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Eisai Submits Supplemental New Drug Application (sNDA) to FDA for FYCOMPA® (perampanel) Pediatric Indications

Eisai Inc. announced that it has submitted a supplemental New Drug Application (sNDA) for priority review to the U.S. Food and Drug Administration (FDA) for its antiepileptic drug FYCOMPA® (perampanel) CIII as monotherapy and adjunctive use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in pediatric patients (ages 2 to less than 12 years). The submission also proposes a pediatric indication for monotherapy and adjunctive use for primary generalized tonic-clonic seizures (PGTC) in children (ages 2 to less than 12 years) with epilepsy. The sNDA is for both the FYCOMPA tablet and oral suspension formulations.
- Source: prnewswire
- 647
- April 4, 2018
Eisai FDA FYCOMPA® New Approvals
On-demand health concierge Accolade lands another $50M in funding

Last week on-demand healthcare concierge for provider employers Accolade received $50 million in funding led by Andreessen Horowitz, Carrick Capital Partners, Madrona Venture Group, and McKesson Ventures, with participation from Cross Creek Advisors and Madera Technologies.
- Source: MobiHealthNews
- 746
- April 4, 2018
Company Insights funding healthcare
Study suggests link between anxiety and smartphone addiction

Feeling emotionally unstable could lead you to rely on your smartphone more, according to new research.
- Source: CTVNews
- 654
- April 4, 2018
Mental health mHealth Researches
Tele-rehabilitiaion platform TheraNow launches

Folks in need of physical therapy services may not have to leave the house for treatment. Therainc has just launched its latest product, TheraNow, an online platform that connects patients to physical therapists through teletherapy.
- Source: MobiHealthNews
- 728
- April 4, 2018
EHR New Approvals Telemedicine
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
- 599
- 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
- 735
- 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
- 566
- 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
- 644
- 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
- 2,098
- 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
- 602
- April 3, 2018
Company Insights digital health investment

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