Recon: FDA Rejects Daiichi Sankyo Blood Cancer Drug After Japanese Approval

• FDA declines to approve Daiichi Sankyo's blood cancer treatment (Reuters) (Endpoints)
• FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older (FDA)
• Merck CEO sees legal challenge if US adopts drug pricing based on other countries (Reuters)
• Merck says it has plenty in the pipe beyond Keytruda (PMLive)
• ICER says Novartis MS drug price out of line with benefit (Reuters) (Endpoints)
• J&J's Esketamine, at current price, is 'low value for money' — ICER (Endpoints) (ICER)
• Sanofi, Regeneron asthma prospect struggles against Dupixent (Fierce) (STAT) (Endpoints) (Press)
• Should the FDA speed up or slow down approval of new cancer drugs? (STAT)
• After a pharma lobbying blitz, Congress softens legislation on drug patents (STAT)
• An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions. (Washington Post)
• After news of EU job cuts, Sanofi confirms it’s offering US workers an 'early exit' (Endpoints)
• House leadership's drug plan targets payers' costliest meds (Politico)
• Azar's Plan To Tie US Drug Prices To Foreign Ones Will Impact Investments In R&D (Forbes)
• Curing Cancer: Easy Politics, Difficult Science (KHN)
• Men expose billion-dollar back surgery scam involving doctor kickbacks and fake hardware (CBS)

• Which top 10 big pharmas have the most to gain — or lose — over the next 5 years? (Endpoints)
• EC Approves Pfizer’s Talzenna (Press)
• EU approval for Novo’s Esperoct (PharmaTimes)
• GSK offers concessions ahead of planned venture with Pfizer (Pharmafile)
• Will 1 Of These 4 Experimental Treatments Cure Ebola? (NPR)
• New Japan PMDA Head Brings Strong Clinical, Patient Focus To Role (Pink Sheet-$)
• EMA Reports Progress with EU Clinical Trial & Orphan IT Systems (Pink Sheet-$)
• 1/3 of Brits stockpile medication (PharmaTimes)

• DNA Microscope Sees ‘Through the Eyes of the Cell’ (NYTimes)
• A universal flu vaccine could finally be within sight (PBS)
• 5 Ways to improve ICER’s value assessment framework (PhRMA)
• FDA’s OPDP Sends Third Untitled Letter of 2019 (Focus)
• FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones (Focus)
• While addiction crisis raged, many surgeons overprescribed opioids, analysis shows (STAT)
• How the Kaiser-Johns Hopkins analysis was done (STAT)
• Blueprint Medicines Aims For Genomically Defined GIST Indication With Avapritinib NDA (Pink Sheet-$)
• How a long-known biomarker backs BioNTech's antibody for pancreatic cancer (Fierce)
• Maze interim chief Charles Homcy passes baton to Jason Coloma; William Collier tapped as CEO of Arbutus (Endpoints)
• HIV, pneumococcal — and what? Merck's unexpected pipeline highlight excites a little biotech (Endpoints)
• Recursion names Theravance veteran as CSO (Fierce)
• Recent FDA Inspection of KCAS Bioanalytical & Biomarker Services’ Kansas City, KS Facility is Successful with No 483s issued (Press)

• Roche/Exelixis' Cotellic fizzles in pivotal melanoma study (Endpoints) (BioPharmaDive)
• FDA fast-tracks Alexion's Ultomiris in 2nd Soliris indication (Fierce)
• Alnylam Announces Progress with RNAi Therapeutics Platform, Including Oral Route of Administration and CNS and Ocular Delivery (Press)
• Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-APOC3 (Press)
• FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity (Press)
• Epizyme Reports Updated Data from Phase 2 Trial of Tazemetostat in Patients with Relapsed or Refractory Follicular Lymphoma (Press)
• Catabasis Pharmaceuticals Presents Preclinical Data Showing Potential for Bone Preservation with Edasalonexent in Duchenne Muscular Dystrophy (Press)
• Onxeo Expands its Pipeline with New Optimized Lead OX401 Entering Proof-of-Concept Preclinical Phase (Press)
• Verastem Oncology Presents COPIKTRA™ (Duvelisib) Data in Peripheral T-Cell Lymphoma at the 2019 International Conference on Malignant Lymphoma (Press)
• Dicerna™ Presents Additional Data from PHYOX™1 Study of DCR-PHXC in Patients with Primary Hyperoxaluria Type 1 (PH1) and Type 2 (PH2) (Press)

