Recon: Novo Nordisk to Cut US Insulin Price With Authorized Generic; Alexion Suffers EU Patent Setback

• Q&A: How the future of medicine looks to the FDA’s top drug regulator (LA Times)
• Novo Nordisk rolls out authorized insulin generics, following similar moves by Lilly and Sanofi (Fierce) (Reuters) (STAT) (Press)
• MD Anderson cancer doctor emerges as a top candidate for FDA job (Washington Post) (WSJ) (STAT) (Politico)
• Inside drugmakers' strategy to boost cancer medicines with 'Lazarus effect' (Reuters)
• Genentech agrees trade secret theft settlement with Taiwan’s JHL (PMLive) (Endpoints)
• Novartis wins FDA's breakthrough tag for lung cancer hopeful (Reuters) (PMLive) (Endpoints)
• Roivant's Vivek Ramaswamy is closing in on a $3B cash deal to sell control of 5 Vants — plus — to Sumitomo Dainippon (Endpoints) (STAT) (BioPharmaDive)
• Opioid maker Mallinckrodt stock rebounds after hitting record low, reaching tentative settlement on Ohio cases (CNBC) (Press)

• Alexion suffers another Soliris patent setback (BioPharmaDive) (SEC)
• Roche CEO touts drugs pipeline, rules out M&A just to boost sales (Reuters)
• Roche scores EU approval twice for Tecentriq in lung cancer (PMLive) (Endpoints) (Press 1, 2)
• Keytruda combo bags EU approval in RCC (PharmaTimes)
• EU Marketing Authorisation granted for Lonsurf (PharmaTimes)
• Novartis' Lucentis secures European approval for infants with rare eye disease (Pharmafile)
• China biotech group shares slide over accusation of sales inflation (Financial Times)

• First hint that body’s ‘biological age’ can be reversed (Nature)
• How Should Scientists' Access To Health Databanks Be Managed? (NPR)
• Bad News – But Not the Unexpected Kind (In The Pipeline)
• FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to Children (Focus)
• Do People Understand Cancer Drug Ads on TV? Drugmakers Weigh in on FDA Research (Focus)
• Randy Schatzman jumps to the helm of another start-up; Novo Nordisk vet lands top post at Macrophage Pharma (Endpoints)
• Remarks by Dr. Sharpless to the Research!America 2019 National Health Research Forum (FDA)
• Takeda recalls eye drug Natpara but warns patients not to abruptly stop treatment (Fierce)
• Celltrion taps Lonza to produce some of its Remicade biosimilar (BioPharmaDive)
• Novo Nordisk Foundation makes green grant to Danish-US university collaboration (BioPharmaDive)
• Lilly's Pain Clinical Trial Protocol Selected for FDA Complex Innovative Trial Designs Pilot Meeting Program (Press)
• Zealand CSO steps up as chief of French biotech (Fierce)
• Eli Lilly and Co., et al.; Withdrawal of Approval of 25 New Drug Applications (FDA)

• Trial of SAGE-217 in Patients with Major Depressive Disorder (NEJM)
• Endo Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite (Press)
• Selvita Announces First Patient Dosed in Phase 1b Study of CDK8 Inhibitor SEL120 in the Treatment of Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome (Press)
• Immunic, Inc.'s Interim Dosing Analysis of IMU-838 as Part of its Ongoing Phase 2 CALDOSE-1 Study in Patients with Moderate-to-Severe Ulcerative Colitis Establishes Broad, Potentially Safe and Effective Dose Range (Press)

• Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations (Focus)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Use of Symbols in Labeling-- Glossary to Support the Use of Symbols in Labeling (FDA)
• J&J’s DePuy to acquire JointPoint hip navigation software (MassDevice)
• What cybersecurity compliance support should look like for healthcare product developers (Emergo)
• WONTECH's Holmium laser 'Holinwon Prima' Received FDA approval (Press)
• LivaNova wins Medicare nod for nerve stimulation trial (MassDevice) (Press)
• Occlutech wins CE Mark for intra-atrial shunt (MassDevice)
• FDA clears Arthrosurface’s Boss toe implant (MassDevice)

• Scientists Unveil Weed Breathalyzer, Launching Debate Over Next Steps (NPR)
• Lawmaker accuses Juul of illegally advertising vaping as a way to quit smoking (CNBC)
• New York State Suspects Vitamin E May Have Played a Role in Vaping Illnesses (NYTimes)
• California Lawmakers Send Contested Vaccine Bill To Governor. Will He Sign It? (KHN)
• San Francisco Bay Area Medicare Kickbacks Scheme Charged (NYTimes)
• On Geraniums, Synthetic Botanicals, and Body-Building: 11th Circuit Court of Appeals Upholds FDA Seizure of DMAA (FDA Law Blog)
• Federal Circuit Issues Order Clarifying Status of Doctrine of Equivalents (Patent Docs)
• A Second Lipitor Cert Petition, This Time Raising Personal Jurisdiction (Drug & Device Law)
• Mylan Tells Fed. Circ. That Sanofi Insulin Patents Not Special (Law360-$)
• Pay-For-Delay Bill Goes Too Far, Conservative Org. Says (Law360-$)

• FDA Advisory Committee Calendar
• FDA-MRA Approaches to Neoadjuvant Treatment in Melanoma: A Public Workshop – 6 November 2019

• Register to make submissions to the MHRA if there is a no-deal Brexit (MHRA)
• Novartis’s Early HTA Engagement Pays Off With Luxturna (Pink Sheet-$)
• EMA/PRAC starts review of data on skin cancer with Picato (PharmaLetter-$)
• Rees-Mogg rebuked for comparing doctor to anti-vaxxer (Financial Times)
• After Canada, Sweden Shows Interest In BeNeLuxA Joint Horizon Scanning (Pink Sheet-$)
• LIVI partners with Boots (PharmaTimes)

• ASEAN Medical Device Directive Implementation Updates (Global Compliance News)

• Pharma cos increasingly to focus on stability studies as norms from US FDA, WHO and D&C Rules mandate product safety info (Pharmabiz)
• Mylan Eylea Biosimilar Gets Green Signal For Trials In India (Scrip-$)

• Consultation: Proposed changes to medical device essential principles for safety and performance (TGA)

• America’s aging population is leading to a doctor shortage crisis (CNBC)
• Weight loss possible with psychiatric drugs (Reuters)
• Tim Ferriss, the Man Who Put His Money Behind Psychedelic Medicine (NYTimes)
• ‘I wanted to trust my body’: Against doctors’ recommendations, some pregnant women refuse ultrasounds (STAT)
• Some 9/11 firefighters may have higher heart risks now (STAT)