Search Results for “FDA” – Page 177 – media

Afatinib Approval Expanded for Rare Lung Cancer Treatment

Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
- Source: Raredr
- 705
- January 17, 2018
afatinib DNA FDA New Approvals NSCLC
AstraZeneca’s PARP inhibitor gains market edge with breast cancer approval

AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
- Source: Biopharmadive
- 578
- January 17, 2018
inhibitor Lynparza New Approvals
Three ways you can act to reduce the risk

If 2017 was about ransomware attacks, 2018 will be about cyber attacks on the Internet of Things (aka medical devices).
- Source: Xceptional
- 761
- January 17, 2018
health IT medical device Researches
UK Takes Stricter Stance on Human Factors Engineering for Medical Devices

Recent guidance from UK medical device market regulators on human factors engineering (HFE) includes some recommendations that differ from HFE requirements established in Europe, suggesting a more standalone British approach to some areas of device development.
- Source: Emergo
- 583
- January 15, 2018
FDA medical device Policy
Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies

Celgene Corporation (CELG) and Impact Biomedicines today announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera. Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.
- Source: finance.yahoo
- 501
- January 12, 2018
Celgene FDA Fedratinib Impact Market Views myelofibrosis
Alzheimer’s Drug Turns Back Clock in Powerhouse of Cell

The experimental drug J147 is something of a modern elixir of life; it’s been shown to treat Alzheimer’s disease and reverse aging in mice and is almost ready for clinical trials in humans.
- Source: Neuroscience News
- 586
- January 12, 2018
Alzheimer's disease Clinical Trials Researches
Fitbit has invested $6 million in glucose-monitoring startup Sano

Fitbit has invested $6 million in a glucose-monitoring startup called Sano, in what appears to be part of Fitbit’s larger plans to make its fitness devices more valuable for overall health.
- Source: The Verge
- 399
- January 11, 2018
Company Insight Glucose Monitoring System wearables
Is the $850,000 price tag for a blindness-curing gene therapy a sign of future medical costs?

Gene therapies are an undeniably exciting new frontier for medicine. From Kymriah's genetically modified, cancer-hunting immune cells, to Luxturna's vision-restoring healthy gene replacement, these therapies are fundamentally unlike 20th-century medicines which generally require ongoing drug treatment. Gene therapies can be one-off doses that in effect, cure a specific disease.
- Source: New Atlas
- 440
- January 11, 2018
FDA Gene therapy Market Views
How doctors and bots can work together

The fear that machines will replace humans in the workplace is not a new one. In 1930, economist John Maynard Keynes conjectured that in the years to come, modern economies would face a new kind of affliction: what Keynes called “technological unemployment.”
- Source: Venturebeat
- 534
- January 10, 2018
AI digital health Market Views
Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.
- Source: Emergo
- 795
- January 10, 2018
CFDA Clinical Trials medical device polices

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