Recon: Swiss Competition Authority Names Boehringer, 10 Others in Antitrust Probe; Roche Pays $200M to License Dicerna RNAi Drug

• Pelosi Calls Pharma’s Bluff on Drug Prices (Bloomberg)
• Insurance, pharma figures spar over drug price legislation’s innovation impact (STAT)
• Merck loses bid to revive $2.54 billion patent verdict against Gilead (Reuters) (Law360-$)
• How Contaminated Stool Left a Fecal Transplant Patient Dead (NYTimes) (STAT) (NEJM)
• CMS proposes lifting restrictions on NGS cancer testing (BioPharmaDive)
• AbbVie's Rinvoq impresses at Ph 3 in active psoriatic arthritis (Pharmafile) (Fierce) (Press)
• Alexander: Senate Health Committee Approves Eight Bipartisan Public Health Bills (Press)
• Did a Drug Company Illegally Experiment on a Louisiana Prisoner? (New Republic)
• Novartis Admits to ‘Mistake’ After Partial Clinical Hold Placed on Zolgensma Trial (Focus)

• GSK raises outlook again amid strong demand for shingles drug (Financial Times) (Yahoo) (PMLive)
• Roche pays $200M for rights to Dicerna's hepatitis B RNAi drug (Fierce) (Endpoints) (Press)
• Sanofi Profit Beats Estimates With New CEO Hudson at Helm (Bloomberg) (Reuters) (PMLive) (Press)
• Dupixent scores another EU extension (PharmaTimes)
• Sanofi axes cancer combo, early next-gen diabetes drug (Fierce)
• Swiss authorities probe Boehringer Ingelheim and other companies for antitrust practices (STAT)
• WHO, Congo eye tighter rules for Ebola care over immunity concerns (Reuters)
• Second Ebola vaccine set to be used soon in Democratic Republic of the Congo (STAT)
• Astellas rejoins the autoimmune antibody craze with Pandion partnership (Endpoints) (Press)
• SinoMab, Alphamab Oncology make their way to the Hong Kong Stock Exchange (Endpoints)
• Eudamed to Launch in 2022 for Both Devices and IVDs (Focus)

• Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas (Focus)
• Bill Gates spends billions on global health. With Alzheimer’s, his science adviser says, money is not the issue (STAT)
• FDA approves cheaper meds for dogs with separation anxiety (NBC)
• Targeted protein degradation: expanding the toolbox (Nature)
• Where Were the Women? Gender Parity in Clinical Trials (NEJM)
• Commentary: Regulators Wonder if Cancer Patients ‘Need’ New Treatments (WSJ)
• The health information exchange has evolved from hunter and gatherer to cultivator (STAT)
• Next BIO CEO Needs Political Savvy, Greenwood Says (Pink Sheet-$)
• Outgoing BIO CEO Focuses On Out-Of-Pocket Costs As Solution To Drug Pricing Woes (Pink Sheet-$)
• Bristol-Myers warns I-O blockbuster Opdivo will be 'under pressure' in 2020 (Fierce)
• Sanofi's oncology R&D group marks a pair of setbacks on isatuximab/Libtayo combo as cancer studies fizzle out (Endpoints)
• Pinteon Gets $17M to Tackle Tau in Alzheimer’s, Other Brain Diseases (Xconomy)
• Vivek Ramaswamy trades top execs and adds stealthy vant to $3B sale, while his new partner tosses Myovant $350M (Endpoints) (BioPharmaDive)
• Genmab's Executive VP and CFO to retire in 2020 (Pharmafile)
• Thermo Fisher hooks gut onto its gene therapy pipeline, inks new collaboration pact (Endpoints)
• Social connections first, science second: How biotech’s recipe for success has its limits (STAT)
• The EMR has changed the doctor-patient duet into a ménage-à-trois (STAT)
• Oz Azam beefs up Tmunity's total raise to $231M as they steer toward human data in the drive to cell therapy 2.0 (Endpoints)
• Vik Bajaj unveils Foresite's new incubator, looking to hatch future giants crossing tech and healthcare (Endpoints)
• Neuroscience biotech led by former Pfizer crew wins $17M to target toxic tau (Endpoints)
• NIH-funded study suggests acetaminophen exposure in pregnancy linked to higher risk of ADHD, autism (NIH)
• ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter (FDA)

