Regulatory Focus™ > News Articles > 8 > Recon: Express Scripts Unveils Exclusion List; UK Considers Biosimilars in Price Controls

Recon: Express Scripts Unveils Exclusion List; UK Considers Biosimilars in Price Controls

Posted 07 August 2018 | By Ana Mulero 

Recon: Express Scripts Unveils Exclusion List; UK Considers Biosimilars in Price Controls

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

In Focus: US
  • Express Scripts to Drop Big Sellers From AbbVie, Gilead in 2019 (Bloomberg)
  • Humana sues dozens of generic drug manufacturers for price-fixing scheme (Fierce) (Law360-$)
  • Carl Icahn Publicly Opposes $54 Billion Cigna-Express Scripts Deal (WSJ) (Bloomberg)
  • Spark’s gene therapy data answer some burning questions — and raise a few more (STAT) (GEN)
  • The Full Senate Position on FDA’s FY 19 Appropriation (Alliance for a Stronger FDA)
  • Musician-scientist Manny Simons and Akouos seek way to treat a gene-based hearing loss (The Boston Globe) (C&EN) (Business Insider) (Xconomy)
  • When more is less: Americans spent lots more on fewer pills (STAT-$)
  • New report singles out Big Pharma players for ringing their blockbusters with patents while hiking prices for years (Endpoints) (The Center for Biosimilars) (Fierce)
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In Focus: International
  • UK government looks to include biosimilars in price controls (PMLiVE) (PharmaTimes)
  • Pfizer to lose patent of drug Viagra, Indian companies gear up with copycat versions (Hindustan Times) (Economic Times)
  • GSK appoints HSBC's Iain Mackay as CFO (PharmaTimes) (Reuters) (The Telegraph) (Endpoints)
  • ABPI Response: MHRA guidance on Brexit Implementation (ABPI)
  • U.K.'s Raid of Concordia in Drug Probe Was Lawful, Judge Rules (Bloomberg-$)
  • Drug prices not always aligned with value, researchers say (ScienceDaily)
  • Affordable healthcare in India: apply for funding (Gov UK)
  • Onward Ho! Glenmark Strikes First Onco Asset Deal With China’s Harbour BioMed (Scrip-$)
  • Two more Chinese pharma groups hit by drugs scandal (Asia Times)
  • Scandal-hit Chinese vaccine maker Changsheng started falsifying records in 2014: Xinhua (Reuters)
  • Sun Pharma recalls over 5.2k units of testosterone cypionate injections from US (Economic Times)
  • Australian state reports its first case of superbug fungus (AP News) (The Australian)
Pharmaceuticals & Biotechnology
  • Congress requests Sackler deposition that Purdue Pharma is fighting to keep sealed (STAT)
  • Skies Darken for Drug Middlemen (WSJ)
  • Allergan builds on gene editing deal (PMLiVE)
  • Keep off-target effects in focus (Nature)
  • Changes To Drug Prices: Gestures And Real Policy Shifts (Forbes)
  • Gilead Said PrEP To Prevent HIV Was 'Not A Commercial Opportunity.' Now It's Running Ads For It (Forbes)
  • Two Mistakes Investors Make When Investing In Biotechnology Companies (Forbes)
  • Biotech Small-Cap Looks to Rival Pfizer With Rare Disease Drug (Bloomberg)
  • Falling Generic Drug Prices Sow Chaos in Drug Industry Earnings (Bloomberg-$)
  • High Court Ruling Can't Help Pfizer 'Win The Day' In Class Suit (Law360-$)
  • Cherokee Nation Wants Purdue Opioid Row In State Court (Law360-$)
  • Providers Say Don't Kill Hospital Bellwether In Opioid MDL (Law360-$)
  • Reality check on PBMs and drug costs (Politico)
  • Generics Generated Over $200 Billion in Savings in 2017 (AJMC)
  • AAM Worries About Continuous Manufacturing, Others Aren't Sure Why (Inside Health Policy-$)
  • Amgen freezes drug prices, credits Trump (Washington Examiner)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Certara modeling aided 95% drug approvals in the first half of 2018, as the FDA looks to greater use of in silico tools (Fierce)
  • The FDA is poised to approve the first-ever drug that mutes disease-causing genes (STAT-$)
  • FDA Advisors Set to Consider Next-Gen Tetracycline for CABP (MedPage Today)
  • PAH therapy tanks in Phase III, obliterating Bellerophon’s stock (Endpoints)
  • Alembic Pharma gets tentative USFDA nod for ophthalmic solution (Economic Times)
  • FDA supplement approval to GSK’s RabAvert (FDA)
  • Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications (FDA)
  • Characteristics of Tianeptine Exposures Reported to the National Poison Data System — United States, 2000–2017 (CDC)
  • US WorldMeds and Salix Announce U.S. Launch of LUCEMYRA (lofexidine) 0.18 Mg Tablets (Press)
  • Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma (Press)
Medical Devices
  • Industry to refocus and reinvest in US following potential medical device tax repeal, say CRO execs (Outsourcing-Pharma)
  • Hologic’s Cynosure to close NY-based plant, layoff 30 (MassDevice)
