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Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017)

Posted 01 December 2017 | By Michael Mezher 

Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017)

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

In Focus: US

  • FDA to Allow Quicker Approval of Some Promising Cancer Drugs (WSJ) (STAT) (Reuters)
  • To Cut Drug Prices, Academy of Sciences Tells the Government to Negotiate With Manufacturers (NYTimes) (Bloomberg) (STAT)
  • Alnylam Chief Makes Pricing Pledges Before Drug Is Even Approved (Forbes)
  • CMS Head Verma eyes new methods for drug pricing (Reuters)
  • More States Hatch Plans to Recycle Drugs Being Wasted in Nursing Homes (ProPublica)
  • Purdue Pharma Discloses Negotiations With AGs on Opioids (Bloomberg)
  • Trends in Cancer Survival by Health Insurance Status in California From 1997 to 2014 (JAMA)
  • When Legal Drugs Harm and Illegal Drugs Help (Scientific American)
  • Prescription Drug Imports Are Banned for a Reason (Bloomberg)
  • Tax bill could trigger significant Medicare cuts (Politico)
  • Cures Act Implementation: Gottlieb Says Faster Cancer Drug Approvals Coming for Secondary Indications (Focus) (FDA)
  • CVS reportedly near deal to buy Aetna for around $66 billion (CNBC)
  • Amazon is in exploratory talks with generic-drug makers (CNBC)
  • Gottlieb Updates on Puerto Rico Shortages (FDA)
  • FDA approves Indivior's monthly injection to treat opioid addiction (STAT) (Endpoints) (FDA) (Gottlieb)
  • Is pharma's biggest internal critic risking a reckoning? (STAT)
  • What's killing patients in Bayer's Xofigo combo study? Researchers halt study early on safety alert (Endpoints)
  • Shire CEO Ornskov woos Bayer's Andreas Busch to run Boston-based R&D group (Endpoints) (Fierce)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • Bristol-Myers set to get a boost in China as Opdivo aces PhIII lung cancer study early (Endpoints) (Press)
  • Astellas buys DMD drug in $450M mitochondrial takeover (Fierce) (Endpoints) (Press)
  • Philippines Suspends Dengue Shots After Drug Firm's Warning (NYTimes)
  • Cancer drug prompts 'drastic' HIV decrease in lung cancer patient (Reuters)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017 (EMA) (PharmaLetter-$)
  • European Regulatory Roundup: EMA's Rent Bill at €448M (30 November 2017) (Focus)
  • Pfizer Enters into Agreement to Develop and Commercialize CRESEMBA® (isavuconazole) in China and Asia Pacific Region (Press)
  • UK doctors test less invasive prenatal screening for Down syndrome (Reuters)
  • Pfizer's Somavert to be funded by NHS Wales (PharmaTimes)
  • NHS England confirms cull of low-value treatments (PharmaTimes)
  • NHS England moves to accelerate progress on CHD standards (PharmaTimes)
  • Mylan: Reinspection of Biocon plant brings biosimilar confidence (BioPharmaReporter)
  • CFIUS clears Bayer's planned takeover of Monsanto (CNBC)
  • Siemens plans Frankfurt listing for Healthineers business that could fetch $12B (MassDevice)
  • Pfizer preps French site for UK prescription-free Viagra (InPharma)
  • ICH Updates on MedDRA: Lower Subscription Rates and New Translations Planned (Focus)

