Recon: Emergent to buy Adapt Pharma; Jazz' Vyxeos Wins EU Approval for Certain Acute Myeloid Leukemias

• Emergent BioSolutions to buy Narcan maker Adapt Pharma (Reuters)
• The IPO boom has been particularly kind to biotech in Massachusetts (STAT) (Endpoints)
• New Hepatitis C Drugs Mean More Organs for More Transplants (Pew)
• FDA directs websites to stop illegally selling opioids online (CNBC) (FDA)
• Revised NAFTA Deal Includes 10-Year Biologics Protection (Biocentury)
• Slack Named Permanent Director Of CDER’s Strategic Programs (Biocentury)
• FDA pushes for development of non-opioid pain medications (Washington Post)
• Sterilization firm Sotera Health explores sale for nearly $5 billion – sources (Reuters)
• You May Start Seeing Drug Prices in Ads, But Will You Understand the Point? (Forbes)
• Pfizer Calls for FDA Guidance to Address False and Misleading Biosimilar Ads (Focus) (FDA Law Blog) (Law360-$)
• US-Mexico Trade Agreement Elicits Another Battle Over Biologics Data Exclusivity (Pink Sheet-$) (Axios)
• Ascend Therapeutics Draws FDA Untitled Letter Over Estrogel Claims (Focus)

• Jazz’ Vyxeos wins EU nod for certain acute myeloid leukaemias (PharmaTimes) (Pharmafile)
• Novartis wins key adjuvant Taf/Mek approval in Europe (PMLive)
• EU OKs first treatment for ultra rare lysosomal storage disorder (Pharmafile)
• NICE u-turn recommends Ipsen’s Cabometyx for kidney cancer (PharmaTimes)
• Novartis to create 450 new jobs at Aargau site after Kymriah thumbs up (Pharmafile)
• No Brexit Fall Out For UK FIH Trials With Over 40% Jump In Applications (Pink Sheet-$)
• As the maiden biotech IPO on the HKEX fizzles, some investment experts see an upside in tempering the hype (Endpoints)
• GSK spinout KaNDy raises $32M to fund a breakthrough shot at a women’s health drug (Endpoints)
• The Number Of Australians Dying From Opioid Overdoses Has Almost Doubled In The Last Decade (BuzzFeed)
• EpiPen shortage is a global problem (Pharmaceutical Journal)
• Indian panel wants Johnson & Johnson to pay compensation over recalled implants (Reuters)
• Congo Republic confirms yellow fever near Angolan enclave (Reuters)
• Novartis says glaucoma stent setback will not derail Alcon spin-off (Reuters)

• RNAi: The Monoclonal Antibody of the 2020s? (BioSpace)
• An Unwarranted Attack On Rare Disease Research (Forbes)
• Roivant appoints NEA partner Torti to oversee its ‘vant’ subsidiaries (Fierce)
• Dongkook products denied entry into US after refusing FDA inspection (Korea Biomedical Review)
• Bristol-Myers promotes a commercial player to top sales job — replacing new Amgen exec Murdo Gordon (Endpoints) (Press)
• Growing human stem cells into functional 3D liver tissue (Fierce)
• NIH Comes Out Swinging on Opioid Abuse With Anticipated $40.4M to Research Chronic Pain (Forbes)
• Heart benefits of fish oil, aspirin questioned in diabetics (Reuters)
• Children taking multiple medications at risk for severe reactions (Reuters)
• Few heavy drinkers get drugs to help curb alcohol use (Reuters)
• Harvard Medical School and BWH select Aetion RWE platform (Outsourcing Pharma)
• Stealth Start-Up Quench Among Teams Tying Protein To Inflammatory Cell Death (BioCentury)
• DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing (FDA)
• Pfizer recalls 1 lot of Children’s Advil due to overdosing concerns (Fierce) (FDA)
• FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products (FDA)

• TB Alliance Starts Pivotal Trial Of Four-Drug Regimen (BioCentury)
• Arena Pharmaceuticals Presented Phase 1 Clinical Data for Ralinepag in Pulmonary Arterial Hypertension at the European Society of Cardiology (Press)

• Why a Texas Man Wants Boston Scientific to Stop Calling Him (MDDI) (MassDevice)
• Outset Medical has created a 37-inch dialysis clinic on wheels for the home (CNBC)
• BD inks UAE insulin pen distro deal with Julphar (Drug Delivery)
• Medtronic touts 1-year Arctic Front cryoballoon study data (MassDevice) (Press)
• InVivo touts 1-year Inspire study results (MassDevice)
• First patients receive Centinel’s 3D-printed titanium spinal implants (Medical Design & Outsourcing)
• Study results support FDA approval of diagnostic algorithm, but experts remain wary (mobihealthnews)

• A Little-Known Windfall for Some Hospitals, Now Facing Big Cuts (NYTimes)
• Teva Can't Move IP Suits Over Opioid Treatment Drug To Del. (Law360-$)
• Co-Owners of Miami Pain Management Clinic Plead Guilty to Conspiracy to Distribute Medically Unnecessary Opioid Prescriptions (DoJ)
• Judge Dismisses GOP Effort To Block Nebraska's Medicaid Expansion Ballot Measure (Forbes)
• Facing Continuation of the Endo/Par Vasopressin Lawsuit, FDA Publishes Notice Concerning List of Drug Substances for Which there is [NOT?] a Clinical Need under Section 503B (FDA Law Blog)

• FDA Advisory Committee Calendar

• At a glance: EMA’s support of paediatric research (EMA)

• ABEC to supply China’s ‘rapidly growing’ biopharma industry from Ireland (BioPharmaReporter)
• China Biologic slams lawsuit filed by former chairman (PharmaLetter-$)

• Maharashtra FDA ex-chief accuses DCGI of delaying action against J&J (Economic Times)
• Glenmark inks licensing pact for generic Tiotropium Bromide dry powder inhaler in Western Europe (Economic Times)
• Pricing key to success of MS drug Aubagio in India, says analyst (PharmaLetter-$)

• Record High Number Of STD Infections In U.S., As Prevention Funding Declines (NPR)
• Inside a Neonatal Clinic in South Sudan: ‘In Some Ways, It Felt Wrong to Be Here’ (NYTimes)