  • Credence MedSystems raises $13m to support syringe systems (DDBN)
  • Machine learning-based skin screening could lead to care disparities for people of color, JAMA op-ed says (MobiHealthNews)
  • As microbiome testing firms proliferate, so do questions about their claims (STAT)
  • Kibosh on Urine Test Cup Suit Springs Leak, Court Revives Suit (Bloomberg-$)
  • At seminar, Medtronic employees told cybersecurity is a 'team sport' (Minneapolis Star Tribune)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices (FDA)
  • Viveve Announces FDA Approval to Continue VIVEVE II Clinical Study (Press)
  • Foundation Medicine Publishes New Data in Nature Medicine Supporting Blood Tumor Mutational Burden (bTMB) as a Novel Predictor of Response to Cancer Immunotherapy (Press)
  • CSA, OWASP Issue Updated Guidance for Secure Medical Device Deployment (Press)
US: Assorted & Government
  • Hope for Lyme disease victims: Researchers race to develop new tests — and a vaccine (CNBC)
  • GoodRx valued at about $2.8 billion after Silver Lake investment, sources say (CNBC)
  • Trump’s Short-Term Health Insurance Policies Quickly Run Into Headwinds (NYT)
  • Human Longevity denied restraining order against J. Craig Venter Institute (The San Diego Union-Tribune)
  • Average insurance deductibles keep rising (Axios)
  • Future of Health Insurance Is at Stake in the Midterms (Bloomberg)
  • Humana’s Walgreens Clinics Could Save Money, Boost Ratings (Bloomberg-$)
  • Health IT Now Leads Coalition Letter Demanding Quick Action on Information Blocking (Health IT Now)
  • CMS Administrator Seema Verma calls for an end to physician fax machines by 2020 (Healthcare IT News)
Upcoming Meetings & Events Europe
  • Biotech entrepreneur Drayson plans to list new AI drug research firm (Reuters)
  • Italy Senate overturns mandatory vaccination law (Financial Times-$)
  • Europe’s Eudamed Database: Five Key Questions (Part 1) (Emergo Group)
  • Exploring the science and innovation behind #WeWontRest (EFPIA)
  • Mining real world data for drug development insights, Woodford-backed AI firm seeks $77M London IPO (Endpoints)
  • Take it personally (President of Mylan Europe)
  • How former drug company labs are becoming contract research firms (C&EN)
  • Individual distinguishing features and safety precautions on the packaging of medicinal products (Swissmedic)
  • Updated: Clinical trials for medicines: authorisation assessment performance (MHRA)
  • Celltrion Enters into Phases 1 and 3 Clinical Trials for the Adalimumab Biosimilar 'CT-P17' (Press)
  • Arcadia Biosciences Responds to EU Court Ruling Regarding Regulation of Organisms Obtained by Mutagenesis (Press)
  • Could a dose of blockchain prevent China’s vaccine production data problem? (Fierce)
  • 59 Korea-made high blood pressure medications called back over cancer fears (Korea Biomedical Review)
  • Blade Runners: Prosthetics Startup Xiborg is Ready for Business (Bloomberg)
  • MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018) (PMDA)
  • Jiangsu special rectification of illegal use of medical equipment online and offline synchronization supervision (CAMDI)
  • Why Torrent Pharma Is Outperforming Its Larger Indian Peers (Bloomberg)
  • Sanofi launches its multiple sclerosis treatment drug in India (Economic Times)
  • Telangana plans country’s first biopharma hub (Economic Times)
  • Gujarat FDCA serves closure notices to three blood banks for putting patient safety at risk (Pharmabiz)
  • iX Biopharma's male erectile dysfunction drug, Silcap receives Australian approvals (Pharmabiz)
  • Research: Software as a Medical Device and Cyber Security for Medical Devices (TGA)
  • Updated: Orphan drug designation: A step-by-step guide for prescription medicines (TGA)
  • Updated: Orphan Drug designation eligibility criteria: Including supporting documentation (TGA)
  • ACMD meeting statement, Meeting 40, 12 April 2018 (TGA)
  • ACMD meeting statement, Meeting 41, 28 June 2018 (TGA)
  • Health Canada issues updated guidance on PMNOC Regulations (Lexology-$)
  • Health Canada Approves HEMLIBRA for Hemophilia A Patients with Inhibitors (Press)
  • Innovus Pharma Announces Three Regulatory Filings with Health Canada for Its Products: Xyralid Suppositories, Beyond Human Testosterone and RecalMax (Press)
General Health & Other Interesting Articles
  • Got skin cancer? Blame the FDA (Fox)
  • Patients who accepted infected kidneys cured of hepatitis C (AP News)
  • Bots Are Dominating The Discussion About E-Cigarettes On Twitter (Forbes)
  • Can a phone app’s warnings to avoid risky friends and places prevent opioid addiction relapses? (STAT)
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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