Recon: Sanofi to Acquire Synthrox for $2.5B While Merck Picks up ArQule for $2.7B

• Sanofi and Merck each buy cancer-focused biotechs (Financial Times) (STAT) (Endpoints) (Xconomy) (WSJ) (Reuters 1, 2)
• Half of lymphoma patients alive three years after Gilead cell therapy treatment (Reuters) (Fierce)
• Bluebird bio’s sickle cell gene therapy shows early-study benefit (PMLive) (Press)
• Bristol-Myers, bluebird therapy for multiple myeloma succeeds in mid-stage trial (Reuters) (Press)
• Revamped Senate package takes aim at drug prices and props up other health programs (STAT)
• Sangamo steps up BioMarin chase with haemophilia gene therapy data (PMLive) (Endpoints) (Press)
• New J&J CAR-T myeloma data confirm strong efficacy, ease doubts raised by Chinese version (STAT) (Endpoints 1, 2) (Press)
• FDA lifts hold on Abeona's butterfly disease therapy, paving way for pivotal study (Endpoints)
• Bristol-Myers reports positive data on cancer treatment acquired in Celgene deal (Reuters) (Endpoints) (PMLive) (Press)
• 3M to Plan $1 Billion Sale of Drug Delivery Systems Unit (Bloomberg) (MasDevice)
• Digital health start-up once worth $1.5 billion is racing to keep lights on as investors flee (CNBC)
• House Republicans fuel Capitol Hill chaos with competing drug pricing bill (STAT)

• Roche faces another delay in struggle to navigate Spark deal past regulators — but this one is very short (Endpoints) (Press)
• Grifols says trial shows positive effects in slowing Alzheimer's (Reuters)
• Scottish HTA body OKs Lynparza For Earlier Use In Ovarian Cancer (Pink Sheet-$)
• Orchard’s Gene Therapy Under Fast-Track Review At EMA (Pink Sheet-$)
• Samoa says almost 90% of people vaccinated against measles after deadly outbreak (Reuters)
• Congo authorities say Ebola survivor falls ill a second time (Reuters)

• Biotech companies defend prices of one-off gene therapy (Financial Times)
• Two New Drugs Help Relieve Sickle-Cell Disease. But Who Will Pay? (NYTimes)
• When Drug Side Effects Pose Real Dangers (NYTimes)
• J&J fronts $750M cash to grab a failed cancer drug that’s been repurposed as a powerful anti-inflammatory (Endpoints)
• Gene editing success heralds era of animal-to-human transplants (Financial Times)
• 3D printing offers hope of building human organs from scratch (Financial Times)
• Organoid innovation offers potential for cancer research (Financial Times)
• AstraZeneca Taps Gatehouse Bio to Identify Potential Drug Targets (Xconomy)
• Therapeutic targeting of the complement system (Nature)
• New Therapies Help Patients With Dementia Cope With Depression (NYTimes)
• Sanofi awarded $226 million by US government to expand pandemic influenza preparedness (Press)
• PIC/S: How Inspectorates Should Assess Pharma Quality Systems For Changes (Pink Sheet-$)
• Prescription Opioid Use Steady, NHANES Data Show (Medpage)
• Constellation’s blood cancer drug shows strong results, but skepticism may not fade (STAT)
• ObsEva makes case for best-in-class hormone suppressive therapy in positive uterine fibroid study (Endpoints)
• KalVista's diabetic macular edema data falls short — will Merck walk away? (Endpoints)
• Regeneron's BCMA bispecific makes clinical data debut, kicking off multiple myeloma matchup with Bristol-Myers (Endpoints)
• Changes in the Board of Directors and the Corporate Executive Committee of Roche (Press)

