Recon: Biogen to Buy Gene Therapy Developer Nightstar for $800M

• Top 10 drugs losing exclusivity in 2019 (Fierce)
• Senators Seek Changes to FDA Guidance to Speed Entry of Insulin Biosimilars (Focus)
• Lilly Offers Half-Price Insulin in Counter to Cost Pressure (Bloomberg) (Reuters) (NYTimes) (Press)
• Big Pharma's Leaner Look Spells Trouble for Obesity Research (Bloomberg)
• Big Pharma Gave Money To Patient Advocacy Groups Opposing Medicare Changes (KHN)
• OxyContin maker Purdue Pharma exploring bankruptcy (Reuters) (Pharmafile)
• Opioid-maker Purdue Pharma seeks to have Massachusetts lawsuit thrown out (STAT)
• Drug Companies and Doctors Battle Over the Future of Fecal Transplants (NYTimes) (Axios)
• Precision Bio Preps IPO to Test “Off-the-Shelf” Cancer Cell Therapy (Xconomy) (Endpoints)
• To end AIDS, we must address the forces driving it (The Hill)
• Former sales exec says opioid maker Insys bribed doctors to prescribe drugs (NBC)
• Novartis agrees to pay $23m following charges it used charities to pay kickbacks to Medicare patients (STAT)
• FDA Tightening Regulatory Requirements For Some Medical Devices (NPR)
• Studies of Deadly Flu Virus, Once Banned, Are Set to Resume (NYTimes)
• The Opioid Dilemma: Saving Lives in the Long Run Can Take Lives in the Short Run (NYTimes)
• Vaccines Save Lives: What Is Driving Preventable Disease Outbreaks? (Senate HELP)

• Biogen to buy Nightstar Therapeutics in a $800 million cash deal (CNBC) (Endpoints) (Bloomberg) (Press)
• Trump’s Brexit trade plan is bad for NHS, say campaigners (PMLive)
• EMA Closes London Office, Preps for New Time Zone (Focus)
• Brexit uncertainty could be affecting surge in drugs on concessions list, warns PSNC (Pharmaceutical Jounral)
• UN report says vaccine hesitancy helped spark worldwide spike in measles cases last year (The Hill)
• Bayer Bosses Beg Risk-Averse Europe To Rethink (Scrip-$)
• Foreign aid doctors want Canada to stop sending homeopaths to Honduras (CBC) (Pharmafile)
• Versum Rejects $6B Merck Offer, Commits to Entegris Deal (Law360-$)
• Expanded PrEP trial places to be opened soon, NHS England confirms (Pharmaceutical Journal)
• Oxford Genetics wins six licensing deals (PharmaTimes)
• Napp launches pegfilgrastim biosimilar in the UK (PharmaTimes)
• Vertex chief Jeffrey Leiden to weigh in on Orkambi inquiry (PMLive) (Endpoints)
• Ebola treatment center in Congo reopens after attack: ministry (Reuters)
• Nessa Carey: ‘The most worrying thing about gene editing is that it’s really easy’ (The Guardian)

• No One Knows The True Cost Of Medicines, And Blaming Other Countries Won't Help (Forbes)
• OPDP Issues First Untitled Letter of 2019 (Focus)
• J&J Says Bedaquiline TB Treatment Cost ‘Fair,’ $1/Day Price ‘Unrealistic’ (Scrip-$)
• Team building. Pipeline revamp. Forward thrust. What does a decade of deals at Gilead tell us about Daniel O’Day’s first M&A moves? (Endpoints)
• FDA Cracks Down on Illegal Broker of Drugs From Canada, UK, Australia (Focus)
• In a blockbuster franchise race, Novo’s Trulicity rival scores more promising late-stage diabetes data (Endpoints)
• Building on momentum from positive diabetes data, Zafgen scoops Biogen alum Priya Singhal as head of R&D (Endpoints)
• Dr Reddy’s CEO On Payer Dynamics, China Commitment And Disruption (Scrip-$)
• Apellis resumes phase 3 AMD trials after addressing safety issue (Fierce)
• Trump Administration Hands Out Record Number of Orphan Approvals (Fortune)
• Latest Data Show That Hospitals Are Still Specialty Drug Profiteers (Drug Channels)
• Endo gains on favorable FDA drug compounding decision (Reuters)
• In the Pharma Pricing Debate, We Are Talking About More Than Apples and Oranges (Eye on FDA)
• US FDA Expands Patient Input To New Area: Orphan Grant Applications (Pink Sheet-$)
• Horizon Pharma Sees Mid-2019 BLA For Tepro After Solid Phase III TED Data (Scrip-$)
• Patients and Insurers Accuse Genentech of Exploiting Cancer Patients (FDANews-$)
• FDA Raps Garden Grove Drugmaker for Slew of Violations (FDANews-$)
• Gilead to help HIV patients ‘Age Positively’ with $17.6M in grants to 30 groups (Fierce)
• Teva launches generic for Pfizer’s Flector pain patch (MassDevice)

