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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)