Recon: Amgen, Lilly Report Tumor Shrinkage in KRAS, RET Lung Cancer Studies

• Lung cancer drug Lilly bought for $8 billion delivers strong results (STAT) (Endpoints) (Reuters)
• Amgen Slips as Gene-Targeting Drug Misses Some ‘Lofty Hopes’ (Bloomberg) (Reuters) (STAT) (Endpoints) (Press)
• Sacklers Reject Demand That They Surrender Personal Wealth To Settle Opioid Claims (NPR)
• Novartis Makes New Data Integrity Commitment (Focus) (Reuters) (STAT)
• Purdue Pharma touts data that downplay its role in the opioid epidemic, new analysis shows (STAT) (The Guardian) (ProPublica)
• Drug Formulary Managers' Use Of Step Therapy Can Lead To Sub-Optimal Outcomes (Forbes)
• New Google Policy Bars Ads for Unproven Stem Cell Therapies (Washington Post)
• Neurotrope shares crash after Alzheimer's drug fails in trial (Reuters)
• FDA approves Boehringer's Ofev for rare lung disease drug (Reuters) (Endpoints) (FDA)
• US recorded 7 new cases of measles last week, lowest of 2019 (Reuters)
• States Pass Record Number Of Laws To Reel In Drug Prices (KHN)
• Durbin calls on Sharpless to act on vaping-linked illness or resign (Politico) (CNBC)
• FDA warns Juul for misleading advertising (Axios) (AP) (Reuters) (NYTimes) (CNBC)

• Drugmakers file second court challenge to Canada's new drug price rules (Reuters)
• London VC raises first tranche of $150m advanced therapies fund (Financial Times) (Endpoints)
• Swiss biotech ADC Therapeutics guns for $150M IPO (Fierce)
• 'Wild speculations': BeiGene hits back at short seller's accusations of 60% sales inflation (Fierce)
• GSK eyes follow-up HPV vaccine (PMLive)
• A team of maverick scientists is trying to build a bootleg version of a million-dollar drug (CBC)
• Slovakian biotech firm signals tentative Alzheimer's drug hope (Reuters)
• Malaria can be eradicated by 2050, say global experts (Reuters)

• Pfizer touts successor to Prevnar 13 (BioPharmaDive) (Press)
• FDA Denies Public Citizen Petition for Moratorium on Opioid Approvals (Citizen)
• Who’s Missing From Breast Cancer Trials? Men, Says the FDA (NYTimes) (Focus)
• US FDA Looks To Standardize Premarketing Safety Assessments (Pink Sheet-$)
• Northwestern University Stem Cell Therapy Clinic Closes Abruptly (The Scientist)
• FDA Gives Drugmakers More Time to Join Quality Metrics Feedback Program (Focus)
• Biotech vet Tony Coles to become CEO of Pfizer neuroscience spinout Cerevel (STAT) (Endpoints)
• Three biotechs hunt $336M-plus in a new round of IPOs — while Dermavant pulls back (Endpoints)
• ‘It’s not working': An FDA insider’s view of where medical innovation falls short (LA Times) (Endpoints)
• WCLC: Merck analyses throw doubt on new biomarker's utility (Fierce)
• The Bio/Pharma Beat - September 2019 (SquirePattonBoggs)
• FDA Adopts Units of Measure Standard for Regulatory Submissions (Focus)
• Neurotrope battered in latest Alzheimer's flop; Platelet BioGenesis raises $26M-plus (Endpoints)
• Astellas hires first chief patient exec to make 'centricity' more than a buzzword (Fierce)
• Gene therapy boom continues (Nature)
• PCSK9-lowering RNAi contender clears first phase III trial (Nature)
• GS1 US Publishes New DSCSA VRS Implementation Guide (RxTrace)
• FDA In Brief: FDA reiterates the importance of vaccines such as the Measles, Mumps, and Rubella (MMR) vaccine (FDA)
• Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; AEGEA
• (FDA)
• International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs (FDA)

