Recon: Merck KGaA Looks to Machine Learning to Prevent Drug Shortages; J&J Raises Outlook Despite Mounting Legal Challenges

• J&J boosts outlook despite uncertainty over legal costs  (Financial Times) (WSJ) (CNBC)
• ‘Gene therapy headwinds’ are blamed for biotech stock woes (STAT)
• House progressives plot overhaul of Pelosi drug pricing bill (STAT)
• Eli Lilly to shutter neuroscience R&D center next year  (Fierce) (Endpoints)
• Faced With a Drug Shortfall, Doctors Scramble to Treat Children With Cancer (NYTimes) (Fierce)
• Allergan investors back AbbVie deal, but is a tax charge looming? (PMLive)
• The health angles to watch in tonight's debate (Politico) (Axios)
• Medical Device Stocks Are in Rude Health (WSJ)
• Gottlieb: Lack of Permanent FDA Commissioner Has an Impact (CHC)

• Time is of the essence for patients who have serious and life-threatening conditions. Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

• Merck KGaA to Test Machine Learning to Prevent Drug Shortages (WSJ) (Fierce)
• Life sciences suffers ‘lost decade’ as investment falls (Financial Times)
• Indivior shares rise as it boosts guidance for a second time (Financial Times) (Reuters)
• European countries increase commitment to responsible antibiotic use in animals (EMA)
• Danish biotech: white coat catalyst (Financial Times)
• Takeda Sheds Select Product Assets In Mid-East, Emerging Markets To Acino (Scrip-$)
• Boehringer Ingelheim-backed Abalos tosses hat into packed oncolytic virus ring (Endpoints)
• Woodford fired from flagship fund — which won't reopen after all (Endpoints) (Scrip-$)
• Floating in stormy seas, RTW seeks $350M for new London-listed venture fund (Endpoints)

• Surprising Wall Street, Reata unveils positive pivotal data on Friedreich’s ataxia drug (Endpoints) (Evaluate)
• Horizon shares data on eye disease drug as FDA decision nears (PMLive)
• The Ethical Dilemmas AI Poses for Health Care (WSJ)
• Ode to Patients (LifeSciVC)
• Gilead's chief strategy exec gets a big promotion after orchestrating multibillion-dollar deals (Endpoints) (Press)
• Gilead vet Alessandro Riva steers Glenmark's biotech spinoff on independent course (Endpoints)
• For pharma services firms, big assets can pose major risks (C&EN)
• Novo Nordisk, Bluebird Targeting ‘Lifelong’ Gene Therapies (Scrip-$)
• Sanofi US plant sets new bar for biologics production (Fierce) (Press)
• RWE: Comparators, Therapeutic Area May Be Key For Trial Replication (Pink Sheet-$)
• Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) (FDA)
• To ease dementia agitation, drugs may not be best option (Reuters)
• Common joint pain treatment may be more harmful than thought (NBC)
• Wanted: better policies and incentives to revitalize R&D for new antimicrobial drugs (STAT)
• DIY drugs: should hospitals make their own medicine? (The Guardian)
• BIO: Two heads are better than one (BioCentury)
• Aeglea, long-term Eli Lilly veteran nabs CMO job at Checkmate (Fierce)
• Ancestry launches consumer genetics tests for health, intensifying rivalry with 23andMe (STAT)
• Using CRISPR to edit eggs, sperm, or embryos does not save lives (STAT)
• Drug reverses signs of liver disease in people living with HIV (NIH)
• Checkmate Pharmaceuticals brings two new execs on board; Takeda sheds 30 drugs, gains $200M in Acino deal (Endpoints)
• Cyteir nets $40M for rad synthetic lethality platform — throwing another monkey wrench at cell repair (Endpoints)
• C-Path, CDISC Develop Standard to Represent Data for Animal Rule Studies (Press)

• U.S. FDA Approves SECUADO® (asenapine) Transdermal System, the First-and-Only Transdermal Patch for the Treatment of Adults with Schizophrenia (Press)
• CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study (Press)
• Relmada Therapeutics to Announce Results of Phase 2 Study of REL-1017 for Treatment Resistant Depression and Conduct Conference Call on Tuesday, October 15 (Press)
• Can-Fite Completes Patient Enrollment in Phase II NASH Study of Namodenoson™ (Press)
• Lineage Cell Therapeutics Presents New OpRegen® Data at American Academy of Ophthalmology Annual Meeting (Press)
• Can CBD temper Parkinson's-related psychosis? UK researchers will look for answers in PhII study (Endpoints)

• Rx for Doctors: Stop With the Urine Tests (NYTimes)
• 3M closes $6.7B Acelity buyout (MassDevice)
• Denterprise International, Inc. Warning Letter (FDA)
• Reports: Medtronic eyes Colorado for new plant (MassDevice)
• Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Health (MassDevice)
• Subtle Medical Receives FDA 510(k) Clearance for AI-Powered SubtleMR™ (Press)

• Partial CBO score gives boost to Speaker Pelosi's drug pricing bill (Politico)
• ATR Leads Coalition Opposed to Pelosi's 95% Drug Tax (ATR)
• Drug Price Controls Gaining Traction At Federal And State Levels (Forbes)
• Most Americans back various ideas to lower drug costs, but some fear impeachment will get in the way (STAT)
• Trump Is Trying Hard To Thwart Obamacare. How's That Going? (NPR)
• How Non-Profit Hospitals Are Driving Up The Cost Of Health Care (NPR)
• Subject: Final FY 2020 Funding Requestsfor Domestic HIV and Related Programs (FAPP)
• DOJ Casting Wider Net In Pharma Kickback Probes (Pink Sheet-$)
• Ninth Circuit Says “No” to Res Ipsa-Based Parallel Claims (Drug & Device Law)
• NeuroGrafix v. Brainlab, Inc. (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar
• Ways & Means Committee: Investing In The US Health System By Lowering Drug Prices, Reducing Out-Of-Pocket Costs, And Improving Medicare Benefits – 17 October 2019
• Antimicrobial Drugs Advisory Committee Meeting – 16 October 2019
• Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Final Guidance – 16 October 2019

• IMI Future Call Topics (IMI)
• HIV-positive British living in Spain could lose healthcare post-Brexit (Reuters)
• Advertising investigations: August 2019 (MHRA)
• Decide if your product is a medicine or a medical device (MHRA)
• Survey reveals 'workforce crisis' in NHS (PharmaTimes)
• New UK Medicines Bill could improve access to new dementia treatments (Pharmafile)

• Health ministry approves transition time of 6 months to implement provisions of new Medical Device Rules, 2017 (Pharmabiz)

• Ontario Expanding Trade and Investment with South Korea (Ontario)
• Astellas Transfers Three Products in Asia Region to Daiichi Sankyo (Press)

• An Oncologist Asks When It’s Time to Say ‘Enough’ (NYTimes)