Recon: Takeda Offloads Xiidra to Novartis, TachoSil to Ethicon to Pay Down Debt

• Bristol-Myers' Opdivo fails late-stage brain cancer trial (Reuters) (Endpoints) (Press)
• Generic Drug Stocks are ‘Worst Ever’ (WSJ)
• Nearly One in Two Americans Takes Prescription Drugs: Survey (Bloomberg)
• Trump gambles in push for drug import proposal (The Hill)
• Prescription Opioid Use Plummeted Most on Record Last Year (Bloomberg)
• Addiction Medicine Mostly Prescribed To Whites, Even As Opioid Deaths Rose Among Blacks (KHN)
• Generic HIV prevention drug coming in 2020, Gilead says (NBC)
• Will Displaying Drug List Prices In Ads Help Lower Costs? (NPR)
• Drugmakers Protest Rule Ordering Prices To Be Shown In TV Ads (NPR)
• The Latest on Drug Failure and Approval Rates (In The Pipeline)

• Takeda Selling Assets to Novartis, J&J to Pay Down Debt (WJS) (PharmaLetter-$)
• Novartis to Buy Takeda Eye Drug Assets in $5.3 Billion Deal (Bloomberg) (Reuters) (Financial Times)
• Novartis confident of Zolgensma supply, calls $2 million price 'speculation' (Reuters)
• Gene therapies are a hard sell. Bluebird hopes to do better in Europe (STAT) (BioPharmaDive)
• How a Wikipedia for drug discovery is disrupting big pharma (The Telegraph)
• Mylan/generic pharma: from heyday to mayday (Financial Times)
• Genetically Modified Viruses Help Save A Patient With A 'Superbug' Infection (NPR)
• Novartis sees Saudi Arabia as promising market for producing its cancer drugs (Fierce)
• Medicines Discovery Catapult to collaborate with LifeArc on new biomarkers (PMLive)
• Brexit "having impact on EU drug development” (PMLive)
• Roche and NHS England hail pricing deal on MS drug Ocrevus (PMLive)
• France OKs Early Access To Tecentriq For SCLC Pending EU Approval (Pink Sheet-$)

• A Decade of Discovery (LifeSciVC)
• Four biotechs haul in $303M+ from a fresh burst of IPOs (Endpoints) (Xconomy)
• Refueling the innovation engine in vaccines (McKinsey)
• Nearly All Medications Contain Potentially Allergenic Inactive Ingredients, Analysis Shows (JAMA)
• Fears of an Amazon Drug Store Disruption Can Be Shelved, Evercore Says (Bloomberg)
• RWE Submissions: FDA Drafts Guidance (Focus)
• Studying Drugs in Pregnant and Nursing Women: FDA Issues Draft Guidances (Focus)
• FDA Advisory Panel Votes in Support of Cystic Fibrosis Drug (FDA News-$)
• Bicycle hires clinical leader ahead of IPO-fueled pipeline push (Fierce)
• Why BI Bid Farewell To Biosimilars (Scrip-$)
• FDA pledges to support cell and gene therapy manufacturing innovation (BioProcessInternational)
• Gene Therapy: Industry Seeks Greater Clarity In Final FDA CMC Guidance On INDs (Pink Sheet-$)
• Fatalities Reported to FDA Following Blood Collection and Transfusion (FDA)
• Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis (FDA)
• Antimicrobial Resistance Is Being Called A Sustainable Development Issue (Forbes)
• Cancer patients should be treated by their doctors, not pharmacy benefit managers (STAT)
• £14m pay deal for boss of 'unaffordable' cystic fibrosis drug (The Guardian)
• Progesterone only prevents miscarriage in women with history of pregnancy loss (Reuters)
• Regulation of Human Genome Editing in the Dawn of the CRISPR Era (Harvard Bill of Health)
• New study spotlights a link between blockbuster SGLT2 drugs and potentially lethal gangrene (Endpoints)
• Once the center of a public storm of anger over denied drug, Chimerix now can’t even recruit patients for their trials (Endpoints)
• Spectrum bags cancer drugs, interferon platform from ImmunGene (Fierce)
• Improving safety and efficacy of immunotherapeutics (Nature)
• Radiation therapy consent forms too difficult to read (Reuters)