• Verastem Oncology Presents Phase 3 DUO™ Data Evaluating COPIKTRA™ (Duvelisib) in Patients with CLL/SLL Who Have Progressed Following Two Prior Lines of Therapy (Press)
• After nebulizer flop, Verona touts interim PhII results on another version of its lead COPD drug (Endpoints)
• BioPharmX Completes Enrollment in Phase 2b Trial of BPX-04 for Patients with Papulopustular Rosacea (Press)
• Aphria Receives Health Canada License Amendment, Approving Fully Expanded Production at Aphria One (Press)
• Sesen Bio Reports Fourth Quarter and Full-Year 2018 Financial Results and Additional Preliminary Data from Phase 3 VISTA Trial (Press)
• Recordati Rare Diseases Canada Inc. announces Health Canada approval of CYSTADROPS ® (cysteamine ophthalmic solution) for cystinosis patients (Press)
• Innovus Pharma Announces the Approval of its RecalMax™ Product in Canada Indicated to Temporarily Relieve Symptoms of Mental Fatigue and Sensation of Weakness and Support Cognitive Functions Including Mental Focus and Stamina (Press)

• Transition to ISO 13485:2016 Comes to an End (Focus)
• Almirall deals ThermiGen medtech assets to Celling Biosciences (MassDevice)
• Medtronic updates on corrected safety analysis for paclitaxel-coated balloon (MassDevice)
• Rani debuts human trial data for robotic pill tech (MassDevice)
• Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell (MassDevice)
• Medtronic registers for undisclosed EU-based debt offering (MassDevice)

• Why HHS wants to rethink dialysis (Politico) (Reuters)
• Novartis Sues Janssen Over False Advertisements for Psoriasis Drug (Focus) (Law360-$)
• NIH letters asking about undisclosed foreign ties rattle U.S. universities (Science)
• Prescription Drug Pricing Hearing: Is The Senate Probing In The Wrong Place? (Forbes)
• A Closer Look At The Drug Rebate Proposal (Forbes)
• Leave Opioid Lawsuits to State Attorneys General (WSJ)
• Ore. Tribe Latest To Join Opioid MDL (Law360-$)
• What the Alliance Is Asking for for FY 20 (Alliance for a Stronger FDA)
• Arizona Lawmakers Consider Loosening Vaccination Requirements (NPR)
• The New York Health Act Just Became Even More Expensive (Forbes)
• Convicted NECC Pharmacists Can Make Case For Acquittal (Law360-$)
• It Was Too Good to Last; 2nd Circuit Overturns District Court’s Dismissal of FTC’s Complaint against Marketers of Prevagen (FDA Law Blog)
• The Latest on Removal Before Service (Drug & Device Law)
• 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program (HHS)

• FDA Advisory Committee Calendar
• 2019 Meeting Materials, Vaccines and Related Biological Products Advisory Committee – 6-7 March 2019

• EMA Qualifies CAR T-Cell Therapy Registry (Focus)
• EMA accepts marketing authorisation applications for Idefirix and Xospata (PharmaTimes)
• Medicines marketing authorisation: change of ownership (MHRA)
• Medicines: licensing time-based performance measures (MHRA)
• All T34 ambulatory syringe pumps need a sponge pad fitted to the battery compartment to prevent battery connection issues (MDA/2019/013) (MHRA)
• Minutes – 9th Meeting of the Working Group on Guidelines on benefit - risk assessment of Phthalates in Medical Devices (EC)

• AmoyDx Wins Chinese Regulatory Approval for BRCA Mutation Test (GenomeWeb)

• Government plans to colour code generic drugs (Economic Times)
• Divi’s, Gland, Fidelity enter race to buy Orchid Pharma (Economic Times)
• CDSCO conducts 170 risk-based inspections across Sch M units in country since October 2015 (PharmaBiz)
• Gujarat FDCA conducts workshop for drug inspectors on regulatory approach towards pharmaceutical utilities (PharmaBiz)

• Understanding Australia's new opioid overdose rescue treatment (TGA)
• SME Assist Workshop: 'Meeting your obligations' (Sydney) (TGA)