Recon: Gilead Buys Forty Seven in $4.9B Deal; US Reports 6 Coronavirus Deaths as Global Cases Rise

• Gilead buys cancer specialist Forty Seven in $4.9B deal (Financial Times) (WSJ) (Reuters) (Endpoints)
• Health officials in Washington state report 6 coronavirus deaths (AP)
• Trump urges pharmaceutical executives to accelerate coronavirus vaccine efforts (The Hill) (Reuters)
• Novartis employee claims she was fired for complaining about incorrect data (STAT)
• Sanofi to pay nearly $12 million for illegally using a charity to pay kickbacks to Medicare patients (STAT) (Reuters) (Press) (DOJ)
• FDA approves first generic version of $750 Daraprim drug (Reuters) (STAT) (FDA)
• Extended-release drugs could be costing U.S. healthcare system billions (Reuters)
• BioPharma M&A Drives More Efficient Resource Allocation (Life Sci VC)
• Supreme Court to Hear Obamacare Appeal (NYTimes) (Politico)

• Big Drugmakers Warn About Coronavirus Impact on Business (WSJ)
• Glaxo Revives Sale of Some Antibiotic Treatments (Bloomberg) (Endpoints) (PMLive)
• AstraZeneca hawks suite of hypertension drugs for $350M in latest asset sale (Fierce) (Press)
• Woodford who? TCR-focused Immunocore soldiers on with $130M+ B round (Endpoints)
• Novartis’ ‘life-changing’ Ilaris set for NHS funding (PharmaTimes)
• EMA organisational changes come into effect (EMA)

• World 'in uncharted territory' as coronavirus spreads: WHO (Reuters)
• Washington state confirms second US coronavirus death; New York reports first case (Reuters) (NYTimes)
• Coronavirus May Have Spread in US for Weeks, Gene Sequencing Suggests (NYTimes)
• Bill Gates: Responding to Covid-19 — A Once-in-a-Century Pandemic? (NEJM)
• US agency investigating production of faulty coronavirus test kits (Reuters)
• Coronavirus outbreak will spread, British PM Johnson says (Reuters)
• Biotechnology trade group taps former Biogen CEO as its coronavirus czar (Reuters) (Endpoints)
• Carson, FDA commissioner added to coronavirus task force (The Hill) (NYTimes)
• Surgeon General Urges the Public to Stop Buying Face Masks (NYTimes)
• Coronavirus unlikely to vanish next year-NIH's Fauci according to source (Reuters)
• Confirmed coronavirus cases in Germany rise to 150: Robert Koch Institute (Reuters)
• UK says four more confirmed cases of coronavirus (Reuters)
• French coronavirus cases rise to 130: public health chief (Reuters)
• Two patients die of coronavirus in northern France: Le Parisien (Reuters)
• Scottish government confirms first coronavirus case (Reuters)
• Coronavirus deaths rise in Italy, government prepares economic support (Reuters)
• Japan confirms at least 15 new coronavirus infections on Monday: Kyodo (Reuters)
• South Korea reports 123 new coronavirus cases, taking total to 4,335: Yonhap (Reuters)
• Indonesia confirms first cases of coronavirus, link to Japanese visitor (Reuters)
• India reports three more cases of coronavirus, including Italian national (Reuters)
• Pakistan's largest city shuts schools for two weeks over virus fears (Reuters)
• China's president says research centers to be set up to help contain coronavirus (Reuters)
• China's Wuhan closes coronavirus hospital as officials hail drop in new cases (Reuters)
• Brazil confirms second case of new coronavirus: Health Ministry (Reuters)
• Ecuador confirms five new cases of coronavirus, all close to initial patient (Reuters)
• Dominican Republic confirms first case of coronavirus (Reuters)
• Bahrain confirms six new coronavirus cases: state news agency (Reuters)
• Egypt detects second case of new coronavirus: health ministry (Reuters)
• Lebanon reports three new coronavirus cases, bringing total to 10 (Reuters)
• WHO technical team arrives in Iran to support coronavirus response (Reuters)
• Coronavirus death toll reaches 66 in Iran, includes a senior official (Reuters)
• Qatar reports first coronavirus case in man who returned from Iran (Reuters)
• Iraq announces two new coronavirus cases - Health Ministry (Reuters)
• Algeria confirms two more coronavirus cases (Reuters)
• Kuwait has 10 new cases of coronavirus, brings total to 56 – TV (Reuters)
• Israel reports 10th case of coronavirus (Reuters)
• Australia confirms first community transmissions of coronavirus (Reuters)

