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Recon: Lawmakers ask FTC for PBM merger review

Posted 30 July 2018 | By Ana Mulero 

Recon: Lawmakers ask FTC for PBM merger review

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • Sienna Biopharma sinks after acne treatment fails two trials (Reuters) (Endpoints)
  • Our bipartisan bill will force drug companies to justify 'drastic' price hikes (CNBC)
  • Johnson & Johnson Adds Zarbee’s Naturals to Consumer Brands (WSJ)
  • CNN Exclusive: Bayer paid doctors millions for questionable birth control device (CNN)
  • Lawmakers ask FTC for retrospective review of PBM mergers (Fierce) (Law360-$) (Bloomberg-$)
  • RedHill sees positive results for anti-MAP Crohn's drug (PharmaTimes) (Fierce) (Reuters)
  • Gottlieb teases guidance on continuous trials, touts surrogate endpoints (BioPharma Dive) (Endpoints)
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In Focus: International
  • Indivior rival granted emergency appeal in opioid treatment patent case (Financial Times) (The
  • Telegraph UK) (Reuters)
  • Takeda signs antibody therapy deal with HiFiBiO (PharmaTimes) (Fierce)
  • Faulty Vaccine Scandal Fuels Rare Public Outburst in China (NYT)
  • China Human Vaccine Scare Wipes $483 Million From Pig Drug Stock (Bloomberg)
  • China tells medical institutions to stop using Huahai heart drug (Reuters)
  • EU Court Tries, But Fails, To Clarify Rules On GMOs And CRISPR (Forbes)
  • UN global declaration on TB faces last-minute objections over access to medicines (STAT-$)
  • Other countries are getting a 'free ride' on prescription drug prices, says former pharma exec (CNBC)
Pharmaceuticals & Biotechnology
  • Meet the Rebate, the New Villain of High Drug Prices (NYT)
  • Amgen Loses Ruling Over Teva, Amneal’s Versions of Sensipar (Bloomberg-$)
  • Senators Push Bipartisan Effort to List Drug Prices in Ads (Bloomberg-$)
  • California Court of Appeal Rejects Challenge to Vaccine Law (Bill of Health)
  • Big Pharma Would Like Your DNA (The Atlantic)
  • Ex-Insys Execs Say Feds' Bid To Redo RICO Case Is Futile (Law360-$)
  • Gilead Sciences’ board is looking for a new CEO. Here’s a list of possible contenders (STAT-$)
  • At PillPack, a lot of credit goes to the father of invention (The Boston Globe)
  • Ex-Biogen manager claims she was fired after filing integrity complaint (Fierce)
  • Lilly firms up cancer collaboration with Dana-Farber (Fierce)
  • Freshly funded IFM Therapeutics defines emerging target for fighting inflammatory disease (Fierce)
  • Big Pharma analyst Tim Anderson drops off the radar at Bernstein, headed to a new research home (Endpoints)
  • Would AbbVie’s top execs really pull the trigger on a $30B M&A deal? Why, yes, actually (Endpoints)
  • Twenty States Passed 37 Bills to Curb Rising Rx Drug Costs in the Short 2018 Legislative Session (NASHP)
  • Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns (FDA)
  • Immunomedics Announces Multiple Clinical and Preclinical Collaborations With Prominent Cancer Research Institutions (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Constrained peptides’ time to shine? (Nature)
  • FDA declines to approve Insys Therapeutic's opioid painkiller (Reuters)
  • Shingrix vaccine makes shingles less severe, disruptive to quality of life (Reuters)
  • Why the Latest Alzheimer’s Drug Study Has So Many People Confused (Fortune)
  • Alzheimer’s study sparks a new round of debate over the amyloid hypothesis (STAT)
  • Richard Lehman’s journal reviews—30 July 2018 (The BMJ Opinion)
  • As it fights looming competition on Suboxone, Indivior gets FDA OK on new schizophrenia drug (Endpoints) (Press)
  • US FDA's Regulatory Flexibility To Be Tested As Delcath Overhauls Melphalan Trial Design (Scrip-$)
  • Advaxis Announces FDA Allowance of IND Application for ADXS-HOT Drug Candidate for Non-Small Cell Lung Cancer (Press)
  • Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA (Press)
Medical Devices
  • Votes against medical device taxes show irresponsibility has a broad constituency (The Washington Post)
  • Bayer hits back at new Netflix medical device documentary (Reuters)
  • "We are Guinea pigs": Filmmakers on the risks of medical devices (CBS News)
