Recon: Pfizer to Acquire Array Biopharma for $11.4B

• Pfizer to boost cancer treatment portfolio with $11.4B Array deal (Financial Times) (STAT) (Endpoints) (CNBC) (Press)
• Pfizer CEO gets 61% pay raise—to $27.9 million—as drug prices continue to climb (Ars Technica)
• Gene therapy R&D deals turn red hot as Big Pharma steps up to play (Endpoints)
• Drug Prices Are a Populist Campaign Issue. Here Are the Latest Proposals to Lower Costs. (NYTimes)
• Trump Wants to Neutralize Democrats on Health Care. Republicans Say Let It Go. (NYTimes)
• Sage gets final US clearance for postpartum depression drug Zulresso (PMLive)
• Celgene dips out of deals ahead of mega-merger (BioPharmaDive) (Endpoints)
• US cities propose framework for nationwide opioid settlement talks (Reuters) (NYTimes)
• U.S. records 22 new measles cases, bringing year's total to 1,044 (Reuters)
• Some stem cell experts want out of documentary after funding source revealed (SF Chronicle)
• Oklahoma governor, GOP leaders: drug settlement violates law (AP)
• Merck's Full Court Press On Oncology (Forbes)

• As global markets for generic drugs fail, poor people pay the price (STAT) (Financial Times)
• China Biotechs Lure Industry Talent in the US (WSJ)
• Gene-Therapy Firm UniQure Explores Options Including Sale (Bloomberg) (Endpoints)
• Health Canada to allow some edible cannabis products starting mid-December (Reuters)
• AstraZeneca commits $630M to Korean drug R&D push (Fierce) (Press)
• GSK pharma head flags need for speed in high-pressure drug market (Reuters)
• Bribes and Backdoor Deals Help Foreign Firms Sell to China’s Hospitals (NYTimes)
• Sanofi Genzyme deserts gene therapy developer Voyager Therapeutics (Endpoints)
• Unsafe medicines stolen in Italy 'entered NHS supply chain' (The Guardian)
• Dr. Reddy’s To Sell Two Neurology Drugs To Upsher-Smith Labs (Bloomberg) (Pharmafile)
• EU SPC Waiver: Originators May Need To Act Soon (Pink Sheet-$)
• WHO panel decides not to declare international Ebola emergency (Reuters) (NPR)

• CRISPR lab begs the question: Where is the line between industry and academia? (STAT)
• The top 20 drugs by 2018 US sales (Fierce)
• Microbes make metabolic mischief by targeting drugs (Nature)
• FDA is Committed to Sound, Science-based Policy on CBD (FDA)
• Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate? (RxTrace)
• Women and Clinical Trials (NYTimes)
• AZ' Calquence shows PFS benefit in CLL patients (PharmaTimes)
• Amgen unveils five-year survival data for Blincyto (PharmaTimes)
• Regeneron's bispecific for lymphoma works in CAR-T failures (PMLive)
• As price of insulin soars, Americans caravan to Canada for lifesaving medicine (Washington Post)
• Innovation, at Universities and in Industry (In the Pipeline)
• IVERIC Bio Enters Into Strategic Manufacturing Relationship With Catalent’s Paragon Gene Therapy For Orphan Inherited Retinal Diseases (Press)
• Despite senior management shake-up, Novartis’ pipeline is primed to deliver (BioCentury)
• Middle class: Lonza on the flexibility of midscale biomanufacturing (BioProcess Int’l)
• Sherlock: Leveraging CRISPR, synthetic biology for diagnostics (BioCentury)
• Jazz plans early July launch for sleepiness med Sunosi after DEA scheduling (Fierce)
• Boehringer Ingelheim opens inhaler plant with 200 jobs (Fierce)
• There Will Be Over 22 Million Cancer Survivors In The US By 2030, Says New Report (Forbes)
• Philadelphia champions life sciences 'co-working,' reviving former GSK campus in $500M makeover (Endpoints)
• AstraZeneca spinout Viela Bio pockets $75M on its way to BLA for autoimmune drug (Endpoints)
• Fueled by early success, Enanta paves way for mid-stage RSV study in adult patients later this year (Endpoints)
• A unicorn stalks Wall Street in search of IPO cash; CASI Pharma in-licenses CD19 therapy from China’s Juventas (Endpoints)
• Medicines Company executive jumps ship to Scynexis (Fierce)
• Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Allergenic Products Advisory Committee (FDA)

