Recon: Sanofi, Pfizer and Shire Q2 Earnings; EC Approves Herceptin Biosimilar

• Pfizer Beats Earnings And Addresses Drug Pricing, Rebates (Forbes) (WSJ) (Reuters) (Axios) (Focus)
• FDA approves Progenics' treatment for two rare tumors (Reuters) (Fierce) (Endpoints)
• Fired Biogen employee sues company for retaliation (Boston Business Journal-$) (STAT-$)(Fierce)
• Shire’s immunology unit shines in Q2 but haemophilia sales stall (Financial Times) (Reuters)
• Illumina’s stock rides wave of high demand for genomic sequencing (Fierce) (Financial Times)
• GV leads $30 million investment in Verana Health to improve clinical research using EHR data (VentureBeat) (Fierce) (San Francisco Business Times-$) (MedCity News)

• Dupixent bounce-back helps stem diabetes declines at Sanofi (PMLiVE) (Reuters) (PharmaTimes)
• EC approves Pfizer's Herceptin biosimilar (PharmaTimes) (The Center for Biosimilars)
• First migraine prevention drug to hit European market (PMLiVE) (PharmaTimes)
• Nigeria recalls 2.4 million bottles of codeine cough syrup (Reuters) (CNN)
• Otsuka’s guadecitabine fails phase 3 AML trial (Fierce) (GEN) (Endpoints)
• Leo Pharma to Acquire Bayer Prescription Dermatology Portfolio (GEN) (Reuters)
• Faster, cheaper DNA sequencing gets Omniome $60M led by Chinese investors (Endpoints)
• Govt’s drug price caps may trigger shutdown with US (Times of India)
• Korea-made drugs nearing US FDA approval, pharma exports to rise (The Korea Herald)
• Takeda Starts to Map Out Shire Plan as Financing on Track (Bloomberg-$)

• The Worst Drug Crisis in American History (NYT)
• Lukewarm reception to FDA biosimilar plan (Politico)
• California: Lawmakers, advocates blast Eli Lilly (Politico) (Sen. Ed Hernandez’s letter)
• Sanofi ships first of 70M doses of flu shots for the 2018-19 season (Fierce)
• Maine Passes Law to Address Misuse of REMS Programs (The Center for Biosimilars)
• After Doctors Cut Their Opioids, Patients Turn to a Risky Treatment for Back Pain (NYT)
• A Ramp Up In Opdivo And Eliquis Sales Will Drive Bristol-Myers Squibb's Future Growth (Forbes)
• Regeneron CEO & CSO: The Real Healthcare Problem Is Bigger Than You Think (Forbes)
• Nebraska lawmaker urges Pfizer to sue over use of its drugs in lethal injection procedure (Fierce)
• Despite high-flying Gardasil sales, Merck executives see 'significant' opportunity ahead (Fierce)
• At Sanofi, a flu expert sees potential for improved vaccines (STAT-$)
• Drug Industry’s `Easy Life’ of Price Hikes Is Over, Sanofi Says (Bloomberg-$)
• Shire Moves to Protect Gattex From Par Generic Challenge (Bloomberg-$)
• Ligand Pharmaceuticals Sued for $3.8 Billion Over Bond Terms (Bloomberg-$)
• Democrats have a Medicare negotiation plan that terrifies Big Pharma (The Hill)
• SteadyMed Shareholders Approve Proposed Acquisition by United Therapeutics (Press)
• Takeda Completes its Acquisition of TiGenix Following Expiration of the Squeeze-out Period (Press)

• Revenue shrinking, Sanofi sweeps a PhII cancer ADC and TB vaccine program out of the pipeline in Q2 cleanup (Endpoints)
• Pfizer drops diabetes and cancer drugs from clinical pipeline (Fierce)
• Shire’s fast track NASH drug abruptly stopped in phase 2 (Fierce)
• DNA Crosslink Repair Central to CRISPR Insert Success (GEN)
• Insys Weighs Next Steps after FDA Rejects NDA for Acute Pain Treatment Buvaya (GEN)
• Teva’s one-time blockbuster-to-be — and now recurring embarrassment — laquinimod fails yet again, this time for Huntington’s (Endpoints)
• Eisai and Merck Announce FDA Grants Breakthrough Therapy Designation for LENVIMA (lenvatinib) in Combination with KEYTRUDA (pembrolizumab) as Therapy for Previously Treated Patients with Advanced and/or Metastatic non-MSI-H/pMMR Endometrial Carcinoma (Press)
• Purdue Pharma L.P. Advances Its Pipeline with Novel, Potential First-in-Class Small Molecule for Insomnia Associated with Alcohol Cessation (Press)
• Akcea Announces Publication of Study Results Showing Multiple Benefits of Patient-to-Patient Connectivity in FCS (Press)
• Asterias Provides 12 Month Cohort 3 and 4 Update for its AST-OPC1 Phase 1/2a Clinical Trial in Severe Spinal Cord Injury (Press)
• KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results (Press)
• MerLion Regains North American Rights to XTOROTM FDA-Approved Antibiotic for Treatment of Ear Infections (Press)

