Regulatory Focus™ > News Articles > 6 > Recon: Mylan Braces for FDA to Reject its Advair Copy for the Second Time

Recon: Mylan Braces for FDA to Reject its Advair Copy for the Second Time

Posted 14 June 2018 | By Ana Mulero 

Recon: Mylan Braces for FDA to Reject its Advair Copy for the Second Time

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

In Focus: US
  • Madrigal Pharma Is Exploring Sale After Receiving Takeover Interest (Bloomberg)
  • Mylan preps for rejection of Advair copy (BioPharma Dive) (Reuters) (Endpoints)
  • ViiV’s two-drug HIV regimen hits PhIII targets (PharmaTimes) (Endpoints) (Reuters)
  • FDA Approves Avastin for Advanced Ovarian Cancer (PMLiVE) (PBR)
  • Massachusetts Sues OxyContin Maker Purdue, Names Executives in Filing (Fortune) (NPR)
  • Kentucky sues Walgreens, says it has role in opioid epidemic (Reuters)
  • The University of California will finally be granted a key CRISPR patent (STAT-$)
In Focus: International
  • On a roll, Sage grabs a $575M deal on limited Asian rights to SAGE-217 — a potential gamechanger in depression (Endpoints) (GEN) (The Pharma Letter-$)
  • GSK's two-drug HIV treatment meets main goal in late stage studies (Reuters) (Financial Times)
  • Study confirms higher risk of dengue in kids who got Sanofi vaccine (Reuters) (STAT)
  • Recipharm to buy Sanofi inhalation contract business and plant in U.K. for $60M (Fierce) (PBR)
  • UK, Germany back routine use of J&J’s Tremfya (PMLiVE) (PharmaTimes)
  • Manufacturers want 50% cap in trade margins for Medical devices (BioSpectrum) (Business Line)
  • Hong Kong market could open cash flood gates for U.S. biotechs (Reuters)
  • GDPR can be a really good thing for international healthcare (Healthcare IT News)
  • China's NHC Releases Guidelines For Updating Rare Disease List (BioCentury)
Pharmaceuticals & Biotechnology
  • Allergan appoints former Abbott executive to its board (Reuters)
  • Can Sanofi compete in lung cancer? With I-O med cemiplumab, it’s aiming for third (Fierce)
  • Drug companies are indeed looking at ‘substantial’ price cuts, HHS Secretary Azar tells lawmakers (Fierce)
  • Alta raises $130M for its new biotech VC fund, missing its $200M goal (Fierce)
  • Biosimilars could still pack revenue-busting punch, analyst suggests (BioPharma Dive)
  • Big pharma shows no signs of 'massive' drug price cuts (BioPharma Dive)
  • Current efforts to fight sepsis aren’t working. We need a bolder approach (STAT)
  • Is it time to target autophagy to treat disease? (STAT-$)
  • Blame the ozanimod fiasco on the Receptos team? Just wait a sec, says ex-CEO, who sold the company to Celgene for $7.2B (Endpoints)
  • Common Drugs May Be Contributing to Depression (NYT)
  • Is ASCO Sending Mixed Messages On Value? (Forbes)
  • Sanofi, Genentech and Celgene Lead the Way in Reputation Institute’s 2018 US Pharma RepTrak, The Largest Study on Reputation of Pharmaceutical Brands in the US (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Lilly's lupus treatment succeeds in mid-stage trial (Reuters)
  • Argenx boosts pipeline with new version of lead drug (Fierce)
  • Nightstar’s drug for rare vision loss admitted to FDA’s gene therapy speedway (Endpoints)
  • Amid tough competition, Novartis makes case for rheumatology drug Cosentyx (pharmaphorum)
  • Albireo gets FDA rare pediatric disease designation for rare liver disease treatment A4250 (PBR)
  • FDA to review Sunovion’s apomorphine sublingual film for Parkinson’s disease (DDBN)
  • U.S. FDA Approves Moxidectin For The Treatment Of River Blindness (Press) (FDA)
  • FDA Approves Merck’s KEYTRUDA (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL) (Press)
