Recon: Apellis’ PNH Drug Tops Soliris in Phase 3 Study; Teva to Pay $54M to Settle Copaxone Bribery Suit

• Apellis' blood disorder drug outdoes Alexion's Soliris in improving hemoglobin levels (Reuters) (STAT) (Endpoints)
• Teva To Pay $54M To End FCA Suit Alleging Bribes To Doctors (Law360-$) (Fierce) (Globes)
• Allergan To Pay $300M To End Birth Control Antitrust Case (Law360-$)
• Merck's Keytruda shows mixed results in phase 3 trial for small cell lung cancer (Reuters) (Endpoints) (Press)
• Shroom-Therapy Startup Edges Toward FDA Approval (Bloomberg)
• Crispr puts first human in-body gene editing to test (Financial Times)
• Grassley turns to House Speaker Pelosi for help selling his bipartisan drug pricing bill (CNBC)
• Public Meeting: Modernizing the Food and Drug Administration's Data Strategy (FDA)
• Artificial intelligence has come to medicine. Are patients being put at risk? (Los Angeles Times)

• Merck, Otsuka Make R&D Pact for Buzzed-About Cancer Target (Bloomberg) (BioPharmaDive)
• AstraZeneca gets in on RNA game with MiNA research collaboration (Endpoints) (Fierce)
• EU, US biotechs merge to create fibrosis, cancer player (PMLive)
• Biocon bags PE funding to prep biologics spinoff—but did it give away too much? (Fierce)
• Bristol-Myers unloads old-school plant as it readies for CAR-T future (Fierce)
• Transparency Advocates Urge Upholding EMA’s Access To Documents Policy (Pink Sheet-$)
• ‘Against all odds’: The inside story of how scientists across three continents produced an Ebola vaccine (STAT)

• FDA’s Deadline Problem? (WSJ)
• Few doctors can legally prescribe opioid-addiction drug (Reuters)
• Value of 2019 FDA approvals: back to the recent average (Nature)
• Prescription Drug Policy: The Year in Review, And the Year Ahead (Health Affairs)
• GSK's plan to take over the HIV drug market hasn't worked out (BioPharmaDive)
• Rulemaking History for OTC Topical Antimicrobial Drug Products (FDA)
• ICER Posts Draft Scoping Document for the Assessment of Treatments for Beta Thalassemia (ICER)
• Katherine Michelle Raab Joins AAM as Vice President, Federal Government Affairs (AAM)
• Should AbbVie break up Allergan? If it wants to make up for Humira, then yes, analyst says (Fierce)
• Anika Therapeutics acquires two companies for their joint-replacement products (STAT)
• Takeda to Fund AI Projects at MIT as Part of New 3-Year Collaboration (Xconomy)
• Antibiotics need a special place in the drug pricing debate (STAT)
• Deal Watch: End-of-Year Biosimilar Agreements (Big Molecule Watch)
• The advantages of a ‘Quality by Design’ approach in pharma drug development (PharmaManufacturing)
• BioIntervene Raises $30M to Move Nerve Pain Drug Into the Clinic (Xconomy)
• New multiple sclerosis treatment trial compares stem cell transplantation to best available drugs (NIH)
• Deep Genomics nabs $40M round, doubles down on AI and Wilson disease work (Fierce)
• Galecto to merge with onetime Celgene partner PharmAkea (Fierce) (Xconomy)
• Vascepa sparkle set to light up Amarin's fourth quarter revenue (Endpoints)
• A Bay Area biotech spells out the stock package it used to woo a new CEO from Big Pharma (Endpoints)
• As Rhythm Pharmaceuticals preps for first approval, CEO hits the exit (Fierce)
• Fresh from $94.5M crossover round, Frazier-groomed dermatology biotech shoots for $100M IPO (Endpoints)
• Fresh from a Pfizer buyout, Luca Santarelli’s crew has created a new company — banking new funds and steering their lead drug to a pivotal (Endpoints)
• Thomas Lynch finds a new home as leader of the Fred Hutch — and he’s staying focused on cancer breakthroughs (Endpoints)
• MPM backs new biotech in the hunt for non-opioid painkiller (Endpoints)
• As investors soured on his bets, records show Woodford paid himself handsome dividends (Endpoints)
• Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Extension of Comment Period (FDA)
• Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Extension of Comment Period (FDA)

