Recon: AbbVie to Acquire Allergan for $63B

• Botox Maker Allergan Is Sold to AbbVie in $63 Billion Deal (NYTimes) (WSJ) (Bloomberg) (STAT) (Endpoints) (CBS)
• Patent office reopens major CRISPR battle between Broad Institute and Univ. of California (STAT)
• Consumer genetic testing companies team up to lobby on privacy policy (STAT)
• Novartis wins Gilenya reprieve as judge blocks generics, for now (Reuters) (BioPharmaDive)
• Conatus Pharma to explore options as liver disease drug fails trial (Reuters) (Endpoints) (Fierce)
• Akorn gets another FDA warning letter, shares slide (Reuters)
• FDA declines to approve Acer Therapeutics' rare genetic disorder treatment (Reuters) (Endpoints) (Fierce)
• Senate healthcare bill includes Creates Act, raises legal tobacco age (Modern Healthcare)
• FBI Probes Whether Lab Startup uBiome Used Improper Billing Codes, Sought Unnecessary Tests (WSJ)
• Purdue’s Sackler Family Must Face Opioid Suits in New York (Bloomberg) (Law360-$)
• Why a cure for dementia would trigger a crisis (Financial Times)
• Researchers look to close the dementia gender gap (Financial Times)
• Oklahoma judge approves Teva's $85 million opioid settlement (Reuters)

• Drug Companies Are Focusing on the Poor After Decades of Ignoring Them (NYTimes)
• Teleflex recalls breathing tubes worldwide after reports of 4 deaths (Reuters)
• Tasly Biopharma pitches long-awaited IPO — will it trigger another $1B gold rush on HKEX? (Endpoints)
• Eyeing a $500M peak sales pot, Almirall doubles down on lebrikizumab as Dermira lines up PhIII (Endpoints)
• Genfit goes to China with a deal worth up to $228M for NASH drug (Endpoints)
• China biotech groups spend billions on overseas drug candidates (Financial Times)
• China urges firms to make generic versions of 34 drugs (Pharmafile)
• Russia Puts The Squeeze On Essential Drug Prices (Pink Sheet-$)

• The maddening saga of how an Alzheimer’s ‘cabal’ thwarted progress toward a cure for decades (STAT)
• Commonly prescribed drugs are tied to nearly 50% higher dementia risk in older adults, study says (CNN) (JAMA)
• Virtual reality is helping scientists discover new drugs (CNN)
• Researching While Chinese (In the Pipeline)
• PatientsLikeMe, forced by U.S. to ditch Chinese investor, sold to UnitedHealth Group (STAT) (CNBC)
• After FDA approval, drug makers often commit to follow-up studies. Few are new, a review finds (STAT)
• FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition (Focus)
• Drugmakers Call for Changes to FDA Bioavailability Guidance (Focus)
• Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database (Psycotherapy and Psycosomatics)
• Crowdfunding for stem cell-based interventions to treat neurologic diseases and injuries (Neuroloy)
• US FDA Begins Building Pharma Industry Activity Prediction Tool (Pink Sheet-$)
• With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 faring? (Endpoints)
• Walgreens to provide drug disposal packets free to customers (Washington Post)
• US FDA First-Cycle ANDA Approvals Not Rising Along With Full Clearances (Pink Sheet-$)
• SQZ, Erytech kick off $57M cell therapy partnership; Jean-Paul Kress lands new CEO gig at MorphoSys (Endpoints)
• After being snapped up by Alexion, Syntimmune's CEO joins MorphoSys (Fierce)
• Novartis sells Colorado site to maker of CBD products (Fierce)
• Verona hires ex-GSK researchers for late-phase push in COPD (Fierce)
• A CVS Lawsuit Uncovers Three Surprising Revelations about Amazon’s PillPack Strategy (Drug Channels)

