BioCentury | Dec 17, 2018
Politics, Policy & Law

When drugs can’t go generic: Honoring our end of the contract with 'synthetic genericization'

The biopharma industry’s social contract with society relies on the idea that drugs eventually go generic and thereafter remain inexpensive. When that can’t happen, the contract breaks down - but there are ways to fix it....
BioCentury | Apr 27, 2018
Emerging Company Profile

Cinclus’ acid inhibition

Cinclus Pharma AG is developing a fast-acting potassium-competitive acid blocker designed to last longer than proton pump inhibitors and marketed P-CABs to treat severe erosive gastrointestinal reflux disease. PPIs such as Nexium esomeprazole and Prilosec...
BC Week In Review | Feb 9, 2015
Clinical News

Nexium esomeprazole magnesium regulatory update

FDA approved an ANDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) for a generic version of Nexium esomeprazole magnesium delayed-release capsules to treat gastroesophageal reflux disease (GERD) in patients ages =1. Nexium is...
BC Week In Review | Jan 12, 2015
Company News

Ranbaxy generics, gastrointestinal, infectious news

Ranbaxy filed a suit in the U.S. District Court for the District of Columbia alleging that FDA improperly concluded that the company forfeited its 180-day exclusivity for a generic version of Valcyte valganciclovir from Roche...
BC Extra | Aug 1, 2014
Financial News

FDA extends review for AZ's olaparib

AstraZeneca plc (LSE:AZN; NYSE:AZN) disclosed in its 2Q14 financial results on Thursday that FDA extended the PDUFA date by three months for cancer product olaparib. The PDUFA date is now Jan. 3, 2015; the previous...
BioCentury | May 12, 2014
Strategy

Build up to break up

Pfizer Inc. continues to give signals that the grand plan is to break itself up, and the reality looks like it absolutely needs AstraZeneca plc 's assets to make it work. Pfizer already has internally...
BC Week In Review | Apr 7, 2014
Clinical News

Nexium esomeprazole magnesium regulatory update

FDA approved an NDA from AstraZeneca for Nexium 24HR esomeprazole 20 mg delayed-release capsules for OTC use to treat frequent heartburn in adults >=18 years of age. Pfizer Inc. (NYSE:PFE, New York, N.Y.) has exclusive,...
BC Week In Review | Mar 31, 2014
Company News

AstraZeneca sales and marketing update

AstraZeneca launched Nexium Direct, a program that provides U.S. patients the option to order Nexium esomeprazole to treat gastroesophageal reflux disease (GERD) online and to be delivered to their home. Nexium is a capsule formulation...
BioCentury | Feb 3, 2014
Finance

Quick payday on single cell sale

A quick turnaround from first financing to takeout netted investors in DVS Sciences Inc. an impressive return in a short time. On Jan. 29, Fluidigm Corp. (NASDAQ:FLDM) announced plans to acquire fellow microfluidics company DVS...
BC Week In Review | Jan 13, 2014
Company News

Amneal Pharmaceuticals, Hanmi Pharmaceutical, AstraZeneca sales and marketing update

Amneal launched in the U.S. an authorized generic of AstraZeneca's gastrointestinal drug Nexium esomeprazole strontium delayed-release capsules. Amneal said it cannot comment on pricing because the company sells esomeprazole strontium delayed-release capsules through wholesalers. Late...
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