Recon: Thermo Fisher to Buy Qiagen for $10B; Novartis’ Sandoz Settles Generic Price Fixing Case for $195M

• Novartis Unit to Pay $195M in Generic-Drug Price-Fixing Case (WSJ) (Reuters) (Endpoints) (DOJ)
• Estimates Fall Short of FDA’s Pledge for 1 Million Coronavirus Tests (NYTimes) (Politico)
• As Coronavirus Numbers Rise, CDC Testing Comes Under Fire (NYTimes)
• Hospitals, Companies Race to Develop Tests to Spot Coronavirus-Linked Illness (WSJ)
• Trump’s tone toward pharma shifts, as he looks to drug makers to help with coronavirus response (STAT) (Endpoints)
• Trump pushing companies for speed on coronavirus treatments (Politico) (Reuters)
• Big Pharma May Pose an Obstacle to Vaccine Development (NYTimes)
• Roche pushes to kick-start lung therapy Esbriet after big writedown (Reuters)(Press))
• West Virginia plan: Companies pay $1.25B to end opioid suits (AP)
• Facebook has a prescription: More pharmaceutical ads (Washington Post)
• Lawmakers close in on $7.5B coronavirus emergency spending package (Washington Post) (The Hill)

• Thermo Fisher to Buy Diagnostic Company for $10.1B (WSJ) (Financial Times) (Bloomberg) (STAT) (Endpoints) (Press)
• Brazil's Hypera Pharma to acquire drugs from Japan's Takeda for $825 million (Reuters)
• J&J ordered to pay $1.7 million to three Australian women in pelvic mesh class action (Reuters
• BeiGene warns of hit to sales and clinical trials from coronavirus outbreak (Reuters)
• India Restricts Exports of Common Drugs on Fear of Coronavirus Shortages (Bloomberg) (Reuters)
• EMA PRIME status granted to Janssen’s inherited retinal disease gene therapy (PharmaTimes)
• European Commission Authorizes Alnylam’s Givlaari to treat Acute Hepatic Porphyria (Press)

• G-7 countries promise to use policy tools but offer no specific actions to combat coronavirus (CNBC) (Reuters)
• A detailed guide to the coronavirus drugs and vaccines in development (STAT)
• Eli Lilly does not expect drug shortages due to coronavirus (Reuters)
• Top CDC official tells Congress coronavirus almost qualifies as a global pandemic (CNBC)
• Public Citizen: Lack of full transparency regarding coronavirus-related drug shortage (Letter)
• Texas mayor declares emergency in bid to keep cruise passengers in quarantine (Reuters)
• Pfizer identified some antiviral compounds with potential as coronavirus treatments (Reuters)
• China allocated $15.6 billion in epidemic prevention funds by March 2 - finance ministry official (Reuters)
• Four Chinese provinces lower coronavirus emergency response level (Reuters)
• China’s cases of Covid-19 are finally declining. A WHO expert explains why. (Vox)
• China doctors seek tougher discharge criteria after positive coronavirus tests (Reuters)
• China urges overseas Chinese to stay away as imported virus cases rise (Reuters)
• China to send plane to Iran to pick up citizens from virus-stricken areas: Global Times (Reuters)
• South Korean president declares war on coronavirus as sect leader tests negative (Reuters)
• Pence Visited School Where Student Is in Coronavirus Quarantine (Bloomberg)
• Australia to use biosecurity law to restrict movements of coronavirus patients (Reuters)
• The European coronavirus response team (EC)
• A tool to investigate outbreaks, Go.Data, is rolled out for COVID-19 in Latin America (PAHO)
• Coronavirus kills 77, infects 2,336 in Iran: deputy health minister (Reuters)
• France says it now has 191 confirmed cases of coronavirus (Reuters)
• Germany reports 31 new coronavirus infections (Reuters)
• Myanmar turns away cruise ship over coronavirus fears (Reuters)
• Ukraine reports first coronavirus case, in man who traveled from Italy (Reuters)
• Pakistan confirms fifth coronavirus case (Reuters)
• Oman confirms six new cases of coronavirus, raises total number to 12: Health Ministry (Reuters)

