Recon: Sanofi Names Novartis’ Hudson as CEO; FDA Panel Backs TB Alliance’s TB Treatment

• Vertex Pharmaceuticals expands into Duchenne gene therapy with new deals (Reuters) (PMLive) (Endpoints) (Fierce)
• FDA advisory panel recommends approval of TB Alliance's tuberculosis treatment (Reuters)
• In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup (STAT) (Endpoints)
• AIDS groups criticize Express Scripts for excluding several HIV medicines (STAT)
• Once picked as a $500M winner, bankrupt Achaogen auctions off its antibiotic for a fraction of that (Endpoints) (Press)
• Warning of ‘Pig Zero’: One Drugmaker’s Push to Sell More Antibiotics (NYTimes)
• GSK’s Nucala gets boost with self-administration approval (PMLive) (PharmaTimes) (Press)
• Top 50 NIH-Funded Research Institutions FY2019 (Patent Docs)
• Biogen completes Nightstar acquisition (PharmaTimes) (Press)
• Eli Lilly throws SCOTUS hail mary in Cialis patent infringement fight (Fierce) (Law360-$)
• GOP senators ask PhRMA for solutions to lower drug prices (The Hill)

• Sanofi appoints top Novartis exec as new chief (Financial Times) (Reuters) (Bloomberg) (Endpoints)
• Marie-France Tschudin, head of Novartis subsidiary AAA, takes over from Paul Hudson as Novartis Pharma CEO (Pharmafile)
• Otsuka to take over Astellas’ Cefixime business (Pharmafile)
• UK biotechs seek to speed up cancer detection (Financial Times)
• Report: Warrant issued for arrest of Samsung BioLogics exec in $3.9B accounting scandal (MedCity) (Yonhap)
• Could Antibiotics Be A Silver Bullet For Kids In Africa? (NPR)
• Aurobindo Pharma says co, subsidiary made party to litigation proceeding in US (Economic Times)
• Argentina Joins International Pharmaceutical Regulators Programme (Pink Sheet-$)
• Perrigo Set Up Israeli Co. To Skip Tax, US Says In $163M Row (Law360-$)
• Chinese Co. Infringed Cholesterol Test Patents: ITC Judge (Law360-$)

• ‘Jumping genes’ could help CRISPR replace disease-causing DNA, study finds (STAT)
• BIO’s new board chair on drug pricing, diversity, and going off-script (STAT)
• CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis (Focus)
• FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations (Focus)
• Biomarkers provide a bridge to the next frontier in immuno-oncology (STAT)
• Accumulated Mutations Create A Cellular Mosaic In Our Bodies (NPR) (STAT)
• An Australian Doctor’s Dream: Curing America’s Opioid Curse (NYTimes)
• Long-term BMS exec Johanna Mercier joins Gilead as new Chief Commercial Officer (Pharmafile)
• Servier, armed with Shire cancer drugs, builds out vision for US future (Fierce)
• Bispecific antibodies: a mechanistic review of the pipeline (Nature)
• Merck, Rigaku to form molecular structure analysis technology collab (PharmaTimes)
• Women Are Underrepresented In Clinical Research On Cannabis (Forbes)
• Aldevron to build out 14-acre gene therapy campus (BioPharmaDive)
• Fresh off being bought, Apceth preps to supply Bluebird's gene therapy (BioPharmaDive)
• Former GSK site to be redeveloped as WeWork-styled life sciences center (BioPharmaDive)
• Lonza to separate out specialty ingredients business (BioPharmaDive)
• FDA Continuous Manufacturing Guidance Raises Concerns About Scope And Cost (Pink Sheet-$)
• BIO 2019 Notebook: M&A Soars, Lartruvo Lookback, BIO Vs. ASCO (Scrip-$)
• Genetic testing: the next big arena for fraud? (STAT)
• La Jolla whips up some love for iron overload drug with promising data snapshot (Endpoints)
• LabCorp selects its new CEO; Pfizer names ex-Genentech vet as new head of oncology R&D (Endpoints)
• As investor confidence crumbles following fund suspension, Neil Woodford faces backlash on fees (Endpoints)
• FDA Issues Guidance for Industry: “Section 503A Bulks List Final Rule Questions and Answers”: The Saga Continues…. (FDA Law Blog)

• Astex and Otsuka Announce Results of the Phase 3 ASCERTAIN Study of the Novel Oral Cedazuridine/Decitabine Fixed-Dose Combination (ASTX727) in Patients with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Press)
• Senseonics Announces FDA Approval for a Non-Adjunctive Indication (Dosing Claim) for the Eversense® 90-day CGM System (Press)
• ArQule to Present Clinical Data for its BTK Inhibitor, ARQ 531, at the 24th Congress of the European Hematology Association (EHA) (Press)
• Boston Biomedical, Inc. Announces the Continuation of the Phase 3 CanStem303C Study of Napabucasin in Patients with Advanced Colorectal Cancer Following Interim Analysis (Press)

• Akonni Bio Obtains FDA 510(k) Clearance for TruDiagnosis MDx System, PGx Test (GenomeWeb)
• Itamar Medical lands FDA clearance for disposable sleep apnea test (MassDevice)
• Solutions and services in medical devices: White space or white elephants? (McKinsey)
• Dexcom, Companion Medical will share glucose, insulin data (MassDevice)

• High-profile data breaches underline cyber threats to health care industry (The Hill)
• Ex-Shire Unit Exec Reaches $2.5M Deal In Kickback Case (Law360-$)
• AbbVie Development Partner Hits Back At $31M FTC Penalty (Law360-$)
• FTC and FDA Send Warning Letters to Companies Selling Flavored E-liquids About Social Media Endorsements without Health Warnings (FTC)
• ‘Unpredictability’ at heart of patent debate (Politico)
• Proposed patent legislation would block research, stifle innovation, and harm patients (STAT)
• Stem cell treatment: FDA court victory opens way to regulation in US (BMJ)
• Scientists are reclaiming psychedelics as “wonder drugs.” Is it time to decriminalize them? (Quartz)
• Smoked Turkey For Barbecue Season (Drug & Device Law)

• FDA Advisory Committee Calendar

• EU MDR/IVDR Coordination Group Answers Questions About Notified Bodies (Focus)
• Pharma Concerned By 'Wholesale' Rise In EMA Standard For Pharmaceutical Water (Pink Sheet-$)
• Italy Relaxes Rules On Pharma’s Use Of Data From Non-Commercial Trials (Pink Sheet-$)

• FiercePharmaAsia—China audits for Big Pharma; Takeda's phase 3 trial failure (Fierce)
• China’s FDA requests small trial of Guided Therapeutic’s LuViva before approval (MassDevice)

• Clinical trials market in Africa sees steady growth: ACE Research (Outsourcing Pharma)