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Regulatory Focus™ > News Articles > 2019 > 9 > Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinck

Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinckrodt to Sell BioVectra for $250M

Posted 10 September 2019 | By Michael Mezher 

Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinckrodt to Sell BioVectra for $250M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pelosi’s drug pricing plan is more aggressive than expected (STAT) (NYTimes) (Washington Post) (CNBC) (The Hill)
  • US judge allows public nuisance claim in opioid trial (Reuters)
  • Sackler Family To Give Up Value Of Purdue Pharma To Settle Opioid Claims (NPR)
  • Delaware DOJ files lawsuit against Sackler family, owners of Purdue Pharma companies (Delaware Online)
  • Frontrunner to lead FDA, dogged by controversies, has developed knack for confronting them (STAT)
  • Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says (Pink Sheet-$)
  • US tells cannabis companies not to advertise disease treatments without science (Reuters) (FTC)
  • Senate spending bills thrown into chaos over abortion policy, border wall (Politico)
  • Azar, other top Trump officials to travel to DRC to assess Ebola crisis (STAT)
  • FDA and NIH push more marijuana for researchers (Politico)
  • Congress' effort on surprise medical bills is flagging (Politico)
In Focus: International
  • Mallinckrodt To Sell BioVectra To HIG For Up To $250M (Law360-$) (Endpoints)
  • Australian cell therapy company Mesoblast joins forces with Germany's Grünenthal to tackle low back pain (Endpoints)
  • RWD Use in Regulatory Submissions Could Start with Rare Diseases: PMDA Chief (PharmaJapan)
  • UK fears crisis as 11.5 million get potentially addictive drugs (Reuters) (The Guardian)
  • Novartis’ CAR-T Kymriah scores SMC approval (PMLive)
  • SMC gives nod for access to new HIV treatment Dovato (Pharmafile)
Pharmaceuticals & Biotechnology
  • US Government Wants to Know More About the Biotech Ecosystem (Focus)
  • FDA Developing Guidance on Real-World Data Quality Issues, Officials Say (Focus)
  • Drugmakers Seek Clarity on Two FDA Labeling Guidances (Focus)
  • US FDA Should Offer Formal Declaration Of Orphan Drug Flexibility, Attorney Says (Pink Sheet-$)
  • ICER's blasted pharma pricing for years, but now drugmakers are 'rolling up their sleeves' to cooperate (Fierce)
  • Drug Prices Keep Rising Amid Political Pressure, But Not As Fast (Forbes)
  • FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs (Focus)
  • Insulin: a case study for why we need a public option in the pharmaceutical industry (STAT)
  • We Shouldn’t Give Up on Biosimilars—And Here Are the Data to Prove it (Drug Channels)
  • Survey suggests Ionis is losing battle against Pfizer and Alnylam (BioPharmaDive)
  • Biomarker data help Merck case for wide use of Keytruda combo (BioPharmaDive)
  • Esketamine Nasal Spray Eases Depression Symptoms In Suicidal Patients (NPR)
  • Remember that post-marketing trial? New study confirms many drugmakers don’t do them — half drag their feet (Endpoints)
  • Bayer’s two-year data confirms Eylea effectiveness (PharmaTimes)
  • Kleiner, GV drive gene editing startup Trucode to $34M round (Fierce)
  • Fast Track Designation Request Performance (FDA)
  • FDA identifies biomarker for immune response to FVIII products used to treat hemophilia A (FDA)
  • Indian manufacturing player Jubilant poaches top Novartis BD exec to run their new biotech startup in Yardley, PA (Endpoints)
  • Alex Zhavoronkov follows landmark AI paper with $37M round for Insilico featuring top-notch China VCs (Endpoints)
  • Fresh off the heels of mega financing round, Germany's BioNTech makes $100M US IPO play (Endpoints) (Fierce)
  • A new player jumps into the heated race for a sickle cell cure, with help from Google's GV (Endpoints)
  • After BioCryst fizzle, a new oral HAE player emerges (Endpoints)
  • The Endpoints 100: Novartis gets 'poor' grade on data scandal, Ned Sharpless isn't a 'wow' and that Canada drug importation plan is a nonstarter (Endpoints)
  • Atomwise, OncoStatyx launch JV to target triple-negative breast cancer; Cancer biotech woos former Spark COO John Furey (Endpoints)
  • Aurobindo recalls mislabeled statin tablets from the US market (Fierce)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS (Press)
  • Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients (Press)
  • Merck Initiates Pivotal Phase III Programme for Investigational Evobrutinib in Relapsing Multiple Sclerosis (Press)
  • Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers (Press)
  • Updated Phase 1 Data for Daiichi Sankyo's U3-1402 in Patients with EGFR Mutated NSCLC Presented at 2019 World Conference on Lung Cancer (Press)
  • Axon Announces Positive Results From Phase II ADAMANT Trial for AADvac1 in Alzheimer's Disease (Press)
  • AVEO Oncology Announces Updated Overall Survival Hazard Ratio of 0.99 in Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma (Press)
  • Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in China for Peritoneal Carcinomatosis (Press)
  • Phase I Study of “Off-The-Shelf” Virus-Specific T Cells Published in BLOOD ADVANCES (Press)
  • New Data from Enanta’s Phase 2a Human Challenge Study of EDP-938 for RSV to be Presented at IDWeek™ 2019 (Press)
  • VBI Vaccines Announces Phase 2a Clinical Evaluation of VBI-1901 Cancer Vaccine Candidate in Combination with GSK’s AS01B Adjuvant System in Recurrent Glioblastoma Patients (Press)
Medical Devices
  • Baxter puts up $230m for Cheetah Medical (MassDevice)
  • FDA Has Calmed Down About Paclitaxel, but Has the Market Recovered? (MDDI)
  • EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer (MassDevice) (Press)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (FDA)
  • Exact Imaging wins CE Mark for transperineal needle (MassDevice)
  • The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers (Bag) Marketed Under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix Names, Due to the Potential for Leaking of the IV Bag at the Chamber Divider Rod (FDA)
US: Assorted & Government
  • Share of Americans With Health Insurance Declined in 2018 (NYTimes)
  • NIH opens inquiry into management, workplace issues at troubled pharmacy (Washington Post)
  • Feds Ask To Delay Proposed Subsys Sale (Law360-$)
  • State Law Issues The Court Missed In Cancer Drug Trial Case (Law360-$)
  • Utah Decision Yields Decidedly Mixed Results (Drug & Device Law)
  • Thinning Out the Bulks List: After the D.C. District Court Upholds FDA’s Restrictive Section 503B Bulks Nomination Process, FDA Promptly Releases its Tentative “No-Go” Analysis for Nine More Substances (FDA Law Blog)
  • Senate to Hold STRONGER Act Hearing (Patent Docs)
  • Genentech Gets Taiwanese Co. To Abandon Biosimilars (Law360-$)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Public Hearing – 4 November 2019
  • Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – 6 December 2019
  • European pharma industry lobbies for regulatory reform (PharmaLetter-$)
  • Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules (Focus)
  • Indian Pharma Market registers 9.4 per cent growth in August 2019 (Pharmabiz)
  • Therapeutic Goods (Complementary and OTC Medicines - Application Form for Approval of an Advertisement) Approval 2019 (TGA)
General Health & Other Interesting Articles
  • Colorectal cancer becoming more common at younger ages (Reuters)
  • Fundraising in academia and the Epstein problem (STAT)
  • Lasker Awards honor scientists for cancer therapy, immune system work (STAT) (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.
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