Regulatory Focus™ > News Articles > 4 > Recon: Prothena's Lead Drug Implodes, Akorn Sues Fresenius Over Terminated Merger

Recon: Prothena's Lead Drug Implodes, Akorn Sues Fresenius Over Terminated Merger

Posted 23 April 2018 | By Ana Mulero 

Recon: Prothena's Lead Drug Implodes, Akorn Sues Fresenius Over Terminated Merger

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In Focus: International
  • Akorn fights back as European drug company retreats from $4.3 billion takeover (Herald & Review) (Reuters) (CNBC) (Bloomberg) (WSJ)
  • The vaccine dilemma: how experts weigh benefits for many against risks for a few (STAT)
  • UK cuts ribbon on £60 million facility to boost cell and gene therapy industry (The Pharma Letter-$) (Pharma Exec)
  • FDA still not happy with Kamada inhaled AAT drug (Fierce)
  • Medtronic extends afib clinical trial support agreement with Arca Biopharma (MassDevice)
  • U.S. Hospital Firms, Hungry to Expand, Look to China (WSJ)
Pharmaceuticals & Biotechnology
  • Squeezed Mylan axing 500 jobs in West Virginia to 'right-size' massive plant (Fierce)
  • Corporate espionage hacks hit health care sector (Axios)
  • How to lower prescription drug costs (Axios)
  • Goldman upgrades Merck, calls it one of the firm's favorite stocks because of Keytruda lung cancer breakthrough (CNBC)
  • On drug pricing, Trump could rely on bluster and bad ideas. But there’s a better alternative (STAT)
  • With a new slate of appointees, Trump’s FTC expected to take tough stand on drug industry (STAT-$)
  • Amid troubles, ex-Rosetta CEO Berlin parachuted in as new Advaxis head (Fierce)
  • Sanofi diabetes research chief takes CSO post at Grünenthal (Fierce)
  • MiraLAX Generics Get FDA Reprieve Despite Bayer Objections (Law360-$)
  • Oregon Tribe Sues Pharma Cos. Over Opioid Epidemic (Law360-$)
  • Janssen Escapes Whistleblower Suit Over Off-Label Opioids (Law360-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Combination immunotherapy may have failed in the Incyte/Merck trial, but it’s here to stay (STAT)
  • Targeting heart disease by focusing on a protein that dilates blood vessels (Fierce)
  • New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis (Press)
  • Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression (Press)
  • MeiraGTx Announces AAV-RPGR Granted Fast Track Designation by U.S. FDA for Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency (Press)
  • CBT Pharmaceuticals and CrystalGenomics Announce Partnership for Co-development of Global Immuno-Oncology Therapy (Press)
  • HitGen Announces Research Collaboration and License Agreement with Simcere (Press)
  • New SPINRAZA (nusinersen) Data Unveiled at AAN Annual Meeting Show Continued Improvement in Motor Function for Broad Age Range and Survival Benefit for Infants (Press)
Medical Devices
  • Philips Is on Lookout for Acquisitions to Sharpen Health Focus (Bloomberg)
  • A timeline to adopt medical device QMS (and why you need to act now) (MedCity News)
  • FDA approves Medtronic’s drug-coated balloon to treat long superficial femoral artery lesions (Drug Delivery Business News) (Press)
  • FDA floats relaxation of regulations to encourage use of mass spectrometry to identify microorganisms (Fierce) (FDA)
  • Laborie Medical closes $214m Cogentix buy (MassDevice) (Press)
  • Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers (MedTech Intelligence)
  • Dearborn-based company unveils world's largest 3-D printed chain (Detroit Free Press)
  • Algorithm highlights cardiovascular disease using smartphone's camera (MobiHealthNews)
  • Why You Should Consider Augmented Reality to Develop Your Next Medical Device (MD+DI)
  • Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter (Press)
  • Lumendi Receives FDA 510(k) Clearance for Dilumen C2 (Press)
  • Sanquin Selects Abbott's 'Alinitys' Solution for Blood and Plasma Screening (Press)
  • Vizient Launches Cybersecurity Task Force to Address Medical Device Safety (Press)
  • Paragonix Technologies Inc., Announces Presentation of the Paragonix SherpaPak Cardiac Transport System at the 98th Annual Meeting of the American Association of Thoracic Surgeons in San Diego, April 28- May 1, 2018 (Press)
  • DecisionDx-Melanoma Test Independently Improved Identification of High-Risk Patients Compared to AJCC Staging in Stage I-II Cutaneous Melanoma (Press)
