Regulatory Focus™ > News Articles > 8 > Recon: Gene-Editing Technique in Human Embryos Draws Skepticism

Recon: Gene-Editing Technique in Human Embryos Draws Skepticism

Posted 09 August 2018 | By Ana Mulero 

Recon: Gene-Editing Technique in Human Embryos Draws Skepticism

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Gene-Editing Technique in Human Embryos Draws Skepticism (WSJ) (Stat) (MIT Tech Review)
  • U.S. joins lawsuits against Indivior, Reckitt over drug Suboxone (Reuters)
  • Perrigo plans to separate prescription drugs business (PharmaTimes) (Reuters)
  • Walden and Hatch call on OMB to review rebate rule (E&C)
  • FDA Advisors Like Novel Tetracycline Analogue (MedPage Today) (Fierce) (Endpoints)
  • Sarepta builds in gene therapy with $30M Lacerta deal (Fierce) (Endpoints) (GEN)
  • Once a multibillion dollar company, OvaScience ends a pennystock vehicle for Millendo’s reverse merger (Endpoints)
  • How one failed drug ensnared so many GOP lawmakers (Axios)
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In Focus: International
  • Merck KGaA profit dragged lower by liquid crystal decline, forex (Reuters) (Bloomberg)
  • Ligand Pharma makes £33 million bid for UK's Vernalis (The Pharma Letter-$) (PharmaTimes)
  • NICE changes its mind on Pfizer’s Besponsa (PharmaTimes) (pharmaphorum) (Pharmafile)
  • Taltz recommended for NHS use (The Pharma Letter) (Pharmafile)
  • A newly approved drug could be a boon for treating malaria (ScienceNews)
  • Why Measles Is Back in the Americas (Fortune)
  • European stocks falter as pharma sector falls (Reuters)
  • Drug firms fight US government’s Iraq corruption probe (pharmaphorum)
  • Pharma companies bag 40% of US generics (Times of India)
  • Ebola vaccination begins in North Kivu (WHO)
  • Argentina’s Senate Rejects Bill Legalizing Abortion (NYT)
  • Why Italy's U-turn on mandatory vaccination shocks the scientific community (CNN)
Pharmaceuticals & Biotechnology
  • Congress needs a commission, not the pharma industry, for its drug policy ideas (STAT)
  • Louisiana explores a ‘Netflix’ subscription model for buying hepatitis C drugs (STAT-$)
  • Clinic to pay back patients illegally charged cash for Suboxone (The Boston Globe)
  • Cancer Clinical Trial Proposal Could Open Door to Thousands (Bloomberg-$)
  • CVS Health's rebate disclosure (Axios)
  • CVS-Aetna Deal Nears Antitrust OK As Drug Plan Divestitures Loom (Forbes)
  • Novo CEO: Expect U.S. diabetes drug prices to continue their downward spiral next year (Fierce)
  • Public awareness of cancer drug shortages is lacking, but most would want to know about drug substitutions if they were patients, study finds (Dana-Farber Cancer Institute)
  • Tapping Chinese investors, Apexigen closes $73M for 8 trials in I/O (Endpoints)
  • Biosimilars the beneficiary of new Medicare step therapy rule (EP Vantage
  • Small and mid-cap share price gains make up for majors (EP Vantage)
  • Praxis Wins $1.5M NIH SBIR Grant toward Abuse-Deterrent Prodrug Stimulant (GEN)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • That BLA little Ampio promised? That’s not going anywhere as FDA slap-down triggers an ugly rout (Endpoints)
  • Kyowa Kirin gets some added love from the FDA, winning their second drug OK in 4 months (Endpoints)
  • DNA/RNA Sequencing Offers Hope to Drug-Resistant Multiple Myeloma Patients (GEN)
  • Opioid Overdose After Surgical Discharge (JAMA)
  • Probiotics to Prevent Clostridium difficile Infection in Patients Receiving Antibiotics (JAMA)
  • Ironshore Pharmaceuticals Announces FDA Approval of JORNAY PMTM (Methylphenidate) Extended-Release Capsules CII for the Treatment of ADHD (Press)
  • Key role found for enzymes in DNA replication and sensitivity to chemotherapeutic drugs (Press)
  • Biomarkers link fatigue in cancer, Parkinson's (Press)
  • Arsenic in combination with an existing drug could combat cancer (Press)
  • Finally, a potential new approach against KRAS-driven lung cancer (Press)
Medical Devices
  • Judge Slashes $15M From Pelvic Mesh Verdict Against J&J (Law360-$)
  • Can A Simple Poop Test Replace Your Colonoscopy? (Forbes)