• Investors fret as VBI's hep B vaccine fails key secondary PhIII study goal (Endpoints) (Reuters) (Press)
• Alnylam Completes Enrollment for ILLUMINATE-A Phase 3 Study of Lumasiran in Patients with Primary Hyperoxaluria Type 1 (PH1) (Press)
• Boehringer Ingelheim and OSE Immunotherapeutics Announce Dosing Of the First Patient in a Phase 1 Trial of SIRPα Antagonist Monoclonal Antibody, BI 765063, in Patients with Advanced Solid Tumors (Press)
• BioNTech and Genmab Initiate First-In-Human Phase I/IIa Trial of Bispecific Antibody DuoBody®-PD-L1x4-1BB in Solid Tumors (Press)
• New Data Presented from Oncopeptides' Pivotal Phase 2 HORIZON Trial Evaluating Melflufen in Relapsed/Refractory Multiple Myeloma at 24th EHA Congress (Press)
• Incyte Announces Positive Results from a Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo (Press)
• RIBOMIC Announces Positive Top-Line Results from the Phase 1/2a Clinical Trial of RBM-007 (SUSHI Study) in Subjects with Wet Age-Related Macular Degeneration (Press)
• ArQule Announces Preliminary Results from Its Phase 1/2 Study of Miransertib (ARQ 092), in Patients with PIK3CA-related Overgrowth Spectrum (PROS) and Proteus syndrome (PS) in an Oral Presentation at the European Society of Human Genetics Conference (Press)
• Sutro Biopharma Announces Encouraging Interim Phase 1 Safety Data on a Potential First-in-Class Antibody-Drug Conjugate STRO-001 for the Treatment of B-cell Malignancies at the European Hematology Association Congress (Press)
• Cellular Biomedicine Group Announces First Patient Dosing in Phase I Clinical Trial of Anti-CD20 CAR-T for Lymphoma in China (Press)
• Xeris Pharmaceuticals Announces Additional Positive Outcomes from a Global Phase 3 Clinical Trial of Its Investigational Ready-to-Use Glucagon (Press)

• FDA adcom to pronounce on paclitaxel-coated devices (Evaluate)
• FDA Grants Breakthrough Device Designation To Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test (Press)
• FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones (Press)

• Eager to Limit Exemptions to Vaccination, States Face Staunch Resistance (NYTimes)
• Drugmakers Sue HHS for Trying to Add Prices to DTC Ads (Focus) (Politico) (Reuters) (NYTimes)
• State Efforts To Rein In Drug Costs Have Mixed Success (Law360-$)
• New Bill Would Reshape Drug Patent Cases In Uncertain Ways (Law360-$)
• No more crickets: The biopharma industry must speak out against the Trump administration’s fetal tissue ban (BioCentury)
• CMS’ coverage determination for CAR-T still delayed after a month, and nobody knows why (MedCity)
• GSK Calls $90M Inhaler IP Damages 'Wildly Inflated' (Law360-$)
• J&J Presses Expert On 'Opioid Mafia' Claim In Okla. Trial (Law360-$)
• Genetic Counseling Medicare Payment Bill Introduced in Congress (GenomeWeb)
• Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices (FDA)
• Inhumane or unavoidable? As Congress scrutinizes an increase in monkey research, scientists defend its necessity (STAT)
• Shut the Door on Punitive Damages “Experts” (Drug & Device Law)

• FDA Advisory Committee Calendar
• Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA) – 2 October 2019

• May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says (Focus)
• EU MDR Q&A: Bos Discusses a Lack of EU-Wide Portfolio Coordination (Focus)
• Joint Procurement Agreement - List of EU countries (EC)
• UK Seeks To Make Clinical Trial Transparency 'Second Nature' For Sponsors (Pink Sheet-$)
• Namal Nawana: Sending shockwaves through Smith & Nephew (Financial Times)

• Generic Share Hits Plateau after Reaching 70%: FPMAJ Pharmacy Survey (PharmaJapan)
• China’s State Council Publishes New Regulations on the Management of Human Genetic Resources (Ropes&Gray)

• Maha FDA starts implementing CDSCO policy not to market changed formulations with old brand name (PharmaBiz)
• India to introduce mandatory barcoding of APIs (EPR)
• Brain disease kills 97 Indian children, 'heat curfew' imposed (Yahoo)

• ICH Adds Four New Regulatory Observers (Focus)