Industry News

- Read more about Glenmark Pharmaceuticals receives ANDA approval for Rosuvastatin Calcium Tablets
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor® Tablets, 5 mg, 10 mg, 20 mg, and 40 mg of IPR Pharmaceuticals, Inc. (IPR).
- Read more about Gilead 's two phase 3b studies evaluating Odefsey meets primary objectives
Gilead Sciences, Inc. announced that two phase 3b switch studies evaluating Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) for the treatment of HIV-1 infection met their primary objectives. The ongoing studies were designed to explore the efficacy and safety of Odefsey among virologically suppressed adult patients switching from the tenofovir disoproxil fumarate (TDF)-based regimens Complera (emtricitabine 200mg/rilpivirine 25mg/tenofovir disoproxil fumarate 300mg) (Study 1216) or Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) (Study 1160). Odefsey combines Gilead's emtricitabine and tenofovir alafenamide with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
- Read more about Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT
Relievant Medsystems, Inc., a privately held medical device company pioneering the therapy of nerve ablation within vertebral bodies for the treatment of chronic low back pain, announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the INTRACEPT® Intraosseous Nerve Ablation System.
- Read more about CytoDyn Submits Orphan Drug Application to FDA for Pretreatment With PRO 140
CytoDyn Inc. announces that it has submitted to the U.S. Food And Drug Administration (FDA) an application for orphan drug designation for the use of PRO 140 (humanized monoclonal antibody to CCR5) in the pretreatment of HIV Type-1 (HIV-1) infection in treatment-naïve adults while they are waiting for drug resistance assay results to construct a subsequent Highly Active Antiretroviral Therapy (HAART) regimen. The generation of these assay results typically takes approximately two weeks.
- Read more about FDA Authorize Viracor-IBT Laboratories, Inc.’s Zika Virus RT-PCR Test for Emergency Use
Viracor-IBT Laboratories, Inc., a wholly-owned subsidiary of Eurofins Scientific (EUFI.PA), announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Zika Virus Real-time RT-PCR assay.
- Read more about FDA Acceptable Filing Letter of Lannett’s ANDA for Fentanyl Patch
Lannett Company, Inc. announced that its strategic partner, Sparsha Pharma USA, Inc., has received an Acceptable for Filing letter from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the generic equivalent of Ortho McNeil's chronic pain treatment Duragesic®.

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- Read more about AveXi’s AVXS-101 Receives U.S. FDA Breakthrough Therapy Designation
AveXis, Inc., a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for AVXS-101, the company’s lead development candidate for the treatment of spinal muscular atrophy (SMA) Type 1 in pediatric patients.
- Read more about EMA accepted Biosimilar Pegfilgrastim
The European Medicines Agency (EMA) has accepted for review, Mylan’s Marketing Authorization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
- Read more about Eisai and Arena Pharmaceuticals receive regulatory approval of VENESPRI in Mexico
Eisai Inc. and Arena Pharmaceuticals, Inc. announced that the Federal Commission for the Protection Against Sanitary Risk has granted regulatory approval of the chronic weight management agent VENESPRI^® for commercialization by Eisai Laboratorios in Mexico.
- Read more about U.S.FDA expanded indication for Synjardy
The U.S. Food and Drug Administration has approved an expanded indication for Synjardy^® (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). SYNJARDY, from Boehringer Ingelheim and Eli Lilly and Company, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both empagliflozin and metformin is appropriate.