Recon: FDA Approves Novartis MS Drug Mayzent; Roche to Shut Rio de Janeiro Facility

• Novartis MS drug wins FDA's blessing amid scrutiny of $88k annual price (Reuters) (Endpoints) (FDA) (Press)
• Tainted Pills Force FDA to Tighten Drug-Safety Regulations (Bloomberg)
• Device-safety experts to FDA: Make data public (NBC)
• Scott Gottlieb On His Time At The FDA (NPR)
• An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions. (Washington Post)
• Want to Reduce Opioid Deaths? Get People the Medications They Need (NYTimes)
• Medicare's Uncapped Drug Costs Take A Big Bite From Already Tight Budgets (NPR)
• The mark of a job well done for a CRISPR lobbyist? Silence in Congress (STAT)
• Lilly and ImmuNext deal focused on autoimmune diseases (PMLive)
• Gilead and Louisiana agree to a ‘Netflix’ subscription model for hepatitis C drugs (STAT) (AP)
• Unvaccinated children face public space ban in New York measles outbreak (Reuters)
• Trump wants to work with Democrats on drug prices, infrastructure: aide (Reuters)
• Democrats Pivot Hard to Health Care After Trump Moves to Strike Down Affordable Care Act (NYTimes)
• Obamacare reversal made over cabinet objections (Politico) (NYTimes)

• Are Vertex and the UK government inching toward a resolution over a pricey drug? (STAT)
• Swiss drugmaker Roche says to shutter Rio de Janeiro plant (Reuters) (AP)
• AstraZeneca to cut nearly 100 jobs at U.K. site as efficiencies 'hammer' workers (Fierce)
• AbbVie gets its first approval for a drug execs believe could be worth up to $5B in annual sales (Endpoints)
• As Brexit Votes Loom, New Drug Regulatory Pathway Takes Shape (BioCentury)
• NICE recommendation for Steglatro in type II diabetes (PharmaTimes)
• Ono pumps cash into U.K. immuno-oncology R&D effort (Fierce)
• Eight months after filing for IPO, the maker of China’s Ebola vaccine joins HKEX with $161M raise (Endpoints)
• France’s NASH contender Genfit leaps onto Nasdaq with $135M IPO (Endpoints)
• Industry must turn words into action on superbugs, says Jim O’Neill (Financial Times)
• Dutch rare disease biotech ProQR carves out new company dedicated to epidermolysis bullosa (Endpoints)
• EMA Discusses Work to Avoid Brexit-Related Drug Shortages (Focus)

• Outcomes-based Pricing Not A Panacea For High Priced Drugs (Forbes)
• Who are the women blazing trails in biopharma R&D? Nominate them for Endpoints’ special report (Endpoints)
• Days after its $63M boost, Imara gains former Pfizer rare disease executive as CMO (Fierce)
• Dr Reddy's launches erectile dysfunction treatment drug in US (Economic Times)
• Alembic Pharma gets USFDA nod for erectile dysfunction drug (Economic Times)
• Table of Pharmacogenomic Biomarkers in Drug Labeling (FDA)
• Initial Opioid Prescriptions among US Commercially Insured Patients, 2012–2017 (NEJM)
• Targeting cancer cell metabolism in glioblastoma (Nature)
• Final FDA Guidance Gives Sponsors More Flexibility In Using Latest Industry Standards For Biologics Submissions (Pink Sheet-$)
• ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity) (FDA Law Blog)
• MCM monitoring and assessment update (FDA)
• Arch-backed Sana bags Harvard off-the-shelf cell therapy tech (Fierce)
• ProQR spins out skin disease drug into nonprofit-backed startup (Fierce)
• Cell and Gene Therapy Initiatives Prominent on Biomanufacturing Agenda of US National Institute of Standards and Technology (IPQ)
• FDA’s Oncology Center of Excellence Touts 2018 Accomplishments (Focus)
• ICH Advances Revised Guideline on Elemental Impurities (Focus)
• Final ICH Guide Corrects Exposure Limit For Inhaled Cadmium (Pink Sheet-$)
• The opioid crisis is partly fueled by insurers’ and employers’ approach to back pain (STAT)
• Pain free? Meet Cassava, the newest Alzheimer’s player on Nasdaq (Endpoints)
• Jim Mellon’s Juvenescence takes a chance on tiny upstart run by former Pfizer exec (Endpoints)
• Eli Lilly joins a troika of Big Pharmas that have tied up to a low-profile biotech with big aspirations in autoimmune disease, cancer (Endpoints)

• Astellas Presents Fezolinetant Phase 2b Clinical Trial Results at Endocrine Society’s Annual Meeting (ENDO) - Investigational compound fezolinetant reduced frequency and severity of vasomotor symptoms in postmenopausal women (Press)
• Triplex Meets Primary Endpoint in Phase 2 Clinical Trial, Reduces Rate of Cytomegalovirus (CMV) Complications in Transplant Recipients by 50 Percent (Press)
• Alnylam to Present Givosiran Phase 3 Data at the European Association for the Study of the Liver (EASL) International Liver Congress (Press)
• Urovant Sciences Initiates Phase 3 Clinical Program with Vibegron for Overactive Bladder in Men with Benign Prostatic Hyperplasia (Press)
• Vaxart Completes Dosing of the Lead-In Cohort in Bivalent Norovirus Vaccine Phase 1b Clinical Trial (Press)
• IAVI Announces First-in-Human Clinical Trial of Native-like HIV Envelope Vaccine Candidate (Press)

• FDA advances landmark policy changes to modernize mammography services and improve their quality (FDA)
• 10 women in medtech manufacturing you should know (MassDevice)
• FDA Preps for Device Shortages as Another Sterilization Facility Will Close (Focus)
• FDA Panel Recommends New Postmarket Requirements for Breast Implants (Focus)
• CDRH Proposes New IMDRF Work Item on Standards (Focus)
• Dune Medical launches first-in-man Smart Biopsy trial (MassDevice)

• US expands abortion 'gag rule,' cuts funding to regional bloc: Pompeo (Reuters)
• Centene to Buy WellCare for $15.3 Billion, Creating Health Care Giant (NYTimes) (Reuters)
• Allergan Gets Shire's Dry-Eye Drug Antitrust Suit Dropped (Law360-$)
• 2nd Circ. Refuses To Revive Complaints In Eliquis MDL (Law360-$)
• Puffery about Regulatory Compliance is Not a Material Misstatement (Drug & Device Law)
• J&J’s DePuy Synthes goes after Orthofix, ex-reps in poaching lawsuit (MassDevice)

• FDA Advisory Committee Calendar

• Implementing the Falsified Medicines Directive: Safety Features (MHRA)

• Asia Regulatory Roundup: TGA Finds Faults During Pharmacovigilance Inspections (Focus)
• Blackstone Bets On Pharma In First Japan Buy, But Why? (Scrip-$)
• Forxiga sNDA approved in Japan for type-1 diabetes (PharmaLetter-$)
• Japanese approval for Biktarvy for HIV-1 (PharmaLetter-$)

• Health ministry issues draft of revised Clinical Establishment Amendment Rules (PharmaBiz)
• Health ministry notifies New Drugs & Clinical Trials Rules; local trial not mandatory for new drugs approved in countries specified by DCGI (PharmaBiz)
• As Health Canada & US FDA raise safety alarm, DCGI asks IPC to provide info on ADRs from use of SGLT-2 inhibitors (PharmaBiz)

• Consumer story: Tim and selective androgen receptor modulators (SARMs) (TGA)