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

Posted 09 April 2018 | By Ana Mulero 

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

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In Focus: International
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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 $52M Series C for bone marrow transplant pipeline (Endpoints) (Press)
  • Survey: patient engagement a low priority in clinical trials (pharmaphorum)
  • Nematodes inspire new class of antibiotic (Fierce)
  • Researchers use genomics to set squamous cell carcinomas apart from other cancers (Pharmabiz)
  • First-quarter floats hold amid uncertain climate (EP Vantage)
  • Research offers clues for improved influenza vaccine design (NIH)
  • Notice of Approval of Products under Voucher: Rare Pediatric Disease Priority Review Vouchers (FDA)
  • Pacira Announces FDA Approval of Supplemental New Drug Application for EXPAREL as a Nerve Block to Produce Regional Analgesia (Press)
  • Immunomedics Appoints Dr. Robert Iannone Head of Research & Development and Chief Medical Officer (Press)
  • GTx Announces Early Completion of Patient Enrollment in the ASTRID Trial, a Phase 2 Clinical Trial of Enobosarm in Stress Urinary Incontinence (Press)
  • Minerva Neurosciences Screens First Patient in Phase 2b Trial of MIN-117 to Treat Major Depressive Disorder (Press)
  • FDA Accepts New Drug Application for Duvelisib and Grants Priority Review (Press)
  • Allogene Therapeutics Completes Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio (Press)
Medical Devices
  • Spotlight – Oxford Nanopore, the disruptive unicorn gunning for Illumina (EP Vantage)
  • Renal denervation: Medtronic wins FDA nod for U.S. pivotal trial (MassDevice) (Press)
  • Cogentix shareholders sue to block Laborie Medical acquisition (MassDevice)
  • Medical Device Cos. Deny FCA Suit's Excess Blood-Test Claim (Law360-$)
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • 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
  • 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
  • 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)
Canada
  • '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)
General Health & Other Interesting Articles
  • 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)
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.

Need to contact the editor of Regulatory Reconnaissance? Find heron Twitter at @anitamulero or send her an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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