Regulatory Focus™ > News Articles > 2019 > 1 > Recon: PhRMA Spent Record $27.5M on Lobbying in 2018; FDA Clears 23andMe Colorectal Cancer Risk Test

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

Posted 23 January 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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-$)
  • EMA cites Slovakian sterile drugmaker and says its meds should be recalled (Fierce)
  • Amgen's Blincyto secures expanded indication in Europe for acute lymphoblastic leukaemia (Pharmafile)
  • GSK completes Tesaro deal (PharmaTimes)
Pharmaceuticals & Biotechnology
  • Leadership At All Levels In Biotech (LifeSciVC)
  • Gene therapies in ophthalmic disease (Nature)
  • An Open Letter in Support of FDA’s Clinical Study Report Pilot Project (The BMJ)
  • Report sees strong year ahead for life sciences IPOs despite headwinds (MedCity)
  • A flashy 2019 start to pharma M&A, but will it last? (BioPharmaDive)
  • With human drugs, a Silicon Valley startup hopes to deliver precision medicine to dogs (STAT)
  • Including prices on TV ads only works when the price is listed alone (Pharmafile)
  • Ex-Pfizer I-O lead joins Sangamo as EVP of R&D (Fierce)
  • Look out for a Q4 surprise from BMS' Opdivo, but Merck's Keytruda will stay on top: analyst (Fierce)
  • Cancer Drug Combination Pricing: Genentech Offers Model For Tecentriq, Avastin (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Biohaven Receives FDA May Proceed Letter For Phase 3 Clinical Trial Of BHV-3241 For Multiple System Atrophy (Press)
Medical Devices
  • 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)
US: Assorted & Government
  • 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-$)
  • Valeant Copycat Drug Row Can Stay In Calif., Judge Rules (Law360-$)
Upcoming Meetings & Events Europe
  • Open access drug development tools feature in new IMI Call for proposals (Pharmanews.eu)
Asia
  • 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-$)
  • Nippon Shinyaku and J&J to co-promote Erleada in Japan (PharmaLetter-$)
India
  • 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)
Australia
  • EpiPen 300 mcg adrenaline auto-injector (TGA)
General Health & Other Interesting Articles
  • 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)
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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