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European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

Combinationpipeline review2016-04-26 17:34 Read   278

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection.

AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis

New Combinationpipeline review2016-04-26 17:30 Read   183

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).

Bevespi Aerosphere™ approved by the US FDA for patients with COPD

DosagePIPELINEREVIEW2016-04-26 17:22 Read   415

AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Cabozantinib (CABOMETYX)

NCE ApprovalFDA2016-04-26 10:52 Read   149

the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe

DosageSynthon2016-04-13 10:45 Read   193

Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone®* for the treatment of relapsing remitting multiple sclerosis (RRMS).

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

NCE ApprovalFDA 2016-04-12 09:53 Read   231

The U.S. FDA today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy.

Sandoz receives EC approval for subcutaneous route of administration in biosimilar Binocrit's® nephrology indication

GenericNovartis2016-04-11 11:11 Read   189

Sandoz, a Novartis division and the global leader in biosimilars, announced today that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit's® (epoetin alfa) nephrology indication*.

FDA Approves BromSite

NCE ApprovalDRUGS2016-04-11 10:49 Read   183

Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)

EU approval for Revolade for children with rare blood disorder

Indicationpharmatimes2016-04-11 10:37 Read   187

The European Commission has approved Novartis’ Revolade (eltrombopag) as a first-in-class therapy for children aged one and over with chronic idiopathic thrombocytopenic purpura (ITP) that have not responded to other treatments.

European Commission Approves Bristol-Myers Squibb’s Opdivo® (nivolumab) for Previously Treated Advanced Renal Cell Carcinoma

IndicationBristol-Myers Squibb Company2016-04-08 16:51 Read   228

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults.

European Commission Approves Expanded Use of Opdivo® (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

IndicationBristol-Myers Squibb Company2016-04-08 16:38 Read   186

This approval expands Opdivo’s existing lung cancer indication in previously treated metastatic squamous NSCLC to include the non-squamous patient population, which together represents 85% of lung cancer cases

Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP

IndicationNovartis2016-04-08 13:51 Read   471

Novartis announced today that the European Commission (EC) has approved Revolade® (eltrombopag) for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).