Newscast – Page 166 – media

J&J lines up its 4-in-1 HIV pill for FDA behind rivals from Gilead, GSK

A couple of months after posting positive late-stage data for its quadruplet-in-one-pill for quelling HIV, J&J says it’s filed a marketing application with the FDA ahead of a planned marketing campaign.
- Source: Endpts
- 563
- September 27, 2017
FDA Gilead GSK HIV J&J Market Views
FEops closes €6m Series B financing

FEops, a leader in personalized computer modeling for structural heart interventions, announced today that it has secured a 6 million euros investment, led by Valiance, and joined by existing investors Capricorn and PMV.
- Source: medicaldevices-business-review
- 632
- September 26, 2017
heart investment Market Views Series
EU green light for Roche’s Tecentriq

Roche has received European Commission(EC) approval for its anti-PD-L1 cancer immunotherapy Tecentriq (atezolizumab) to treat specific lung and bladder cancers. The green light means that it can be used as monotherapy for people in the EU with previously-treated locally advanced or metastatic non-small cell cancer (NSCLC), or those with metastatic urothelial carcinoma (mUC) who have received a platinum-based chemotherapy or who are ineligible to receive cisplatin chemotherapy.
- Source: Pharmatimes
- 573
- September 26, 2017
bladder cancer Company Insight immunotherapy lung
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
- 524
- 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
- 557
- 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
- 747
- 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
- 422
- 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
- 524
- 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
- 710
- 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
- 432
- September 22, 2017
bacterial vaginosis FDA New Approvals

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