Recon: Novartis to Spin Off Alcon; Biogen to Pay $700m for Samsung Joint Venture Stake

• Biogen to pay $700M to boost stake in Samsung biologics joint venture (Boston Business Journal-$) (GEN) (Reuters) (Endpoints) (Fierce)
• Novartis to Spin Off Alcon Eye-Care Business (WSJ) (Financial Times) (Bloomberg) (Reuters)
• CVS to Pay $1.5M to Settle Probe of Opioid Reporting Lapses (Bloomberg) (Reuters)
• Indivior gets breather after court extends order blocking generic rival (Reuters) (Forbes)
• After nearly 3 years, FDA lifts hold on Aptose cancer drug (Fierce) (Endpoints)
• AbbVie retreats as Galapagos offers mixed PhII CF data, leaving a major alliance in peril — Vertex shares surge (Endpoints) (Fierce) (BioSpace)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug (FDA)
• Pharma drops its lawsuit against Nevada over drug pricing transparency law (STAT-$) (Inside Health Policy) (The Nevada Independent)

• Start MDR /IVDR transition planning before it’s too late! We've now assembled and updated the "best of" these resources, for those who have questions at all stages of the transition from the previous Medical Device Directive, 93/42/EEC and In-Vitro Diagnostic Directive (98/79/EC). Our free transition readiness package includes an initial review checklist, MDR technical documents requirements, regulation details, post market surveillance requirements, MedDev 2.7.1 alignment, SPR mapping and more.

• Andriukaitis: SPC manufacturing waiver does not damage pharma innovation (Euractiv)
• Acceleron blood disease drug hits goal in pivotal clinical trial (STAT) (Endpoints) (Fierce)
• Update: MHRA streamlines services for devices customers (MHRA)
• ICH M9 reaches Step 2b of the ICH Process (ICH)
• Commission and WHO discuss how to strengthen their collaboration (EC)
• Anvisa maintains status in the European Union for pharmaceutical supplies (Anvisa)
• WHO health supplies reach southern Syria as needs grow amid increased fighting (WHO)

• Top Policy Expert’s Ties To Giant Drugmaker Often Go Unstated (Kaiser Health News)
• Biosimilars Forum Releases Position on Non-Medical Switching (Biosimilars Forum)
• Status of U.S. Biosimilar Approvals and Pending Applications (Patent Docs)
• Federal watchdog bashes controversial drug discount program for lax oversight (Washington Examiner) (GAO)
• Quality metrics – the next step (Lachman Consultants)
• How Big Pharma Was Captured by the One Percent (The New Republic)
• Bayer teams up with the Broad to tackle congestive heart failure (The Boston Globe)
• What does PBM stand for? In Ohio (and elsewhere), it’s programs bilking millions (STAT)
• Investors are bored with Big Biotech. Here’s a look at the numbers (STAT-$)
• How does the first half of 2018 measure up against the last 7 years for biotech IPOs? (Endpoints)
• FDA chief on Amazon's health-care move: 'Disruptive competition is a good thing' (CNBC)
• Amazon's PillPack Acquisition All Started With an MIT Hackathon (Bloomberg)
• AI Will Not Threaten Pharma Patents – Not This Way (Science Translational Medicine)
• Human nature: the next frontier for pharma? (PharmaTimes)
• Voyager Therapeutics poaches Genzyme, Sanofi executive Andre Turenne as new CEO (Fierce)
• DIA18: CRISPR, AI, blockchain and the future of drug development (BioPharma Dive)
• ICER Weekly View 06-29-18 (ICER)
• Clarifications to FDA’s Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (FDA Law Blog)
• Court Rules That Boehringer Doesn’t Have to Give Barr Deal Analysis to the FTC (FDA Law Blog)

• Novo Nordisk trumpets more Januvia-topping data for oral semaglutide (Fierce)
• Gemphire sparkles on third trial win for lead drug gemcabene (Fierce)
• FDA approves Dermira's wipe for excessive armpit sweating (Reuters)
• Cel-Sci vindicated in CRO arbitration (BioPharma Dive) (Washington Business Journal-$)
• Approved Anti-Cancer Drugs Reveal New Target: Non-Coding RNAs (GEN)
• CAR-T Cells Just Got Some "Killer" Competition (GEN)
• Novel drug therapy partially restores hearing in mice (NIH)
• Ocular Therapeutix Announces NDA Resubmission of DEXTENZA (Press)
• ACADIA Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for NUPLAZID (Pimavanserin) (Press)
• Spectrum Pharmaceuticals Presents ADVANCE Phase 3 ROLONTIS (eflapegrastim) Data at MASCC 2018 and Announces the Phase 3 RECOVER Study Met the Primary Endpoint (Press)
• Alder BioPharmaceuticals Presents New One-Year Data for Eptinezumab from PROMISE 1 Phase 3 Trial Demonstrating Long-Term Efficacy in Episodic Migraine (Press)

