Recon: Drug Prices Continue to Rise Despite Political Pressure; CRUK Backs £200m Oncology Investment Fund

• Drug prices persistently rising despite Trump efforts (Politico) (WSJ)
• Researchers use CRISPR to eliminate HIV in mice (STAT) (CNBC)
• Sen. Warren blasts former FDA commissioner for joining Pfizer’s board (STAT) (CNBC) (The Hill) (Warren)
• Former FDA Commissioner Gottlieb defends decision to join Pfizer board (CNBC) (Endpoints)
• Exclusive: FDA enforcement actions plummet under Trump (Science)
• FDA rebuffs allegations that it has deprioritized enforcement (BioCentury) (Endpoints)
• Biogen bounces back with Spinraza early treatment data (PMLive) (Endpoints)
• Facebook to tackle content with misleading health claims (Reuters)
• FDA ties three deaths to Edwards Lifesciences' recalled heart devices (Reuters)
• Senators widen probe into groups with ties to opioid makers (STAT)
• Trump advisers pursue Democratic drug-price ideas as campaign looms (Washington Post)

• Cancer Research backs £200m oncology investment fund (Financial Times) (Fierce) (Endpoints)
• Patent panic gives green light to mega pharma deals (Financial Times)
• Pharma lobby presses case for funding new medicines (Irish Times)
• Sanofi/Regeneron’s IO latecomer Libtayo approved in Europe (PMLive)
• Pfizer, Sanofi, to boost South African Biovac's vaccine output (Reuters)
• China's first vaccine law aims to restore public confidence (BioCentury)
• Novo Nordisk’s Jorgensen: If it was easy to correct pricing, we would be doing it already (STAT)
• Incyte flips China rights of MacroGenics' PD-1 to an ambitious Zai Lab (Endpoints)

• FDA Eliminates REMS for HIV Drug Truvada and its Generics (Focus)
• Watch out AbbVie: Gilead is fast on your heels at the FDA with rival JAK inhibitor filgotinib (Endpoints)
• FDA Drafts Two New Guidances on Drug Labeling (Focus)
• Biologics Are Not Natural Monopolies (Health Affairs)
• Sending The Wrong Price Signal: Why Do Some Brand-Name Drugs Cost Medicare Beneficiaries Less Than Generics? (Health Affairs)
• CBER Plans Draft Guidance on ‘Sameness’ of Gene Therapies Under Orphan Drug Regulations (Focus)
• Mylan investors favor expanding exec pay clawbacks. Will the company listen? (Fierce)
• Rival accuses Kaleo of cybersquatting in 'elaborate scheme' (BioPharmaDive)
• Another effort on pancreatic cancer flops, as Boston Biomedical cans phase 3 combo test (Fierce) (Press)
• Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period (FDA)
• CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate (Pink Sheet-$)
• Tiziana joins type 1 diabetes prevention field (PMLive)
• Amarin raises sales guidance for heart drug Vascepa, hires more sales reps for larger marketing push (STAT) (Endpoints)
• Biosimilars: Some Patient And Prescriber Groups Appear To Warm Up To Arbitrary Suffixes (Pink Sheet-$)
• Pharma to FDA: Limit or Spell Out Use of Covariates in Randomized Trials (FDANews-$)
• A Special Class of Proteins Are Promising Targets for Drugs for Cancer and Alzehimer's (Scientific American)
• Thermo Fisher and Catalent to manufacture gene therapies being developed by Amicus (Fierce)
• Emboldened by ASCO data, FDA etches speedy approval path for Iovance's cervical cancer therapy (Endpoints)
• Digging into the FDA’s grievance hotline (STAT)
• Research supports better integration of patient voice in health technology assessments (PharmaTimes)
• Merrimack CEO, CFO bow out, months after last clinical drug fizzles (Endpoints)

• Monopar Therapeutics and the Spanish Sarcoma Group (GEIS) Team Up on Phase 2 Sarcoma Trial With Monopar's Novel Camsirubicin (Press)
• Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year (Press)
• Bioinvent Receives Ind Approval For Phase I/iia Trial of Anti-fcγriib Antibody (Press)
• Teva Presents Positive Results Showing Improvement in Disability and Quality of Life from the Phase IIIb FOCUS study of Fremanezumab in Adults with Migraine (Press)
• Dicerna™ to Begin Clinical Development of DCR-A1AT for Treatment of Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Press)

• FDA Finalizes Rule for Appealing CDRH Decisions (Focus)
• IMDRF Releases New and Revised Documents Following March Meeting (Focus)
• Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks (FDA)
• FDA sets medtech cybersecurity advisory meeting (Medical Design & Outsourcing)
• FDA Approves Foundation Medicine CDx Test for Lynparza (GenomeWeb)
• Luminex Submits MRSA Assay for FDA Clearance (GenomeWeb)
• Medtronic Announces Closing of Public Offering of €5 Billion of Senior Notes (Press)

• GOP states seek delay in Obamacare case (Politico)
• Trump’s ex-FDA chief calls 2020 Dem hopefuls’ ‘Medicare for All’ innovation-stifling (CNBC)
• Device Manufacturer’s Criminal and Civil Penalties Deserve Closer Attention (FDA Law Blog)
• How To Get an Answer to a Legal Question – Certify It (Drug & Device Law)
• CRISPR Battle Joined Again (Patent Docs)
• How Opioid 'Negotiating Class' Would Affect Civil Claims (Law360-$)
• Opioid MDL Litigants Seek Triumphs Before Bellwether Trial (Law360-$)
• Consumers Still Paying for Sham Insurance Products Sold by Simple Health to be Notified About the Fraud and Provided an Opportunity to Enroll in Comprehensive Health Insurance Plans During a Special Enrollment Period (DOJ)

• FDA Advisory Committee Calendar
• Overview of FDA’s Perinatal Health Center of Excellence: Development and Validation of Predictive Systems – 11 July 2019
• Patient Engagement Advisory Committee; Notice of Meeting – 10 September 2019

• EC Offers Two New Guidance Documents on MDR/IVDR (Focus) (Medical Devices Legal)
• MHRA: Business Impact Target (MHRA)
• NICE pushes social prescribing for dementia (PharmaTimes)
• EFPIA welcomes EMA’s future-proofing of processes (PharmaLetter-$)
• ‘No-Deal Brexit’ Pharmacy Substitution Rules Take Effect In UK (Pink Sheet-$)

• Asia Regulatory Roundup: TGA Details How Manufacturers Can Seek GMP Clearance Prioritization (Focus)
• South Korean MFDS rolls out new regulation for IVD devices (Emergo)
• Korea Eases Stock Rules To Help Bioventures Stay Listed, Focus On R&D (Scrip-$)
• Asia Deal Watch: Oxford Biomedica’s First Japanese Partnership Focuses On Rare Retinal Disorder (Scrip-$)

• TN IDMA signs pact with Chinese organisation to manufacture medicines in China’s Pilot Zone (Pharmabiz)
• BSE Healthcare index dips by 7.4% in first half of 2019, Sensex moves up by 9.2% (Pharmabiz)

• Australia TGA publishes guidance on recognized standards for quality management systems and sterile devices (Emergo)
• Therapeutic Goods Advertising Consultative Committee, 13 June 2019 (TGA)

• Weight loss support helps people with fatty liver disease (Reuters)