer study flops (Endpoints)
  • FDA Panel Backs New Warning for Gadolinium Contrast Agents (Medpage)
  • Doctors who take pharmaceutical money use Twitter to hype drugs (Reuters)
  • Do Interim Results Need A Warning Label? (Medpage)
  • Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability (FDA)
  • Off-label prescribing is legitimate, but you should ask a few questions (Washington Post)
  • Shingrix Shingles Vaccine: FDA Wants GSK To Monitor Inflammation Risk (Pink Sheet-$)
  • Diarrhea Drug Abuse Shouldn't End OTC Sales, FDA Hears (Law360-$)
  • Romosozumab — Promising or Practice Changing? (NEJM)
  • Statins may help people with COPD live longer (Washington Post)
  • Idera TLR9 drug boosts Yervoy in PD-1-refractory patients (Fierce)
  • AbbVie and Pfizer hover at top, J&J Stelara surges in August TV pharma ad spend (Fierce)
  • Clarus Adds Former Genentech Ceo Ian Clark (BioCentury)
  • Kura surges on early readout in head and neck cancer trial (Fierce)
  • FDA Animal Drug Safety Communication: Micotil 300 User Safety Alert (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Pfizer Presents Overall Survival Data of XALKORI in Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer (Press)
  • Sanofi And Regeneron Announce Positive Dupilumab Topline Results From Phase 3 Trial In Uncontrolled Persistent Asthma (Press)
  • Sage Therapeutics Reports Top-Line Results from Phase 3 STATUS Trial of Brexanolone in Super-Refractory Status Epilepticus (Press)
  • Lilly to Present New Data for Olumiant® (baricitinib) and Taltz® (ixekizumab) at the European Academy of Dermatology and Venereology (EADV) Annual Congress (Press)
  • IRX Therapeutics Presents Positive IRX-2 Phase 2a Head and Neck Squamous Cell Carcinoma Clinical Results at the European Society for Medical Oncology Annual Congress 2017 (Press)
  • Merck Announces Findings from Phase 3 Study of KEYTRUDA® (pembrolizumab), Compared to Standard of Care, in Patients with Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Press)
  • FDA Accepts Adello Biologic's Biosimilar Biologics License Application for a Proposed Filgrastim Biosimilar (Press)
  • Transgene Receives FDA IND Approval to Begin a Clinical Trial with TG4010 + Nivolumab + Chemotherapy in the First-Line Treatment of Lung Cancer (NSCLC) (Press)

Medical Devices

  • CDRH to Launch 'Critical to Quality' Pilot Program (Focus)
  • Left to Their Own Devices: The Promise and Dangers of IoT-Connected Medical Devices (MDDI)
  • Tim Cook: Healthcare is a big area for Apple's future (MedCityNews) (MobiHealthNews) (Fortune)
  • Integra LifeSciences deals $48m in neurosurgery assets to Natus Medical (MassDevice)
  • New Legislation Gives More Time for Medical Device Reporting (NationalLawReview)
  • Leica Wins FDA Clearance for Novel Neurosurgical Microscopy Filter for Detailed View of Blood Flow (medGadget)
  • Pulse Biosciences pulls, plans to refile FDA 510(k) clearance bid for PulseTx nanostim (MassDevice)
  • T2 Biosystems files 510(k) for T2Bacteria Panel (MassDevice)

US: Assorted & Government

  • Federal "Right to Try" Legislation – Perpetuating a Misguided Skepticism Towards the FDA (Harvard Bill of Health)
  • How HHS is responding to Hurricane Irma (Politico)
  • Dr. James Ostell named Director of the National Center for Biotechnology Information (NIH)
  • A Non-Drug/Device Preemption Win with a Caveat (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Brexit certainty for pharmaceutical companies comes beyond the EU (Withdrawal) Bill (ABPI)
  • Genedrive HCV ID Kit Gets CE-IVD Marking (GenomeWeb)
  • Gecko Biomedical wins CE Mark for Setalum vascular sealant (MassDevice)

India

  • Despite A Booming Economy, India's Public Health System Is Still Failing Its Poor (Forbes)
  • Government to revisit stent price control in February (Economic Times)
  • Patented drug launches help MNCs score over Indian peers (Economic Times)
  • Strides Shasun gets USFDA nod for kidney stone tablets (Economic Times)

Australia

  • Presentation: Medicinal Cannabis Evidence for Efficacy Clinical Guidance Development (TGA)
  • Outcomes of advertising complaints - compliance following TGA intervention (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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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