• Avita Medical acquires California plant producing its burn treatment device (Fierce)
• Neuronetics goes public with $93.5M IPO following several VC rounds (Fierce)
• ReWalk Robotics expands ReStore soft exo-suit trial (MassDevice)
• Medical device security software startup MedCrypt pulls in $1.9M (MobiHealthNews) (MedCity News)
• Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology Hyperlordotic ALIF Interbody Spinal Fusion System (Press)
• Embolx Announces FDA Clearance of Next Generation Sniper Balloon Occlusion Microcatheter to Deliver Pressure-Directed Therapy for Tumors, Enlarged Prostate and Fibroids (Press)
• Apollo Endosurgery Receives Special 510(k) Clearance for OverStitch Sx Endoscopic Suturing System (Press)
• GenMark Diagnostics Announces FDA Submission of its ePlex Blood Culture Identification Gram Positive Panel (Press)

• 2018 PDA/FDA Joint Regulatory Conference (FDA)
• Important Information for Blood Establishments Regarding Brodifacoum Contamination of Synthetic Cannabinoids (FDA)
• Biological Product and HCT/P Deviation Reports – Annual Summary for Fiscal Year 2017 (FDA)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online (FDA)
• FDA allows off-label health care economic discussions. Is there more to come? (STAT)
• Amazon swooped in to buy PillPack for around $1 billion after Walmart dragged its feet (CNBC)
• Amazon Faces Challenges in Cracking $300 Billion Pharmacy Market (Bloomberg)

• FDA Advisory Committee Calendar

• UK Watchdog Looks To Revive £89M Drug Pricing Fine (Law360-$)
• EU approves Pfizer’s Xeljanz for psoriatic arthritis (PharmaTimes)
• Puma Biotech gets EU panel nod for breast cancer drug (Reuters)
• Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma (Press)

• Mitsubishi and Janssen tweak Stelara collaboration in Japan (The Pharma Letter)
• Sanofi Korea presents findings on head-to-head trial on Toujeo vs. Tresiba (Korea Biomedical Review)
• BMS Korea wins fight for Eliquis patent (Korea Biomedical Review)
• Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer (JAMA)
• Daiichi Sankyo and Menarini Enter into Exclusive Licensing Agreement for Commercializing LIXIANA in the Philippines, Malaysia and Singapore (Press)
• Zai Lab Announces Dosing of First Patient in Phase 3 China Registration Trial of ZL-2306 (niraparib) for First-Line Maintenance Therapy in Platinum Responsive Ovarian Cancer (Press)

• Patents After Kennedy • Black Market Fertility • Devices in India (Bloomberg)
• Fortis Healthcare extends deadline of binding bids to July 3 (Times of India)

• New warnings on labels of medicines containing neuromuscular blocking agents (TGA)
• Medicine labels: Guidance on TGO 91 and TGO 92 (TGA)

• Canada’s Supreme Court Preserves Drug Price Control Powers (Bloomberg)
• Drug and health product submissions under review (SUR) (Health Canada)
• Notice - Revision to the Post-Notice of Compliance (NOC) Changes - Notices of Change: Level III Form (Health Canada)
• Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes - Safety and Efficacy (Health Canada)
• Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Framework Guidance Document (Health Canada)
• Notice: Consultation: Release of Draft (Step 2) ICH Guidance: Q3D: Guideline for Elemental Impurities (Cadmium Inhalation PDE revision) (Health Canada)
• Radiopharmaceuticals, Kits, and Generators – Submission Information for Schedule C Drugs: Draft Guidance Document for Consultation (Health Canada)
• Health Canada Approves PrSYMDEKO (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene (Press)
• EsopH, an innovative therapy for heartburn, approved for Canada (Press)

• Are There No Limits To Human Lifespan? Here Is What This Study Said (Forbes)
• Amazon is taking on health care’s most vexing challenge — the chronically ill (STAT-$)
• New team assembled to unlock the innovation potential in healthcare data (Microsoft)