Recon: FDA Staff Raise Safety Concerns for Trevena’s Opioid Injection Ahead of Advisory Panel

• Drug sensitivity and resistance testing could make ‘right to try’ a real thing (STAT)
• The Uphill Fight Against Fake Prescription Drugs (WSJ)
• FDA staff raises safety issues over Trevena opioid injection (Reuters) (Endpoints)
• Questions about funding and purpose loom over a foundation Congress created to help the FDA (STAT)
• Pfizer incoming CEO announces new executive team (Financial Times) (Endpoints) (Press)
• Akcea Therapeutics genetic disease treatment gets FDA approval (Reuters) (BioCentury) (Fierce)
• FDA Approves Leadiant Therapy For ADA-SCID (BioCentury) (PMLive) (Press)
• HPV Vaccine Expanded for People Ages 27 to 45 (NYTimes) (FDA)
• USITC to investigate Resmed for alleged patent infringement (Reuters)
• Bausch Health's plaque psoriasis lotion gets tentative FDA approval (Reuters)
• J&J's Stelara succeeds in chronic bowel disease study (Reuters)
• Merck snags national VA contract for its Remicade biosimilar thanks to discount pricing offer (Fierce)

• UK clinical trials fall as Brexit clouds drug approval process (Reuters) (PMLive)
• Clinical trial ‘High Throughput Centres’ could help UK compete post-Brexit (PMLive)
• World Regulators Wrestle With Advanced Therapies (Pink Sheet-$)
• MDR/IVDR Implementation: the transition period halfway point (MedicalDevicesLegal)
• MSD signs $117m deal with Samsung Bioepis over Janssen biosimilar (Pharmafile)
• NICE expands backing for Pfizer’s Mylotarg (PharmaTimes)
• Why China is going all out to invent new, stronger, cheaper drugs … it’s not all about challenging the West (South China Morning Post)
• GlaxoSmithKline helps immunometabolism startup Sitryx to $30M round (Fierce)
• EMA To Review Bluebird's Thalassemia Gene Therapy (BioCentury) (PharmaTimes)
• FDA, EMA To Review Novartis' Siponimod For Secondary Progressive MS (BioCentury) (PharmaTimes)
• Five new Ebola cases confirmed in eastern Congo: health ministry (Reuters)
• FMD regulations won’t apply after ‘no-deal’ Brexit, says MHRA (Pharmaceutical Journal)
• India on alert as zika virus hits tourism hotspot of Jaipur (Reuters)
• New WHO regional chief must battle lifestyle conditions, tropical diseases (Reuters)
• GSK to ‘phase out’ manufacture of active ingredients at UK plant, 200 jobs cut (InPharmaTechnologist)

• How to Make Biopharmaceuticals Quickly in Small Batches (NIH)
• New Alzheimer’s drug draws on 40 years of research (Financial Times)
• Woodcock Becomes PCORI Board's First FDA Representative (Pink Sheet-$)
• On to PDUFA VII? Yes And No, Woodcock Says, With Sentiment Of Fatigue (Pink Sheet-$)
• Ahead of ODAC Meeting, FDA Documents Say CT-P10 is Highly Similar to Rituxan (Center for BioSimilars)
• How Current is Your Stability Program? (Lachman)
• Non-profit generic drug company Civica Rx appoints former Amgen quality chief as new CEO (Pharmafile)
• ICER takes aim at half-million dollar Onpattro price tag (PharmaLetter-$)
• 5AM partners set a wakeup call for biotech Fund VI, shooting for a record $350M (Endpoints)
• CRISPR cures inherited disorder in mice, paving way for genetic therapy before birth (STAT) (Endpoints)
• Transformational Medicine: It Starts And Ends With Patients (Forbes)
• GlaxoSmithKline taps Publicis—and its 'platformGSK' setup—for $1.5B media account (Fierce)
• In Sight Of Uncharted Territory (BioCentury)
• Large Cap Comeback: Biotech’s Large Caps Led The Way In 3q18 For First Time In Past Six Quarters (BioCentury)
• One of Affimed’s new glass slippers cracks as a deadly incident forces halt to PhI cancer trials (Endpoints)
• Checkpoint therapies before surgery? MD Anderson team reports encouraging efficacy but worries about toxicity (Endpoints)
• MIT spinout from Sangeeta Bhatia’s lab gets a $22M round to develop new disease and drug sensors (Endpoints)
• Spark plans 2019 clinical trial of gene therapy for Pompe disease after positive mouse study (Fierce)
• Report: Bioprocessing trends 2018-2023 (BioPharmaReporter)
• Sinntaxis bags option on ex-AstraZeneca mGluR5 antagonist (Fierce)
• Novartis cozies up to Silicon Valley with new lab (Fierce)
• How empowered patients are taking a more active role in their healthcare (MedCity)

