Regulatory Focus™ > News Articles > 2019 > 6 > Recon: AbbVie to Acquire Allergan for $63B

Recon: AbbVie to Acquire Allergan for $63B

Posted 25 June 2019 | By Michael Mezher 

Recon: AbbVie to Acquire Allergan for $63B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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 $228M for NASH drug (Endpoints)
  • China biotech groups spend billions on overseas drug candidates (Financial Times)
  • China urges firms to make generic versions of 34 drugs (Pharmafile)
  • Russia Puts The Squeeze On Essential Drug Prices (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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
  • Asia Regulatory Roundup: TGA Creates Guidance on Device Standards for Quality Management Systems (Focus)
India
  • Maharashtra FDA witnesses surge in new product approvals after initial hiccups following CDSCO mandated stability data (PharmaBiz)
Canada
  • Summary Safety Review - Opdivo (nivolumab) and Yervoy (ipilimumab) used alone, or in combination (Health Canada)
Australia
  • Australia Preps for Medicine Ingredient Name Changes (Focus)
  • Excluded autologous human cells and tissues (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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