Recon: Novartis to Acquire Gene Therapy Company AveXis for $8.7B

• Novartis Bets $8.7 Billion on Gene-Therapy Company (WSJ) (Reuters) (Endpoints) (Financial Times) (Bloomberg) (Axios)
• Constellation snags $100M 2 years after Genentech snub (Fierce) (pharmaphorum) (Endpoints)
• Ionis may get up to $300 million in licensing deal with AstraZeneca (Reuters) (Fierce) (Endpoints)
• Merck racks up another win in wide-ranging PhIII Keytruda lung cancer study, this time as solo therapy (Endpoints) (Reuters) (BioPharma Dive)
• Therapix's cannabinoid Tourette drug makes the grade in phase 2 (Fierce) (Reuters) (Endpoints)
• New US approval for Clovis' Rubraca (PharmaTimes) (BioPharma Dive) (The Pharma Letter)
• Menlo’s IPO hangover begins with a failed PhII for an old Merck castoff (Endpoints) (Fierce)
• Canon gets FDA nod for high-resolution CT system (Fierce) (MassDevice)

• AstraZeneca taps Owlstone for breath biopsy services (Fierce) (EPM Magazine) (Drug Delivery Business News)
• MorphoSys launches $200 million US IPO in largest biotech listing in a decade (Renaissance Capital) (MarketWatch)
• NICE u-turn sees Roche’s Tecentriq backed for lung cancer (PharmaTimes) (Fierce)
• Tremfya approved for psoriasis and psoriatic arthritis in Japan, Brazil and Australia (The Pharma Letter) (Pharmabiz)
• Teva to shut Ashdod plant within year, with loss of 175 jobs (Times of Israel) (Reuters)
• Heart patients among those to benefit as NHS England backs innovation (NHS England) (National Health Executive) (PharmaTimes)
• South Africa may ask pharma firms for fee to clear drug review backlog (Reuters)
• Trump tariffs threaten to cost medical device industry billions (Fierce)
• NIH scientists develop macaque model to study Crimean-Congo hemorrhagic fever (NIH)
• Agency Publishes Final Guidance on Data Integrity – the British Medicines and Healthcare Products Regulatory Agency that is (FDA Law Blog)

• Celgene hunts deals to offset loss of Revlimid patent protection (Financial Times)
• Avexis buy endorses gene therapy and gives Biogen a headache (EP Vantage)
• CVS points finger back at pharma for drug prices (BioPharma Dive)
• The ties between drug companies and patient groups (Axios)
• InVivo plans 1-for-25 reverse stock split (MassDevice)
• Mass. governor defends Vertex drug pricing, saying ‘innovation is expensive’ (STAT)
• Why are some of New York’s top investors bullish on biotech? The science is getting better (STAT-$)
• Already hobbled by Medicare, Gilead’s Yescarta faces another hurdle as CMS stalls add-on hospital payments (Fierce)
• FDA Commissioner Dr Scott Gottlieb on drug prices (C-SPAN)
• Drug Cos., Pharmacies Want Pause In Cherokee Opioid Suit (Law360-$)
• Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback? (KHN)

• This Lung Cancer Drug Could Let Patients Forgo Chemo—And It's Sending Merck's Stock Soaring (Fortune)
• AbbVie’s promised rheumatoid arthritis blockbuster upadacitinib hits its marks in another PhIII — this time without any deaths (Endpoints) (Press)
• Magenta bags $52M Series C for bone marrow transplant pipeline (Endpoints) (Press)
• Survey: patient engagement a low priority in clinical trials (pharmaphorum)
• Nematodes inspire new class of antibiotic (Fierce)
• Researchers use genomics to set squamous cell carcinomas apart from other cancers (Pharmabiz)
• First-quarter floats hold amid uncertain climate (EP Vantage)
• Research offers clues for improved influenza vaccine design (NIH)
• Notice of Approval of Products under Voucher: Rare Pediatric Disease Priority Review Vouchers (FDA)
• Pacira Announces FDA Approval of Supplemental New Drug Application for EXPAREL as a Nerve Block to Produce Regional Analgesia (Press)
• Immunomedics Appoints Dr. Robert Iannone Head of Research & Development and Chief Medical Officer (Press)
• GTx Announces Early Completion of Patient Enrollment in the ASTRID Trial, a Phase 2 Clinical Trial of Enobosarm in Stress Urinary Incontinence (Press)
• Minerva Neurosciences Screens First Patient in Phase 2b Trial of MIN-117 to Treat Major Depressive Disorder (Press)
• FDA Accepts New Drug Application for Duvelisib and Grants Priority Review (Press)
• Allogene Therapeutics Completes Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio (Press)

• Spotlight – Oxford Nanopore, the disruptive unicorn gunning for Illumina (EP Vantage)
• Renal denervation: Medtronic wins FDA nod for U.S. pivotal trial (MassDevice) (Press)
• Cogentix shareholders sue to block Laborie Medical acquisition (MassDevice)
• Medical Device Cos. Deny FCA Suit's Excess Blood-Test Claim (Law360-$)
• Amarantus Bioscience ropes in rights to Avant Diagnostics’ Alzheimer’s Dx (Fierce) (Press)
• Consumers don’t need experts to interpret 23andMe genetic risk reports (STAT)
• The Changing Face of Medical Device Sales: Can You Make the Cut? (ProSellus)
• 3M signs on with C3 for its AI predictive software for clinical and supply chain analytics (Healthcare IT News)
• Weill Cornell Integrates Cancer Exome Test Into EHRs With Eye Toward Next Version (GenomeWeb)
• Companies push back against allegations of FCA violations over excess at-home blood testing (Drug Delivery Business News)
• Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator (Press)
• EyeGate receives FDA feedback on investigational device exemption amendment for second pilot study of ocular bandage gel (Press)
• Sonoma Pharmaceuticals Announces FDA Approval for Antimicrobial Post-Therapy Gel (Press)

