Regulatory Focus™ > News Articles > 2 > Recon: Trump Signs Bill to End Shutdown, Boost Spending; Prosecutors Say Greek Politicians May Have

Recon: Trump Signs Bill to End Shutdown, Boost Spending; Prosecutors Say Greek Politicians May Have Taken Bribes From Novartis

Posted 09 February 2018 | By Michael Mezher 

Recon: Trump Signs Bill to End Shutdown, Boost Spending; Prosecutors Say Greek Politicians May Have Taken Bribes From Novartis

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

In Focus: US

  • Trump Budget to Target Drug Prices, Out-of-Pocket Costs, Azar Says (Bloomberg) (WSJ) (AP) (Daily Caller)
  • Trump signs deal to end brief government shutdown, increase US spending (Reuters) (Politico)
  • New Drugs Are Coming to Fight Nasty Flu Seasons (Bloomberg)
  • Investors just pulled more money out of biotech funds than they have in 2 years (STAT) (Endpoints)
  • Drug Industry Wages Opioid Fight Using an Anti-Addiction Ally (NYTimes)
  • Patient Advocate Says Novartis' $475,000 Breakthrough Should Cost Just $160,000 (Forbes)
  • Regeneron CEO says fears over Eylea 'greatly exaggerated' (Reuters)
  • Insulin quality study worries some with diabetes (CBS)
  • Statin Critic Accused Of Image Manipulation In Earlier Research (Forbes)
  • Erelzi's Disappearing Indications: Biosimilar Loses Two Of Enbrel's Labeling Claims (Pink Sheet-$)

In Focus: International

  • Greek Politicians May Have Taken Bribes from Drug Maker, Prosecutors Say (NYTimes) (Fierce)
  • Teva warns on 2018 profit, may face migraine drug delays (Reuters) (WSJ) (The Street)
  • Teva chief reports 'strong progress' in restructuring plan (CNBC)
  • Allergan snatches Australian aesthetics company Elastagen for $95M (Endpoints)
  • Japan Finalizes Drug Pricing Reforms (BioCentury)
  • ViiV kicks off PhIII trial of two-drug HIV regimen (PharmaTimes)
  • Boehringer scraps PDE9 Alzheimer's program after trial flop (Fierce) (Endpoints) (Press)
  • Chinese Regulators Issue Near-Term Plan for Medical Device Standards Development (Emergo)
  • SFO bribery investigation into GSK opens old wounds (Pharmafile)
  • A week of UK deals exemplifies China's growing role in global biotech investment (Endpoints)
  • NICE asks Tesaro to submit CDF application for Zejula (PharmaTimes)
  • Liver cancer patients barred from NHS access to Bayer's Stivarga (PharmaTimes)
  • Sarepta halts its golodirsen Duchenne MD study in UK after patient experiences adverse event (Endpoints) (EP Vantage)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee  - Feb 2018 (EMA)
  • EMA Set To Adopt Safe-Use Recommendations For Anti-Epilepsy Drug Valproate (Pink Sheet-$) (EMA)

Pharmaceuticals & Biotechnology

  • We're two shots away from preventing HPV-related cancers (STAT)
  • Many people take dangerously high amounts of ibuprofen (Reuters)
  • How do researchers know what vaccines to make for the flu? (CBS)
  • Celgene Executive Chairman Bob Hugin retires (Pharmafile)
  • Stada poaches Novartis exec for fifth CEO in two years (Pharmafile)
  • CEO Eliot Forster leaves Immunocore as the UK biotech unicorn hunts cash (Endpoints)
  • Two Prostate Cancer Drugs Delay Spread of the Disease by Two Years (NYTimes)
  • Drug Sponsors Who Fail To Submit One-Time Marketing Report Face Big Penalty (Pink Sheet-$)
  • Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy (Harvard Bill of Health)
  • MannKind entices Lilly VP to CMO role (Pharmafile)
  • Seattle Genetics seeds a new immuno-oncology collaboration with the protein explorers at Pieris (Endpoints) (Fierce)
  • Madrigal says NASH drug also works in genetic cholesterol disorder (Fierce)
  • Alexion Guides Cautiously For 2018 (BioCentury)
  • Zarxio reveals all: the US biosimilars market (GaBI)
  • Bioverativ execs haul in new fortunes after patiently waiting for Sanofi to bid up its $11.6B exclusive buyout (Endpoints)
  • CSO Bill Lundberg transitions to advisor role at CRISPR Therapeutics; Prothena loses CMO Sarah Noonberg; Sanofi vet Mark Nuttall jumps to Kymera (Endpoints)
  •  

