Business Wire

FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted ...
FiercePharma

FDA Approves Esbriet® (pirfenidone) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) in the United States

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Esbriet® (pirfenidone) as a treatment for idiopathic ...
AOL

Roche evaluates options for its lung disease drug

(Reuters) - Swiss drugmaker Roche said on Monday it is evaluating options for its lung disease drug Esbriet, which has seen declining sales due to competition from cheaper copycat versions. A company ...
Nasdaq

Roche's (RHHBY) Esbriet sNDA Gets Priority Review From FDA

Genentech, a wholly owned subsidiary of Roche Holding AG RHHBY, announced that the FDA has accepted the supplemental new drug application (sNDA) for Esbriet (pirfenidone) for the treatment of ...
FierceBiotech

InterMune Receives European Union Approval for Esbriet® (pirfenidone)

- First Approved Medicine for Idiopathic Pulmonary Fibrosis Patients in the EU - - InterMune to Host a Conference Call Today at 8:30 a.m. EST - BRISBANE, Calif., March 3, 2011 /PRNewswire/ -- ...
Drug Store News

FDA committee recommends approval for InterMune’s Esbriet

BRISBANE, Calif. A Food and Drug Administration committee has recommended approval for an investigational drug for treating a rare and fatal lung disease. The FDA’s Pulmonary-Allergy Drugs Advisory ...
Drug Store News

Alembic releases generic Esbriet

Alembic's pirfenidone tablets, 267 mg will be available in a single carton containing three 90-count bottles and the 801 mg dosage strength will come in 90-count bottles.
FierceBiotech

PureTech's lung fibrosis drug slows decline in phase 2 trial

PureTech’s only internal drug program has slowed lung function decline in a phase 2 trial in idiopathic pulmonary fibrosis (IPF). The med, called deupirfenidone, is a deuterated form of Roche’s ...
FiercePharma

Avalyn advances inhaled twist on Roche fibrosis drug

Avalyn Pharma has outlined plans to take an inhaled formulation of pirfenidone into phase 3 after generating data in patients with idiopathic pulmonary fibrosis (IPF). The formulation is designed to ...
BioWorld

InterMune Skyrockets on CHMP Thumbs-up for IPF Drug Esbriet

Shares of InterMune Inc. shot up a whopping 144.5 percent Friday on a positive opinion by the European Committee for Medicinal Products for Human Use (CHMP) for idiopathic pulmonary fibrosis (IPF) ...
Business Wire

FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the ...