• Microsoft files patent application for eyeglasses that gauge blood pressure (Healthcare IT News)
• Nano-optic endoscope for high-resolution optical coherence tomography in vivo (Nature)
• District Court Takes Another Logical Step to Expand the Safe Harbor (FDA Law Blog)
• ITC backs Hologic in mammography patent spat with FujiFilm (MassDevice)
• Fresenius extends deadline for $2B NxStage buyout, tops Q2 earnings forecast (MassDevice)
• Nevro, Boston Scientific bury the hatchet (MassDevice)
• Medtronic Receives FDA Approval for Implantable System for Remodulin to Treat Patients with Pulmonary Arterial Hypertension (Press)
• Sekisui Diagnostics Receives FDA Clearance for SEKURE HbA1c Assay (Press)
• Surmodics IVD Launches Breakthrough MatrixGuard Diluent (Press)
• QIAGEN and Hamilton Launch New Collaboration to Improve Pre-Analytical Sample Processing for QuantiFERON-TB Gold Plus (Press)
• RadianceTx Raises $1 Million First Tranche to Develop Novel Glaucoma Therapy (Press)
• Pulse Biosciences Treats Initial Patient in Its Human Study Evaluating the Effects of Nano-Pulse Stimulation in Basal Cell Carcinoma (Press)
• Six proposals receive seed funds to develop medical devices for children (Press)

• WellCare Sees Multi-State Growth For Its Future PBM (Forbes)
• What single-payer health care would cost the U.S. (Axios)
• Charity for Gain: DOJ Eyes Patient Assistance Program Fraud (Bloomberg-$)
• Liberal Dems lay groundwork to push Medicare for All (The Hill)
• Robert Wilkie sworn in as Trump’s Veterans Affairs secretary (AP News)
• Trump Picks Marine Vet To Take Over Veterans Affairs IT (Nextgov)
• Trump administration approves Maine’s request to shore up Obamacare exchange (Washington Examiner)
• Trump Spurns Medicaid Proposal After Furious White House Debate (NYT)
• OIG fines eClinicalWorks $132,500 for patient safety reporting failures (Fierce)
• Commentary: Ties between pharma, healthcare industry blamed for opioid epidemic (Modern Healthcare)

• FDA Advisory Committee Calendar

• Medical device maker warns of export risk post-Brexit (Irish Times)
• Sanofi Top UK Exec Plans For Hard Brexit, Blasts 'Poor Access' To New Drugs (Scrip-$)
• Being overweight tied to changes young adults' heart structure, function (Reuters)
• SkinVision gets $7.6M to continue expanding skin cancer app (MobiHealthNews)
• Batches of Durex condoms recalled: people urged to check their batch numbers (MHRA)
• European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection (Press)
• Aegerion’s Myalepta Approved in Europe : the First Treatment Indicated for Patients with Ultra-Rare Disease, Lipodystrophy (Press)
• ReShape Lifesciences Announces European Trial to Support CE-Mark of ReShape Vest (Press)
• Rapid Medical Receives CE Mark Approval for TIGERTRIEVER 13 (Press)

• A spokesperson of the State Food and Drug Administration introduced the situation of Wuhan Biobaibai Breaking Vaccine (NDA)
• Diagnosing Depression By Blood Biomarkers: A Viable Approach? (Forbes)
• First-of-its-kind clinical trial will use reprogrammed adult stem cells to treat Parkinson’s (Science)
• Fresh out of 6 Dimensions’ incubator, Curon launches with $150M and backing from Boyu, Temasek (Endpoints)
• BioLineRx expands I-O deal with pharma giant (The Pharma Letter)
• Do You Know How to Manage Japan’s Revised Reimbursement Approach? (MD+DI)
• Eli Lilly Korea gets reimbursement for psoriasis treatment Taltz (Korea Biomedical Review)
• Infraredx Announces Launch of Makoto Intravascular Imaging System and Dualpro IVUS+NIRS Catheter in Japan (Press)

• Drug safety under scrutiny as Ayush ministry review finds chinks in states’ regulatory mechanism (Pharmabiz)
• Quality control testing of viral load monitoring kits for HIV, HCV & HBV - Reg. (CDSCO)

• Consumers face health risks buying erectile dysfunction medicines online (TGA)
• Special Access Scheme online system (TGA)
• Australia's private private health sector has become a prime target for data hacks (Business Insider)
• Australians are 'rightly' questioning My Health Record, says Privacy Commissioner (The Sydney Morning Herald)

• Antibe Therapeutics Provides Clinical Development Update on Its Lead Drug (Press)
• Puma Biotechnology Files New Drug Submission for NERLYNX in Canada (Press)

• Genetic Hotspot Studies Could Lead to Better Understanding of Cancer (GEN)
• Hospital mergers or acquisitions may cause short-term patient safety issues (STAT)
• VIDEO: Opioid Crisis Spurs Demand for Telehealth Options (Bloomberg)