Newscast – Page 166 – media

FDA approves Abiomed’s new pump for right heart failure

Abiomed has received pre-market approval (PMA) from the US Food and Drug Administration (FDA) for its Impella RP heart pump.
- Source: medicaldevice-network
- 514
- September 26, 2017
FDA heart pump New Approvals PMA
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Previously Treated Patients

Merck, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
- Source: Merck
- 545
- September 25, 2017
adenocarcinoma anti-PD-1 GEJ keytruda New Approvals
MIT’s new injection tech delivers multiple vaccines with one poke

Regardless of what it’s protecting you against, few people would likely say that getting a vaccine injection is an altogether enjoyable vaccine. Fortunately, engineers at the Massachusetts Institute of Technology are coming to the rescue with a new 3D fabrication technique that could allow for multiple doses of a drug or vaccine to be delivered to a patient over an extended period of time — with just one jab needed.
- Source: digitaltrends
- 729
- September 25, 2017
Company Insight fabrication needle-phobic vaccine
Court ruling not needed to withdraw care, judge says

Legal permission will no longer be required to end care for patients in a permanent vegetative state, a judge has ruled.
- Source: BBC
- 414
- September 25, 2017
patient permission Policy
Remote Diagnostic introduces new system for monitoring and defibrillation

UK-based firm Remote Diagnostic Technologies (RDT) has introduced a new system, Tempus ALS, to enable monitoring and defibrillation to improve emergency responses.
- Source: medicaldevice-network
- 516
- September 22, 2017
Company Insight defibrillation Tempus ALS
Pfizer sues Johnson & Johnson, alleging anticompetitive practices to maintain a drug monopoly

A legal brawl between two of the world’s largest drug companies could shape the future of a nascent market of copycat drugs that are intended to bring down the cost of the most advanced and expensive medicines.
- Source: Washingtonpost
- 702
- September 22, 2017
biosimilar Johnson & Johnson Pfizer rheumatoid arthritis
FDA Approves Symbiomix Therapeutics’ Solosec™ (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women

Symbiomix Therapeutics announced the U.S. Food and Drug Administration (FDA) has approved its lead product Solosec™ (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
- Source: news.pharmacodia
- 425
- September 22, 2017
bacterial vaginosis FDA New Approvals
The world is running out of antibiotics, WHO says

(CNN)Too few new antibiotics are under development to combat the threat of multidrug-resistant infections, according to a new World Health Organization report published Tuesday. Adding to the concern: It is likely that the speed of increasing resistance will outpace the slow drug development process.
- Source: edition
- 660
- September 22, 2017
antibiotics Researches WHO
IDbyDNA and ARUP Laboratories introduce diagnostic test for pneumonia

ARUP Laboratories and metagenomics firm IDbyDNA have introduced a new next-generation sequencing (NGS) test, Explify Respiratory, for the diagnosis of respiratory diseases such as pneumonia.
- Source: medicaldevice-network
- 619
- September 21, 2017
NGS pneumonia Researches respiratory
Medtronic secures FDA approval for Intellis spinal cord stimulator

Medtronic has secured the US Food and Drug Administration (FDA) approval for its next generation spinal cord stimulator branded as Intellis platform for the management of certain forms of chronic intractable pain.
- Source: medicaldevices-business-review
- 1,001
- September 21, 2017
chronic Company Insight spinal cord stimulator

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