  • Genentech Announces New OCREVUS (Ocrelizumab) Data on Long-Term Disability Benefits in Primary Progressive Multiple Sclerosis and Initiation of Two Global Studies in Progressive MS  (Press)
  • XARELTO (rivaroxaban) Associated with Significantly Reduced Time in Hospital and Decreased Costs Compared to Standard of Care in New Study of Patients with Low-Risk Pulmonary Embolism (PE) (Press)
  • Motif Bio Submits NDA for Iclaprim (Press)
  • Alexion Announces Selection of Positive Phase 3 Clinical Data for ALXN1210 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) for Late-Breaking Oral Presentation at Annual Conference of the European Hematology Association (EHA) (Press)
  • Certara Supports the Not-for-profit Biotechnology Company Medicines Development for Global Health (MDGH) on the FDA New Drug Approval of Moxidectin for the Treatment of River Blindness (Onchocerciasis), a Neglected Tropical Disease (Press)
Medical Devices
  • New research shows up to 1,000 patients harmed by medical device breaches (Fierce)
  • US FDA Recognizes ISO 18562 Biocompatibility Standard for Medical Devices (Emergo Group)
  • Experimental blood tests predict week of pregnancy and preterm birth risk (Reuters)
  • Engineering Implantable, Laboratory-Grown Organs To Cure Disease (Forbes)
  • Wright Medical wins FDA PMA for Augment injectable bone graft (MassDevice)
  • Intuitive Surgical pays $43m to settle class actions (MassDevice)
  • Early Dementia Detected in Hypertensive Patients Using MRI (GEN)
  • J&J Gets $70M Punitives Slashed In Surgical Stapler Case (Law360-$)
  • LivaNova Receives FDA Clearance and Completes First Implant for its MEMO 4D Semi-rigid Mitral Annuloplasty Ring (Press)
  • Cutting-edge Alinity ci-series diagnostics system comes to the U.S. (Press)
  • Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal (FDA)
  • InstruSafe by Summit Medical Launches New Trays for da Vinci SP Surgical System Instrumentation (Press)
  • Venus Medtech Enters North American Market (Press)
  • Optovue Announces Expanded FDA Clearance of Epithelial Thickness Mapping (Press)
US: Assorted & Government
  • Fighting back against the opioid crisis (The Hill)
  • The most important opioid bills in the House (Axios)
  • Frank Pallone: GOP push of opioid bills ‘total hypocrisy’ (Washington Examiner)
  • NIH-supported researchers find link between allergen in red meat and heart disease (NIH)
  • Birth control and beer kegs: How Trump’s tariffs will hit Middle America (Politico)
  • Google is hiring people to work on improving visits to the doctor's office with voice and touch technology (CNBC)
  • IBM Has Invented a Machine-Learning Device To Help You Stay Fit During Long Meetings. It Wants a Patent. (Fortune)
  • A bill would preserve the status quo of a contentious drug discount program for hospitals (STAT-$)
  • More Good News For CVS-Aetna With AMA Quiet On Deal (Forbes)
  • A New Congressional Proposal For A Medicare Long-Term Care Insurance Benefit (Forbes)
  • Gottlieb hungry for progress on three fronts (The Pharma Letter-$)
  • New Jersey dangles tax savings in front of Teva in bid to bag US HQ as revamp costs 200-plus jobs (Endpoints)
  • US Doesn't Owe ACA Money To Insurers, Fed. Circ. Rules (Law360-$)
  • If Big Health Deals Are a Go, Why Not Anthem-Humana? (Bloomberg)
  • The Eleventh Circuit Avoids Opining on the FTC’s Authority to Police Negligent Data Security Practices in Healthcare (FDA Law Blog)
  • Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—August 22, 2018 (CMS)
Upcoming Meetings & Events Europe
