Recon: AZ Claims Phase III Success for Lynparza in Prostate Cancer; NICE Backs Nerlynx in Adjuvant HER2+ Breast Cancer – Regulatory Focus

Posted 07 August 2019 | By Michael Mezher 

Recon: AZ Claims Phase III Success for Lynparza in Prostate Cancer; NICE Backs Nerlynx in Adjuvant HER2+ Breast Cancer
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

  • Amag's female libido injectable therapy to sell at $899 (Reuters)
  • Patient groups push back against Gilead's pricey HIV prevention treatment (Reuters)
  • Opioid Distributors Propose $10 Billion to End State Claims (Bloomberg) (CNBC)
  • US Judge Expresses Support for Novel Opioid Settlement Talks Framework (Reuters)
  • Boom in overdose-reversing drug is tied to fewer opioid deaths (NBC)
  • Key White House health  aide to depart (Politico)
  • Jazz Pharma (JAZZ) Q2 Earnings and Sales Beat Estimates (Yahoo)
  • Amazon’s PillPack is battling with CVS and Walgreens over getting patient prescriptions (CNBC)
  • Updated: FDA Reviewing Data Manipulation in Application for Novartis Gene Therapy Zolgensma (Focus) (NYTimes)
  • Senate's Prescription Drug Pricing Bill's Limited Impact On Drug Prices (Forbes)
  • Permira proposes to take Cambrex private in $2.4B deal, stirring up CDMO M&A (Endpoints) (BioPharmaDive)
  • Conservatives buck Trump over worries of ‘socialist' drug pricing (The Hill)

In Focus: International

  • Pending litigation weighs on Teva (Financial Times)
  • Teva to lose CFO, with turnaround still under construction (Endpoints) (BioPharmaDive)
  • AstraZeneca's Lynparza helps prostate cancer patients live longer (Reuters) (Endpoints) (Press)
  • Mitsubishi Tanabe’s ALS drug approved in China (PharmaLetter-$)
  • China restricts opioid in tighter painkiller controls (Reuters)
  • Lex In Depth: Bayer’s €50bn blunder (Financial Times)
  • Keytruda now available for lung cancer patients via Cancer Drug Fund (PMLive)
  • NICE recommends Pierre Fabre's Nerlynx in adjuvant HER2+ breast cancer (Pharmafile) (PharmaTimes)
  • Which are the key medical devices for primary health care services (PAHO)

Pharmaceuticals & Biotechnology

  • FDA Reports on Status of Postmarketing Requirements and Commitments (Focus)
  • US FDA's Abernethy ‘Cautious' About Real-World Evidence (Pink Sheet-$)
  • Goldilocks And GMP (LifeSciVC)
  • FY2018 Biological Product and HCT/P Deviation Reports (FDA)
  • Arthritis Tied to Heart Disease. Pain Relievers May Be to Blame. (NYTimes)
  • Cancer hospital affiliation tied to lower cancer surgery mortality rates (Reuters)
  • Marijuana-derived epilepsy drug doubles sales, sending GW Pharma stock soaring (MarketWatch)
  • ‘Every man and his dog’ does cell therapy. Vor’s new CEO says the company wants to be different (STAT)
  • 8 Ways Overseas Drug Manufacturers Dupe The FDA (Wired)
  • When Lifesaving Drugs Are in Short Supply (US News)
  • Gilead's newly departed R&D chief re-emerges as CEO of a rival hep B biotech looking to make a comeback (Endpoints)
  • Loxo chief Josh Bilenker steps in (temporarily) to head oncology R&D at Eli Lilly as Levi Garraway steps out (Endpoints)
  • Part procedure, part drug: Robert Ang joins Siddhartha Mukherjee in pioneering a new type of cell engineering (Endpoints)
  • XyloCor hires Reinhardt as CMO to lead gene therapy programs (Fierce)
  • Athenex's oral chemotherapy formulation scores in pivotal study; Glycomine brings in $33M in Series B haul (Endpoints)
  • What’s a late-stage IL-23 drug worth these days? We’re about to find out (Endpoints)
  • Funded By FDA, C-Path And NORD To Launch Rare Disease Data Analytics Platform (Press)
  • Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nomination for Nonvoting Industry Representatives on the Vaccines and Related Biological Products Advisory Committee (FDA)

