Recon: Gene-Editing Technique in Human Embryos Draws Skepticism

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)