FDA

Jan 08, 2019

The oral depression drug of Sage Therapeutics meets phase 3 efficacy A phase 3 trial of oral treatment of Sage Therapeutics for postpartum depression (PPD) has hit its primary endpoint. The drug, SAGE-217, showed significant improvements on a depression score and saw no fainting cases. SAGE-217 is an a...

Dec 11, 2018

Axovant tips nelotanserin from small molecule R&D Axovant has stopped nelotanserin development after it missed the primary endpoint in a phase 2 trial in patients with Lewy body dementia. The dull data compelled Axovant to miss the drug and finish its pivot from small molecules to gene therapies. The parent comp...

Dec 05, 2018

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Dec 04, 2018

If dementia genes are found, drug discovery can be accelerated in brain disorders The overproduction of a protein called tau has been detected in the neuron degeneration that causes Alzheimer’s and other forms of dementia. But the exact genetic process that causes tau is still a mystery. Scientists of the University...

Nov 29, 2018

Prometic bags USD 50 Million stock sale option to ease a cash crunch Prometic Life Sciences got into an agreement for selling USD 50 million in stock. This gives Prometic a way to escape its current financial pressures. Canada-based Prometic was asked by the FDA to make and validate process changes for Ryplazim, a c...

Nov 22, 2018

Cambrex takes over Avista in USD 250 Million agreement Cambrex, life sciences company, is taking over Avista Pharma Solutions with a deal of USD 250 million to become a leading contract development and manufacturing organization (CDMO). The agreement includes the early-stage drug development and manufacturing capabi...

Nov 20, 2018

Gene editing, a possible treatment, for inherited kidney disease Joubert syndrome, an inherited brain disorder that causes kidney failure in patients. This requires a transplant or dialysis. A mutation in the gene CEP290 causes the inherited form of kidney disease and scientists in the U.K. to apprise of having an e...

Nov 06, 2018

FDA approves Zulresso of Sage Sage Therapeutics, a clinical-stage biopharmaceutical company committed to the treatment of central nervous system (CNS) disorders, receives U.S. approval for its postpartum depression (PPD) drug Zulresso from the Food and Drug Administration when received 17-1 in favour of the therapy...

Oct 30, 2018

TherapeuticsMD bags FDA approval for hormone therapy The FDA has nodded hormone therapy of TherapeuticsMD for hot flashes that are associated with menopause. Bijuva is an oral treatment that contains molecularly identical (bio-identical) versions of the hormones estradiol and progesterone for menopausal women with a...

Oct 29, 2018

Oral Mucositis (OM) refers to erythematous and ulcerative lesions of the oral mucosa observed in cancer patients under chemotherapy or radiation therapy. In its severe form, OM presents as confluent, deep ulcerations. Typical manifestations are atrophy, erythema, ulceration, and swelling of the mucosa. It appears fi...