  • What the Netflix Documentary ‘Bleeding Edge’ Gets Right About the Dangers of Medical Devices in America (TIME)
  • New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices (Forbes)
  • Health Tech Co. Escapes 2 Derivative Suits Post-Settlement (Law360-$)
  • Hologic wins $5m from Minerva Surgical in patent infringement spat (MassDevice)
  • J&J seeks retraction of paper critical of Pinnacle hip study (MassDevice)
  • Abbott's FreeStyle Libre 14 Day Flash Glucose Monitoring System Now Approved in U.S. (Press)
  • CIVCO Partner Adaptiiv Receives FDA 510(k) Clearance to Market 3D Bolus Software (Press)
  • Physio-Control Receives Premarket Approval From the FDA On Its Full Portfolio of LIFEPAK Professional Devices (Press)
US: Assorted & Government
  • FDA’s Appropriation for FY 19: Upsides and Downsides (Alliance for a Stronger FDA)
  • FDA Publishes New Field Alert Reporting Draft Guidance (FDA Law Blog)
  • Durbin Presses Senate To Support Bipartisan Amendments Requiring Drug Companies To Disclose Prices In Direct-To-Consumer Advertising (US Senate Democratic Whip Dick Durbin)
  • The Stealth Campaign to Kill Off Obamacare (NYT)
  • Timing for Senate Opioids Package Still Unclear (Bloomberg-$)
  • Study: ‘Medicare for all’ projected to cost $32.6 trillion (AP News)
  • Later this year you'll be able to get a futuristic medical check-up at Mount Sinai — we got an early peek (CNBC)
  • Wisconsin Must Pay for Transitional Surgeries of Two Transgender Medicaid Recipients, Federal Judge Rules (Fortune)
  • Curtailing Medicaid’s transportation benefit is ‘penny-wise and pound-foolish’ (STAT)
  • VCs are pouring money into digital health. Are they making smart bets? (STAT-$)
  • Brady Statement on HHS, CMS Proposals to Combat Opioid Crisis (House Ways and Means)
Upcoming Meetings & Events Europe
  • EU ruling could change the way gene-editing technology is regulated (EU Policies)
  • Startup aims to use AI to spot connections in published research (Fierce)
  • Nanobiotix inks $47m financing to support nanomedicine development (DDBN)
  • Workshop with stakeholders on support to quality development in early access approaches (i.e. PRIME, Breakthrough Therapies) (EMA)
  • Class 3 Medicines Recall: Sodium Cromoglicate eye drops and Murine Hayfever Relief eye drops (MDR 072-05/17) (MHRA)
  • Field Safety Notice - 23 to 27 July 2018 (MHRA)
  • Japan scientists to use 'reprogrammed' stem cells to fight Parkinson's (Reuters)
  • Singapore Data Breach Could Damage Banks’ Health (Bloomberg)
  • No Profit? No Problem. Another Billionaire Rises in China (Bloomberg)
  • Wockhardt builds $40M plant in Dubai to produce ‘superbug’ fighters (Fierce)
  • Clinical Innovations expands into China with new subsidiary (Fierce)
  • Roche Diagnostics Korea launches digital pathology device (Korea Biomedical Review)
  • Dr Reddy’s Laboratories: Boosted by launches (The Hindu Business Line)
  • How lack of medical history online is killing healthcare in India (Livemint)
  • Gujarat could get medical devices park ICMR DG (Times of India)
  • Nod for Aurobindo Pharma to make, market Bivalirudin injection (Economic Times)
  • India launches Viral Hepatitis Control Program as domestic drugmakers challenge patents (The Pharma Letter-$)
  • Compliance and education for listed medicines (TGA)
  • Australian government adds hepatitis and diabetes drugs to reimbursement scheme (The Pharma Letter-$)
  • Australia's healthcare system saved my life (The Sydney morning Herald)
  • Poor and elderly Australians let down by ailing primary health system (The Conversation)
  • Montreal’s public health director backs Toronto health authorities’ call for drug decriminalization (The Canadian Press)
General Health & Other Interesting Articles
  •  When Medicines Affect a Child’s Mind and Behavior (NYT)
  • Don’t panic if you’re put on a waiting list for the new shingles vaccine (The Washington Post)
  • Fuel For Mommy Shaming: Breastfeeding And Alcohol Study Deeply Misleading (Forbes)
  • Get an Amazon Gift Card for Helping Fight a Critical Blood Shortage (Fortune)
  • He turns color into a precision tool to untangle the ‘dance of molecules’ (STAT)
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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