  • How A Supercomputer Named Dr. Crusher Perfected Cancer Treatments For 21 Patients (Forbes)
  • Cardiogram integrates with Garmin wearables for heart health insights (MobiHealthNews)
  • AdvaMedDx Applauds Hill's Release of FDA’s Technical Assistance to Advance Legislation to Modernize Regulation of Clinical Diagnostics (AdvaMedDx)
  • Association of Broad-Based Genomic Sequencing With Survival Among Patients With Advanced Non–Small Cell Lung Cancer in the Community Oncology Setting (JAMA)
  • Electrocardiographic Monitoring for Prevention of Atrial Fibrillation–Associated Cardioembolic Stroke (JAMA)
  • Screening for Atrial Fibrillation With Electrocardiography: US Preventive Services Task Force Recommendation Statement (JAMA)
  • A First in the World of Radiology: Aidoc Receives FDA Clearance to Enable Radiologists to Triage Patients Using AI (Press)
  • AVITA Medical Announces Expanded Compassionate Use of RECELL Device in Life-Threatening Burns (Press)
  • Medtronic Begins Pilot Study of Investigational Extravascular ICD System (Press)
  • Newly Published Independent Study on a Prospective Cohort Highlights DecisionDx-Melanoma Prognostic Test’s Ability to Accurately Identify High-Risk Melanoma Patients (Press)
  • Research brief: New 3D-printed device could help treat spinal cord injuries (Press)
  • MRI may facilitate the diagnosis and evaluation of the treatment outcomes of depression (Press)
US: Assorted & Government
  • Rite Aid, Albertsons Abort Merger On Eve Of Shareholders Vote (Forbes)
  • Grassley: Congressional oversight of health care is essential for a healthy America (STAT)
  • After 30 years, an immunotherapy to rival CAR-T finally nears the clinic (STAT-$)
  • Preventing Hair Loss During Chemotherapy Is Now Possible, But Insurance Coverage Is Inconsistent (Forbes)
  • Medicare Advantage enrollment soared in Puerto Rico. Now it's starving the island's health system (Fierce)
  • Kratom Investigation Concludes (JAMA)
  • Protecting NIH’s Integrity and Trustworthiness in Public-Private Partnerships (JAMA)
  • Trump administration clears way for Obamacare insurer program (Washington Examiner)
  • Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments (FDA)
Upcoming Meetings & Events Europe
  • Brexit, medical devices and transfer of notified bodies. What will be the procedure? (Lexology-$)
  • Touting its manufacturing strengths, Tot Biopharm raises $102M mega-round to ramp up cancer R&D (Endpoints)
  • State Council investigation team announced the progress of Changchun Changsheng's illegal production of rabies vaccine (CNDA)
  • Notice on Printing and Distributing the Vaccination Program for Vaccination of Changchun Changsheng Company's Rabies Vaccine (CNDA)
  • The State Food and Drug Administration maintained communication with the WHO Representative Office in China on the Changchun Longevity Rabies Vaccine Case (CNDA)
  • Manpower at CDSCO increased to 510 & testing capacity of govt labs are being strengthened to improve drug standard: Minister (Pharmabiz)
  • Wireless medical devices: Making medical implants hacker-safe (Financial Express)
  • Astrazeneca Pharma India receives Import and Market permission for Osimertinib Tablet (Business Standard)
  • Consultation: Proposed therapeutic goods advertising code guidance (TGA)
  • Prescription medicines: registration of new generic medicines and biosimilar medicines (TGA)
  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)
  • Crowdsourcing algorithms to predict epileptic seizures (Press)
  • Health Canada-approved study to look at pot-based medical products for pets (The Canadian Press)
  • Federal health minister hears stigma is a problem in Windsor opioid crisis (CBC News)
General Health & Other Interesting Articles
  • Integrating Innovation Into Healthcare (Forbes)
  • Inducing labor at 39 weeks is safe and linked to lower risk of C-section, study finds (STAT)
  • Common skin cancer can signal increased risk of other cancers (Stanford Medicine)
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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