Pharmaceutical & Biotechnology: Study Results, Filings & Designations

  • Basilea moves closer to US filing of novel antibiotic (PMLive)
  • Rhythm Pharmaceuticals' lead drug scores in pivotal rare obesity trials (Endpoints) (Fierce)
  • Verona Pharma share positive ensifentrine results in COPD (PharmaTimes)
  • First patient dosed in Astellas’ late-stage menopause trial (PharmaTimes)
  • MC2 Therapeutics A/S Completes Enrollment of EU Phase 3 Head-to-Head Study in Patients With Plaque Psoriasis Treated With MC2-01 PADTM Cream (Press)
  • Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-123 Treatment For Acne Vulgaris In Lotion Form (Press)
  • Stoke Therapeutics Granted FDA Orphan Drug Designation for STK-001, an Investigational New Treatment for Dravet Syndrome (Press)

Medical Devices

  • ExThera Medical wins CE Mark approval for blood filter (MassDevice)
  • CDRH Seeks Computational Model of Human Heart to Speed Device Development (Focus)
  • Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx (GenomeWeb)
  • Avanos Medical beats the Street in Q2 results (MassDevice)
  • FTC clears Boston Sci’s $4B purchase of BTG (MassDevice)
  • BD beats Wall Street on Q3 earnings, reveals FDA denial of Lutonix PMA for PAD (MassDevice)
  • Haemonetics beats Wall Street on Q1 EPS, revenue (MassDevice)
  • Perfuze Receives Breakthrough Device Designation Status from U.S. Food and Drug Administration (FDA) for Millipede CIS (Clot Ingestion System) (Press)
  • NinePoint Medical Announces FDA Clearance for Pancreatic and Biliary Applications of the NvisionVLE® Imaging System (Press)
  • Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus (FDA)

US: Assorted & Government

  • Are Trump’s Top Medicaid Regulators Ignoring Major Problems? Insurance Giant’s Tense Meeting With a Senator Adds to Growing Concern. (ProPublica)
  • McKesson Tries To Nix Derivative Suit Over Drug Price-Fixing (Law360-$)
  • Considering The Current And Future Legality Of CBD (Law360-$)
  • Mylan Blasts '11th Hour' Discovery Push In EpiPen Row (Law360-$)
  • DePuy Gets $8.2 Million Patent Judgment Slashed In Half (Law360-$)
  • Bayer says next glyphosate lawsuit likely to be postponed (Reuters)
  • Walgreens to close about 200 stores in United States (Reuters)
  • CVS posts big earnings beat, raises full-year forecast (CNBC)
  • CMS Finalizes Path to Boost Reimbursement for Breakthrough Devices (Focus)
  • FDA statement on court ruling related to compounded bulk drug substances and the agency's ongoing efforts to implement its compounding authorities (FDA)
  • News from Abroad — Australia Reigns Supreme over U.S. in Patenting Diagnostic Methods (Patent Docs)
  • Silicone Implant Defendants Prevail on Fraudulent Joinder and Preemption (Drug & Device Law)

Upcoming Meetings & Events
Europe

  • Troy Robinson promoted to managing director of Chugai Pharma Europe (Pharmafile)
  • Guidance on Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) in a no deal Brexit (MHRA)
  • Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit (MHRA)
  • Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal (MHRA)

Asia

  • Thailand unveils first batch of medical marijuana for hospital distribution (Reuters)

India

  • PvPI study reveals major suspected ADRs in anti-retroviral drugs like lamivudine, efavirenz and tenofovir (Pharmabiz)
  • Commerce ministry to implement online system for tracing & authentication of export packages from April 1, 2020 (Pharmabiz)

Australia

  • Australian traveller fined for importing unapproved products in luggage (TGA)
  • GMP Clearance applications using Health Canada evidence (TGA)

General Health & Other Interesting Articles

  • Tech Meets Health Care, Sometimes Shakily (NYTimes)

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? Email us at news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Source: https://www.raps.org/news-and-articles/news-articles/2019/8/az-claims-phase-iii-success-for-lynparza-in-prosta


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