Recon: FDA Panel Backs Akcea-Ionis Rare Disease Drug

• Akcea, Ionis win over most FDA experts to their rare disease drug volanesorsen, vastly improving odds of success (Endpoints) (Fierce) (PharmaTimes) (PMLiVE)
• AstraZeneca's Fasenra Fails in Trial of Severe Lung Disease (Bloomberg) (Reuters) (BioCentury)
• Akari CEO Horn Solomon ousted after allegedly abusing the company credit card (Endpoints) (BioSpace)
• Faron fingers low bioactivity as possible cause of phase 3 flop (Fierce) (The Pharma Letter-$)
• Trump touts plan to lower drug costs but rejects Medicare negotiations (Politico) (NYT)
• HHS Secretary, FDA Commissioner, CMS Administrator: Help is on the way for Americans facing high drug prices (Fox)

• Johnson & Johnson unveils new Asia-Pacific headquarters in Singapore (HRM Asia) (The Straits Times) (The Pharma Letter-$)
• Fortis Healthcare board opts for Munjal-Burman combine’s bid for sale of business (Financial Express) (Reuters) (Bloomberg) (Business Standard) (Times of India)
• US needs to pressure foreign countries to pay more for prescription drugs through trade agreements: HHS chief Azar (CNBC)
• Whisky and Apologies Aided Takeda's $62 Billion Shire Gamble (Bloomberg)
• DoJ investigates Mylan on trade compliance for certain products (Reuters)
• 11 additional cases of hemorrhagic fever in Congo including 1 death (CNN)
• Time to eradicate HTLV-1, World Health Organisation is warned (The Guardian) (ABC News)

• La Jolla grabs $125M royalty deal to back drug launch, fund R&D (Endpoints)
• Rest easy, pharma. Word is, Trump's drug pricing plan won't be a tough pill to swallow (Fierce)
• Getting contraceptives for men to the market will take pharma’s help (STAT)
• White House trumpeting drug plan as most far-reaching ‘of any president’ (STAT)
• In taking on high drug prices, Trump faces a complex nemesis (AP News)
• HHS Secretary Azar says everybody is 'wetting their beak ' on high drug list prices (CNBC)
• Cramer vets biotech giants Biogen, Celgene, Gilead and Regeneron for positive prospects (CNBC)
• Our new drug could drastically change hemophilia patients' lives, Biomarin CEO says (CNBC)
• Trump plan for drug prices seen largely sparing industry (Reuters)
• The 5 most expensive drugs in the United States (CNN)
• Why VC Tim Draper Keeps Defending Theranos CEO Elizabeth Holmes (Fortune)
• That $1.2 Million Payment to Trump's Lawyer Wasn't Even a Drop in the Bucket for Novartis (Fortune)

• Celldex plans life after glembatumumab, cutting 2 more drugs from pipeline (Fierce)
• Puma shares plummet as results from key trial delayed (BioPharma Dive)
• Will Real World Performance Replace RCTs As Healthcare's Most Important Standard? (Forbes)
• CABANA: No Outcomes Benefit In First Big Trial Of AF Ablation (Forbes)
• Ablation groups scramble to cope with Cabana (EP Vantage)
• PharmaCyte completes pore size studies in Cell-in-a-Box capsules used in pancreatic cancer therapy (Pharmabiz)
• PARP-1 mutations could drive PARP inhibitor resistance (BioCentury)

• This tiny chip uses A.I. to control blood sugar levels for critical diabetes patients (CNBC)
• Instead of Giving Her a Prosthetic Ear, Army Doctors Grew a New One in This Soldier's Arm (Fortune)
• FDA clears PeraHealth’s lifesaving clinical surveillance tech (pharmaphorum)
• CARB-X backs Talis to develop point-of-care gonorrhea tests (Fierce)
• Mayo Clinic and AliveCor use AI to detect ‘invisible’ heart condition (Fierce)
• AI predicted a patient’s odds of dying with 90% accuracy (Axios)
• BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application (Press)

• FDA Publishes Long-Awaited Draft Guidance on Waivers, Exceptions, and Exemptions from the DSCSA (FDC Act Section 582) (FDA Law Blog)
• Stop the Presses: FDA Publishes Policy for Granting Requests to Conduct Expedited Reviews of NDA and BLA CMC Prior Approval Supplements (FDA Law Blog)
• Connecticut legislature passes pricing transparency bill (BioCentury)
• Amazon is building a 'health & wellness’ team within Alexa as it aims to upend health care (CNBC)
• How Humana And Walmart Can Overcome Organizational Autoimmune Disease (Forbes)
• GOP senator calls for mandatory Medicaid work requirements (The Hill)
• Nurse charged with neglect, manslaughter in death of former Trump adviser H.R. McMaster's father (ABC News)
• Senators to Azar: Why aren't you fixing Medicare wage index? (Modern Healthcare)
• Anthem PBM CEO Brian Griffin leaving after a few months in the role (Modern Healthcare)
• Who should lead Veterans Affairs? Five veterans explain what they’re looking for in a leader. (The Washington Post)
• June 12, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
• Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee—July 25, 2018 (CMS)

• FDA Advisory Committee Calendar

• EMA’s PRIME driving innovation to where it is most needed (The Pharma Letter-$)
• Janssen’s Tremfya backed for NHS use (PharmaTimes)
• Updated: Good clinical practice inspection metrics (MHRA)
• Marketing authorisations granted in April 2018 (MHRA)
• Parallel import licenses granted in April 2018 (MHRA)
• Brainomix Announces CE Mark Certification for New e-CTA Software (Press)

• Avid CEO talks expansion, capacity and Asia (BioPharma Dive)
• Chinese biotech firm Ascletis first to apply for Hong Kong IPO (BioSpectrum)
• Betting the pharma -- Japan's misdirected M&A boom (Nikkei Asian Review)

• Epygen looking to raise Rs.300 cr to propel biosimilars in India (Pharmabiz)
• Can Modicare cure India's healthcare woes? (Financial Times)
• Clinical trials by pharmaceutical companies still gasping for transparency (Economic Times)
• Novartis India appoints Milan Paleja as vice chairman and MD (Economic Times)
• FDA warning letter tells India's Goran Pharma to get professional help (Fierce)
• Why Pharma Doesn't Always Keep Phase IV Promises In India (Scrip-$)

• Fitness apps found to make almost no difference to users' health (The Guardian)
• Australian scientists welcome boosts in new federal budget (Science Magazine)
• NSW mental health units face overhaul (The Australian)
• Philips, Emory Healthcare and Royal Perth Hospital in Australia partner to launch new remote intensive care monitoring program (Press)

• Why Canada hasn’t issued a recall on romaine lettuce after an E. coli outbreak (Global News)
• ReShape Lifesciences Announces Submission for Approval of ReShape Balloon  in Canada (Press)

• To make medicines of the future, hospitals build their own cell factories (STAT-$)
• Some opioid-hit areas left off rural response grants priority list (Modern Healthcare)
• Medicare covers less than you might think. Here's how to avoid surprises (CNBC)
• The Most Potent Prescription Ever: Take Time For Yourself, As Directed By Your Doctor (Forbes)
• Hangover Pill Shows Promise in Lab Tests (Fortune)
• The shrinking health spending gap (Axios)