Recon: FDA Rejects Sunovion's Parkinson's Drug; Aveo Plunges After Delaying NDA Submission for Kidney Cancer Drug

• FDA stiff-arms Aveo on tivo, again; Sunovion Parkinson’s drug rejected (Endpoints) (Boston Business Journal 1, 2) (Xconomy) (Sunovion) (Aveo)
• Mylan Wins FDA Approval for First Advair Generic (Focus) (Reuters) (Endpoints) (AP) (FDA)
• House E&C Questions Insulin Manufacturers (Focus) (CNBC) (Reuters)
• ‘Can we stop that work, can we delay that work?’ Bristol-Myers’ top execs outline their game plan for absorbing Celgene (Endpoints)
• Celgene profit beats as psoriasis drug sales surge (Reuters)
• Romney to speak before closed-door meeting of drug industry CEOs (STAT)
• Many doctors are uncertain about the FDA approval process — and don’t like off-label marketing (STAT)
• American scientist played more active role in ‘CRISPR babies’ project than previously known (STAT)
• Recall of infant liquid ibuprofen sold at CVS, Walmart expands over safety worries (NBC) (FDA)
• OxyContin Maker Explored Expansion Into “Attractive” Anti-Addiction Market (ProPublica)
• Opioid Lawsuits Are Headed to Trial. Here's Why the Stakes Are Getting Uglier. (NYTimes)
• Opioids: Boston trial opens what could be year of reckoning for executives (The Guardian)
• Alexion lines up a $60M option to buy Fortress-incubated biotech focused on a lucrative rare blood disease (Endpoints) (Fierce)
• A 'one-off opportunity:' Drug company hikes price of blood pressure drugs after competitors' drugs recalled (USA Today)
• How the Trump administration wants to change Medicare Advantage (Politico)

• US, EU Pledge to Cooperate on UDI Specifications (Focus)
• Culture of ‘Bending Rules’ in India Challenges US Drug Agency (Bloomberg)
• Taking no for an answer (Sarcoma UK/Medium)
• Swiss government is asked to issue a compulsory license for a Roche cancer drug (STAT)
• Roche posts 2018 sales beat with strong growth from its new medicines (CNBC) (Financial Times) (PMLive) (Press)
• An Israeli Company Claims That They Will Have A Cure For Cancer In A Year. Don't Believe Them. (Forbes)
• Novartis Plots New Course For Sandoz (BioCentury)
• Vertex an “extreme outlier” in pricing and behaviour, says NHS England (PMLive)
• Estonia Houses The Biggest Biobank In Europe (Forbes)

• Predicting The Next Dominoes to Fall in 2019 (LifeSciVC)
• Can Digital Medicine Improve Drug Adherence? (Forbes)
• Marketing Status Notifications: FDA Drafts Guidance (Focus)
• Multi-target drugs should be in the pharma pipeline along with precision drugs (STAT)
• A new NIH rule won’t be enough to make clinical research more inclusive (STAT)
• FDA blesses Merck’s PhIII effort to topple a mega-blockbuster — but there’s also a little biotech in this game (Endpoints) (PharmaLetter-$)
• So good it hurts: Why drug makers looking to replace opioids want to keep some pain in the picture (STAT)
• FDA moving to 'risk-based' inspections even as valsartan scare adds new wrinkle to oversight (Fierce)
• With US government shutdown over, Gossamer reverts to traditional IPO plan (Endpoints)
• Their lead drug failed both main goals in key study, but Orphazyme plans to pitch subgroup analyses to regulators (Endpoints)
• Aduro Biotech Slashes Staff 37%, Turns Focus to Lead Cancer Drugs (Xconomy)
• With $100M MeiraGTx Deal, J&J Signals Bigger Move Into Gene Therapy (Xconomy) (Endpoints)
• Rotavirus Vaccine May Protect Against Type 1 Diabetes (NYTimes)
• Richard Ridinger resigns from CEO position at Lonza causing shares to plummet (Pharmafile)
• Key Insights from FDA’s Webinar on the Breakthrough Designation Program (FDA Law Blog)

• Sylentis' dry eye drug misses primary goals in phase 3 (Fierce)
• First phase 3 data back Scynexis' new-class antifungal (Fierce)
• FDA Expands Lilly's ALIMTA® (pemetrexed) Label with Combination of KEYTRUDA® (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer (Press)
• Prana Receives First Orphan Drug Designation from the FDA for the Treatment of Multiple System Atrophy (Press)
• Dr. Cynthia Verst Of IQVIA Elected 2019 ACRO Chair (ACRO)

• Medtronic touts study data for thoracic aortic stent (MassDevice) (Press)
• GE gains on Q4 revenue beat, swing to black (MassDevice)
• Hologic FY2019 Q1 earnings beat The Street (MassDevice)
• Boston Scientific pulls Agile biliary stent on migration reports (MassDevice)
• Cardiovascular Systems posts Street-beating FY2019 Q2 earnings (MassDevice)
• Siemens Healthineers posts mixed-bag FY2019 Q1 earnings (MassDevice)
• FDA approves J&J’s Tremfya self-injection pen for psoriasis (Drug Delivery)
• Stryker's Mako Sales Were 'Super Impressive' in Q4 (MDDI)
• Spotlight on Human Factors Engineering: Should kids be operating medical devices independently? (Emergo)

• Approaching Antibody Patents After Amgen V. Sanofi (Law360-$)
• Pharma Fraudsters To Pay Valeant $11.8M Over Kickback Plot (Law360-$)
• Boston's Opioid Suit Won't Get Pulled Into Federal Court (Law360-$)
• Can’t Tell Who Is in the Class? Class Cert Denied (Drug & Device Law)
• Barry v. Medtronic, Inc. (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar
• Microbiology Devices Panel Advisory Committee; Notice of Meeting – 8 March 2019
• Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 21 March 2019
• Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting – 27 March 2019
• Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee – 12 February 2019

• European Commission Consults on Orphan Drug Applications (Focus)
• Repurposed drugs: UK Supreme Court deals a blow to patentees (Pharmafile)
• Can GDPR work for health scientific research? (EFPIA)
• Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005) (MHRA)
• Advertising investigations: December 2018 (MHRA)
• Another Reason to Update Your Biocompatibility Approach: EU MDRs (MDDI)
• Johnson & Johnson plans €36M expansion in Ireland (MassDevice)

• Curetis Receives Malaysia, Thailand Regulatory Approvals (GenomeWeb)
• Hong Kong Medical Device Regulatory Update: IVD listings, acceptance period for NMPA approvals (Emergo)

• Dr Reddy's Laboratories Ltd appoints Axis Bank ex-MD Shikha Sharma as independent director (Economic Times)
• InvAscent-led India Life Sciences Fund raises $250 million (Economic Times)

• Regulatory options for appropriate access and safety controls for alkyl nitrites - Public meeting questions and answers (TGA)

• Health Canada Seeks to Better Define Regulatory Requirements for SaMD (Focus)

• Sri Lanka halts imports of Johnson & Johnson Baby Powder pending asbestos tests (Reuters)

• Immune cells in the gut may explain why some people can't lose weight (NBC) (NIH)