Recon: Department of Justice Investigating Acadia’s Nuplazid Marketing Practices

• New Parkinson's psychosis drug target of DOJ investigation (CNN) (Pharmafile)
• Roche's Tecentriq notches win in breast cancer with US approval (Reuters) (AP) (STAT) (Endpoints) (Press 1, 2)
• Trump's 2020 budget to be unveiled (Politico) (Alliance for a Stronger FDA)
• Bristol scrambles to push Celgene deal, but are the odds as high as some think? (STAT)
• Microbiome-based drugs likely to face FDA’s biologics pathway (STAT)
• Gottlieb’s Exit Interview (BioCentury)
• Early data snapshots of Axovant’s gene therapies for Parkinson’s, Tay Sachs appear promising (Endpoints)
• 23andMe thinks polygenic risk scores are ready for the masses, but experts aren’t so sure (MIT Technology Review) (CNBC)
• How Much Difference Will Eli Lilly's Half-Price Insulin Make? (NPR)
• OxyContin maker Purdue Pharma loses bid to delay opioid epidemic trial (Reuters) (Washington Post)
• Could gene therapy cure sickle cell anemia? (CBS)

• Japanese drugmaker moves European HQ from London over Brexit (Financial Times) (MedCity)
• Founder of pharma unit leads way in African drug discovery (Financial Times)
• As polio goal nears, Pakistan pushes against vaccine misinformation (Reuters)
• World must prepare for inevitable next flu pandemic, WHO says (Reuters) (WHO)
• What to expect for 2019 with MDR and IVDR implementation? (medicaldeviceslegal)
• Novo Opens Incubator In China (BioCentury)
• Lundbeck fund backs a $50M launch round for SNIPR Biome, a new brand of CRISPR Cas biotech (Endpoints)
• Vertex CEO says he will bring ‘new ideas’ to break a stalemate in the U.K. over a cystic fibrosis drug (STAT)
• Real-World Evidence: Is Adoption In Latin America Possible? (Pink Sheet-$)
• NICE nod for Almirall's Ilumetri, UCB's Cimzia (PharmaTimes)
• Takeda’s Entyvio tops Humira in ulcerative colitis (PMlive)
• Doctors pray for sick as blackout batters Venezuelan hospitals (Reuters)
• 1 Killed In Latest Attack On Ebola Treatment Center In Congo (NPR) (WHO)
• Measles outbreak in New Zealand's Canterbury widens to 20 (Reuters)

• Peace over promise: ALS patient quits taking drug aimed at slowing disease (St. Louis Dispatch)
• Drug hunters explore allostery’s advantages (C&EN)
• Patients need transparency and relief from high drug costs, not defense of the status quo (HHS)
• Principia, AbbVie walk away from 2017 partnership for inflammatory, autoimmune drugs (Endpoints)
• Sharpless Has The Edge On FDA Job (BioCentury)
• French biotech Cellectis picks U.S. for commercial CAR-T production (Fierce)
• Two big pharma execs share the same challenges, but compensation? They’re not even close (Endpoints)
• New FDA Web Portal Allows for Patient Questions, Meeting Requests (Focus)
• An Audience With Bahija Jallal (Nature)
• The Medicines Company: Innovating Innovation (Forbes)
• Is second time the charm for ozanimod? Celgene starts to find out with EMA filing (Endpoints) (Xconomy)
• Precision Medicine’s Impact on the Doctor-Patient Relationship (Harvard Bill of Health)
• The Life, Troubles, and Celgene Legacy of Deal Guru George Golumbeski (Xconomy)
• WuXi AppTec Testing Facilities Complete Three Regulatory Inspections from US FDA, OECD, and CNAS with Excellent Results (Press)
• After Several Attempts to Get it Right: FDA Releases Final Guidance on Evaluation of Bulk Substances for Use in Section 503B Outsourcing Facilities (FDA Law Blog)

• Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine (Press)
• Celltrion Healthcare showcases initial data from year-long study for subcutaneous formulation of CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (Press)
• Eisai and Imbrium Therapeutics Announce FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia (Press)
• Alnylam Submits CTA Application for ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension in High Unmet Need Settings (Press)
• New Phase 3 STELARA® (ustekinumab) Data Show Positive Results as Maintenance Therapy in Adults with Moderate to Severe Ulcerative Colitis (Press)
• FDA Grants Genentech’s Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer (Press)
• Adare Pharmaceuticals Announces Achievement of the Primary End-Point in Phase IIb Study (FLUTE™) for APT-1011 in Patients with Eosinophilic Esophagitis (Press)
• Tenax Therapeutics Enrolls First Patient for Phase 2 Pulmonary Hypertension Clinical Trial (Press)
• Arrowhead Pharmaceuticals Begins Dosing in Phase 1 Study of ARO-APOC3 for Treatment of Hypertriglyceridemia (Press)

• FDA Flags 41,000 Adverse Event Reports Linked to Surgical Staplers, Staples (Focus) (FDA) (Medpage)
• Agency Information Collection Activities; Proposed Collection; Comment Request; Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements (FDA)
• Page.AI Nabs FDA Breakthrough Device Designation for First AI-driven Cancer Diagnosis (Focus)
• Integra gets FDA warning letter for Boston plant (Reuters) (MassDevice)
• Edwards Lifesciences gets in on Corvia, Mitralign (MassDevice)
• RTI Surgical closes $300m Paradigm Spine buy (MassDevice)
• Medical Device Recalls Spike in February (MDDI)
• GE’s Datex-Ohmeda wins another DoD patient monitoring contract, this time for $100m (MassDevice)

• State of Diabetes Briefing on Capitol Hill (Children with Diabetes)
• Mumps, other outbreaks force US detention centers to quarantine over 2,000 migrants (Reuters)
• Prison officials launch a probe into Martin Shkreli’s latest antics, allegedly running his biotech business with a contraband cell phone (Endpoints)
• FDA Clears Way for AquaBounty to Raise Salmon in America’s Heartland (Xconomy) (FDA)
• Allergan Rivals Ask Supreme Court Not to Review St. Regis Tribe Patent Deal (FDANews-$)
• Senate Patent Bill To Boost Biosimilars Needs Work, Attys Say (Law360-$)
• Ni-Q, LLC v. Prolacta Bioscience, Inc. (D. Or. 2019) (Patent Docs)
• Takeda Unit Fights $155M IP Loss, Bayer Wants $27M More (Law360-$)
• Spark's $4.8B Sale To Roche Is 'Unfair,' Investor Claims (Law360-$)
• Wadler V. Bio-Rad Poses Noteworthy Whistleblower Questions (Law360-$)
• Learned Intermediary Rule – Back to the Future (Drug & Device Law)
• Utah’s first step toward importing drugs from Canada has died. But lawmakers remain interested, warning ‘people are going without their medicines and bad things are happening.’ (Salt Lake Tribune)

• FDA Advisory Committee Calendar

• Lundbeck appoints Keld Flintholm Jørgensen as EVP and Chief Business Officer (Press)
• HMA Offers Recommendations on Complex Clinical Trials (Focus)
• Early access to medicines scheme: expired scientific opinions (MHRA)
• Medical Device Alert issued for urogynaecological mesh manufactured by C.R. Bard (MHRA)
• Clinical trials for medicines: authorisation assessment performance (MHRA)

• GST relief for pharma samples, discount offers (Economic Times)
• Drug regulator directs J&J to pay Rs 74 lakhs to a patient (Economic Times)
• NPPA's bid to reduce 42 cancer drug prices through trade margin capping 'inadequate & flawed': NGOs (PharmaBiz)
• Medical devices industry urges govt to ensure compliance of labeling requirement as is done in drugs (PharmaBiz)

• Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C (NEJM)

• Illegal Marketing of Drugs and Devices (Health Canada)

• Brazil’s Fight against Hepatitis C — Universalism, Local Production, and Patents (NEJM)

• GoFundMe should stop embracing and promoting unproven clinical research (STAT)
• Unvaccinated Boy, 6, Spent 57 Days In The Hospital With Tetanus (NPR)