• Galderma Investigational Therapy Nemolizumab Granted FDA Breakthrough Therapy Designation for the Treatment of Patients Suffering from Prurigo Nodularis (Press)
• ASH: Roche bispecific delivers for hard-to-treat lymphoma patients failed by CAR-Ts (Fierce)
• ASH: Amgen's BiTE stalls multiple myeloma relapse in mice in combo with BMS' Revlimid (Press)
• ASH: Eli Lilly plots 'ambitious' cancer program after sharing early BTK data (Fierce) (Press)
• Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer (Press)
• Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials (Press)
• ASH: AstraZeneca's Calquence posts sky-high survival numbers in previously untreated CLL (Fierce) (Press)
• Genentech Announces New Data on Novel Cd20-cd3 Bispecific Cancer Immunotherapies in People With Difficult-to-Treat Lymphomas (Press)
• ASH: Takeda details Ninlaro's miss in scrapped AL amyloidosis trial (Fierce) (Press)
• ASH: AbbVie, Roche pad their case for fixed-duration Venclexta use in CLL (Fierce) (Press)
• ASH: BeiGene, eyeing Imbruvica's CLL share, touts more early Brukinsa data (Fierce)
• Imbruvica®▼(ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leukaemia (Press)
• Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL) (Press)
• Epizyme Presents Updated Phase 2 Data at the 2019 ASH Annual Meeting Supporting Planned Tazemetostat NDA Submission for Follicular Lymphoma (Press)
• ASH: Novartis trumpets hospitalization data for newly minted sickle cell drug Adakveo (Fierce)
• Sesen Bio Initiates Rolling Submission of BLA for Vicinium to FDA (Press)
• Cellular Biomedicine Group Presents First Clinical Data of IIT Phase 1 Trial of C-CAR088, a Novel BCMA CAR-T (Press)
• BerGenBio Presents Preliminary Clinical Data From Phase II Combination Trial of Bemcentinib and LDAC in Elderly AML Patients (Press)
• Portola Pharmaceuticals Presents New Interim Data from Ongoing Phase 2a Study of its Oral SYK/JAK Inhibitor Cerdulatinib in Heavily Pre-Treated T-Cell Malignancies (Press)
• Updated Clinical Data from Phase 2 SPiReL Study Evaluating DPX-Survivac as a Combination Therapy in r/r DLBCL Presented (Press)
• Verastem Oncology Presents Phase 2 PRIMO Study Data Evaluating Duvelisib in Relapsed or Refractory Peripheral T-Cell Lymphoma (Press)
• ALX Oncology Presents Initial Data from the ALX148 Clinical Trial Non-Hodgkin Lymphoma Combination Cohort (Press)
• FORMA Therapeutics Announces Positive Preliminary Phase 1/2 IDH1m Inhibitor Olutasidenib Results Demonstrating Rapid Clinical Remissions and Mutation Clearance in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome (Press)
• Cerevel Therapeutics Announces Phase 1 Results for CVL-865, a Novel α2/3/5-subtype GABAA Positive Allosteric Modulator in Development to Treat Epilepsy (Press)
• Additional Analyses From Phase 3 study With Doptelet ® (avatrombopag) for the treatment of Chronic Immune Thrombocytopenia Provides Evidence of Long-term Response Rates (Press)
• Actinium Pharmaceuticals Announces Phase 3 SIERRA Trial Dosimetry Results Support Low Dose Iomab-B for Targeted Lymphodepletion Prior to Adoptive Cell Therapy (Press)
• Aurora Bio, Inc Announces Clinical Data on Lead Program, AUR01, a Novel Systemic Amyloidosis Imaging Tracer (Press)
• Blueprint Medicines Announces Initial Data from Phase 2 PIONEER Trial of Avapritinib in Patients with Indolent Systemic Mastocytosis Showing Activity at All Dose Levels Tested (Press)
• Xencor Presents Initial Data from Phase 1 Study of XmAb®13676 in B-cell Malignancies (Press)
• ArQule Announces Final Phase 1 Clinical Data for Its Reversible BTK Inhibitor, ARQ 531 (Press)
• KalVista Pharmaceuticals Reports Phase 2 Clinical Trial Results in Patients with Diabetic Macular Edema (Press)
• Nouscom - First Patient Dosed in a Phase 1 Trial With NOUS-209, an 'off-the-shelf' Neoantigen Cancer Vaccine, in MSI-High Solid Tumors (Press)
• Alpine Immune Sciences Presents ALPN-101 Phase 1 Healthy Volunteer Study Data and Details of Upcoming Phase I/II BALANCE GVHD Study (Press)
• Rocket Pharmaceuticals Announces Preliminary Data from Phase 1/2 Trial of RP-L201 for Leukocyte Adhesion Deficiency-I (Press)
• Rocket Pharmaceuticals Presents Promising Preliminary Results from Phase 1 Trial of Commercial-Grade RP-L102 “Process B” for Fanconi Anemia (Press)
• Can-Fite Completes 50% Patient Enrollment in its Phase III Psoriasis Trial (Press)
• Achieve Life Sciences Announces Completion of Meeting with the U.S. Food & Drug Administration (FDA) on Cytisinicline Smoking Cessation Phase 3 Clinical Development Program (Press)
• Newron Pharmaceuticals to Request Type A FDA Meeting Prior to Unblinding of STARS Clinical Trial Data (Press)

