Recon: Amgen, Novartis Halt Alzheimer’s Studies After Patients Worsened

• Amgen, Novartis abandon two Alzheimer’s drug studies (Financial Times) (Endpoints) (Pharmafile) (Press)
• Nexus to build $250M manufacturing facility in Wisconsin (BioPharmaDive)
• Indivior says Reckitt settlement in U.S. unrelated to its cases (Reuters)
• ‘There’s a lot of screaming into the void’: Toddler’s parents battle for coverage of $2.1 million gene therapy (Washington Post)
• White House scraps key plan to lower drug prices; may target drugmakers (Reuters) (NPR) (CNBC)
• Alex Azar's no-good, very tough week (Politico)
• Six Reasons Why the Rebate Rule Failed—And What’s Next (Drug Channels)
• Grassley: Deal to lower drug prices moving forward 'very soon' (The Hill)
• Lawmakers seek scientific review of plan to tightly regulate all fentanyl copycats (Reuters)
• 23andMe is moving into Apple’s territory with a pilot to pull in medical data, not just DNA (CNBC)
• Illumina plunges after slashing revenue expectations (CNBC)
• For Big Pharma, the revolving door keeps spinning (The Hill)

• Johnson & Johnson to test experimental HIV vaccine in U.S., Europe (Reuters)
• Congo rules out using additional trial vaccines to combat Ebola (Reuters)
• Croatia's drugs wholesalers limit hospital deliveries as debts rise (Reuters)
• US and EU Fully Implement Mutual Agreement on GMP Inspections (Focus)
• German court blocks sale of Sanofi, Regeneron cholesterol drug (BioPharmaDive) (Fierce)
• AstraZeneca takes lessons from fast food to serve China (Financial Times)
• Ambitious WHO Plan To Help 50 Nations Improve Regulatory Capacity (Pink Sheet-$)
• How An Island In The Antipodes Became The World's Leading Supplier Of Licit Opioids (Pacific Standard)

• Revenues From New Drugs – And Thoughts on Chance (In the Pipeline)
• Drug pricing concerns return for pharma (Vantage)
• Lilly's Shaw to head Gilead's cancer push as new CEO of Kite (BioPharmaDive)
• Broad star Feng Zhang unveils a new CRISPR platform, editing RNA and eliminating Alzheimer's threat — in cells (Endpoints)
• ICER update on Duchenne drugs pushes up price estimates for Exondys 51, Emflaza ahead of July panel review (Endpoints)
• Supercharging CAR-T with cancer vaccine, MIT team spotlights some new tech underpinning Darrell Irvine's startup (Endpoints)
• Sanofi, Regeneron turn to photos, data plots to set Libtayo apart from I-O rivals (Fierce)
• Pairing targeted drugs could overcome breast, lung cancer treatment resistance (PharmaTimes)
• Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations (Focus)
• FDA Revises 1999 Draft Guidance on Population Pharmacokinetics (Focus)
• Minority Males Less Aware Than Whites of HIV-Protection Drugs (US News)
• Ex-DARPA director pursues all-in-one cancer pill as NED CEO; Karyopharm loses commercial chief ahead of drug rollout (Endpoints)
• Sofinnova lends AbiVax a hand for PhII anti-inflammatory trials, picking up €12M worth of stock (Endpoints) (Fierce)
• Drug Trials Snapshots: VYLEESI (FDA)

• AstraZeneca's Imfinzi gets orphan drug designation from FDA (Pharmafile)
• Janssen Submits Application to U.S. FDA Seeking Approval of New DARZALEX® (daratumumab) Subcutaneous Formulation (Press)
• Sensorion Receives FDA IND Approval for Arazasetron (SENS-401) (Press)
• GenSight Biologics completes enrollment of GS010 REFLECT Phase III trial in the treatment of Leber Hereditary Optic Neuropathy ahead of schedule (Press)

• A Genetic Test That Reveals Alzheimer's Risk Can Be Cathartic Or Distressing (NPR)
• Abbott recalls select Ellipse ICDs due to damaged wires (MassDevice)
• Class 1 Device Recall Alaris" Pump Infusion Sets (FDA)
• Class 1 Device Recall Giraffe Warmer (FDA)
• Class 1 Device Recall Panda Infant Radiant Warmer (FDA)
• Class 1 Device Recall Hamilton G5 Ventilator (FDA)
• FDA issues another reminder about the risks of connected medical devices to hacking (AHCJ)
• iCad’s AI-assisted mammography tech wins CE Mark (MassDevice)
• Nemaura bids for de novo clearance from FDA for SugarBEAT glucose monitor (MassDevice)
• FDA clears RaySearch’s RayStation 8B (MassDevice)
• Avoset to develop infusion pump with unnamed pharma giant (MassDevice)

• There are fewer opioid prescriptions being written for Medicare Part D beneficiaries (STAT)
• After Dozens of Fentanyl Killings, Hospital C.E.O. and 23 Employees Are Forced Out (NYTimes)
• US Democratic hopeful Amy Klobuchar proposes drug cost plan aimed at seniors (Reuters)
• DOJ Lawyers Try New Tricks To Undo Obamacare. Will It Work? (KHN)
• Biosimilar Patent Litigation Bill Would Change BPCIA Strategy (Law360-$)
• Gilead Seeks To Nix Patients' Suit Over HIV Drug Toxicity (Law360-$)
• Eli Lilly Searches For New GC As Top Atty Plans To Retire (Law360-$)
• Reed Smith Atty's Widow Fails To Reclaim $3M Win Over GSK (Law360-$)
• A Money-For-Nothing Pharmaceutical Class Action In California (Drug & Device Law)
• Telemedicine: Understanding FDA’s Role in Recent Regulatory and Enforcement Actions (FDA Law Blog)
• The STRONGER Patents Act of 2019: Weakening Post-Grant Proceedings (Patent Docs)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Danish Regulator Bans Staff From Owning Shares in Pharma, Device Companies (Focus)
• PRAC recommends new measures to avoid dosing errors with methotrexate (EMA)
• Medicines and Healthcare products Regulatory Agency Privacy Notice (MHRA)

• Japanese pharma companies closely following 'Boycott Japan' campaign (KoreaBioMed)

• USFDA issues 5 observations to Dr Reddy's plant in Hyderabad (Economic Times)
• Pharma sector to post double-digit revenue Q1 growth: Analysts (Economic Times)
• IPC identifies 17 medical device monitoring centres pan India to analyse SAEs exclusively (Pharmabiz)
• Audit of Laurus Labs completed by USFDA without objections (Economic Times)
• Code prohibits doctors from taking gifts from pharmaceutical companies (Economic Times)

• CannTrust suspends sales of cannabis products during Canada regulatory review (Reuters)

• NZ Plans New Medicinal Cannabis Regulatory Scheme & Agency (Pink Sheet-$)