• PhIII lung cancer data signal potential approval for AstraZeneca's Imfinzi (Endpoints) (Press)
• Ridgeback Biotherapeutics LP announces receipt of Breakthrough Therapy designation from FDA for mAb114 (Press)
• Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension (Press)
• Acadia declares early win on Nuplazid dementia study, stunning analysts and sending shares soaring (Endpoints) (BioPharmaDive) (Press)
• Biohaven Presents Data Demonstrating Reduction In Migraine-Related Disability And Improvement In Patient Reported Outcomes After Oral Treatment With Rimegepant At The International Headache Conference Late Breaking Session (Press)
• Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration (Press)
• MicuRx Pharmaceuticals Reports Positive Top-Line Results From a US Phase 2 ABSSSI Clinical Trial of Novel Antibiotic Contezolid Acefosamil (Press)
• Ipsen and Servier announce initial Phase II/III clinical data evaluating investigational liposomal irinotecan (ONIVYDE®) as a second-line treatment for small cell lung cancer (SCLC) at the IASLC 2019 World Conference on Lung Cancer (Press)
• Horizon Therapeutics plc Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED) (Press)
• Recardio's Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin Now Enrolling and Recruiting in All Global Centers (Press)
• New Data from Esketamine Nasal Spray Phase 3 Studies Showed Rapid Reduction of Depressive Symptoms in Adult Patients with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent (Press)
• Lipidor Announces Enrolment of Last Patient in Calcipotriol/AKVANO Spray (AKP01) Phase III Study Targeting Psoriasis (Press)
• Theravance Biopharma Reports Positive Results from Phase 1 Clinical Trial of TD-8236, an Investigational, Lung-Selective, Inhaled Pan-Janus Kinase (JAK) Inhibitor for Inflammatory Lung Diseases (Press)

• De Novo Requests: FDA Finalizes Three Guidances (Focus)
• ICS Medical Advisory (ICSMA-19-248-01) BD Pyxis (ICS)
• Why Medical Device Regulation? (Harvard Bill of Health)
• Medtronic’s In.Pact AV DCB meets endpoints in trial (MassDevice)
• SoniVie wins FDA breakthrough device designation for pulmonary hypertension device (MassDevice)
• Abbott Shines Light on “Forgotten Valve” with New Pivotal Trial (MDDI)
• Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System (Press)

• Why Should FDA Warning Letters Be Any Different? (Drug & Device Law)
• Allergan Sales, LLC v. Sandoz, Inc. (Fed. Cir. 2019) (Patent Docs)
• California lawmaker, governor reach deal on vaccine bill (ABC)
• Considerations For Expanding International Reference Pricing Beyond Medicare Part B (Health Affairs)
• Senators Question DHS, HHS Over Vaccinations for Migrants Held by CBP (Letter)
• Trump Administration Is In Court To Block Nation's 1st Supervised Injection Site (NPR)
• Vantage Solutions Supports FDA Pilot for Verification Router Service (Press)
• Why Opioid Suits Avoid GCs — And Why That Could Change (Law360-$)
• Zicam Maker Hit With Patent Suit Over Nasal Spray Formula (Law360-$)
• Stryker Must Pay For IP Marking Failure, Acantha Says (Law360-$)
• Fed. Circ. Clouds Landscape For Medical Treatment Patents (Law360-$)
• Biopharma Co. Regulus Dodges Stock Suit Over Drug Trials (Law360-$)
• European Doctor Who Prescribes Abortion Pills To U.S. Women Online Sues FDA (NPR)
• The FDA commissioner sweepstakes: Is Azar yearning to get out of Gottlieb’s shadow? (STAT)
• Los Angeles County resident dies of lung illness, fifth U.S. death possibly tied to vaping (Reuters)
• MIT’s star tech guru Joi Ito resigns biotech chair post in wake of Jeffrey Epstein scandal (Endpoints)

• FDA Advisory Committee Calendar

• EMA Begins Review of Skin Cancer Data for Patients Using Picato (Focus)
• Questions & Answers: Global Vaccination Summit (EC)
• 2 new reference standards and 18 replacement batches released in August 2019 (Council of Europe)
• To marketing authorisation holders: The process for notifying shortages will change gradually starting from 1 October 2019 (Fimea)

• PDMA seeks PM’s intervention to clean up CDSCO from corrupt officials (PharmaBiz)

• Notice of Consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution) (Health Canada)

• Improved Consumer Medicine Information template (TGA)

• Comments on agenda items for the 63rd meeting of the Medicines Classification Committee to be held on 10 October 2019 (Medsafe)
• New WHO Public Inspection Report (WHOPIR) published (WHO)