Recon: Amgen and Allergan Launch Avastin and Herceptin Biosimilars

• Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States (Center for Biosimilars) (Endpoints) (Fierce) (Press)
• Canada warns US against drug import plans, citing shortage concerns (Reuters)
• Biotech enters an era of ‘platform’ dominance (STAT)
• Second opioid distributor charged over role in US drug epidemic (Reuters)
• Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia? (STAT)
• Ultragenyx close to learning whether gene therapy gamble will pay off (BioPharmaDive)
• UnitedHealth Reverses Denials And Will Cover Expensive Gene Therapy For Kids (Washington Post)
• Novartis hands off 3 preclinical programs to the antiviral R&D masters at Gilead (Endpoints) (Fierce) (Press)
• Amazon threatens to sue major pharmacy player if it prevents PillPack from accessing patient drug data (CNBC)
• Novartis' sunny Sandoz forecast is at odds with the reality of the U.S. generics market: analysts (Fierce)

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• Health Canada to keep importing Kaleo's epinephrine shot amid shortages (Reuters)
• What the Ebola emergency means, what it doesn’t mean, and what’s next (STAT)
• WHO flags Ebola risk in Rwanda, but then withdraws its report (Reuters)
• Novartis and J&J back latest €400m Medicxi biopharma fund (PMLive) (Endpoints)
• Curious case of stock price moves reveals Sumitomo Dainippon is eyeing $202M buyout of Australian stem cell player (Endpoints)
• Boehringer taps Korea’s Bridge for Ofev follow-up (PMLive)
• Industry Demands Rethink Of German HTA Data Requirements (Pink Sheet-$)
• Novartis's older MS drug Gilenya wins Chinese approval (Reuters)
• Eisai's Halaven, GSK's Lupus Drug Among Latest China Approvals (Pink Sheet-$)

• Does Precision Medicine Have A Minority Problem? (Forbes)
• After a decade, ViiV CSO John Pottage says it's time to step down — and he's handing the job to longtime colleague Kim Smith (Endpoints)
• FDA Offers Technical Specifications for Submitting NGS Data on Antivirals (Focus)
• FDA to Study Physicians’ Interpretations of Drug Information (Focus)
• Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II (Focus)
• Catalent to help make Novartis' Zolgensma at Maryland site (BioPharmaDive)
• Antibiotic Stakeholders Discuss Ethics Of Testing Limited Population Drugs In Broader Populations (Pink Sheet-$)
• Precision BioSciences backs off-the-shelf cancer cell therapy effort with new manufacturing plant (Endpoints)
• Pfizer's keys to juggling 8 U.S. launches? Organization, accountability, clear goals (Fierce)
• NASH-linked gene discovery could inspire new drugs to treat liver damage (Fierce)
• Seer adds ex-FDA chief Mark McClellan to the board; Hercules Capital makes it official for new CEO Scott Bluestein (Endpoints)
• On a hot streak, Novartis execs run the odds on their two most important PhIII readouts. Which is 0.01% more likely to succeed? (Endpoints)
• US FDA Trains Reviewers For Consistency On Post-Q12 Manufacturing Changes (Pink Sheet-$)
• Animal experiment stats show reluctance to embrace modern tools (PharmaTimes)

• Aridis Pharmaceuticals Receives Orphan Drug Designation From the European Medicines Agency for AR-501 (Press)
• Janssen Seeks EMA Approval for Novel Subcutaneous Formulation of DARZALEX®▼ (daratumumab) (Press)

• FDA Validates Streamlined Review of SaMD Under PreCert Pilot (Focus)
• Centinel Spine wins FDA nod for Prodisc implants trial (MassDevice)
• The 17 most innovative medical devices of 2019 (MassDevice)
• Intuitive Surgical beats The Street on Q2 earnings (MassDevice)

• Ditch the opioid 'negotiating class' proposal, experts say. State attorneys general are better suited to reach a deal (Fierce)
• UnitedHealth Group increases guidance after quarterly profits surpass $3B (StarTribune) (NYTimes)
• Health care moves to center stage in Democratic primary fight (The Hill) (Politico)
• Will Slew of Patent Bills Lower Drug Prices? (Pink Sheet-$)
• Qui Tam Action Filed under False Claims Act over Certain Prescription Drug Prices (Patent Docs)
• Pfizer Hid Risks Of Sepsis, Amputation On Labels, Suit Says (Law360-$)
• Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions (FDA)
• DOJ's Investigation Of Reckitt's Suboxone Promotions Marks The Return Of The Big Settlement (Pink Sheet-$)
• Stryker Slams Zimmer's High Court Bid Following $254M Loss (Law360-$)
• Ill. Latest Battleground For Bayer In Essure Safety Suits (law360-$)
• Pfizer Wants Breast Cancer Drug MDL Consolidated In Del. (Law360-$)
• One Step Back: Mixed Personal Jurisdiction Result in Actos Case in EDPa. (Drug & Device Law)

• FDA Advisory Committee Calendar
• ICH E8(R1) Public Stakeholder Meeting – 31 October 2019

• Canada, Netherlands to Collaborate on Issues Related to Expensive Medicines (Rijksoverheid)
• Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds (Focus)
• EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers (Focus)
• EU Accelerated Assessment – Hard To Get, Hard To Keep (Pink Sheet-$)
• Royal Pharmaceutical Society in Scotland says contingency plans do not mitigate risk of no-deal Brexit (Pharmafile)

• Takeda Brings Rare Disease Drugs To India But Access Questions Linger (Scrip-$)
• Dr Reddy's launches generic version of Allegra D in US (Economic Times)

• Agile regulations for advanced therapeutic products and clinical trials (Health Canada)

• Testing of biological medicines (TGA)