  • Canakinumab reduces gout rate by more than half (European Pharmaceutical Review)
  • Samsung Bioepis to promote rheumatism treatments in Europe (Korea Biomedical Review)
  • Information Commissioner urges NHS Trusts to prioritise privacy (pharmaphorum)
  • Immigration cap on doctors and nurses to be lifted to relieve NHS (The Guardian)
  • Number kept waiting too long for NHS treatment tops 500,000 (The Guardian)
  • NHS 'will need to build 80 more hospitals without fundamental reforms' (The Telegraph)
  • Steroid use for ideal body a 'time bomb' for Welsh NHS (BBC News)
  • Testicular Cancer Mapped Genomically and Epigenomically (GEN)
  • Wales backs NHS use of Actelion’s Uptravi for PAH (PharmaTimes)
  • Mental health spend must double to raise treatment levels, finds report (PharmaTimes)
  • European Patent Office validates Diffusion Pharma's oral formulations of TSC (Pharmabiz)
  • New Medical Device Regulation – an obstacle to progress (MedTech Views)
  • IT systems unavailable from 15 to 18 June 2018: EMA website and online applications will be temporarily unavailable (EMA)
  • New centres to speed up patient diagnosis: apply for funding (Innovate UK)
  • Medicines: new manufacturing and wholesale dealer licences (MHRA)
  • Register of brokers authorised to deal in human medicines (MHRA)
  • Medicines: terminated and cancelled manufacturing and wholesale dealer licences (MHRA)
  • amg International GmbH Receives European CE Mark Approval for ARCHIMEDES Biodegradable Biliary and Pancreatic Stent (Press)
  • Tilak Announces CE Marking for Odysight, Its First Mobile Medical Game in Ophthalmology (Press)
  • Ascletis' Ganovo gets CFDA approval for treatment of viral hepatitis C (PBR)
  • Regulatory Changes for Medical Devices in Singapore (Lexology-$)
  • Pharnext Announces PXT3003 was Granted Priority Review by the China Food and Drug Administration (Press)
  • Aptose Enters Into License Agreement With CrystalGenomics to Acquire CG-806 Rights in China (Press)
  • India's Fortis Healthcare pulls out of amalgamation scheme with Fortis Malar, SRL (Reuters)
  • Alembic Pharma spurts after USFDA nod for Doxycycline Hyclate capsules (Business Standard)
  • Maha FDA seizes fake ayurvedic drug cos having mfg base in Uttarakhand, Punjab, J&K, Raj, MP, Guj and Maharashtra (Pharmabiz)
  • Pharma in better health, these five stocks may be a good bet (Economic Times)
  • Push to get health services out of hospitals, into the home (The Australian)
  • ACSS public statement, 27-28 October 2017 (TGA)
  • From EpiPens to antibiotics, report finds Canada's drug shortages could be getting worse (CBC News)
  • First-line lung cancer approval for Roche drug in Canada (The Pharma Letter-$)
  • Health Care Has Its Own Barriers Preventing Women From Reaching The Top (HuffPost)
  • List of Drugs for an Urgent Public Health Need (Health Canada)
  • Canada's scientists can pitch projects that bridge artificial intelligence, health research (Press)
General Health & Other Interesting Articles
  • Kids in U.S. "hotspots" most vulnerable to vaccine-preventable disease, research finds (CBS)
  • Listen: How can we make best use of health data? (Financial Times)
  • How Cognitive Behavior Therapy May Help Suicidal People (NYT)
  • DNA Detectives Are Searching for Killers in Your Family Tree (Bloomberg)
  • Do we keep waiting for the next pandemic or try to prevent it? (STAT)
  • Scientists At WFIRM Have Successfully Developed A 3-D Brain Organoid (Forbes)
  • Exosomes Shown to Be Involved in Spread of Amyloid Beta in Alzheimer’s (GEN)

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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