00:24 , Jun 21, 2019 |  BC Extra  |  Company News

June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more

Priority Review for Alexion's Ultomiris sBLA  FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome....
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
18:42 , Jun 3, 2019 |  BioCentury  |  Product Development

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...
17:56 , May 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Adrenergic receptor inhibitor combo to treat stroke

DISEASE CATEGORY: Neurology INDICATION: Stroke Mouse studies suggest inhibiting ADRA1, ADRA2 and ADRB could help treat acute ischemic stroke. In two mouse models of ischemic stroke, the combination of the ADRA1 antagonist prazosin, the ADRA2...
20:54 , Apr 11, 2019 |  BC Week In Review  |  Company News

Ocugen to go public via Histogenics reverse merger

Ocugen will reverse merge with Histogenics to form a public company focused on discovering, developing and commercializing therapies for rare eye diseases. Ocugen Inc. (Malvern, Pa.) stockholders will own about 90% of the resulting company,...
18:50 , Mar 29, 2019 |  BC Week In Review  |  Clinical News

Velicept's overactive bladder therapy meets in Phase IIb

Velicept said solabegron met the primary endpoint in the Phase IIb VEL-2002 trial to treat overactive bladder. The company plans to start a Phase III program of the next-generation adrenergic receptor β 3 (ADRB3) agonist...
17:23 , Mar 19, 2019 |  BC Extra  |  Clinical News

Urovant shares slide on vibegron overactive bladder data

Despite hitting the co-primary endpoints for an indication in need of treatment options, Urovant's overactive bladder therapy vibegron underwhelmed investors with its latest data on Tuesday by performing only marginally better than the generic comparator...
23:52 , Mar 14, 2019 |  BC Week In Review  |  Company News

Tonix's PTSD therapy loses breakthrough therapy designation

FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder (PTSD), saying an interim analysis of the Phase III HONOR trial did not sufficiently support the designation. In...
19:48 , Feb 15, 2019 |  BC Week In Review  |  Company News

ZappRx, Teva partner to increase patient access to specialty respiratory drugs

The Teva Respiratory LLC unit of Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) gained access to a digital platform from ZappRx Inc. (Boston, Mass.) to streamline prescription of Teva’s specialty respiratory medications. Financial terms were...
19:36 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

Eyenovia planning NDA in 1Q20 for microdose ophthalmic solution to induce mydriasis

Eyenovia Inc. (NASDAQ:EYEN) plans to submit an NDA to FDA in 1Q20 for MicroStat to induce mydriasis (dilation of the pupil) after the product met the primary endpoint in the Phase III MIST-1 trial. MicroStat...