• Pushing hard for blockbuster returns, Novartis finds PhIII data to assert Mayzent boosts cognitive powers in MS patients (Endpoints)
• Preclinical data on MD Anderson Cancer Center-developed drug offers hope for Imbruvica-resistant mantle cell lymphoma patients (Endpoints)
• Akebia Therapeutics Reports First Quarter 2019 Financial Results; Announces Full Enrollment of Phase 3 INNO2VATE Studies and Announces Key Executive Appointments (Press)
• Magenta Therapeutics Presents Updated Phase 2 Clinical Data on MGTA-456 Cell Therapy at American Academy of Neurology Annual Meeting (Press)
• Blaze Bioscience Announces the Publication of Phase 1 Clinical Trial Results for Tumor Paint: BLZ-100 (tozuleristide) in Adults with Glioma (Press)
• Promethera Biosciences Announces First-Dosing in Phase 2a Clinical Study Evaluating World’s First Liver Stem Cell Therapy in Late-Stage NASH Patients (Press)

• Reassessing the Regulation of High-Risk Medical Device Cases (Stanford Public Law Working Paper)
• Cardinal Health tops fiscal Q3 forecasts, raises earnings guidance (MassDevice)
• Medtronic bails on bundled knees, to sell Responsive Orthopedics (MassDevice)
• Podimetrics completes $13.4 million funding for disease-detecting foot mat (Reuters)
• Varian acquires CyberHeart, inks deal with China’s Shangdong Cancer Hospital (MassDevice)
• CryoConcepts Receives FDA Clearance on Two Cryosurgical Devices for the Physician Office Market (Press)
• New Study Demonstrates Safety and Effectiveness of the MiniMed(TM) 640G System Reducing Hypoglycemia Compared with Insulin Pump Therapy Without CGM in Type 1 Diabetes (Press)

• House Unanimously Passes Bills Updating FDA’s Orange and Purple Books (Focus)
• Trump to speak on surprise medical bills (Politico)
• Denver votes to become first U.S. city to decriminalize 'magic mushrooms' (Reuters)
• BIO Continues Partnership with NIH for Fifth “Innovation Zone” Exhibit (BIO)
• Plaintiff Has To Pay Retail For Medical Device Exemplars (Drug & Device Law)
• DOJ Offers Drugmakers ‘Get out of FCA Litigation Free’ Card (FDA News-$)
• Elizabeth Warren, Unveiling Opioid Plan, Says Sackler Name Should Come Off Harvard Buildings (NYTimes)
• Michigan Man Sentenced for Unlawfully Importing and Distributing Misbranded Drugs (DoJ)
• New York Diagnostic Testing Facility Owners Plead Guilty in More than $18.5 Million Health Care Fraud Scheme (DoJ)
• USPTO Issues CBD Trademark Guidelines in Light of 2018 Farm Bill: Key Takeaways (Patent Docs)
• New Jersey Attorney General Loosens Rules on the Acceptance by Prescribers of Remuneration from Drug Manufacturers (FDA Law Blog)
• Walgreens Board Says It Reacted Quickly To Theranos Fraud (Law360-$)
• Federal judge boots Sterigenics suit to state court (MassDevice)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Ireland Hires IVD, Medical Device Staff Ahead of EU Legislative Changes (Focus)
• EU Consults On Harmonizing Regulation Of Allergen Products (Pink Sheet-$)
• Perrigo to acquire Ranir Global Holdings in $750 million all-cash deal (Market Watch) (Press)
• Early access to medicines scheme applications: pending, refused, granted (MHRA)

• Abbott anti-profiteering case stayed, hope for other firms (Economic Times)
• Indian Pharma Market gains double digit growth of 10.4% in April 2019 (PharmaBiz)
• Maharashtra FDA grants Rs. 74 lakh to J&J faulty hip implant affected patient following Centre’s directive (PharmaBiz)