Recon: PhRMA Spent Record $27.5M on Lobbying in 2018; FDA Clears 23andMe Colorectal Cancer Risk Test

• PhRMA spends record high $27.5 million on lobbying in 2018 (The Hill) (STAT) (Bloomberg)
• Grassley to hold drug pricing hearing (The Hill) (Senate Finance)
• 23andMe Gets FDA OK for Genetic Risk Report on Hereditary Colorectal Cancer Syndrome (GenomeWeb) (Bloomberg) (Press)
• Once a last resort, this pain therapy is getting a new life amid the opioid crisis (STAT)
• Shutdown risks delaying FDA approval of potentially lifesaving drugs and therapies (CNBC) (Politico) (Endpoints) (Fierce) (Letter)
• Biosimilars and interchangeability: The FDA’s science-based standards will ensure safety (STAT)
• J&J, U.S. states settle hip implant claims for $120 million (Reuters)
• Walgreens pays $269.2 million to settle US civil fraud lawsuits (Reuters)
• Platform Trials Could Be A Solution To Expanded Access, Woodcock Says (Pink Sheet-$)
• The Importance Of Patient-Centric Opioid Prescribing Guidelines (Forbes)
• Consumer Orgs Say NAFTA 2.0 Will Keep Drug Prices High (Law360-$)
• UniQure cleared to start Huntington gene therapy trial (PMLive)

• CR UK streams £60m into tackling global cancer (PharmaTimes) (Endpoints) (CRUK)
• Sun to overhaul business practices to allay concerns (Economic Times)
• Roche says 'no thanks' to megadeals, but don't count out smaller M&A (Fierce) (CNBC)
• Bill Gates: My 'best investment' turned $10 billion into $200 billion worth of economic benefit (CNBC)
• Takeda said to consider $3 billion product sale in emerging markets (PharmaLetter-$)
• 'Rule Out No-Deal Brexit,' BIA Tells Government (Pink Sheet-$)
• EMA cites Slovakian sterile drugmaker and says its meds should be recalled (Fierce)
• Amgen's Blincyto secures expanded indication in Europe for acute lymphoblastic leukaemia (Pharmafile)
• GSK completes Tesaro deal (PharmaTimes)

• Leadership At All Levels In Biotech (LifeSciVC)
• Gene therapies in ophthalmic disease (Nature)
• An Open Letter in Support of FDA’s Clinical Study Report Pilot Project (The BMJ)
• Report sees strong year ahead for life sciences IPOs despite headwinds (MedCity)
• A flashy 2019 start to pharma M&A, but will it last? (BioPharmaDive)
• With human drugs, a Silicon Valley startup hopes to deliver precision medicine to dogs (STAT)
• Including prices on TV ads only works when the price is listed alone (Pharmafile)
• Ex-Pfizer I-O lead joins Sangamo as EVP of R&D (Fierce)
• Look out for a Q4 surprise from BMS' Opdivo, but Merck's Keytruda will stay on top: analyst (Fierce)
• Cancer Drug Combination Pricing: Genentech Offers Model For Tecentriq, Avastin (Pink Sheet-$)
• Silicon Valley startup launches first drug development program with novel nonprofit partnership (MedCity)
• US Biosimilars: FDA Seeks To Build On Record Number Of Approvals, But Shutdown May Blunt Progress (Pink Sheet-$)
• Rotavirus vaccination tied to lower rates of type 1 diabetes (Reuters)
• Aspirin lowers heart attack risk but raises risk of dangerous bleeding (Reuters)
• Buprenorphine May Best Morphine for Treating NAS (Medpage)
• Equity, not equality, will advance cancer care (The Hill)
• BioNTech doubles down on an antibody discovery group, scooping up a new team to play for the mRNA specialist (Endpoints)
• KKR backs monster $300M raise to build up a new-model biotech — designed by Neil Kumar and MIT’s Andrew Lo (Endpoints)
• Health start-up uBiome cuts more than 50 jobs (CNBC) (Endpoints)
• Turning the table on CD47, Penn team primes macrophages to ignore ‘don’t eat me’ signal (Endpoints)
• UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP (FDA)

• Biohaven Receives FDA May Proceed Letter For Phase 3 Clinical Trial Of BHV-3241 For Multiple System Atrophy (Press)

• Abbott misses Wall Street expectations on Q4 sales (MassDevice)
• CE Mark suspended for Endologix Nellix stent graft (MassDevice)
• Iradimed pulls MRI-safe patient monitor after running afoul of new EU regulations (MassDevice)
• Blood test shows promise for early detection of severe lung-transplant rejection (NIH)
• One School Shocks Students With Disabilities. The FDA Is Moving To Ban The Practice (NPR)
  LunaDNA Health Data Platform to Merge with Genetic Alliance Database (Xconomy)
• Abbott touts effective pain management, lower energy use in BurstDR SCS study results (MassDevice)
• Smith & Nephew closes Ceterix buyout (MassDevice)
• Rebound Therapeutics Announces FDA Clearance of the Aurora Surgiscope System for Minimally Invasive Neurosurgery (Press)

• Rate of Americans without insurance rises to 4-year high as Trump weakens Obama health law, Gallup survey finds (CNBC)
• Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019 (FDA Law Blog)
• Minnesota Requires General Acceptance of Expert’s Opinion, not Merely the Methodology Underlying It (Drug & Device Law)
• New Part D Enrollment Data: CVS Extends Its Lead in 2019 Preferred Pharmacy Networks (Drug Channels)
• Keep the Six Protected Classes, protected (PhRMA)
• California governor appoints first-ever surgeon general (NBC)
• Hologic Settles Fujifilm's IP, Antitrust Mammography Suit (Law360-$)
• Valeant Urges Fed. Circ. To Revive Antifungal Patent (Law360-$)
• Valeant Copycat Drug Row Can Stay In Calif., Judge Rules (Law360-$)

• FDA Advisory Committee Calendar

• Open access drug development tools feature in new IMI Call for proposals (Pharmanews.eu)

• The BMJ special supplement: Innovation for Neglected Diseases in South Asia (DNDi)
• Hanmi To Step Up Global Drug Development As Lilly Returns BTK Rights (Scrip-$)
• Nippon Shinyaku and J&J to co-promote Erleada in Japan (PharmaLetter-$)

• 50 Cancer, Rare Disease Drugs to Get Cheaper (Times of India)
• CDSCO to meet stakeholders to streamline SAE reporting mechanism & procedures to expedite payment of compensation (PharmaBiz)

• EpiPen 300 mcg adrenaline auto-injector (TGA)

• Measles outbreaks make 2018 a near-record year for US (NBC)
• Cases of polio-like acute flaccid myelitis hit 201 in 2018, CDC says (NBC)
• Dengue immunity may be protective against symptomatic Zika, study finds (NIH)