• New Phase I Clinical Trials for Two Proposed Ustekinumab Biosimilars (Big Molecule Watch)
• U.S. FDA Agreed with Can-Fite’s Proposed Pivotal Phase III Trial Design to Support a New Drug Application Submission and Approval of Namodenoson in the Treatment of Liver Cancer (Press)
• Injection That Makes Colorectal Cancer ‘Glow’ During Surgery Enters Phase 3 Trial (Forbes)
• Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis (Press)
• New England Journal of Medicine Publishes Results from Astellas’ Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia1 (Press)
• Phase 3 Results from Two Studies of TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Triple Combination Treatment for Cystic Fibrosis Concurrently Published in The New England Journal of Medicine and The Lancet (Press)
• Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial (Press)
• Aldeyra Therapeutics Releases Expanded Results from Allergen Chamber Trial and Announces Plans to Initiate the Phase 3 INVIGORATE Trial in Patients with Allergic Conjunctivitis (Press)
• Aurinia Announces Initiation of Patient Dosing in Phase 2/3 AUDREY™ Clinical Trial for Dry Eye Syndrome (Press)
• ACADIA Pharmaceuticals Initiates Phase 3 Pivotal Study of Trofinetide in Rett Syndrome, a Rare Neurodevelopmental Congenital CNS Disorder (Press)
• Pinteon Therapeutics Launches Phase 1 Trial of Novel Tau Antibody that Targets a Potent Driver of Neurodegenerative Disease (Press)
• Knight and TherapeuticsMD Announce Filing of New Drug Submission for Joyesta™ in Canada (Press)

• Senators Reiterate Concerns About FDA’s Software Pre-Cert Program (Focus)
• Apple hires another prominent cardiologist as it makes heart health a big area of focus (CNBC)
• Smith & Nephew raises revenue guidance for second straight quarter (Financial Times) (MassDevice)
• Exact Sciences Q3 revenue jumps 85% but Cologuard orders disappoint (MedtechDive)
• Sharp drop in Chinese sales drags Qiagen down in Q3 (MedtechDive)
• Abiomed jumps on fiscal Q2 earnings beat (MassDevice)
• Integer bests Q3 earnings forecast despite plunging profits (MassDevice)
• Ethicon recalls Echelon Flex Endopath staplers (MassDevice)
• NuVasive gains on beat-n-raise Q3 numbers (MassDevice)
• With a new hip or knee, most return to driving in a few weeks (Reuters)
• Class 1 Device Recall CentriMag Acute Circulatory Support System Motor (FDA)

• Obamacare markets stronger than ever, as lawsuit looms (Politico)
• US lawmaker urges White House to quickly finalize plan to pull flavored e-cigarettes off the market (CNBC)
• Outcome Health Resolves Criminal Fraud Probe, Acknowledges Wrongdoing (WSJ) (Reuters)
• Sanofi pays $315 million to settle Lemtrada go-slow claims (BioPharmaDive)
• Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. (Fed. Cir. 2019) (Patent Docs)
• Judge Rips Risperdal Trial Team's 'Fabricated' Recusal Bid (Law360-$)
• Sens. Urge Changes At USPTO To Improve Patent Quality (Law360-$)               
• McKesson Can't Ditch Generic Drug Price-Fixing Fraud Suit (Law360-$)
• What is Past is Prologue for Personal Jurisdiction (or maybe it’s Not?) (Drug & Device Law)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers (Focus)
• EMA closed 1 November 2019 (EMA)
• UK Gov't Disowns ‘Secret’ Meetings With US On Post-Brexit Drug Pricing (Pink Sheet-$)
• Transactions in the pharma sector: Through the EU merger review looking-glass (Pharmafile)
• Social media used to boost cancer screening rates (PharmaTimes)
• AZ divests rights to Seroquel in Europe, Russia (PharmaTimes)
• Exporting active substances for medicines after Brexit (MHRA)
• Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039) (MHRA)

• Singapore HSA issues new guidance on special authorization routes for medical devices (Emergo)

• Sanofi inks pact with Unitaid; To reduce TB drug Rifapentine price by 70% (Economic Times)
• Health ministry to develop action plan to monitor misleading advertisements of Ayush drugs (Pharmabiz)

• Submissions received: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin (TGA)
• Consent to supply therapeutic goods that do not comply with subsection 9(2) of Therapeutic Goods Order No. 92 (TGA)

• Knight Therapeutics makes ‘transformational’ acquisition in Brazil (PharmaLetter-$)
• Brazil approves single-dose tafenoquine for radical cure of P. vivax malaria (PharmaLetter-$)

• The patient lasted just minutes after being taken off life support. By then it was too late (ProPublica)