Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Production & Manufacturing
Process & Production
Return to: PBR Home | Production & Manufacturing | Process & Production
Search Refinements
Search Results: Process & Production
1-15 of 2268 results
Teva seeks FDA approval for migraine drug fremanezumab
By PBR Staff Writer
Israel-based Teva Pharmaceutical Industries is seeking approval of its migraine drug fremanezumab in the US having filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
Ignyta’s Entrectinib gets EMA prime designation for NTRK fusion-positive solid tumors
Ignyta’s entrectinib has been granted Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Production & Manufacturing > Process & Production > News
FDA panel backs approval of Aerie’s Rhopressa for glaucoma treatment
By PBR Staff Writer
Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution) 0.02% has been recommended for approval by an advisory panel of the US Food and Drug Administration (FDA) for the treatment of glaucoma and ocular hypertension.
Production & Manufacturing > Process & Production > News
FDA panel supports Spark Therapeutics gene therapy approval for rare form of blindness
By PBR Staff Writer
Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been recommended for approval by an advisory panel of the US Food and Drug Administration (FDA) for the treatment of blindness caused by an inherited retinal disease (IRD).
Production & Manufacturing > Process & Production > News
Gilotrif gets FDA priority review for uncommon EGFR mutations in advanced NSCLC
Boehringer Ingelheim reported that the supplemental New Drug Application (sNDA) for Gilotrif (afatinib) has been accepted for filing and secured Priority Review from the US Food and Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
AstraZeneca gets FDA breakthrough therapy designation for Tagrisso
By PBR Staff Writer
AstraZeneca’s cancer drug Tagrisso (osimertinib) has secured the Breakthrough Therapy Designation (BTD) in the US for the first line treatment of non-small cell lung cancer (NSCLC).
Production & Manufacturing > Process & Production > News
Roche's Perjeta regimen secures FDA priority review in breast cancer
The US Food and Drug Administration (FDA) has granted priority review for Roche’s Perjeta in combination with Herceptin and chemotherapy to treat HER2-positive early breast cancer after surgery.
Production & Manufacturing > Process & Production > News
CHMP recommends GSK, Innoviva’s single inhaler triple therapy for COPD
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
Production & Manufacturing > Process & Production > News
FDA advisory panel recommends approval of GSK’s shingles vaccine Shingrix
By PBR Staff Writer
An advisory committee of the US Food and Drug Administration (FDA) has recommended the approval of GlaxoSmithKline’s (GSK) Shingrix vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
Production & Manufacturing > Process & Production > News
Deciphera gets FDA orphan drug designation for DCC-2618 to treat glioblastoma multiforme and anaplastic astrocytoma
Deciphera Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of glioblastoma multiforme and anaplastic astrocytoma.
Production & Manufacturing > Process & Production > News
Bayer submits BLA to FDA for BAY94-9027 to treat Hemophilia A
By PBR Staff Writer
Bayer is seeking approval from the US Food and Drug Administration (FDA) for its its long-acting factor VIII, BAY94-9027, to treat Hemophilia A.
Production & Manufacturing > Process & Production > News
Roche secures priority review from FDA for haemophilia A drug emicizumab
By PBR Staff Writer
Roche's emicizumab prophylaxis (preventative) has been granted priority review by the US Food and Drug Administration (FDA) for haemophilia A with factor VIII inhibitors.
Production & Manufacturing > Process & Production > News
Epygenix gets FDA orphan drug status for EPX-300 to treat Dravet Syndrome
Epygenix Therapeutics has secured orphan drug status from the US Food and Drug Administration (FDA) for its EPX-300 to treat patients with Dravet Syndrome.
Production & Manufacturing > Process & Production > News
Seattle Genetics gets FDA priority review for Adcetris in Cutaneous T-Cell Lymphoma
Seattle Genetics reported that the US Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
Production & Manufacturing > Process & Production > News
H3 Biomedicine gets FDAorphan drug status for acute myelogenous leukemia treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation for H3 Biomedicine's H3B-8800, its lead clinical compound for the treatment of patients with Acute Myelogenous Leukemia (AML) and Chronic Myelomonocytic Leukemia (CMML).
Production & Manufacturing > Process & Production > News
1-15 of 2268 results