• Xencor’s lead lupus antibody misses phase 2 endpoint (Fierce) (PharmaTimes)
• Menlo Therapeutics' cough drug fails to meet primary endpoint in phase II trial (Pharmafile)
• Phase 3 rare disease flop leaves Diurnal reeling (Fierce)
• Roche to present new positive data from its broad cancer immunotherapy programme and across a wide range of cancers at the European Society for Medical Oncology (ESMO) 2018 Congress (Press)
• Karyopharm's Selinexor Gets Priority Review For Penta-Refractory MM (BioCentury)
• New Phase 3 Data Show Single Dose of STELARA® (Ustekinumab) Induces Clinical Remission and Response in Adults with Moderate to Severe Ulcerative Colitis (Press)
• AVEO Oncology to Present Updated Interim Results from the Phase 2 Portion of the TiNivo Study of Tivozanib and Nivolumab (OPDIVO®) in RCC at the ESMO 2018 Annual Congress (Press)
• Celgene Announces Phase 3 STYLE Study of OTEZLA® (apremilast) in Moderate to Severe Scalp Psoriasis Met Primary Endpoint (Press)
• Aerie Pharmaceuticals, Inc. Announces Drug Application for Regulatory Approval Accepted for Review in Europe (Press)
• REVOLUTION Medicines Announces First Patient Dosed with RMC-4630 in Phase 1 Clinical Study in Patients with Advanced Solid Tumors (Press)
• Arcus Biosciences to Present Final Results from the Phase 1 Study of AB928 in Healthy Volunteers at ESMO 2018 Congress (Press)
• Exelixis Initiates Phase 3 Pivotal Trial (COSMIC-311) of Cabozantinib in Patients with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy (Press)
• Blueprint Medicines Announces Updated Data from Phase 1 ARROW Clinical Trial Showing Broad, Durable Activity of BLU-667 in Advanced RET-Altered Medullary and Papillary Thyroid Cancers (Press)
• Cavion Announces Promising Phase 2 Data for Essential Tremor in T-CALM Proof-of-Concept Study (Press)
• Poxel Announces Completion of Patient Enrollment for TIMES 2 Trial in Phase 3 Registration Program for Imeglimin, an Investigational Therapeutic Agent for Type 2 Diabetes, in Japan (Press)
• Dicerna Announces Late-Breaking Data from the PHYOX Phase 1 Clinical Trial of DCR-PHXC Will Be Presented at ASN Kidney Week 2018 (Press)

• FDA allows marketing of first self-fitting hearing aid controlled by the user (FDA)
• Malware hits medical devices at 18 percent of healthcare orgs in last year (HealthcareITNews)
• It’s another big year for medtech M&A (Medical Design & Outsourcing)
• BD’s Bard reported to win third IVC bellwether (MassDevice)
• Continuous Quality: FDA’s Goal for the Case for Quality Program (MDDI)
• ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations (Emergo)
• Eximo Medical Receives FDA Clearance for B-Laser™ Atherectomy System to Treat Peripheral Artery Disease (Including ISR) (Press)

• Supreme Court Denies Certiorari in Regeneron Pharmaceuticals v. Merus (Patent Docs)
• How The Support Act Gives FDA New Tools To Combat The Opioid Abuse Epidemic (BioCentury)
• ShamWow: FDA Addresses Alleged Citizen Petition Abuse (FDA Law Blog)
• Can We Play, Too? (Drug & Device Law)
• Congress Expands Sunshine Reporting (FDA Law Blog)
• Government Urges Reversal of Third Circuit Fosamax Decision (Drug & Device Law)

• FDA Advisory Committee Calendar

• A Common Data Model for Europe? Why? Which? How? (EMA)
• Four new therapies to be funded by NHS Scotland (PharmaTimes)
• EMA Urged To Expand 'Unmet Needs' Definition To Support New Antibiotics (Pink Sheet-$)
• Bioneer Obtains CE-IVD Marking for HIV-1 Kit (GenomeWeb)
• Clinical trials for medicines: authorisation assessment performance (MHRA)
• Notify MHRA about a clinical investigation for a medical device (MHRA)

• Chinese Regulators Continue Adding Medical Devices, IVDs to Clinical Trial Exemption List (Emergo)
• Tencent Aims To Train AI To Spot Parkinson's In 3 Minutes (Fobres)

• Changes made to the Therapeutic Goods Advertising Code 2018 following public consultation during April 2018 (TGA)
• Submissions received: Advertising code 2018 and guidelines (TGA)

• Cuba's CECMED Director Reflects On Agency Transformations, Ongoing Challenges (Pink Sheet-$)