• Sanofi Says US List Price For Sarclisa Is $650 Per 100 Mg Vial & $3,250 Per 500 Mg Vial (Reuters) (Endpoints) (FDA) (Press)
• Cancer biotech gets another new name – Xilio – and more than $100 million (STAT)
• When a Drug Study Abruptly Ends, Volunteers Are Left to Cope (NYTimes)
• Precision medicine: course correction urgently needed (STAT)
• ICER to Postpone Assessment of Gene Therapy for Beta Thalassemia (ICER)
• Failure-prone Unum cuts jobs, loses scientific chief, and changes focus yet again (Endpoints) (BioPharmaDive)
• Hear hear! Ear gene therapy player Akouos draws $105M in fresh capital (Endpoints)
• 'Precision Medicine' Raises Complex Legal And Ethical Issues (Law360-$)
• Misleading ads turn people away from HIV-prevention meds (Reuters)
• US FDA To Seek Expanded Pharmaceutical Distribution Tracking Authority (Pink Sheet-$)
• The Top 15 U.S. Pharmacies of 2019: Specialty Drugs Drive the Industry’s Evolution (Drug Channels)
• Orphan Drug Designations are declining, says market analysis (EPR)
• BARDA rejects Pluristem's request for radiation study funding (Fierce)
• With one rival down, Novartis-partnered biotech scores $100M round to fund mid-stage trials of fibrosis drug (Endpoints)
• Boasting new discoveries from Xtandi, Erleada inventors, ORIC pitches $86M IPO on cancer drugs targeted at resistance (Endpoints)
• Vertex, Seattle Genetics, Alpine withdraw from investor conference as biotechs brace for coronavirus (Endpoints)
• Biogen’s early R&D chief exits for ARCH and Bezos-backed anti-aging biotech (Endpoints)

• Merck's Keytruda builds blood cancer case with head-on win against SeaGen's Adcetris (Fierce) (Press)
• Ayala Pharmaceuticals Granted U.S. FDA Fast Track Designation for AL101 for the Treatment of Recurrent or Metastatic Adenoid Cystic Carcinoma (Press)
• Arrowhead Pharmaceuticals Initiates Phase 1/2 Study of ARO-HSD in Normal Healthy Volunteers and Patients with NASH or Suspected NASH (Press)
• VBI Vaccines Provides Update on Part A of Ongoing Phase 1/2a Study Demonstrating Overall Survival Benefit for VBI-1901 Vaccine Responders in Recurrent GBM Patients (Press)
• GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 (LUMEVOQ™) Phase III Trials at the 46th Annual Meeting of NANOS (Press)
• Can-Fite is Filing Drug Safety Update Report Showing Positive Safety Results from Phase II and Phase III Studies of Namodenoson and Piclidenoson (Press)
• MiNA Therapeutics Announces Initiation of Phase I Clinical Study of MTL‑CEBPA in Combination with anti-PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumours (Press)
• EpicentRx IND Application for Second Immuno-oncology Program, a TGF-β Trap Adenovirus, Receives FDA Clearance (Press)
• Neuraly Announces First Patient Dosed in Phase 2 Clinical Trial of NYL01 for Patients with Parkinson’s Disease (Press)
• Immunomic Therapeutics Announces Completion of Pre-IND Meeting with US FDA for ITI-1001, a Vaccine for the Treatment of GBM (Press)

• FDA’s Retooled Quality System Regulation Coming ‘Sometime This Year,’ CDRH Chief Shuren Says (Medtech Insight)
• Insulet pauses automated dosing system trial amid software glitch (MedtechDive)
• Advanced Bionics recalls certain cochlear implants due to hearing degradation (MassDevice)
• Access Vascular wins FDA clearance for HydroPICC catheter (MassDevice)
• BGI Coronavirus Molecular Diagnostic Test Garners CE Mark (GenomeWeb)
• Genome BC Announces C$10M to Study Clinical Genomics Implementation (GenomeWeb)

• California slams AmerisourceBergen over opioid shipments to pharmacies (STAT)
• Senators Warren and Casey Request Information on FDA and FTC Efforts to Protect the American Public from Coronavirus Scams (Warren)
• Contract spells out how the University of Chicago shared patient data with Google (STAT)
• Coronavirus Knocks Drug Pricing Down – But Not Off – Political Priority List In US (Pink Sheet-$)
• Vaccine Requirements Are On The Ballot In Maine, After A New Law Divided Parents (NPR)
• Mediators To Form Plan For Purdue Ch. 11 Claims Distribution (Law360-$)
• GSK Settles Anemia Drug Patent Claims On Eve Of Trial (Law360-$)
• AGs Claim Ample Evidence In Generic Drug Price-Fixing Suit (Law360-$)
• Hetero, Zydus Settle Novartis MS Drug Suits Before IP Trial (Law360-$)
• Medical Devices – Don’t Call Them Consumer Goods (Drug & Device Law)

• FDA Advisory Committee Calendar
• FDA Grand Rounds – 12 March 2020

• EFPIA boss damning on European pharma investment (PharmaLetter-$) (EFPIA)
• New figures show 3.5 million unlicensed erection pills seized in 2019 (MHRA)
• Disruptive and avoidable: GDPR challenges to secondary research uses of data (Nature)

• Setting up pharma R&D bases in India will soon be incentivised (Economic Times)
• India soon to become ICH member (Pharmabiz)
• India Pharma Forum: What The FDA, Indian Regulator Flagged Up (Pink Sheet-$)

• New Shortage Notification Rules Bear Fruit In Australia (Pink Sheet-$)
• International scientific guidelines adopted in Australia (TGA)
• Update on reclassification of a number of medical devices (TGA)

• New Guidelines Urge Most U.S. Adults to be Screened for Hepatitis C (NYTimes)