Pirfenidone News and Research

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Cipla launches generic Pirfenidone for IPF

Cipla, among the world's leading generic pharmaceutical companies, has introduced Pirfenidone in India under the brand name Pirfenex, for the treatment of IPF. A chronic progressive form of lung disease, IPF has average survival rates as low as 3-5 years which is less than many cancers. Till now there is no approved treatment for IPF.

20 Oct 2010

Roche receives development and commercialization rights for danoprevir drug

InterMune, Inc. today announced that it has sold worldwide development and commercialization rights to danoprevir (also known as RG7227 or ITMN-191) to Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd. for $175 million in cash.

7 Oct 2010

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

InterMune, Inc. today announced that four oral presentations related to the company's development program for pirfenidone and idiopathic pulmonary fibrosis will be presented at the Annual Congress of the European Respiratory Society, to be held September 18-22 in Barcelona, Spain.

13 Sep 2010

InterMune second-quarter total revenue decreases to $5.9 million

InterMune, Inc. today announced results from operations for the second quarter and six months ended June 30, 2010. InterMune also highlighted its recent clinical development and business activities, and provided forward-looking financial guidance for 2010.

28 Jul 2010

Data on Qnexa to be presented at World Congress on CODHy in Prague

VIVUS, Inc. today announced that data on Qnexa, an investigational drug candidate, will be presented at the 3rd World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension in Prague, Czech Republic.

13 May 2010

Stereotaxis to be featured prominently in 31st HRS

Stereotaxis' safety and efficacy in the treatment of patients with complex arrhythmias such as atrial fibrillation, ventricular tachycardia, and congenital heart defects will be featured prominently in the scientific program of the 31st Annual Heart Rhythm Scientific Sessions in Denver, Colorado. Eight podium presentations and eight posters will underscore the broad clinical leadership that Stereotaxis has achieved in the treatment of patients with complex cardiac arrhythmias.

13 May 2010

Graymark Healthcare first-quarter consolidated net revenues increase 7% to $27.6 million

Graymark Healthcare, Inc. today announced progress on Fiscal 2010 Initiatives and financial results for the Quarter ending March 31, 2010.

13 May 2010

PAREXEL further expands presence in China with offices in Chengdu and Guangzhou

PAREXEL International Corporation, a leading global biopharmaceutical services provider, today announced that the Company has opened offices in Chengdu and Guangzhou, China to support a growing requirement for a broad range of clinical development and regulatory consulting capabilities in the country and throughout the Asia/Pacific region.

From Parexel 13 May 2010

Solta Medical honored with Provectus Award at first annual Bright Lights Conference

Solta Medical, Inc., a global leader in the medical aesthetics market, today announced that it has received the Provectus Award presented by MDB Capital Group at the first annual Bright Lights Conference, the first public company conference to focus exclusively on companies with disruptive and market changing intellectual property (IP).

13 May 2010

Amira Pharmaceuticals' LPA1 receptor antagonist program data published in British Journal of Pharmacology

Amira Pharmaceuticals, Inc. announced today that preclinical data from its LPA1 receptor antagonist program has been published in the British Journal of Pharmacology.

7 May 2010

FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

The Coalition for Pulmonary Fibrosis (CPF), representing tens of thousands of patients, is responding to the news that the FDA chose to ask for further study of Pirfenidone, which will delay potential approval of the first drug in the treatment of Pulmonary Fibrosis (PF), a lethal lung disease that is irreversible, progressive and deadly in an average of three years. On March 9, 2010, an FDA Advisory Committee recommended approval of the drug by the FDA.

5 May 2010

New findings show seaweed extract inhibits H1N1 virus

In a breakthrough that offers new hope for the containment of influenza outbreaks, an Australian biotechnology company has isolated a natural extract from seaweed which has been shown to inhibit the H1N1 virus.

5 May 2010

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

InterMune, Inc. today announced results of all three cohorts from a 15-day Phase 1b multiple-ascending-dose (MAD) study of low doses of danoprevir (also known as RG7227 and ITMN-191) boosted by low-dose ritonavir (RTV) in patients chronically infected with hepatitis C virus (HCV) genotype-1.

16 Apr 2010

EMA validates InterMune's pirfenidone MAA for IPF

InterMune, Inc. today announced that the company's Marketing Authorization Application (MAA), submitted on March 2 seeking approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, was validated by the European Medicines Agency (EMA). Validation of the MAA by the EMA indicates that the application is complete and that the review process will begin on March 24. The proposed trade name for pirfenidone in both the United States and Europe is Esbriet®.

23 Mar 2010

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

The Coalition for Pulmonary Fibrosis and the Pulmonary Fibrosis Foundation are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options.

15 Mar 2010

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

InterMune, Inc. announced today that the U.S. Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.

9 Mar 2010

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

InterMune, Inc. announced that NASDAQ has today halted trading of InterMune's common stock. The Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration meets today to review and discuss the company's New Drug Application for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis.

9 Mar 2010

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune, Inc. announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting to review the New Drug Application (NDA) for pirfenidone, InterMune's investigational drug candidate for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. The proposed trade name for pirfenidone is Esbriet®.

5 Mar 2010

InterMune seeks European marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in the European Union (EU). Currently, there are no EMA-approved treatments for IPF in the EU.

2 Mar 2010

FDA grants Priority Review designation for InterMune's NDA for pirfenidone

InterMune, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted Priority Review designation for the company's New Drug Application (NDA) for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

4 Jan 2010

Pirfenidone News and Research

Cipla launches generic Pirfenidone for IPF

Roche receives development and commercialization rights for danoprevir drug

InterMune's development program for pirfenidone, IPF to be presented at Annual Congress of ERS

InterMune second-quarter total revenue decreases to $5.9 million

Data on Qnexa to be presented at World Congress on CODHy in Prague

Stereotaxis to be featured prominently in 31st HRS

Graymark Healthcare first-quarter consolidated net revenues increase 7% to $27.6 million

PAREXEL further expands presence in China with offices in Chengdu and Guangzhou

Solta Medical honored with Provectus Award at first annual Bright Lights Conference

Amira Pharmaceuticals' LPA1 receptor antagonist program data published in British Journal of Pharmacology

FDA's call for further review of pirfenidone disappointing for Pulmonary Fibrosis patients, says CPF

New findings show seaweed extract inhibits H1N1 virus

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

EMA validates InterMune's pirfenidone MAA for IPF

CPF, PFF applaud PF patients' efforts to plead with FDA Advisory Panel regarding lack of treatment options

FDA's Advisory Committee votes 9-3 to recommend approval of Esbriet for treatment of patients with IPF

NASDAQ halts trading of InterMune's common stock, FDA PADAC to discuss pirfenidone NDA

FDA's PADAC meeting to review pirfenidone NDA: InterMune posts briefing documents

InterMune seeks European marketing approval for pirfenidone

FDA grants Priority Review designation for InterMune's NDA for pirfenidone

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