01:31 , Mar 1, 2019 |  BC Week In Review  |  Financial News

Oyster Point raises $93M series B to bring dry eye nasal spray to FDA

Oyster Point Pharma Inc. (Princeton, N.J.) raised $93 million on Feb. 26 in a series B round, which the company believes will provide enough runway to take one of its dry eye disease candidates through...
14:01 , Feb 26, 2019 |  BC Extra  |  Financial News

Oyster Point raises $93M series B to bring dry eye nasal spray to FDA

Oyster Point Pharma Inc. (Princeton, N.J.) raised $93 million Tuesday in a series B round, which the company believes will provide enough runway to take one of its dry eye disease candidates through an NDA...
22:03 , Jan 8, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Pain Mouse studies suggest inhibiting inflammatory macrophages could help treat Type II diabetes-associated pain. In a mouse model of Type II diabetes, the macrophage-targeting immunotoxin Mac1-saporin decreased disease-induced mechanical allodynia compared with vehicle. Also...
13:51 , Nov 19, 2018 |  BioCentury  |  Regulation

FDA to apply light touch to biopharma apps

Concerned that regulatory uncertainty is preventing biopharma companies from developing digital tools that could help patients manage their health, FDA plans to exempt a broad range of apps and other software from premarket review. In...
22:53 , Jul 9, 2018 |  BC Extra  |  Company News

Trump blasts Pfizer for price hikes, threatens to respond

President Donald Trump threatened to take action against companies for increasing drug prices in a tweet Monday that specifically named Pfizer Inc. (NYSE:PFE). Trump tweeted, “Pfizer & others should be ashamed that they have raised...
07:00 , Sep 5, 2016 |  BioCentury  |  Strategy

Back to School: Haste, not waste

As researchers in industry and academia rapidly unravel molecular disease mechanisms and drug developers become more adept at intervening in disease pathways with drugs targeted to specific populations, the current clinical development paradigm cannot keep...
07:00 , Aug 8, 2016 |  BioCentury  |  Regulation

Better Modeling Through PDUFA

During negotiations over PDUFA VI FDA and industry agreed on initiatives to advance the agency's capability to accommodate "model-informed drug development" and novel clinical trial designs, two domains that could dramatically improve the speed and...
07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Chantix varenicline regulatory update

A joint meeting of FDA's Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory committees voted to retain boxed warning statements on Pfizer's Chantix varenicline for smoking cessation and reassess the statements once an...
07:00 , Sep 22, 2014 |  BioCentury  |  Strategy

Weighing in on obesity

Contrave naltrexone/bupropion will be the first new obesity drug launched in the past two years to have the full weight of a large pharma partner with an established commercial footprint in the cardiometabolic space behind...
07:00 , May 12, 2014 |  BC Week In Review  |  Company News

U.S. Department of Health and Human Services, U.S. Department of Labor, U.S. Department of the Treasury neurology news

A Q&A document prepared jointly by HHS, the U.S. Department of Labor and the Treasury said that under the Affordable Care Act health insurance issuers must cover, without cost-sharing, screening for tobacco use and at...