Recon: Roche’s Spark Buyout Delayed Again on FTC Review; CHMP Recommends 13 Medicines for Approval

• Trump says people must get vaccinated amid historic year for measles cases (CNBC) (STAT)
• Trump's latest pharma slam? 'I don't want their money' for 2020 campaign (Fierce)
• Roche faces further delay in $4.3 billion Spark deal amid FTC review (Reuters) (Endpoints) (Press)
• Newsom: California Leads On Prescription Drugs (KHN)
• Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep Drug Prices High (KHN)
• Breaking Biotech Barriers: One Woman's Nontraditional Rise To The Top (Forbes)
• Questions about BMS-Celgene integration plans? Obviously. Answers? Not so much (Fierce)
• Keytruda PhIII failure in gastric cancer blights Merck’s quest for frontline dominance (Endpoints) (Press)
• FDA Approves 19th Biosimilar, 2nd for Enbrel (Focus)
• After 11 days, still no verdict in trial of former Insys drug executives (STAT)
• Mass. General Hospital receives record $200 million gift to endow vaccine-research center (STAT)
• Bausch Health's lotion for plaque psoriasis wins FDA approval (Reuters) (CNBC) (Press)

• The top 25 pharmaceutical companies by market cap (Endpoints)
• Drugmakers Brace for Sales to Slow in China Amid Generic Drug Push (WSJ)
• EMA Calls for Cancer Drug Withdrawal Following Negative Trial Results (Focus) (EMA)
• GSK's HIV drug wins European panel thumbs-up (Reuters)
• Pfizer Gets Positive CHMP Opinion for Talzenna (Press)
• AstraZeneca cancer drugs drive growth in sales (Financial Times)
• Orphan drugs market to soar to $224bn by 2024 (PMLive)
• Next IMI Projects To Include Advanced Therapies And CAR-Ts (Pink Sheet-$)
• Canada Develops RWE Guide Anticipating Increased Submissions (Pink Sheet-$)
• Nine listings and $3.8B later, HKEX celebrates one-year biotech anniversary with $194M CRO IPO (Endpoints)
• Sanofi Reports Q1 Earnings (Press)
• Celgene Submits Luspatercept MAA for MDS and Beta-Thalassemia to EMA (Press)
• Novo Nordisk files for EU approval of Ozempic in type II diabetes (PharmaTimes)
• Funding to fight malaria falls $2 billion short of WHO target, study shows (Pharmafile)

• ‘Deep medicine’ will help everyone, especially people like me with a rare disease (STAT)
• Cancer patients using alternative therapies may hesitate to tell doctors (Reuters)
• Competitive Generic Therapy Exclusivity Offers Benefits (Law360-$)
• PhRMA Says ‘Status Quo Must Change’ on Diabetes Prices (FDA News-$)
• AstraZeneca dumps Amgen-partnered drug after midphase fail (Fierce)
• ReNeuron climbs on updated vision loss cell therapy data (Fierce)
• Accelerated Approval Withdrawals Through The Years (Pink Sheet-$)
• Rabies Monoclonal Antibody Development Plan Gets US FDA Panel Backing (Pink Sheet-$)
• As Amgen's Aimovig Momentum Continues, Challenges To Current Blockbusters Loom Large (Scrip-$)
• FDA: Despite Improvement, Particulate-Related Injectables Recalls Remain A Concern (Pink Sheet-$)
• ‘Something needs to change’: An Allergan analyst spells out why next week’s vote could still spark a major revamp (Endpoints)
• Celebrating sustained sales growth, AstraZeneca quietly executes some aging mid-stage drug projects (Endpoints)
• Canine club: Elanco Animal Health makes takeover play for partner Aratana in up to $245M deal (Endpoints)

• BioTime to Present SCiStar Clinical Study Top-Line Data at the 26th Annual American Society for Neural Therapy and Repair Conference (Press)

• FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions (Focus)
• IMDRF Takes Another Stab at IVDs, MDSAP (Focus)
• FDA Finalizes Guidance on Convenience Kit UDI Marking (Focus)
• FDA Finalizes Guidance on UHMWPE in Orthopedic Devices (Focus)
• 3M to Lay Off 2,000 Employees after Weak 1Q19 Earnings (MDDI)
• Zimmer Biomet shares up on Street-topping Q1 (MassDevice)
• Hill-Rom shares rise on Street-beating Q2 earnings (MassDevice)
• AtriCure shares steady on Street-beating Q1 (MassDevice)
• Natus shares rise on Street-topping Q1 (MassDevice)
• Class 1 Device Recall Fogarty Dilation Atrioseptostomy Catheter (FDA)
• Class 1 Device Recall Miller Balloon Atrioseptostomy Catheter (FDA)

• Trump's Title X rules are blocked (Politico)
• U.S. judge blocks new Trump abortion rule for health clinics (Reuters)
• Novartis Settles Suit Saying Janssen Maligned Rival Drug (Law360-$)
• J&J Trashes 'Radical' Okla. Opioid Case As Trial Looms (Law360-$)
• Okla. Cities Not Bound By Purdue's Opioid Deal, Judge Says (Law360-$)
• PacBio DNA Patent Suit Survives Dismissal Push (Law360-$)
• It’s “Hip” to Be Timely: Plaintiff’s Hip Implant Claims Barred by Texas’s Fifteen-Year Statute of Repose (Drug & Device Law)

• FDA Advisory Committee Calendar
• FDA announces public meeting to discuss safety and utility of higher-dose opioid analgesics – 11-12 June 2019
• Antimicrobial Drugs Advisory Committee Meeting Announcement – 26 April 2019

• Swiss Medtech Group Warns of What’s to Come Without Updated EU MRA (Focus)
• Experts ‘deeply concerned’ about NHS’ long-term sustainability (PharmaTimes)
• Government cap on branded medicine prices may be unsustainable, warns ABPI (Pharmaceutical Journal)
• Germany's Merck outlines business plan at 2019 general meeting (PharmaLetter-$)
• Class 4 Medicines Defect Information: Prednisolone 5mg Tablets (MDR 61-04/19) (MHRA)

• USFDA makes 'certain' observations for Torrent Pharma's Indrad plant (Economic Times)
• Union health ministry to notify surgical gowns, surgical drapes and incision drapes under D&C Act (Pharmabiz)

• Final decisions and reasons for NCEs, medicines and chemicals, November 2018 (TGA)

• Measles Outbreak Prompts Quarantines at U.C.L.A. and California State-Los Angeles (NYTimes)