• Merck’s Bavencio hits targets in bladder cancer interim analysis (PharmaTimes)
• AtriCure Announces Successful Completion of Patient Enrollment of aMAZE Clinical Trial and FDA Approval of Continued Access Protocol (Press)
• Lyra Therapeutics Announces FDA Clearance of Investigational New Drug Application for a Phase 2 Clinical Trial of LYR-210 for Chronic Rhinosinusitis (Press)
• Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of Its Developmental Ready-To-Use (RTU) Glucagon in Patients at Risk of Hypoglycemia During and after Aerobic Exercise (Press)
• Transgene and NEC Start Two Clinical Trials with TG4050, an AI-Powered Cancer Vaccine for Ovarian and Head & Neck Cancers (Press)
• Exelixis Further Expands Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid Tumors (Press)
• Guided Therapeutics Raises Funds Aimed at Increasing International Sales and Restarting US FDA Approval Process (Press)
• OrphoMed Initiates US Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D (Press)
• Data from the Phase II Liver Cancer Study with Namodenoson will be presented at the ISCORT Conference by Dr. Stemmer (Press)
• Revolution Medicines to Present Preliminary Data from Phase 1 Clinical Trial of RMC-4630 at 6th AACR-IASLC International Joint Conference (Press)

• Hospitals Are Encouraged To Do More To Avoid Medical Device Hacking (NPR)
• Latest FDA clinical decision support software draft a step forward, industry says (MedtechDive)
• Medtronic warns of Mazor X detachment issue in robotic surgery (MedtechDive)
• The devices, software and other health tech headlines of CES 2020 (mobihealthnews)
• Teleflex’s UroLift wins new FDA designation (MassDevice)
• Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola Virus (FDA)

• Will Supreme Court expedite Obamacare lawsuit? (Politico)
• Conservative group with pharma ties makes clear there are drug pricing reforms they can support (STAT)
• The VA approach to buying drugs means patients are less likely to skip medications due to cost (STAT)
• More than a third of U.S. healthcare costs go to bureaucracy (Reuters)
• Pfizer Unit's Alleged Drug Supply Cuts Aren't Anticompetitive (Law360-$)
• Insys Execs Say Restitution Should Be $18.4M, Not $306M (Law360-$)
• Florida becomes the latest state to examine Sun Pharma licenses for distributing samples (STAT)
• US Senators Introduce Law to Enable WGS Testing on Children With Rare Diseases (GenomeWeb) (Collins)
• Washington took a decade to approve an obscure drug-pricing bill. That’s a bad omen for more ambitious reforms (STAT)
• Just before the Compliance Date, FDA Issues Final Guidance on Serving Size-Related and Miscellaneous Issues Regarding the “New” Nutrition Labeling Regulations (FDA Law Blog)
• Mensing Applies to Cross-Claims Too (Drug & Device Law)

• FDA Advisory Committee Calendar
• Public Meeting: Modernizing the Food and Drug Administration's Data Strategy – 27 March 2020

• Pharmeuropa 32.1 just released (Council of Europe)
• Performance-based managed entry agreements for new medicines in OECD countries and EU member states: How they work and possible improvements going forward (OECD)
• Move to hide medical evidence threatens patients and public health across Europe (TransariMed)

• Top cancer drugs may come under price control (Economic Times
• FDA approves Glenmark's generic version of Novartis' Exjade tablets for chronic iron overload (Pharmafile)

• Temporary permission granted to advertise puffers and other inhalers with salbutamol (TGA)
• TGA Laboratories testing report: Measles vaccines monitoring (TGA)

• Statement of the Twenty-Third IHR Emergency Committee Regarding the International Spread of Poliovirus (WHO)

• Most older men don't need testosterone replacement, new guidelines say (Reuters)