Pharmaceuticals & Biotechnology

  • Gene Therapy Is Booming, But How Will We Manage The Costs? (Forbes)
  • Site Visit Training Program for Office of Pharmaceutical Quality Staff (FDA)
  • Next generation antibody drugs: pursuit of the 'high-hanging fruit' (Nature)
  • Mechanistic enzymology in drug discovery: a fresh perspective (Nature)
  • Science for the season: BioWorld's 11th annual Holiday Gift Guide (BioWorld)
  • Patients Don't Benefit From Drug Discounts To Insurers, PhRMA Report Says (Forbes)
  • Samsung BioLogics says 180,000L plant is completed but not validated (BoiPharmaReporter)
  • Brain organoids get cancer, too, opening a new frontier in personalized medicine (STAT)
  • Drug price reforms that limit incentives for biomedical innovation are shortsighted (STAT)
  • Researchers use PD-1 checkpoint drug in pursuit of a promising curative approach to HIV (Endpoints)
  • Building An Integrated Biopharma Commercialization Services Offering (SCRIP-$)
  • Laura Shawver hits the ground running, scouting new investors for tiny Synthorx (Endpoints)
  • Teva boots its R&D chief; Ironwood grows the C-suite and Intercept taps new EVP of research (Endpoints)
  • Orchard expands Californian in-house gene therapy capabilities (BioPharmaReporter)
  • Aradigm Announces FDA Advisory Committee Meeting for Linhaliq (Press)
  • Glass act: Corning set to expand capacity to tap pharma opportunities (InPharma)
  • Whitepaper: Downstream biopharmaceutical operations (EPR)
  • A Status Check Of The Alzheimer's Trial Landscape (SCRIP-$)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Orphan status for Shire's experimental UC drug (PharmaTimes)
  • Switching To Toujeo® In A Real-World Setting Produced A Similar Number Of Severe Low Blood Sugar Events As Insulin Degludec (Press)
  • EMA accepts Mylan and Biocon's proposed biosimilars trastuzumab and pegfilgrastim (PharmaLetter)
  • Phase III trial of radium Ra 223 dichloride in combination with abiraterone acetate and prednisone/prednisolone for patients with metastatic castration-resistant prostate cancer unblinded early (Press)
  • Impact Biomedicines Closes First Tranche of Oberland Capital Financing Following FDA Meeting (Press)
  • Lannett Announces FDA Acceptance Of 505(b)(2) New Drug Application For Cocaine Hydrochloride Topical Solution, A Proprietary Anesthetic Product (Press)

Medical Devices

  • Meet The Startup Revolutionizing The Lab Testing Industry (Forbes)
  • CDRH Issues Final Guidance on De Novo Classification Process and Draft Guidance Regarding De Novo Submission Acceptance Review (FDA Law Blog)
  • Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom to be Renamed Single-Use Internal Condom (FDA)
  • Check Out the New DES on the Block (MDDI)
  • Advanced Bionics receives FDA and Health Canada approval for the Naída CI Q90 Acoustic Earhook (Press)
  • The Case for Real-World Evidence (RWE) in Medical Device Development (MassDevice)
  • Rotation Medical touts consistent healing, tear mitigation in rotator cuff study (MassDevice)

US: Assorted & Government

  • Hospital quality-control program tied to rise in heart failure deaths (Reuters)
  • Eleventh Circuit Affirms Preemption of HRT Complaint (Drug & Device Law)
  • NJ Panel Advances Bill To Close Loophole For Opioid Access (Law360-$)
  • Farmers harder hit by opioid crisis than rest of rural US: survey (Reuters)
  • JPML Open To Opioid MDL Despite Concerns About Size (Law360-$)
  • Roche Drops Medical Supply Co. From $89M Test Strips Suit (Law360-$)
  • Gifts Tied to Opioid Sales Invite a Question: Should Museums Vet Donors? (NYTimes)
  • Is a Patent a Private or Public Right? -- Supreme Court Hears Oral Arguments in Oil States Energy Services, LLC. v. Greene's Energy Group, LLC (Patent Docs)

Upcoming Meetings & Events

Europe

  • Advertising investigations: October 2017 (MHRA)
  • Results of juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children (EMA)
  • Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation (EMA)
  • List of centrally authorised products requiring a notification of a change for update of annexes (EMA)
  • EMA-EUnetHTA meeting June 2017 - Final minutes now available (EUnetHTA)
  • Nevro wins CE Mark for Senza II spinal cord stim device (MassDevice)

Asia

  • Shanghai's Genomicare Closes Series A (BioCentury)

India

  • Gujarat FDCA facilitates setting up of new mfg units in the state as part of ease of doing business (PharmaBiz)
  • Pharmexcil to conduct interactive meeting with Cuban delegation on Dec 7 in New Delhi (PharmaBiz)

Other International

  • South Africa approves first non-originator biological (GaBI)
  • Highlighting the importance of standards on World Aids Day (ISO)

General Health & Other Interesting Articles

  • 'Overlapping' neurosurgery not tied to higher complication or death rates (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.


Categories: Recon, Regulatory News

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