• MDIC Releases Case for Quality CAPA Process Improvement Whitepaper (MDIC)
• House bill would speed CMS coverage for breakthrough medtech (MedtechDive)
• Impeachment clouds year-end medical device tax repeal, industry priorities (MedtechDive)
• More Real-World Evidence Needed in Device Trials, Experts Say (Medpage)
• GE Healthcare partnering on regenerative tissue manufacturing (MassDevice)
• Aptar’s Nasal Unidose Device Approved by U.S. FDA for First Nasal Rescue Treatment for Frequent Seizure Activity (Press)
• Axonics® Provides Survey Results from Physician Seminar Series Showcasing the Recently FDA Approved Axonics r-SNM® System (Press)
• Abbott issues field safety notice for Heartmate 3 LVAS power unit (MassDevice)
• Schiller issues field safety notice for Tempus LS defibrillators (MassDevice)
• MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear – P180035 (FDA)

• Ban on Surprise Medical Bills May Pass After All (NYTimes)
• The extraordinary drama inside HHS (Politico)
• US Supreme Court rejects Arizona opioid case against Purdue, Sackler family (Reuters) (Law360-$)
• Wrong Court and Wrong-er Reasoning − Ignoring 75 Years of Controlling Precedent (Drug & Device Law)
• Solicitor General Recommends That Supreme Court Deny Certiorari in Hikma Pharmaceuticals v. Vanda Pharmaceuticals (Patent Docs)
• SEC Scores Early Win In Mass. Biotech CEO Fraud Suit (Law360-$)
• Calif. CBD Co. Sued After FDA Warning About Illegal Goods (Law360-$)
• Fed. Circ. Judge Challenges USPTO Role In Biogen Appeal (Law360-$)

• FDA Advisory Committee Calendar
• Hearing On “Securing The U.S. Drug Supply Chain: Oversight Of FDA’s Foreign Inspection Program" – 10 December 2019
• Axios: How to expand America’s access to comprehensive healthcare – 11 December 2019

• Dutch government moves to ban laughing gas (Reuters)
• French regulator to ban some glyphosate products over health risks (Reuters)
• Corrigendum 2 and the (potential) consequences for class I devices (MedicalDevicesLegal)

• India's proposal to cap trade margins to drug distributors not to hurt pharma companies: Fitch Ratings (Pharmabiz)
• USV in talks with Novartis to buy Jalra Trademark for Rs. 200 Crore (Economic Times)

• Consultation: Export of therapeutic goods from Australia (TGA)

• Johnson & Johnson to support Rwanda’s preparations against Ebola outbreak (Pharmafile)
• This Is What It's Like To Be An Ebola Doctor Under Fire In Congo (NPR)

• Flu season off to a fast start, driven by unexpected virus, CDC says (NBC)
• Surgeons Transplant a Testicle From One Brother to His Twin (NYTimes)