Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

• There’s a fight brewing in Congress over pharma’s patents (STAT)
• With eyes on Gilead, lawmakers want details on how HHS reviews possible patent infringement (STAT) (House Oversight)
• No provisions in USMCA to change U.S. pharmaceutical patent laws: Lighthizer (Reuters) (AAM)
• Why Democrats reopened the debate about germline gene editing (STAT)
• Merck racks up another FDA approval for Keytruda cancer drug (BioPharmaDive) (Endpoints) (FDA) (Press)
• Google’s life sciences unit reveals data-driven opioid addiction centre (Financial Times)
• Israel's Zebra Medical gets FDA ok for brain bleeds product (Reuters)
• FDA approves Novo Nordisk's Victoza for children with type 2 diabetes (Pharmafile) (FDA) (Press)
• By the Numbers: Vaccines Are Safe (NYTimes)
• Vaccine Injury Claims Are Few and Far Between (NYTimes)
• FDA poliovirus assay is faster and more versatile than current assays used in vaccine development and environmental surveillance (FDA)
• Mylan Escapes Novartis MS Drug Patent Suit (Law360-$)

• Roche wins Japan approval for personalized cancer drug Rozlytrek (Reuters) (Endpoints) (Press)
• AstraZeneca's Lynparza gets EU nod as first-line ovarian cancer maintenance treatment (Reuters) (Endpoints)
• China's Fosun Mulls Joint Bid for Bayer Animal Health Arm (Bloomberg) (Financial Times)
• French drugmaker Sanofi, Google to use data tech for innovations (Reuters) (Endpoints) (PMLive) (Financial Times)
• Uganda clears three experimental Ebola treatments, watches for spread (Reuters)
• Right back at you, Pfizer: BeiGene and a Pfizer spinout launch a newco to develop a MEK/BRAF inhibitor that could rival $11.4B combo (Endpoints)
• NICE To Be Sovereign: U.K. Rejects Trump Suggestion To Include NHS In Possible Trade Deal (Forbes)
• GSK pharma head flags need for speed in high-pressure drug market (Reuters)
• EMA to Reinstate Some Activities Halted by Brexit (Focus) (BioCentury)
• Brazil’s ANVISA adjusts upcoming regulation for custom-made medical devices (Emergo)
• Korea Steps Up AI Adoption In Drug Discovery, Repositioning And Surveillance (Scrip-$)
• PMDA to Prohibit Staffers from Trading Pharma Shares (PharmaJapan)

• Fourth Carcinogen Discovered in Heart Pills Used by Millions (Bloomberg)
• Biotech ETFs are breaking out—here are 3 ways to play the space (CNBC)
• Zolgensma: A Remarkable New Treatment, An ICER Analysis, And A Poorly Justified Price (Health Affairs)
• Meet the Top Ten Drugs of 2024 (Maybe) (Drug Channels)
• Common nerve pain drug linked to suicidal behavior, overdose (Reuters)
• New Study Questions the Need for 12 Years of Market Exclusivity for Biologics (Focus) (Nature)
• Study: Just Half of Postmarketing Commitment Trials are Published (Focus)
• VBI's shares plunge after hep B vaccine fails secondary goal in late-stage trial (Reuters)
• Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife (Pink Sheet-$)
• US FDA Seeks Ways To Prevent Non-Responders From Sinking Tissue-Agnostic Indications (Pink Sheet-$)
• Tissue-Agnostic Cancer Treatments: Can US FDA-Approved Diagnostics Limit Access? (Pink Sheet-$)
• US FDA Pressing Industry To Use Standards For Cell and Gene Therapies (Pink Sheet-$)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Data to Support Social and Behavioral Research as Used by the Food and Drug Administration (FDA)
• After watching its share price soar on a Bloomberg report and heated rumors, Biohaven stock takes a billion-dollar bath (Endpoints)
• Roche's Floodlight MS app mines 'hidden' data to advance disease mapping (Fierce)
• Why some people don’t respond to childhood vaccines—and how our DNA could fix it (PBS)
• Unity Biotechnology, with big hopes for longevity drugs, shows results highlighting long road ahead (STAT) (Endpoints)
• Sanofi, Voyager Therapeutics rejig gene therapy partnership (MedCity)
• AstraZeneca spinout Viela bags $75M as FDA filing nears (Fierce)
• GSK snares top pharma honors at Lions Health with first Grand Prix in years (Fierce)

• Positive results for AZ’ Lokelma in hyperkalaemia (PharmaTimes)
• Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (PBH) (Press)
• Rocket Pharmaceuticals Announces Patient Dosing Has Commenced in Phase 1 Clinical Trial of RP-A501, the First Gene Therapy to Treat a Monogenic Heart Failure Syndrome (Press)
• Hypercholesterolemia Drug Repatha® SC Injection Receives Supplemental Indication Approval As Monotherapy For Treating Hypercholesterolemia Patients Not Suitable For Statin Therapy (Press)
• Triumvira Immunologics Announces Clearance of IND and CTA by U.S. FDA and Health Canada for Its First TAC T-cell Therapeutic Product Candidate, TAC01-CD19 (Press)
• Imara Presented Positive, Interim Phase 2a Data on IMR-687 for the Treatment of Sickle Cell Disease at the 24th Congress of the European Hematology Association (Press)
• Navidea Biopharmaceuticals Announces Day and Time of SNMMI Presentation of Phase 1/2 Study Results and Enrollment Update on its Phase 2B Study (Press)

• The FDA’s NEST Initiative and Women’s Health (Harvard Bill of Health)
• Zoll acquires TherOx (MassDevice)
• CDRH Discusses Evolution of Q-Submission Program (Focus)
• Miracle Machine Makes Heroic Rescues — And Leaves Patients In Limbo (KHN)
• Edwards Lifesciences warns on risk of IntraClude balloon bursting (MassDevice)
• Merit puts $50m on the table for Brightwater (MassDevice)
• Gel-e Gets Breakthrough Device Designation for internal-use flowable device (Press)
• Real-World Data Collection – What Role Could Your Device Play? (MDDI)
• Gel-e gains breakthrough device nod for internal bleeding control device (MassDevice)
• Axonics wins FDA nod for MR-safe neurostim device in trial (MassDevice)
• Murata Vios, Inc. Announces FDA Clearance for Second Generation Wireless Monitoring Platform (Press)

• Former FDA chief Scott Gottlieb says some claims about health benefits of CBD are ‘pretty hokey’ (CNBC)
• The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability (Senate Aging)
• Welcome to the Preemption Family (Drug & Device Law)

• FDA Advisory Committee Calendar
• FDA Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs – 12 July 2019
• June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

• EMA Begins Review of Handling Errors Linked to Leuprorelin (Focus)
• EC Cautions on MDR/IVDR Impact on Device Availability (Focus)
• Ireland Makes a Push to Switch to Biosimilar Adalimumab and Etanercept (CFB)
• MHRA Register of Written Confirmations For UK Active Substance Manufacturers (MHRA)
• UK Request Pushes Illumina's Timeline for Completion of PacBio Acquisition to Q4 (GenomeWeb)

• Shanghai's Zai Lab in-licenses novel oncology candidate (PharmaLetter-$)
• ADHD drug Intuniv now approved for adults in Japan (PharmaLetter-$)

• Biocon board approves sale of branded formulations business to subsidiary (Economic Times)

• Introduction to TGA Business Services (TBS) (TGA)

• Xiaflex® (Collagenase Clostridium Histolyticum) Product Discontinuation From New Zealand On 28 June 2019 (Press)