Recon: UCB to Buy Ra for $2.1B; Reata to Pay $330M to Reacquire Drug Rights from AbbVie

• Bill Gates backs Ginkgo Bioworks' $350M raise to fuel the buzzy synthetic biology 'revolution' (Endpoints)
• AbbVie uncoupling costs Reata $330M in cold, hard cash (Endpoints) (BioPharmaDive) (Press)
• Big Pharma Bets on Body’s Garbage-Disposal System to Beat Cancer (Bloomberg)
• J&J hands off non-opioid painkiller to an upstart in the race for next-gen analgesics (Endpoints) (Press)
• Gene testing firm gets 25-year ban in $42.6 million kickback settlement (Reuters) (DOJ)
• Massive jury award against J&J highlights risks of its legal strategy (Reuters)
• Flow of US biotech VC dollars on track to match record 2018 levels — China? Not so much (Endpoints)
• Chairman Neal Announces A Hearing On Investing In The US Health System By Lowering Drug Prices, Reducing Out-Of-Pocket Costs, And Improving Medicare Benefits (House Ways & Means)
• Executive Order on Promoting the Rule of Law Through Improved Agency Guidance Documents (White House)

• Belgium's UCB to buy Ra Pharmaceuticals in $2.1 billion cash deal (Reuters) (Endpoints) (BioWorld) (Press)
• Wall Street trims cancer drug developer BioNTech's unicorn valuation (Endpoints)
• Life Sciences and UK's future role: Sir John Bell delivers MHRA annual lecture (GOV.UK)
• International donors pledge $14 billion to tackle AIDS: Macron (Reuters)
• Chinese growth shot’s some years away for pharma companies (Economic Times)
• BeiGene opens phase one of $320M plant with 180 workers (Fierce)
• Elmiron bags draft NICE approval (PharmaTimes)
• Chinese biotech: from copycat to innovator (Financial Times)
• Daiichi starts challenging Astellas for Japanese AML market (PMLive)
• Congo's Ebola outbreak slows but still entrenched in insecure areas: WHO (Reuters)

• With a new guide to tapering opioids, federal health officials seek a balanced approach to prescribing (STAT)
• Alexion bags option on Stealth's phase 3 rare disease drug (Fierce)
•  Leave No Stone Unturned: A Pipeline Story (LifeSciVC)
• After A Life Of Painful Sickle Cell Disease, A Patient Hopes Gene-Editing Can Help (NPR)
• Beyond ICER: Arnold Foundation Wants To Dig Deeper On R&D And Pricing (Pink Sheet-$)
• After Biosimilar Fee Collections Fall Short, US FDA Modifies Carryover Spend-Down Plan (Pink Sheet-$)
• Talking about Toxicity — “What We’ve Got Here Is a Failure to Communicate” (NEJM)
• Parexel embraces real world evidence, enlisting Datavant to drill it into CRO workflow (Endpoints)
• Influenza candidate vaccine viruses improved by amino acid substitution in hemagglutinin (FDA)
• 3D Printing a Human Heart Valve (NIH)
• The great escape: tumour cell plasticity in resistance to targeted therapy (Nature)
• How Express Scripts Plans to Disrupt the Emerging Cell and Gene Therapy Channel (Drug Channels)
• Novartis has its blockbuster Beovu OK, but its 'hot mess' label leaves something to be desired: analysts (Fierce)
• Feeling pressure in hemophilia, Novo signs gene editing deal with Bluebird (BioPharmaDive) (PMLive)
• Viagra May Enhance Stem Cell Treatments For Leukemia (Forbes)
• Neglected on Wall Street, little Stealth Bio finds an affluent chum with $30M in cash and high hopes for their PhIII drug (Endpoints)
• Flemming Ørnskov takes on a new challenge, driving a $10B dermatology spinout with some big plans for growth (Endpoints)

• Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation (Press)
• Dermira to Present Data from Phase 2b Study of Lebrikizumab in Patients with Atopic Dermatitis at Fall Clinical Dermatology Conference (Press)
• Seattle Genetics Announces Initiation of Phase 3 Clinical Trial of Tucatinib in Combination with Ado-trastuzumab Emtansine (T-DM1, Kadcyla®) for Patients with Advanced or Metastatic HER2-Positive Breast Cancer (Press)
• Galderma Advances Phase 3 Clinical Study with Nemolizumab in Moderate-to-Severe Atopic Dermatitis (Press)
• Forbius: Phase 2 Clinical Data with Tumor-Selective Anti-EGFR ADC AVID100 Featured at AACR-NCI-EORTC and World ADC San Diego (Press)
• MGB Biopharma Announces Promising Phase IIa Clinical Trial Update for MGB-BP-3, a Novel, Potent Bactericidal Antibiotic Targeting Clostridium difficile-Associated Diarrhoea (CDAD) (Press)
• EicOsis Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain (Press)

• Device Industry Backs Proposed Changes to Anti-Kickback Statute, Stark Law (Focus)
• FDA Issues Two Final Guidances on Guidewires, Catheters and Delivery Systems (Focus)
• FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials (Focus)
• FDA’s bill of materials creates a cybersecurity blind spot for medical devices (Healthcare IT News)
• MITA Releases National Standard For Medical Device Security (MITA)
• THINK Surgical Receives FDA Clearance to Market Active Robot for Total Knee Replacement Procedures in the United States (Press)
• Mobidiag Gets CE Mark for Intestinal Parasites Test (GenomeWeb)

• Planned Parenthood announces first 2020 endorsements (Politico)
• Precision Medicine Gets A Boost From Congress (Forbes)
• The Biosimilars Forum Applauds Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) for Introducing Legislation Mandating a CMS Star Ratings Program for Biosimilars (Biosimilars Forum)
• Acting FDA chief inspects two international mail facilities for illicit vaping and opioid products (CNBC)
• Chinese Distributor Can't Shake Trade Secrets Suit (Law360-$)
• Grogan Implies HHS Adding Part D Drugs To Int’l Pricing Index Demo (IHP-$)
• HHS Safe Harbor For Value-Based Drug Contracts May Be On Horizon (Pink Sheet-$)
• Following More Than Just Money (Drug & Device Law)
• USPTO Meets Pendency Goals for FY2019 (Patent Docs)

• FDA Advisory Committee Calendar

• 5 Ways A Hard Brexit Will Sicken Britain’s Healthcare (Forbes)
• UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline (Focus)
• EU Regulatory Roundup: Ireland’s HPRA Floats Fee Increases as Brexit Creates Challenges (Focus)
• EC Unveils First Notified Body Designation Under IVDR (Focus)
• No-deal Brexit likely to increase cost of new medicines, Scottish government says (Pharmaceutical Journal)
• Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use (MDA/2019/036) (MHRA)
• Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037) (MHRA)

• China Joins IMDRF’s Safety Information Exchange Program (Focus)

• India’s Health Ministry seeking to speed approvals of vaccines (PharmaLetter-$)
• Patients' group opposes stent categorization (Economic Times)

• Summary Safety Review - Avalon Fetal Monitor FM20, Avalon Fetal Monitor FM30, Avalon Fetal Monitor FM40 and Avalon Fetal Monitor FM50 manufactured by Philips Medizin Systeme Boeblingen GmbH - Health Canada (Health Canada)

• Stroke rates continue decline in the US (Reuters)
• Change in memory test scoring could help catch Alzheimer's earlier in women (NBC)