Recon: Gilead to Donate 2.4 Million Bottles of Truvada to US HIV Prevention Initiative

• Gilead will donate Truvada for HIV prevention, but reaction is mixed (STAT) (NYTimes) (CNBC) (Politico) (AP) (Washington Post)
• How Insys undermined an FDA effort to protect the public from dangerous opioids (STAT)
• ICER chastises J&J for overpricing depression drug esketamine ‘where there is such need for treatment’(Endpoints)
• Puma investors fret, as Nerlynx Q1 sales fall uncomfortably short of Wall Street estimates (Endpoints)
• Allegations of widespread fraud raise questions about the safety of generic drugs made overseas (CBS)
• Tainted drugs: Ex-FDA inspector warns of dangers in U.S. meds made in China, India (NBC)
• Bayer kicks off a $150M add-on for its campus in Berkeley (Endpoints) (Fierce)
• Trump slams drugmakers, vows to let U.S. states buy cheaper medicines abroad (Reuters)
• Trump’s drug pricing agenda shifts the political landscape, but not drug costs (Politico)
• Has Trump Actually Done Anything About Drug Prices? (The Atlantic)
• Opioid overdose deaths decline when pharmacists can dispense naloxone (Reuters)
• Warren Bringing Opioids Message to Hard-Hit W.Va., Ohio (AP)
• Medtronic Enters Into Definitive Agreement to Acquire Titan Spine (Press)

• Situation Report: Use and Abuse of Opioid Analgesics (ANSM)
• Eisai inks deal for SC rheumatic agent in Japan (PharmaLetter-$)
• Waylivra gets conditional EU nod in ultra-rare disease (PharmaLetter-$)
• Pharma Wants Changes To EU's Revised Orphan Designation Guide (Pink Sheet-$)
• Thousands of EU nurses and midwives leave NHS because of Brexit (Pharmafile)
• Trade frictions raise questions about China's fentanyl promise (Reuters)
• China Alarms Excipient Suppliers With Proposed Requirement To Share Proprietary Information (Pink Sheet-$)
• Calm Before The Storm: Pharma Opens 2019 With A Bang In China (Scrip-$)
• China tests experimental brain implants to treat opioid addiction (CBS)
• Chinese bioethicists call for ‘reboot’ of regulations following CRISPR babies (BioCentury)

• Interchangeable Biosimilars: FDA Finalizes Guidance (Focus)
• Is It A Feminist Right To Want More Sex? One Company Thinks A Pill Is The Answer (KHN)
• So Far, Just One Thing Has 'Experimental Support' In Staving Off Alzheimer's (Forbes)
• Building New Models To Support The Ailing Antibiotics Market (Forbes)
• Catalent, hindered by Softgel weakness, sees stronger growth ahead (BioPharmaDive)
• Servier's US push takes shape as Boston HQ opens (BioPharmaDive)
• ICH Drafts Revised Guideline on General Considerations for Clinical Studies (Focus)
• When to Submit an ANDA vs. a 505(b)(2)? FDA Explains (Focus)
• FDA Finalizes Maximal Usage Trials Guidance for Topical OTC Drugs (Focus)
• Orphan Products: US FDA Working On ‘Sameness’ Policy For Cell And Gene Therapies (Pink Sheet-$)
• US Brand Drug Prices Grew At Historically Low Rates In 2018 – IQVIA (Scrip-$)
• Experimental Drug For Huntington's Disease Jams Malfunctioning Gene (NPR)
• Medicines Patent Pool Unveils New Approach To Drug Candidate Selection (Pink Sheet-$)
• PhI may still be a killing field of failure but PhIII success rates have surged, signaling tectonic shifts in biopharma R&D (Endpoints)
• Fibrogen’s obtuse disclosures about anemia pill raise concerns over heart safety, putting approval at risk (STAT) (Fierce) (PMLive)
• Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance (Focus)
• AAM Rejects FDA’s Updated Biosimilar Naming Policy (FDA News-$)
• Many U.S. allergists now prescribe tablets instead of shots (Reuters)
• A newly formed biotech launched out of George Daley’s Harvard lab adds global players to its syndicate, bringing its haul to $83M (Endpoints)
• Potential first ever targeted therapy designed for ‘untreatable’ childhood brain cancer (PharmaTimes)
• That feeling you get when you hit the finish line, and then set new goals (Endpoints)
• Semma goes on a successful ‘fishing’ expedition in its hunt for a diabetes cure (Endpoints)
• Chutes & Ladders—Eisai installs new Alzheimer's leadership team (Endpoints)
• Clinical trial will test long acting HIV injection (Pharmafile)

• Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia (Press)
• Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
• Moderna Announces Publication of Phase 1 Data for mRNA Vaccines Against Two Potential Pandemic Influenza Strains (Press)
• NeuroVive's IND for Clinical Development of NeuroSTAT Approved by FDA (Press)
• New Phase 2b Analysis Suggests AEROSURF® may Reduce Incidence and Severity of Bronchopulmonary Dysplasia in Preterm Infants with RDS (Press)
• EnGeneIC Announces First Patients with Advanced-Stage Pancreatic Cancer Dosed in Phase 1/2a Clinical Study of Targeted Cytotoxic Immunotherapy (Press)
• Noveome Biotherapeutics, Inc. Announces Publication of Further Preclinical Results Supporting the Neuroprotective Properties of ST266 in Retinal Ganglion Cells (Press)

• The Safety Record of Medical Devices (NYTimes)
• Sen. Murray goes after duodenoscope makers (MassDevice)
• Will Vertiflex Boost Boston Scientific's Pain Portfolio? (MDDI)
• Edwards adds $1B to share repurchase program (MassDevice)
• Bio-Rad shares steady on Street-topping Q1 earnings (MassDevice)
• Medtronic to Announce Financial Results for Its Fourth Quarter and Fiscal Year 2019 (Press)
• New Studies Highlight Underuse of Implantable Cardiac Devices (Press)

• Why The New Office Of Inspector General Drug Rebate Rule Deserves (Cautious) Support (Health Affairs)
• Assessing Treatment Expansion Efforts and Drug Control Strategies and Programs (GAO)
• Drug Cos. Call 'Blocking Patent' Rule An 'Existential Threat' (Law360-$)
• Nabriva Hit With Stock-Drop Suit Over FDA Drug Rejection (Law360-$)
• Ain’t That A Sham: US House Bill Tries To Thread The Needle On Citizen Petitions (Pink Sheet-$)
• Amarin Pharma, Inc. v. ITC (Fed. Cir. 2019) (Patent Docs)
• If We’re Not All Wet, We’re Still Rather Damp (Drug & Device Law)
• CMS Finalizes Regulations Requiring WAC Disclosure in TV Ads for Rx Drugs (FDA Law Blog)

• FDA Advisory Committee Calendar

• Industry Works to Circumvent EU MDR/IVDR ‘Horror Story’ (Focus)

• Lupin launches generic seizure drug in US (Economic Times)