Recon: Amicus Buys Celenex Gene Therapy Portfolio for $100M; EU Approves 5th Humira Biosimilar

• Amicus Therapeutics acquires portfolio of gene therapies targeting neurologic disorders (STAT) (Endpoints) (Forbes) (Xconomy)
• In the battle for life sciences companies, one state shows up behind enemy lines (STAT)
• Life sciences industry rallies behind Calif. bill to prevent a nightmare scenario for clinical research (STAT)
• Shares in Molecular Templates surge after the announcement of Takeda collaboration (Pharmafile) (Endpoints)
• GOP strategy on pre-existing conditions: 'Duck and cover' (Politico)
• Medtech pioneer Rowe, Deerfield launch $275m medical device incubator (MassDevice)
• Senate bill would save money and allow generics to reach market more quickly, according to CBO report (Pharmafile)
• J&J files ‘breakthrough’ bladder cancer drug in US (PMLive)
• French Medical Device Maker Sued Over Clot Filter Failure (Law360-$)
• Will CVS Caremark Make ICER The American NICE? (Forbes)

• EU approves fifth copy of AbbVie's $18 billion drug Humira (Reuters)
• With new $10.6B fund, Hillhouse Capital sets the stage for splashy Asia-focused biotech deals (Endpoints)
• WHO launches first investment case to save up to 30 million lives (WHO) (Statement)
• Portugal to also benefit from EU-US mutual recognition agreement for inspections (EMA)
• CRUK forges £30m ‘post-Brexit’ R&D alliance (PMLive) (Fierce)
• Merck follows Opdivo’s suit, prices Keytruda in China at half its U.S. tag: report (Fierce)
• UK court invalidates Gilead's Truvada patent extension, allowing PrEP generics (Fierce)
• Novartis Diabetes Triple Drug Combination Deemed 'Irrational' In India (Pink Sheet-$)
• China Looks To Hone Essential Drug System (BioCentury)
• Zimbabwe seeks $35 million to fight cholera outbreak (Reuters)
• CCI probe finds unfair practices by three drug companies (Economic Times)
• Post-Johnson & Johnson, Indian government plans law to put onus on medical companies (Economic Times)
• Government to soon bring Indian standardisation for medical devices: senior official (Economic Times)
• Newly prequalified Active Pharmaceutical Ingredients (APIs) (WHO)

• Ron DePinho raises seed cash for MD Anderson colleague’s work on a ‘Holy Grail molecule’ in cancer, inflammation (STAT)
• Thermo Fisher licenses CRISPR tech from Broad Institute (BioPharmaDive)
• Setback for Pharming’s bid to expand use of Ruconest (PharmaTimes)
• Clearing out old cells might help the brain (MIT Technology Review)
• FDA Wants Extra Trial For Pharming's Ruconest As HAE Prophylactic (BioCentury)
• Being PrEPared — Preexposure Prophylaxis and HIV Disparities (NEJM)
• Galera Raises $150m To Take Lead Drug From Phase III To NDA Submission (SCRIP-$)
• FDA Warning Wire: Beer Brewing At Lab, Mice At Egg Giant (Law360-$)
• Strides Acknowledges Receipt of FDA 483 With Three Citations (Strides)
• Eli Lilly's Animal Health Unit Elanco Raises $1.5B In IPO (Law360-$)
• Journalist Blocked From Covering Major Cardiology Meeting (Forbes)
• Patient Experience Data: US FDA’s Evidentiary Standards Should Reflect Intended Use (Pink Sheet-$)
• Contract Manufacturers Cautioned On Allure of Novel Cell and Gene Therapies (Pink Sheet-$)
• CDER Exclusivity Board: Can 3-Year Exclusivity Applied to a Prodrug Block 505(b)(2) NDA Approval for the Active Metabolite? (FDA Law Blog)
• Mayo team spotlights the role of senescent cells in neurodegeneration, starting down a pathway that may lead to Alzheimer’s (Endpoints)
• Polverino swaps interim CSO role at Kite for permanent gig at Zymeworks (Fierce)
• Drumbeat of bad news continues at OncoMed as Celgene dumps option on one of its last pipeline efforts (Endpoints)
• NIH launches study to test combination antibody treatment for HIV infection (NIH)
• Children’s Hospital Los Angeles-Led Consortium Awarded $6.6 Million Grant by the FDA to Advance Pediatric Innovation (Press)

• Pfizer Granted FDA Breakthrough Therapy Designation for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older (Press)
• Astellas’ kidney disease drug shows promise in PhIII (PharmaTimes)
• Trial takes FibroGen’s renal anemia drug closer to EU filing (Fierce)
• TherapeuticsMD Announces the FDA has Granted AnnoveraTM Marketing Exclusivity as a New Chemical Entity (Press)
• Cardurion Pharmaceuticals Announces Initiation of Phase 1 Study of CRD-733, a PDE-9 Inhibitor in Development for the Treatment of Heart Failure (Press)
• Exicure Announces Positive Phase 1 Results for its Lead Immuno-Oncology Asset (Press)

• Korea’s Hironic wins FDA nod for AFit laser acne device (MassDevice)
• Heidelberg Engineering wins FDA nod for upgraded eye imaging technology (Medical Design & Outsourcing)
• Cepheid Fingerstick HCV Test Receives CE-IVD Clearance (GenomeWeb)

• Anatomy of a Mass Tort 2.0 (Drug & Device Law)
• Pfizer Unit, Teva Must Face Effexor Antitrust Litigation (Law360-$)
• SEC Accuses Breast Implant Maker's Ex-CEO Of Stock Fraud (Law360-$)
• Allergan Loses 'Meritless' Bid To Gut Restasis Antitrust MDL (Law360-$)
• No Need To Reconsider Immunity At PTAB, Fed. Circ. Hears (Law360-$)
• Novartis Warping Kickback Standard In FCA Case, DOJ Says (Law360-$)

• FDA Advisory Committee Calendar

• Voluntary recall of USA-manufactured homeopathic products: check for affected products (MHRA)
• Paris steps up efforts in precision medicine research (PharmaLetter-$)
• Latvian drugmakers welcome healthcare reforms (PharmaLetter-$)

• Rare disease patients in financial peril despite Rs. 100 crore corpus fund; confusion prevails over aid to APL category (PharmaBiz)

• Australian Competition and Consumer Commission clears Arrow and Apotex merger: Strides (Economic Times)