• Aldeyra's eye drug fails pivotal test in patients with rare, inflammatory disease (Endpoints)
• GSK/Tesaro PARP inhibitor Zejula wins another speedy review (Endpoints) (Fierce)
• Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline® Depot (lanreotide) (Press)
• BioPharmX Announces Positive Topline Results from Phase 2b Trial of BPX-04 for Papulopustular Rosacea (Press)
• Poxel and Sumitomo Dainippon Pharma Announce Second Positive Top-Line Results for Imeglimin Phase 3 Trial (TIMES 3) in Japan for the Treatment of Type 2 Diabetes (Press)
• I-Mab Announces Dosing of First Patient in a Phase I Clinical Trial of TJC4, a Potentially Differentiated CD47 Antibody, for the Treatment of Cancers in the United States (Press)
• Imbrium Therapeutics Advances Insomnia Pipeline Through Initiation of a Phase 2 Study of Potential First-in-Class Molecule for Insomnia Associated with Alcohol Cessation (Press)
• Rodin Therapeutics Announces Positive Phase 1 Results Supporting Continued Development of RDN-929 for Treatment of Neurologic Diseases (Press)
• TILT Biotherapeutics Initiates Collaboration With Merck KGaA, Darmstadt, Germany and Pfizer Investigating the Combination of Oncolytic Virus, TILT-123, And Anti-PDL1 Antibody, Avelumab (Press)
• Tricida Announces Publication of Positive Long-Term Phase 3 Clinical Trial Results of Veverimer (TRC101) in The Lancet (Press)

• FDA Updates MDR Program in an Effort to Increase Transparency (FDA Law Blog)
• IVDs Top the List of Devices Seeing Field Safety Corrective Actions, Report Shows (Focus)
• Playing with tech to create drug-free ADHD treatment (Financial Times)
• FDA OKs trial for Micro Medical’s below-the-knee stent (MassDevice)
• Zoll warns on AED Pro defibrillator issue (MassDevice)
• Transplant Biomedicals touts kidney transport device study results (MassDevice)

• Trump signs order that aims to reveal real health care costs (AP)
• Connecticut AG Releases Unredacted Generic Drug Price Fixing Complaint (Focus) (Law360-$)
• Theory and Practice: How Appropriations Will Actually Work for FY 20 (Alliance for a Stronger FDA)
• Hospitals, insurers resist Trump's executive order (Politico)
• How judges added to the grim toll of opioids (NBC)
• The FDA’s Challenge on E-Cigs (WSJ)
• Amgen petitions for rehearing en banc following Federal Circuit decision (Big Molecule Watch)
• New Colorado Law Requires Manufacturer Sales Reps to Provide Prescribers with Pricing and Generic Information (PolicyMed)
• FDA issues warning letters to companies selling drugs containing kratom (Reuters) (FDA)
• High Court Roundup: Justices Won't Hear 3 Patent Cases (Law360-$)
• Fed. Circ. Lets Merck Add Parent Co. Without Resetting IPR (Law360-$)
• Valeant Kickback Case Puts Skilling To Test In 2nd Circ. (Law360-$)
• It’s a big week for debates about drug prices, whether pharma likes it or not (STAT)
• Pelvic Mesh MDL Slashes Plaintiffs’ Expert’s Fees (Drug & Device Law)

• FDA Advisory Committee Calendar
• FDA Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs – 12 July 2019

• EMA validates Santhera’s Puldysa MAA (PharmaTimes)
• Investment Plan for Europe: EIB finances Almirall's research into new skin disease treatments (EC)
• Life Science Competitiveness Indicators (UK Office of Life Sciences)
• New templates for manuscripts of Information for healthcare professionals and Patient information (Swissmedic)
• Advertising investigations: May 2019 (MHRA)

• Asia Regulatory Roundup: TGA Creates Guidance on Device Standards for Quality Management Systems (Focus)

• Maharashtra FDA witnesses surge in new product approvals after initial hiccups following CDSCO mandated stability data (PharmaBiz)

• Summary Safety Review - Opdivo (nivolumab) and Yervoy (ipilimumab) used alone, or in combination (Health Canada)

• Australia Preps for Medicine Ingredient Name Changes (Focus)
• Excluded autologous human cells and tissues (TGA)