  • Brainlab Introduces New Hi-Res Planning Algorithm for VersaHD (Press)
US: Assorted & Government
  • Henry Schein to spin off, merge its animal health business with start-up (CNBC)
  • Stay Away From All Forms of Romaine Lettuce, CDC Warns (Fortune)
  • Using Air Force ‘boldface’ to ease the opioid crisis (STAT)
  • SEC extends probe into Northwest Biotherapeutics as financial struggles mount (STAT-$)
  • How Health Plans Adapt in this Era of Healthcare Reform (WellDoc)
  • A Busy Week for the Supreme Court in FCA Matters (FDA Law Blog)
  • Health Insurers: Trump's Short-Term Plans Will Trigger Loss Of Coverage (Forbes)
  • Some Democrats want to punish opioid makers (Axios)
  • A Simplified, Five-Step Approach To Applying FDA's Human Factors Guidance (Med Device Online)
  • Trump delays drug pricing speech, no set date yet (Reuters)
Upcoming Meetings & Events Europe
  • Synpromics to partner with Lonza to improve biopharmaceuticals manufacturing (PBR) (Press)
  • EMA committee recommends Alnylam’s early-stage ATTR amyloidosis drug for orphan status (Endpoints) (Press)
  • Pfizer's first U.K. ads for OTC Viagra put erectile dysfunction in perspective (Fierce)
  • Ministers write letter to Vertex over Orkambi debate (PharmaTimes)
  • CHMP rejects AB Science’s ALS drug (PharmaTimes)
  • European Prialt rights transferred to Riemser (The Pharma Letter-$)
  • Updated guidance: Decide if your product is a medicine or a medical device (MHRA)
  • Committee for medicinal products for human use (CHMP) Draft agenda for the meeting on 23-26 April 2018 (EMA)
  • European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European Medicines Agency (EMA)
  • Draft Guideline on Manufacture of the Veterinary Finished Dosage Form (EMA)
  • MYLOTARG Approved In The EU For The Treatment Of Previously Untreated, De Novo, CD33-positive Acute Myeloid Leukemia In Combination With Chemotherapy (Press)
Asia
  • Trade war worries Philips as it banks on China growth (Reuters)
  • Ping An Good Doctor Starts Preparing $1.1 Billion Hong Kong IPO (Bloomberg-$)
  • Clouds over Indian hospital chain Fortis keep suitors from making higher bids (Reuters)
  • China-Denmark drug regulatory thematic seminar held in Beijing (The Pharma Letter)
  • EpimAb Biotherapeutics and Zhejiang Teruisi Biopharmaceutical Announce Development Collaboration on Epimab’s FIT012 Bispecific Antibody Program (Press)
India
  • Glenmark clinical trial in Jaipur dragged into controversy, CDSCO to probe allegations (Economic Times)
  • Twitter co-founder Biz Stone invests in Delhi-based Artificial Intelligence-powered health chatbot (Financial Express)
  • Cancer in India: Novel approach helping Noida clinic diagnose patients, break fears associated with disease (Financial Express)
Australia
  • SA Government providing free flu vaccinations for children under five for the first time (ABC News)
  • New interactive tool for sponsors: Which clinical trial scheme should I choose? (TGA)
  • Consultation: Management and communication of medicines shortages (TGA)
  • Events & training by the TGA (TGA)
  • GMP clearance process improvements - Post implementation update (TGA)
  • Implementation of reforms - public consultation forecast: Review of medicines and medical devices regulation (TGA)
  • The Poisons Standard and medical devices: Guidelines for labelling (TGA)
  • Indee Labs receives funding to develop revolutionary gene therapy manufacturing technology in Australia (Press)
Canada
  • Health Canada investigating use of unlicensed homeopathic remedy made from rabid dog saliva (CBC News)
  • Does Canada's healthcare system treat everyone equally? (CityNews)
General Health & Other Interesting Articles
  • You can get rid of your unused medications at these drugstores (CNBC)
  • In-Depth: How digital health is changing marathons (MobiHealthNews)
  • Kaiser Permanente Shows How To Start Tackling The Childhood Obesity Epidemic (Forbes)
  • No thanks to eggs: Next year's flu shot will shield only 20% against dominant strain (Fierce)
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? Email us at news@raps.org.
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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