Recon: Sanofi Sees Sales Growth in Q3; Orchard Raises $200M in IPO

• Biotechs With No Drugs in Trial are Raising Millions in IPOs (WSJ)
• FDA Approves Sandoz' Humira Biosimilar (Press)
• Pfizer CEO: 'Business as normal' on drug prices next year despite Trump pressure (The Hill) (STAT)
• Pharma's support of Trump's drug pricing plan is fraying heading into midterms (CNBC)
• Manufactured Crisis: How Drugs Can Cost 7x More in Versailles, MO than in Versailles, France (Senate HSGAC)
• In new document, the Trump administration labors to defend its latest drug pricing proposal (STAT)
• Acadia Pharma conjures black magic to spin a failed depression drug trial (STAT) (Endpoints)
• FDA says it will consider approval of first dengue vaccine, despite controversy (STAT) (Fierce) (Press
• Five burning questions ahead of Sage Therapeutics’ date with the FDA (STAT)
• Amgen posts higher quarterly EPS, Repatha sales fall short (Reuters) (Fierce)
• Gilead throws its weight — and $50M cash — behind Tango’s I/O discovery engine (Endpoints) (Fierce) (C&EN)
• Whither CRISPR? University of California/Berkeley Granted Another CRISPR Patent (Patent Docs) (BioCentury)
• Merck's Keytruda secures broader lung cancer approval (BioPharmaDive) (Press)
• Former Valeant and Philidor executives are sentenced to one year in prison (STAT) (DoJ)

• UK police charge pharmaceutical company over hospital baby deaths (Reuters) (Financial Times)
• Working with stakeholders to improve availability of medicines in the EU Share (EMA)
• Make Them In Europe: The French Solution To Drug Shortages (Pink Sheet-$)
• Want to operate in China’s biotech scene? Here are five tips (STAT)
• Sanofi Returns to Growth (WSJ) (Press)
• Takeda raises forecast on cancer drug outlook (Financial Times)
• Finally! Innovent hikes on Hong Kong debut amid cloudy market sentiments (Endpoints)
• Orchard, Fueled by GSK’s Ex-Gene Therapy Biz, Nets $200M in IPO (Xconomy) (Endpoints)
• NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer (PharmaTimes) (Pharmafile)
• France opens national investigation after reports of spike in birth defects (Reuters)
• Shingles vaccine helps GSK shrug off Advair threat (Financial Times)
• Long-lasting HIV injection is a step closer after second GSK study (Reuters)
• GSK tosses a trio of clinical-stage drugs on trial failures, winnowing out its respiratory pipeline as cancer moves to center stage (Endpoints)
• Pharmacies could struggle to recruit in a 'no-deal' Brexit, pharmacy organisations tell MPs (Pharmaceutical Journal)
• Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018 (EMA)
• Why Are People So Angry At Ebola Responders In The Democratic Republic Of The Congo? (NPR)

• 2018 FY OGD Statistics Finalized (Lachman)
• Pfizer’s Hospital-Drug Problems Won’t Go Away (Bloomberg)
• Samsung joins Soliris biosimilar quest (EP Vantage)
• Weeks after launching Aeterna Zentaris castoff, Strongbridge turns around and sells rights to Novo Nordisk — at a premium (Endpoints)
• Allergan beats on Botox boost, but can migraine sales withstand CGRP rivals? (Fierce)
• FDA updates on angiotensin II receptor blocker (ARB) recalls (FDA)
• Lonza invests in ‘game-changer’ automated cell therapy manufacture (BioPharmaReporter)
• Thermo Fisher expands center to ease clinical trial logistics (Outsourcing Pharma)
• With Clear FDA Path, Clementia Raises $70.2M (BioCentury)
• Chinese-American startup Terns Pharmaceuticals raises $80M for NASH, cancer drugs (MedCity)
• Language Barrier Means Millions Of Elderly Can't Access Alzheimer's Trials (NPR)

• ACADIA Pharmaceuticals Announces Positive Top-line Results from Phase 2 CLARITY Trial of Pimavanserin for Adjunctive Treatment in Patients with Major Depressive Disorder (MDD) (Press)
• Galderma, Nestlé Skin Health’s Medical Solutions Business, Announces Positive Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis (Press)
• Rgenix Treats First Patient in Phase 1 Trial of RGX-202 (Press)

• Cybersecurity Déjà Vu (FDA Law Blog)
• Baxter dips on Q3 sales miss (MassDevice)
• LivaNova takes a hit on Q3 sales miss, despite raised outlook (MassDevice)
• Biotronik receives FDA approval for covered coronary stent (Medical Design & Outsourcing)
• Cerus Receives FDA Breakthrough Device Designation for Pathogen-Reduced Cryoprecipitate (Press)
• FDA Grants Ansh Labs a De Novo Clearance for the MenoCheck® Blood Test as an Aid in the Determination of Menopausal Status in Women (Press)

• Feds are ready to claw back billions from Medicare insurers (Axios)
• Trump Administration to Revise Birth Control Exemptions in Hopes of Saving Them (NYTimes)
• Amarin Says Supplement Cos. Can't Tout Its Omega-3 Trial (Law360-$)
• Waxman Opposes Hatch Plan To Keep Generics Out Of PTAB (Law360-$)
• FDA says it had 'constructive' meetings with e-cigarette manufacturers on teen epidemic (CNBC)
• Rite Aid shareholders vote to support increased oversight of opioid sales (STAT)
• DC Circ. Backs FDA Denial Of Rx-Only MiraLAX Generics (Law360-$)
• Insurer Wants Out Of Covering Pharma Co. In Opioid Suits (Law360-$)
• Social Stigma Is One Reason The Opioid Crisis Is Hard To Confront (NPR)
• Get the lead out of hair dyes, FDA orders (NBC) (FDA)
• Court Puts Stake in Heart of Hip Implant Negligence Claim vs. Distributor; Plaintiff’s Summary Judgment Motion Doesn’t Stand a Ghost of a Chance (Drug & Device Law)

• FDA Advisory Committee Calendar

• Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations (EDQM)

• China Regulatory Express: New Essential Medicines Include Anticancers, HCV Combo (Pink Sheet-$)

• Madras High Court grants interim injunction against online medicine sale (Economic Times)
• Strides Pharma Science to get USD 20 mn funding for consumer healthcare business (Economic Times)

• Industry Raises Concerns Over Australian ‘Boxed Warning’ Proposals (Pink Sheet-$)
• Australia Wants To Link Regulatory Review Of CDx And Associated Drugs (Pink Sheet-$)
• Webinar: Advertising therapeutic goods in 2019: The Code basics (TGA)
• Summary of changes to the Therapeutic Goods Advertising Code 2018 (TGA)
• Complying with the Therapeutic Goods Advertising Code (No. 2) 2018 (TGA)
• Therapeutic goods advertising: Update 31 October 2018 (TGA)

• Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions (Emergo)

• CDC confirms 10 new cases of rare polio-like neurological condition (Reuters)