Recon: Novartis to Buy Endocyte for $2.1B

• Proposed Rule Requiring Drug Prices in TV Ads Could Impact Marketing Strategies (WSJ)
• Requiring Price Info in Drug Ads May Strain Agency Authority (Bloomberg)
• The Trump administration hints at new drug pricing regulations on Medicaid, biologics (STAT)
• FDA slaps down Novartis’ blockbuster pitch for canakinumab — so what went wrong? (Endpoints)
• FDA slaps a full hold on Affimed’s T cell engager in wake of a lethal reaction (Endpoints)
• The EKG is only a start. Apple wants to seize the market for patient monitoring (STAT)
• Merck, Pfizer combo treatment meets main goals of kidney cancer trial (Reuters)
• New England Journal pulls one paper, probes two others from stem cell researcher (STAT)
• Science journal to withdraw chronic fatigue review amid patient activist complaints (Reuters)
• Amgen sharpens focus on genetic sequencing with $66M investment (Endpoints)
• AbbVie frontloads Morphic fibrosis development deal with $100M in cash (Endpoints) (Xconomy)
• GSK to axe 99 positions at Memphis site (Pharmafile) (Fierce)
• McConnell says Senate Republicans might revisit Obamacare repeal (Reuters)
• Walmart executive to replace Ostroff in foods post at FDA (Politico)
• GOP Senator Pushed VA to Use Unproven “Brainwave Frequency” Treatment (ProPublica)
• Health Care Tops Guns, Economy As Voters’ Top Issue (KHN)
• White House to celebrate its opioid work next week (Politico)

• Novartis to Buy Cancer-Drug Maker Endocyte for $2.1 Billion (WSJ) (STAT) (Endpoints) (Press)
• Novartis Needs US Security Nod for Endocyte Under New Rules (Bloomberg)
• AbbVie settles Humira biosimilar dispute with Fresenius Kabi (Reuters)
• Congo's Ebola outbreak to worsen without stepped-up response: WHO committee (Reuters)
• WHO: Ebola Outbreak in Congo Not a PHEIC (Medpage) (WHO)
• Upcoming WHO and CND Meetings Could Impact Scheduling of CBD and Cannabis (FDA Law Blog)
• NHS green light for Novartis skin cancer combo (PharmaTimes)
• UK fights EpiPen shortage by extending injector expiry dates (Fierce) (Pharmafile)
• Why HIV vaccine research is now about much more than HIV (STAT)
• HIV prevention drugs could dramatically cut new infections (Reuters)
• Gilead, Aelix ally to trial HIV-suppressing combination (Fierce)
• Opening speech for the World Health Summit (WHO)
• The ICH S11 draft Guideline presentation available now (ICH)
• EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says (Pink Sheet-$)

• Vaccines Almost Eradicated Polio. Now A Disease Like It Is Back. (Forbes)
• Can Pfizer's new breast cancer drug Talzenna really make a dent in the PARP field? (Fierce)
• PhRMA CEO discusses industry’s new approach to DTC television advertising (PhRMA)
• On Track for a Record Breaking 2018 – #BIF18 Opening Plenary (BIO)
• Allergan to file ubrogepant for migraine early next year (PharmaTimes)
• Boosting Cybersecurity in Pharma (Pharmaceutical Manufacturing)
• Anatomy Of A Biotech Company: Acorda Gets Dressed For A Second Act (Pink Sheet-$)
• Parker Institute backs an upstart biotech looking to develop a new, convertible CAR-T (Endpoints)
• Data Integrity And The Iceberg Concern (Pink Sheet-$)
• Biotech vets launch a neuro startup with $54.5M to kickstart R&D (Endpoints)
• Afferent executives launch next-generation neuro hopeful, gaining J&J backing (Fierce)
• Phasebio, Osmotica Price IPOs Well Below Range (BioCentury)
• Researchers identify immune culprits linked to inflammation and bone loss in gum disease (NIH)
• Genomic analysis offers insight into 2018 Nigeria Lassa fever outbreak (NIH)
• Oligomerix Awarded $1.98 Million NIH SBIR Phase IIb Grant to Advance its Lead using Transgenic Models for Alzheimer’s Disease and Frontotemporal Dementia (Press)
• Determination of Regulatory Review Period for Purposes of Patent Extension; OCREVUS (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; AFSTYLA (FDA)

• Priority review for imbruvica-gazyva combo to treat CLL, SLL (BioCentury)
• Eisai, Purdue Insomnia Candidate Meets In Second Phase III (BioCentury)
• First Patient Dosed in a Phase 1/2 Trial of Transgene’s Oncolytic Virus TG6002 Administered Intravenously in Patients with Advanced Gastrointestinal Tumors (Press)
• Novaliq Announces Positive Topline Results for Its CyclASol® Phase 2B/3 Essence Trial in Patients with Dry Eye Disease (Press)
• GenSight Biologics reports positive 72-week data from REVERSE Phase III clinical trial of GS010 for the treatment of Leber Hereditary Optic Neuropathy (LHON) (Press)

• Real-World Data: Precertification Could Aid Use For Regulatory Decisions (Pink Sheet-$)
• Fresenius plunges on missed prelims, guidance cut (MassDevice)
• Dexcom wins CMS nod for latest glucose monitor (Drug Delivery)
• Abbott CEO on Libre: ‘We’re just getting started’ (Drug Delivery)
• Abbott's Growth is Impressive, but What about That Elephant? (MDDI)
• VISEON, Inc. Announces FDA Clearance of the Voyant System for Minimally Invasive Spine Surgery Access, Visualization, and Illumination (Press)

• New Patent Appeal Standard Praised By PhRMA, BIO; Rankles Generics (IHP-$)
• AAM Files Amicus Brief in Helsinn v Teva (AAM)
• Trump's Rulemaking Agenda Aims To Cut $18B In Costs (Law360-$)
• Study Challenges Hospitals’ Use of Accrediting Watchdogs (WSJ)
• Calif. Tribes Become Latest To Bring Opioid Crisis Suits (Law360-$)
• Bayer Cholesterol Drug FCA Suit Survives Dismissal Bid (Law360-$)
• 20 Drugmakers Must Face Generic Price-Fixing MDL (Law360-$)
• J&J Wants $20M Pa. Mesh Award Axed Over Alleged Time Bar (Law360-$)
• Medtech issues again take center stage in Minn. Congressional races (MassDevice)
• Guest Post – What Does Your Dismissal Without Prejudice Mean? − A 50 State Survey of Savings Statutes (Drug & Device Law)

• FDA Advisory Committee Calendar

• We need to think differently on cancer to save even more lives says Sir Harpal Kumar at MHRA annual lecture (MHRA)

• A Long March After Approval: What You Need To Launch Orphan Drugs In China (SCRIP-$)

• Zydus Cadila gets USFDA nod for generic gout attacks drug (Economic Times)

• Adverse event reporting made easier for GPs (TGA)

• Flat Out: Rejecting Breast Reconstruction (NYTimes)