FDA

Feb 05, 2019

FDA discards depression drug ALKS 5461 of Alkermes The FDA has rejected approval for ALKS 5461 of Alkermes in major depressive disorder. ALKS 5461 is a fixed-dose combination of buprenorphine and samidorphan. Alkermes designed the combination to act on the mu- and kappa-opioid receptors that eventually showed im...

Jan 17, 2019

Anti-aging startup Juvenescence raises USD 46 Million Juvenescence has bagged the USD 46 million in series B financing. The investment tees the anti-ageing startup to progress the multi-asset pipeline. Jim Mellon, a British billionaire biotech investor, created Juvenescence with early Medivation backer Greg Bai...

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

[caption id="attachment_3727" align="aligncenter" width="2322"] FDA[/caption]

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...