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA expands J&J Zytiga combo's indication to include castration-sensitive prostate cancer (Pharmafile)
  • Aerpio Pharmaceuticals Completes Patient Enrollment in TIME-2b Study, a Phase 2b Clinical Trial of Lead Candidate AKB-9778 in Patients with Diabetic Retinopathy (Press)
  • Results From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma Published In The Lancet Oncology (Press)

Medical Devices

  • Vela Diagnostics HSV Test Gets FDA Clearance (GenomeWeb)
  • chemoWave app offers patients support during chemotherapy (MobiHealthNews)
  • Class 1 Device Recall HeartStart MRx Monitor/Defibrillator (FDA)

US: Assorted & Government

  • Biologic Fights Drive PTAB Drug Challenges To Record High (Law360-$)
  • Purdue Says Collegium's Nucynta Sales Infringe 3 Patents (Law360-$)
  • Sens. Unveil Bill Aimed At Curbing Opioid Crisis (Law360-$)
  • Pressure Rises for Right-to-Try Bill (Medpage)
  • Maryland sues Insys to enforce subpoena in opioid probe (Reuters)
  • Opioid Judge Doesn't Want The Media To Know Details Of Settlement Talks (Forbes)
  • CVS still expects Aetna deal to close in the second half of the year (CNBC)
  • Illinois Court Rejects Novel Claims Alleging Deficiencies In Post-Approval Studies (Drug & Device Law)
  • Medicare Fee-For-Service: Modernizing Cost-sharing Design Would Involve Trade-offs, the Results of Which Would Depend on Time Horizon (GAO)
  • J&J Hit With Stock-Drop Suit Over Claims Of Asbestos In Talc (Law360-$)

Upcoming Meetings & Events

Europe

  • EU FMD: The One-Year Countdown (Pharma Manufacturing)
  • UK launch for Bayer's five-year contraceptive Kyleena (PharmaTimes)
  • WP4 OTCA03 on "Screening of fetal trisomies 21, 18 and 13 by non invasive prenatal testing" is now available (EUnetHTA)

Asia

  • FiercePharmaAsia—GSK scandal sequel, AstraZeneca China alliances, Samsung BioLogics sales jump (Fierce)
  • Couple arrested over fake Harvoni in Japan (SecuringIndustry)
  • Industry 4.0: Reinvigorating ASEAN manufacturing for the future (McKinsey)

India

  • Malvinder Singh and Shivinder Singh resign from Fortis Healthcare board (Economic Times)
  • Singh brothers are said to have taken $78 million out of Fortis(Economic Times)
  • Jubilant Pharma gets USFDA nod for Symmetrel's generic version(Economic Times)

Australia

  • Australia Plans Changes To GMP Fee Structure To Help Cover Costs (Pink Sheet-$) (TGA 1, 2)
  • Complementary medicines reforms – Permitted Indications, including traditional indications (TGA)
  • All TGA approvals for prescription medicines in 2017 met the statutory timeframe of 255 working days (TGA)

Canada

  • Summary Safety Review - SGLT2 inhibitors - Assessing the potential risk of a rare brain condition (posterior reversible encephalopathy syndrome) in patients who have developed high levels of acids in the blood (diabetic ketoacidosis)   (Health Canada)

General Health & Other Interesting Articles

  • U.S. child mortality rates remain higher than in other wealthy nations (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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