Recon: FDA Rejects Vanda’s Jet Lag Drug; Roche and AbbVie Price New Cancer, RA Drugs

• AbbVie prices new rheumatoid arthritis drug at $59,000 a year (Reuters)
• Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakv (Reuters)
• Minority racial groups continue to be dismally represented in cancer trials (Endpoints) (STAT) (JAMA)
• Vanda shares slide after FDA spurns their big endpoint and rejects a pitch on jet lag relief (Endpoints) (Press)
• Chinese investment in US biotechs to slow further (BioCentury)
• Gilead did not seek US exclusivity on PrEP with Truvada (Financial Times)
• US records 21 new measles cases as of last week (Reuters)
• Sarepta's Lone Analyst Skeptic Takes On 22 Bulls With Renewed Warnings (Bloomberg) (Endpoints)

• UK faces food, fuel and drug shortages, says contested leaked document (Reuters) (The Times) (PMLive)
• UK's Johnson slams 'mumbo-jumbo' about vaccines after measles rates rise (Reuters)
• Brexit: Boris Johnson delights Eurosceptics with pledge to end Brussels law (The Times) (GOV.UK)
• Novartis CEO Battles Fallout From Data Manipulation (WSJ) (Endpoints)
• Novartis executive sold shares before drug data manipulation made public (Reuters) (Bloomberg)
• Roche taps Lilly executive Garraway as chief medical officer (Reuters) (Fierce)
• Dr Reddy's launches Roche's Avastin biosimilar in India (Economic Times)
• Juvenescence raises another $100m to invest in longevity (Financial Times) (Fierce) (Endpoints)
• Italy Unveils New Payment Model For Novartis’s CAR-T Kymriah (Pink Sheet-$)
• China’s biosimilars in fast lane (BioCentury)
• Combo drugs: latest trend in local pharmaceuticals (Korea Biomedical Review)
• Ebola spreads to remote, militia-run Congo territory (Reuters)
• WHO Director-General underscores commitment to strengthening health in Pacific Islands (WHO)

• Ahead of FDA decisions on one antibiotic, Nabriva plans resubmission of another (BioCentury)
• EMA and FDA Historically Agree on Just About Every New Drug Approval, but is That Slowly Changing? (Focus)
• Here Come the Oncology Biosimilars in the US: How Low Will Prices Go? (Focus)
• Generic Drug Approvals Hit Another Record High as Competition, Quality Questions Linger (Focus)
• Lyrica looking grim: Pfizer blockbuster's market share crumbles under generic attack (Fierce)
• Pfizer’s Ibrance And The Realities Of 'Real-World' Evidence (Pink Sheet-$)
• Clarus Therapeutics Announces FDA Award of 3-Year Market Exclusivity for Jatenzo® (Press)
• SpringWorks plans $115M IPO to take ex-Pfizer drugs to market (Fierce) (Xconomy) (Endpoints)
• Novartis consolidates $600 million media account with custom group created by Publicis’ Starcom and Epsilon (Fierce)
• ACRES’ plan to harmonize clinical trials across many lands (BioCentury)
• Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee (FDA)

• ActoBio Therapeutics Receives IND Green Light for New Antigen-Specific Immunotherapy Study Aimed at Improving Celiac Patients' Tolerance of Gluten (Press)
• Eton Pharmaceuticals Announces Positive Results from Clinical Study Report of ET-104 (Press)
• Knopp Biosciences Announces Start of Phase 2 Clinical Trial Evaluating Oral Dexpramipexole in Moderate-to-Severe Eosinophilic Asthma (Press)
• Vascular Therapies Completes Enrollment in the ACCESS Study, a US Phase III Clinical Trial (Press)

• CVRx’s Barostim Neo system earns FDA approval (MassDevice) (FDA)
• MDIC Kicks Off Framework on Patient Input in Device Trials (Focus)
• August Is Hot with New FDA Breakthrough Device Designations (MDDI)
• Inflammatix Preps Immune-Response Sepsis Dx for FDA Clinical Trial, Lays Out Future Test Plans (GenomeWeb)

• The Right’s Left Turn on Drug Prices (WSJ)
• Despite their pledges, Democrats haven’t yet lowered drug prices. Here’s how they’re explaining themselves (STAT)
• Medicare could have saved billions if older generics were prescribed, study finds (STAT)
• Grassley puts teeth back in Senate Finance (Politico)
• Glenmark Wants Out Of Pharmacies' Pay-For-Delay Lawsuits (Law360-$)
• SC AG Hits 3 Opioid Distributors With Suit Over Crisis (Law360-$)
• Sterigenics Emissions Suits Kicked Back To Ill. State Court (Law360-$)
• Prescription Medical Product Causation – Expert Required – Part Two (Drug & Device Law)
• Note to Pharma: Stop With the Dancing! (And Get Off My Lawn) (FDA Law Blog)
• Explaining Medicare Part D's Success As A Byproduct Of Flat Voucher Subsidies (Forbes)
• Planned Parenthood May Withdraw From Title X Funding (NYTimes)
• When parents say 'no' to HPV shots, teens have no choice. Some states are changing that. (NBC)

• FDA Advisory Committee Calendar
• Antimicrobial Drugs Advisory Committee; Notice of Meeting – 16 October 2019
• Implementing the Food and Drug Administration’s Predictive Toxicology Roadmap: An Update of the Food and Drug Administration’s Activities – 18 September 2019
• Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting – 30 October 2019

• Novo Nordisk shareholder revolt reaches Europe (PMLive)
• New sort of applicable economic operators regulation: the Market Surveillance Regulation (MedicalDevicesLegal)
• Medical Devices Alerts issued in July 2019 (MHRA)
• Daratumumab (Darzalex): risk of reactivation of hepatitis B virus (MHRA)
• Naltrexone/bupropion (Mysimba): risk of adverse reactions that could affect ability to drive (MHRA)
• Carfilzomib (Kyprolis): reminder of risk of potentially fatal cardiac events (MHRA)
• Letters and drug alerts sent to healthcare professionals in July 2019 (MHRA)

• APEC Members See Increased Regulatory Convergence (Focus)
• Is Pfizer's established drugs' decline in China the ‘canary in the coalmine?’ (Fierce)

• Sun Pharma's future brightens considerably with FDA plant upgrade and China drug deal  (Fierce)
• Make in India plan in works to attract medical device companies (Economic Times)
• Indian High Court rules against Bayer on Nexavar and Xarelto API exports (PharmaLetter-$)
• Indian pharma industry may achieve double-digit growth by 2030 (PharmaBiz)
• NPPA fixes retail and ceiling prices of 13 formulations under DPCO 2013 (PharmaBiz)
• CDSCO ushers in pharmacovigilance for vaccine ADR collection and reporting (PharmaBiz)

• As Americans get heavier, obesity-linked cancers may strike earlier (Reuters)