• FDA petitioned to recall batches of metformin diabetes pill over a possible carcinogen (STAT) (Fierce)
• Integrated Drug Reviews at the US Food and Drug Administration—Legal Concerns and Knowledge Lost (JAMA)
• A New Trend in Drug Development: Leveraging Data from Expanded Access (Cancer Therapy Advisor)
• Something Ventured: Vor Biopharma and 3 other startups got venture funding a year ago. Did it help them do what they said it would? (STAT)
• MorphoSys’ off-the-shelf rival to CAR-T approaches finish line with a speedy review (Endpoints)
• Waksal's bid for Redx ends, forcing biotech to avert cash crunch (Fierce)
• Former Sanofi CEO Brandicourt takes board seat at RNAi therapy maker Alnylam (Fierce)
• Real-world evidence and regulatory drug approval (Nature)
• Individualized Gene Therapy: US FDA Considering Device-Like Manufacturing Approval Process (Pink Sheet-$)
• Florida law limiting first opioid prescription linked to drop in use (Reuters)
• NORD Launches Natural History Study for Undiagnosed Rare Diseases (Global Genes)
• Determination that NEO TECT KIT (Kit for the Preparation of Technetium TC-99m Depreotide Injection) was not Withdrawn from Sale for Reasons of Safety or Effectiveness (FDA)

• FDA approves GSK's Advil Dual Action with Acetaminophen for over-the-counter use in the United States (Press)
• Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival Compared with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) (Press)
• Urovant Sciences Announces Publication of Phase 3 EMPOWUR Trial Results in the Journal of Urology (Press)
• AbbVie Provides Update from Phase 3 Study Evaluating VENCLEXTA® (venetoclax) in Combination with Low-Dose Cytarabine in Newly-Diagnosed Patients with Acute Myeloid Leukemia (AML) (Press)
• Karyopharm to seek expanded use of multiple myeloma drug following positive clinical trial (STAT) (Endpoints)
• Clovis Oncology Announces Availability and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Spain (Press)
• Merck clears PFS endpoint in confirmatory trial for Keytruda in classical Hodgkin lymphoma (Endpoints)
• Novus Therapeutics Completes Enrollment of Phase 2a Trial of OP0201 in Pediatric Patients with Acute Otitis Media (Press)
• U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis (Press)
• Gamida Cell Announces Updated Data from Phase 1 Study of GDA-201 to be Presented at the Annual Meeting of the European Society for Blood and Marrow Transplantation (Press)
• VBI Vaccines Announces Dosing of First Recurrent GBM Patient in Phase 2a Study of Cancer Vaccine Candidate, VBI-1901, in Combination with GSK’s AS01B Adjuvant System (Press)

• Companion Medical wins FDA nod for InPen diabetes management system (MassDevice)
• Insulet pauses automated dosing system trial amid software glitch (MedtechDive)
• Tandem Diabetes Care Announces FDA Designation of Basal-IQ Technology as an Interoperable Automated Glycemic Controller (Press)

• Cardinal Health to pay $8 million for failing to prevent bribes paid in China (STAT)
• A Small Victory for Theranos – Judge Dismisses 4 Counts of Conspiracy and Wire Fraud Against Former Executives (FDA Law Blog)
• Is It Time To Reconsider Federal Officer Removal? (Drug & Device Law)
• Illumina Sues Chinese Rival, Again, For 'Brazen Infringement' (Law360-$)
• Surescripts Can't Limit Discovery In FTC Case (Law360-$)

• FDA Advisory Committee Calendar

• UK To Seek Only Limited Regulatory Alignment With EU (Pink Sheet-$)
• Class 2 Medicines Recall: AOP Orphan Pharmaceuticals AG, Tetrabenazine 25 mg tablets, PL 21344/0015, (EL (20)A/13) (MHRA)

• COVID-19 stalling Chinese venture financings (BioCentury)
• Eyes On Pricing As Zolgensma Moves Closer To Japan Market (Scrip-$)

• Drug price regulator exempts Meril Life Sciences from price controls for a stent developed 3 years ago (Economic Times)
• Niti Aayog, health ministry reach consensus on Medical Devices Bill (Economic Times)
• Sun Pharma flags hypertension drug shortage (Economic Times)

• Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for Orally Inhaled Products (Health Canada)

• New Shortage Notification Rules Bear Fruit In Australia (Pink Sheet-$)

• Broken Health: The medical crisis that’s aggravating Iraq’s unrest (Reuters)