Recon: Gottlieb Returns to Biotech VC Firm; UN Creates New Ebola Chief Role

• Former FDA head Scott Gottlieb rejoins VC firm (Axios) (WSJ) (Endpoints) (Fierce)
• Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range (Reuters) (STAT)
• Did FDA unfairly treat Catalyst by approving a similar drug from another company? (STAT)
• In a change of plans, Nektar spins out its opioid into a new biotech subsidiary as FDA PDUFA date looms (Endpoints)
• AlloVir, first to test ElevateBio's model, raises $120M ahead of Phase III (BioCentury)
• Trump's threat won't stop drug price reform (Politico)
• Trump Administration Struggles To Confront Fentanyl Crisis (Washington Post)
• This May Hurt a Little (Or a Lot) as Opioids Haunt Pharma Bonds (Bloomberg)
• Bipartisan Proposal Aims to Curb Health-Industry Contracts That Block Competition (WSJ)
• Gilead, Baxter Ramp Up Lobbying on Trump’s HIV, Kidney Plans (Bloomberg)
• US imposes sanctions on Argentina-based online pharmacies for opioids (Reuters)
• Men Are Paying Sixfold Markups to Feel Cool About Buying Generic Viagra (Bloomberg)
• Tougher vaccine rules move forward in California (AP)

• Novartis has 25 blockbusters in the pipeline: CEO (Reuters) (Endpoints) (Press)
• UN creates new Ebola chief role to tackle security, political issues in Congo (Reuters)
• Congo wants more use of Merck vaccine rather than J&J newcomer: minister (Reuters)
• Venezuela turns to Russia, Cuba, China in health crisis (Reuters)
• India’s Biggest Drugmaker Plans to Start Developing Its Own Medicines (Bloomberg)
• 700% Price Spike Spurs UK to Allege Four Pharma Companies Agreed to Restrict Competition (Focus) (Financial Times)
• Big pharma poured £57m into UK patient charities which could influence NHS drug decision makers, report finds (Independent)
• Glaxo Changes How It Pays Sales Reps as Drugmaker Bets on Cancer (Bloomberg)
• Still no breakthrough on Orkambi talks, MPs want answers (PMLive)
• Boehringer Ingelheim plans 3-year, $84M expansion in Mexico (Fierce) (Milenio)
• Daiichi Sankyo reportedly selling OTC unit for $900M in pivot to oncology — but company says it’s ‘incorrect’ (Endpoints) (Fierce) (Press)
• Fountain Healthcare raises €118M for EU-focused fund (Fierce)
• The Philippines Is Fighting One Of The World's Worst Measles Outbreaks (NPR)

• Making Sure the Drugs We Take Are Safe (NYTimes)
• Treading on Nasdaq turf, NYSE cuts listing fees to woo biotech (Endpoints)
• Spring Regulatory Agenda for FDA: What New Rulemakings are Coming (Focus)
• Debate erupts over whether Sarepta’s rare disease drug has enough clinical data to determine cost-effectiveness (STAT) (Endpoints)
• Pharma's Desperate Struggle To Teach Old Data New Tricks (Forbes)
• Stung by critics, J&J says antidepressant Spravato saves money (PMLive)
• SPR994:  A Long Shot, With Lots Of Twists And Turns To Phase III (LifeSciVC)
• Calls For Pharma To Come Clean On R&D Spending Grow Louder (Pink Sheet-$)
• Insilico, ARK initiate health-span and longevity partnership (PharmaTimes)
• FDA Issues 483 to Lupin (FDA)
• Ideaya and Bicycle Therapeutics IPOs Raise $110M for Cancer Drug R&D (Xconomy) (Endpoints)
• Microbiome therapies could be the next frontier in medicine. But how exactly do you make them? (STAT)
• Institutional Investors and Medical Innovation (SSRN)
• QIDP Roundup: Familiar Names Dominate 2019 Designations (Pink Sheet-$)
• FDA Proposal On 'Inordinate' Interstate Compounding Sparks State Oversight Debate (Pink Sheet-$)
• Affimed scraps T-cell engager program, parts company with CSO (Fierce)
• Santhera enters license agreement with Chiesi Group; Tonix’s cocaine intoxication drug, Iovance’s cervical cancer treatment win FDA’s breakthrough status (Endpoints)
• Sentinel PRISM Program Final Report: Rapid Surveillance Of The 2017-18 U.S. Seasonal Influenza Vaccines (FDA)
• Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications (FDA)

• Cstone partner Agios Announces the Phase 3 ClarIDHy Trial of TIBSOVO (ivosidenib) Achieved its Primary Endpoint (Press)
• Cadent Therapeutics Receives Milestone Payment for Initiation of Phase 2 Trial of MIJ821 in Treatment-Resistant Depression (Press)

• FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea (FDA) (GenomeWeb)
• FDA Solicits PreCert Software Developer Volunteers (Focus)
• Medtronic Reports Fiscal Year and Fourth Quarter 2019 Financial Results (Press)
• Roche Obtains FDA Clearance for Sexually Transmitted Disease Test (GenomeWeb)

• House Committee Proposes 6% Increase in FDA Funding for FY 2020 (Focus)
• European doctor defies FDA orders to stop sending US women abortion pills by mail (CNN)
• Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses (Federal Register)
• District Court Orders Illinois Compounding Company and Two Executives to Comply with Drug Safety Standards (DoJ)
• Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities (FDA)
• District Court Enters Permanent Injunction Against Texas Compounding Pharmacy and Its Owners to Prevent Distribution of Adulterated Drugs (DoJ) (FDA)
• Amgen Says Rival Used Trade Secrets To Poach 14 Reps (Law360-$)
• Ex-Olympus Exec Ducks Prison In Tainted Scopes Case (Law360-$)
• New Views On Statistical Significance Affect Expert Testimony (Law360-$)
• In a remote Vermont ski town, 3 execs raised $93M for a stem cell research campus. Prosecutors say it was all just a scam (Endpoints)
• GSK, Teva Urge 3rd Circ. To Nix Lamictal Class Cert. (Law360-$)
• Reflections on Albrecht – What Preemption Being a “Legal Question” Might Mean (Drug & Device Law)
• Jury Orders J&J to Pay Woman $80M in Vaginal Mesh Case (MDDI)

• FDA Advisory Committee Calendar
• Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations – 17 July 2019

• PIC/S Finds A Way To Solve Divergences With EU ATMP Guide (Pink Sheet-$)
• EU Regulatory Roundup: EMA’s PRAC Calls for Withdrawal of Fenspiride Cough Medicines, Temporary Restrictions on Xeljanz (Focus)
• Scancell, CR UK publish joint vaccine update (PharmaTimes)
• Akcea's Tegsedi secures NICE approval for Stage 1 or 2 polyneuropathy in hATTR (Pharmafile)

• HealHealth Canada Gives Green Light to ECG App on Apple Watch (MacRumors)

• Fees and charges: summary from 1 July 2019 (TGA)
• TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings (Focus)