Regulatory Focus™ > News Articles > 7 > Recon: Sanofi, Pfizer and Shire Q2 Earnings; EC Approves Herceptin Biosimilar

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

Posted 31 July 2018 | By Ana Mulero 

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

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In Focus: US
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In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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 $1 Million First Tranche to Develop Novel Glaucoma Therapy (Press)
  • Pulse Biosciences Treats Initial Patient in Its Human Study Evaluating the Effects of Nano-Pulse Stimulation in Basal Cell Carcinoma (Press)
  • Six proposals receive seed funds to develop medical devices for children (Press)
US: Assorted & Government
  • WellCare Sees Multi-State Growth For Its Future PBM (Forbes)
  • What single-payer health care would cost the U.S. (Axios)
  • Charity for Gain: DOJ Eyes Patient Assistance Program Fraud (Bloomberg-$)
  • 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 $132,500 for patient safety reporting failures (Fierce)
  • Commentary: Ties between pharma, healthcare industry blamed for opioid epidemic (Modern Healthcare)
Upcoming Meetings & Events Europe
  • Medical device maker warns of export risk post-Brexit (Irish Times)
  • Sanofi Top UK Exec Plans For Hard Brexit, Blasts 'Poor Access' To New Drugs (Scrip-$)
  • 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)
Asia
  • 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)
India
  • 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)
Australia
  • 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)
Canada
  • Antibe Therapeutics Provides Clinical Development Update on Its Lead Drug (Press)
  • Puma Biotechnology Files New Drug Submission for NERLYNX in Canada (Press)
General Health & Other Interesting Articles
  • 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)
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.
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