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Another immunometabolism deal? Johns Hopkins spinout Dracen lands $36M investment from Deerfield

The company, founded just a year ago, is developing novel glutamine antagonists that work as inhibitors of cancer metabolism, choking out tumors and their normal metabolic function.
- Source: Endpts
- 610
- April 3, 2018
cancer inhibitor Market Views metabolism
UCB Announces Filing Acceptance with the China Food and Drug Administration for CIMZIA® (certolizumab pegol) for the Treatment of Moderate-to-Severe Rheumatoid Arthritis

UCB, a global biopharmaceutical company, announced the submission of an application for an Import Drug License to the Chinese Food and Drug Administration (CFDA) for the approval of CIMZIA® (certolizumab pegol) to treat moderate-to-severe rheumatoid arthritis (RA).
- Source: ucb
- 768
- April 3, 2018
CFDA CIMZIA® New Approvals RA
Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bremelanotide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women.
- Source: drugs
- 575
- April 3, 2018
bremelanotide FDA New Approvals
Takeda moots Shire move but big questions remain

Takeda is considering making a bold move for Shire, after announcing, as per UK regulations, that it may make an approach for the company.
- Source: takeda
- 655
- April 3, 2018
Company Insights Shire Takeda
Procedures and Requirements of GMP Certification of Pharmaceutical Drugs in the Philippines

According to the latest data, the population of the Philippines has exceeded 100 million, and the demand for various types of medicine shows a steady increase. With the advancement of relations between China and the Philippines and collaborations in economy and trade, the Philippines has become a prime exporting country for Chinese pharmaceutical companies.
- Source: Ddu
- 2,110
- April 3, 2018
Ddu College Philippines
Record Q1 brings in $1.6B for digital health investments, disease diagnosis segment dominates

Investment in digital health rose to its highest level for the first quarter of the year at $1.6 billion compared with $909 million for the same time last year, according to a new report by Rock Health. That figure reflected investment across 77 digital health deals, dominated by the category of disease diagnosis in terms of total investment and monitoring of disease category in terms of deal volume.
- Source: MedCityNews
- 613
- April 3, 2018
Company Insights digital health investment
Tiny ‘hearing’ device is 100,000 times thinner than your eardrum

The super small vibrating sensor can detect signals at the highest reported dynamic range of frequencies, up to ~110dB, at radio frequencies (RF) up to over 120MHz.
- Source: Engadget
- 1,219
- April 3, 2018
medical device Researches wearables
Device able to quickly and accurately detect stroke

A new visor-like device worn by patients can help providers and emergency medical personnel detect a stroke that requires comprehensive care within seconds and with greater than 90 percent accuracy.
- Source: Health Data Management
- 738
- April 3, 2018
FDA medical device New Approvals stroke
EMA to review sotagliflozin as potential treatment for type 1 diabetes

The European Medicines Agency (EMA) has accepted for review Sanofi’s regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus.
- Source: mediaroom.sanofi
- 580
- April 2, 2018
diabetes New Approvals sotagliflozin
Shire Reports Regulatory Milestones for Investigational Hereditary Angioedema (HAE) Treatment Lanadelumab

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for lanadelumab (SHP643) and also reports that Health Canada has completed screening and accepted the New Drug Submission (NDS) under Priority Review for this investigational compound.
- Source: Shire
- 621
- April 2, 2018
angioedema HAE lanadelumab New Approvals

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