Industry News

- Read more about FDA approves new orphan drug to treat pulmonary arterial hypertension
U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.
- Read more about FDA approves Zurampic to treat high blood uric acid levels associated with gout
The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.
- Read more about Merck KGaA, Darmstadt, Germany and Pfizer Advance Clinical Development Program with Two Additional Phase III trial of Avelumab
Merck KGaA, Darmstadt, Germany and Pfizer announced the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer. The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.
- Read more about Brilique receive positive opinion of EMA committee for extended treatment of patients with history of heart attack
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Astrazeneca's Brilique (ticagrelor) 60mg for the treatment of patients with a history of heart attack and at high risk of having a further atherothrombotic event. The opinion states that, treatment may be started as continuation therapy after an initial one-year treatment with dual anti platelet therapy.

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- Read more about Boehringer Ingelheim's BI 1482694 get US FDA Breakthrough Therapy status
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Boehringer Ingelheim's novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The BTD is based on results from the phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore.
- Read more about EMA committee recommends marketing approval for AstraZeneca's Tagrisso
AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
- Read more about Torax Medical get US FDA approval for Fenix continence restoration system
The US Food and Drug Administration approved Torax Medical In's Fenix continence restoration system to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
- Read more about CHMP issues positive opinion on lesinurad for Gout
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorisation of lesinurad 200mg tablets. Lesinurad, in combination with a xanthine oxidase inhibitor (XOI), is recommended for the adjunctive treatment of hyperuricaemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid levels (sUA) with an adequate dose of a XOI alone.
- Read more about Cipla introduce Hepcvir-L for chronic hepatitis C genotype 1 patients
Cipla Ltd, a Rs. 10,880 crore plus fifth largest pharma company in India, has launched generic drug ledipasvir-sofosbuvir in India under the brand name Hepcvir-L. Hepcvir- L, the first once-a-day, fixed-dose oral combination therapy that has been approved for chronic hepatitis C genotype 1 patients.
- Read more about FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
The U.S. Food and Drug Administration approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. The LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation based in Pittsburgh, Pennsylvania.