• Paclitaxel-Coated Devices’ Late Mortality Signal Not Well Understood, FDA Panel Hears (Focus)
• Medtronic Statement Regarding FDA Circulatory System Devices Panel (Press)
• With US Congress Considering Changes to Patent Laws, Dx Stakeholders Offer Differing Views (GenomeWeb)
• Ocular Therapeutix gains second indication for drug-delivery eye insert (MassDevice)
• 8 medical device industry supplier innovations you need to know (MassDevice)

• Trump to Issue Executive Order on Health-Care Price Transparency (WSJ) (Reuters)
• Federally funded research drives nearly one-third of U.S. patents, report finds (STAT)
• Woodcock: OTC Monograph Reform Could Boost Self-Care, Cut Costs (IHP)
• How Should Medicaid Pay For Cures? Sen. Grassley Likes Annuity Model (Pink Sheet-$)
• Vaccine Drama On Display In California’s Capitol (KHN)
• Rubio wants to block U.S. military from buying drugs made in China (BioCentury)
• Congress’ Next Steps On REMS Abuses: Will Improving FDA-FTC Communication Help? (Pink Sheet-$)
• CVS just laid out a big reason why health companies are worried about Amazon (CNBC)
• Pharma CEOs didn’t show up for a congressional scolding, so progressives shadowboxed instead (STAT)
• Pharmaceutical Manufacturers Argue Price Disclosure Rule Will Mislead Consumers (FDA Law Blog)
• The Other Shoe Drops: Summary Judgment for Bayer in Mirena IIH MDL (Drug & Device Law)
• After years of claims and accusations, fraudster Martin Shkreli settles up with Retrophin (Endpoints)
• The DISARM Act Can Help Fix the Broken Antibiotics Market (BIO)
• BIO’s Hans Sauer Calls for Less Confusing Patent Eligibility Standards (BIO)
• Ex-FDA chief Scott Gottlieb: ‘Juul is going to be in a hard spot to ever get their product approved’ (CNBC)

• FDA Advisory Committee Calendar
• Allergenic Products Advisory Committee; Notice of Meeting – 13 September 2019
• Antimicrobial Drugs Advisory Committee; Notice of Meeting – 7 August 2019

• EMA accepts first ‘China-developed’ biosimilar, Henlius’ HLX02, for review (PharmaLetter-$)
• Medicines for Europe responds to call for increased access (PharmaLetter-$)
• EU Regulatory Roundup: EMA, Running Two Years Behind Schedule, Gears up for Clinical Trial Portal Audit (Focus)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 June 2019 (EMA)
• Early access to medicines scheme (EAMS) scientific opinion: Raxone to treat the decline of respiratory function in patients with Duchenne Muscular Dystrophy (MHRA)

• Genexine Hopes To Become 'Asia’s Amgen' After ToolGen Merger (Scrip-$)
• FiercePharmaAsia—Japan's global first nods; Celgene hands back PD-1; China's copycat invite (Fierce)

• Price of 1032 medicines capped by govt: Mansukhlal Mandavia (Economic Times)
• Aurobindo Pharma gets warning letter from USFDA for Andhra Pradesh unit (Economic Times)
• IPA's 'Vision 2030' defines roadmap for Indian pharma industry to grow from US$ 38 to 120 billion by 2030 (Pharmabiz)
• CDSCO conducts raid on 2 API suppliers’ premises in Chennai for supplying spurious drugs manufactured by Chinese companies (Pharmabiz)

• Notice – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD) (Health Canada)

• Iran, Argentina Join International Drug Regulators Group (Focus)