Regulatory Focus™ > News Articles > 4 > Recon: Ferring Acquires Microbiome Drug Developer Rebiotix

Recon: Ferring Acquires Microbiome Drug Developer Rebiotix

Posted 05 April 2018 | By Ana Mulero 

Recon: Ferring Acquires Microbiome Drug Developer Rebiotix

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

In Focus: US In Focus: International
  • Boehringer breathes new life into “don’t eat me” approach (EP Vantage) (BioPharma Dive) (Endpoints) (Fierce)
  • BIO Submission to the China Section 301 Investigation (BIO)
  • Hopes rise for Shire sale as Takeda CEO discusses case for deal (Reuters) (The Economist)
  • Novo Nordisk buys blood drug licence to boost anaemic biopharma business (Reuters) (FirstWord Pharma) (BioPharma Dive)
  • Adjustment of EMA Pharmacovigilance fees for inflation (Regulation (EU) No 658/2014) (EC)
  • Evolus touts equal efficacy for its Botox me-too drug in Ph III European/Canadian trials (Endpoints)
  • Keytruda’s Catch-22 Situation In India Amid Compliance Questions (Pink Sheet-$)
  • EU green light for Chiesi’s Lamzede (PharmaTimes) (Endpoints)
  • Takeda to sell Brazil subsidiary (The Pharma Letter)
  • Biopharma caught in the crosshairs of U.S.-China trade tussle (Fierce) (WTO Complaint)
  • Health Canada and CPSC Release New Draft Guidance Document for Consumer Product Industry (Lexology)
Pharmaceuticals & Biotechnology
  • Payer Power: Why Eli Lilly, Janssen, and Merck Deeply Discount Their Drug Prices (Drug Channels)
  • Kaleo expanding access in U.S. to drug to reverse opioid overdose (Reuters)
  • Investors smart at ailing pharma deals (Financial Times)
  • With the drug industry as its partner, an addiction policy group invites tough questions (STAT)
  • Drug makers still have a bad reputation among patient groups (STAT-$)
  • Trump administration is urged to override patents on pricey muscular dystrophy drug (STAT-$)
  • Creative Minds: Optimizing Radio-Immunotherapy for Cancer (NIH)
  • ImmunoRestoration, Inc. Selects Premier Research for Pre-Trial Services (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Novartis-backed Conatus highlights a silver lining, but PhIIb NASH setback causes whiplash in share price (Endpoints)
  • RA Capital jumps into the melee on TTR amyloidosis, backing a $91M development plan for a BridgeBio drug (Endpoints)
  • Nordic Nanovector further delays pivotal lymphoma readout, parts company with CEO (Fierce)
  • Pfizer, Acadia fund Fox Foundation’s new tool for Parkinson’s clinical studies (Fierce) (Press)
  • Unnecessary exclusions shut patients out of clinical trials (STAT)
  • Clinical Trials in Medical Center Advertising (JAMA)
  • High prevalence of S. pyogenes Cas9-specific T cell sensitization within the adult human population - A balanced effector/regulatory T cell response (bioRxiv)
  • First Patient Dosed In Pivotal Biomarker-Guided Phase 3 Study Of First Line Therapy With DB102 + R-CHOP In Patients With High-Risk Diffuse Large B-Cell Lymphoma (Press)
Medical Devices
  • Repro-Med defeats an appeal from EMed in needle-stick patent case (MassDevice)
  • Axonics executes $40M financing to commercialize neuromodulation device (Fierce)
  • RefleXion Medical reaps $100M in series C round (Fierce)
  • Ascensia looks to expand access to blood glucose monitoring tech for UnitedHealthcare enrollees (Drug Delivery Business News)
  • Apple launches Health Records with 39 health systems. How soon will it reach clinical studies? (Fierce)
  • This patented 3D printing method could boost medical device innovation (Medical Design & Outsourcing)
  • 3 New Settlements Highlight DOJ Scrutiny Of Device Makers (Law360-$)
  • Eye implant made from stem cells could halt macular degeneration (Fierce)
  • LivaNova Completes Acquisition of TandemLife (Press)
  • FDA Clears Automated Vasculitis Test from AESKU (Press)
US: Assorted & Government
  • JP Morgan CEO Sees Long Timeline, Big Goals for Health Venture (Bloomberg)
  • Rural health care is expensive, and Washington isn't helping (Axios)
  • The Role of Health Care Practitioners (JAMA)
  • Six organizations ask HHS Secretary Azar to take title of 5 patents on Exondys 51, as remedy to failure by inventors to disclose NIH funding (Knowledge Ecology International)
  • Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting (FDA)
  • Agency Information Collection Activities; Submission for Office of Management and Budget Review; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (FDA)
Upcoming Meetings & Events Europe
  • NICE denies multiple sclerosis star Ocrevus on price, thwarting Roche yet again (Fierce)
  • Greek prosecutor ratchets up inquiries in Novartis bribery probe: report (Fierce)
  • Bulgaria reports H5N8 bird flu outbreak in duck farm (Reuters)
  • CurveBeam wins CE Mark for LineUP, InReach ortho CTs (MassDevice) (Press)
  • Nox Medical claims win over Natus Medical in EU sensor patent spat (MassDevice)
  • Minutes of the Extraordinary Management Board meeting for the building approval process of EMA premises in Amsterdam (EMA)
  • Kaiku Health Raises €4.4 Million Series A Financing to Accelerate Its Digital Therapeutics Pipeline Led by Debiopharm and Tesi (Press)
Asia
  • With Drug Price Cuts Done, MHLW Now Running Ministry-Wide Initiative to Shave Prescriptions (Pharma Japan)
 
India Australia
  • Adverse events (‘side effects’) reporting survey (TGA)
  • Updating an existing Class 1-3 in-house IVD notification (TGA)
Canada
  • Before voting, understand these facts about health care (Toronto Star)
General Health & Other Interesting Articles
  • The stark disparities in how infectious diseases kill Americans (Axios)
  • Monkey study suggests Zika infection in infancy could cause brain damage (STAT)
  • Poll: Most Americans wary of those suffering from addiction, despite recognition of medical condition (STAT)
  • Fall prevention gets harder when elderly leave hospital (Reuters)
  • Taxing Soda and Booze Can Spark Healthy Spiral, Experts Say (Bloomberg)
  • Fur-covered robots are the new therapy animal (CNET)
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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