• Trump taps new director for office on Medicare reforms (The Hill)
• Health Insurers Tout Strides In Preventive Care Amid Attacks On Medicaid (Forbes)
• Two experts debate whether Facebook should get into health (CNBC)
• New York panel to review Vertex pricing in first test of new law (STAT-$)
• In key Kentucky House race, healthcare anxieties loom large (Reuters)
• New Jersey health officials investigating potential E.coli outbreak (Reuters)
• Medicare to pay hundreds of thousands for CAR-T therapies (BioPharma Dive)
• ONC launches tool to help patients navigate health data (Healthcare IT News)
• Feds Want Input On Marijuana Reclassification (Forbes)

• FDA Advisory Committee Calendar

• Recordati acquires rights to Cystagon from Mylan (The Pharma Letter)
• How GDPR affects personal data use in clinical trials (MassDevice)
• Reig Jofre invests 30 million euros in expansion of injectable products plant (The Pharma Letter)
• EMA to review Aradigm's appliation for Linhaliq (The Pharma Letter) (Press)
• Public hearing on 13 June 2018: Citizens to be consulted on quinolone and fluoroquinolone antibiotics (EMA)
• Review into NHS overseas visitor charges: call for submissions (MHRA)
• Guidance: Notify MHRA about a clinical investigation for a medical device (MHRA)
• Open consultation: Personal health budgets and integrated personal budgets: extending legal rights (MHRA)
• Guidance: General ophthalmic service fees and voucher values from April 2018 (MHRA)
• Summary List of field safety notices (FSNs) from medical device manufacturers from 02 – 06 April 2018 (MHRA)
• NHS England to Fund Endocuff Vision for Cancer Screening Colonoscopies Bowel (Press)
• Tandem Diabetes Care and Movi SpA Announce Agreement for Distribution of Insulin Pump Products in Italy (Press)

• Israel’s ReWalk turns focus to stroke victims with cheaper walking device (Times of Israel)
• China’s CAR-T Therapy Race (PharmExec)
• Pakistan launches countrywide polio eradication drive (Reuters)
• MorphoSys' licensee Janssen receives Japanese approval for Tremfya to treat moderate to severe forms of psoriasis & psoriatic arthritis (Pharmabiz)
• Daiichi Sankyo, DarwinHealth ink research agreement for novel cancer target initiative (Pharmabiz)
• UAE approval heralds Mavenclad’s arrival in new market (The Pharma Letter-$)
• China moves on to ICH GCP, despite great challenges (The Pharma Letter-$)

• India’s move to universal healthcare: will the government salvage the healthcare system? (Qrius)
• India To Spend Rs 16,717 Crore On Modi’s Health Insurance Plan In Two Years (Bloomberg)
• Corrigendum against S.O. 1463(E) dated 02-04-2018. (NPPA)
• Indian Pharmaceutical Alliance urges govt to effectively use patent law to safeguard public health (Pharmabiz)
• Indian pharma companies secure 51 final ANDA approvals during Jan-March 2018 (Pharmabiz)
• Healthium MedTech acquired by Apax Partners to boost its market presence (Pharmabiz)

• Australia missing psychedelic drug 'renaissance' for mental health (The Sydney Morning Herald)
• Report: Almost Half of Australian Military Veterans Suffer Mental Health Conditions (Voice of America)
• WHO says Australia exported listeria-tainted melons to nine countries (Reuters)
• Safety alert- Black Ant King tablets (TGA)
• Safety alert - Vegetal Vigra capsules (TGA)
• TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018 (TGA)
• Elto Pharma Receives Notice of Allowance in Australia for Patent Covering Eltoprazine in the Treatment of Parkinson's Levodopa-induced Dyskinesia (Press)

• 'Miracle' tonic event in Calgary prompts probe by Health Canada (CBC News)
• Canada’s big city mayors calling for national benchmarks to tackle mental health crisis (Global News)
• Mental health in our cities is a crisis (The Toronto Star)
• Register of Innovative Drugs (Health Canada)
• Notice of Compliance (NOC) Data Extract (Health Canada)
• FTC Staff Comment Supports Proposal to Enhance Access to Dental Care in New York (FTC)
• Health Canada approves TECENTRIQ (atezolizumab) for the treatment of patients with metastatic non-small cell lung cancer (Press)
• Pfizer Canada and MaRS Innovation Partner to Convert Great Science into Solutions to Benefit Canadians’ Health (Press)
• BESPONSA Approved by Health Canada for the Treatment of Adults with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia (Press)

• Why Trump’s Tariffs Could Raise the Cost of a Hip Replacement (NYT)
• For Uber And Lyft, Medicare Could Be The Next Profitable Ride (Forbes)
• The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care (CNBC)
• 30,000 Strong and Counting, UnitedHealth Gathers a Doctor Army (Bloomberg-$)
• The Medical Marketplace Is Changing Fast (Bloomberg-$)
• Don't overlook the expanded tax deduction for medical expenses (CNBC)
• Many People Taking Antidepressants Discover They Cannot Quit (NYT)
• More companies to tap lucrative robot-assisted surgical systems market: GlobalData (Pharmabiz)
• Scientists are thinking the unthinkable: CRISPR might one day reverse devastating brain diseases (STAT-$)
• The strange story of a global pharma company’s Silicon Valley winery (STAT)
• Where AI has the most promise for reducing healthcare costs (Healthcare IT News)