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1-15 of 1882 results
Pharming submits supplemental BLA to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).
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Janssen seeks EMA approval for Darzalex for newly diagnosed multiple myeloma
Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), for its immunotherapy Darzalex (daratumumab).
Production & Manufacturing > Process & Production > News
EMA grants PRIME designation for Mereo’s BPS-804 to treat osteogenesis imperfecta
Mereo BioPharma Group’s BPS-804 has been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of osteogenesis imperfecta (OI), or "brittle bone disease."
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EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.
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Novartis seeks FDA approval for second Kymriah indication
Novartis has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
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Merck withdraws European application for Keytruda in first-line NSCLC
By PBR Staff Writer
Merck has withdrawn its European application seeking approval of its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin (pem/carbo) in Europe as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC).
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Novartis’ cancer combo Tafinlar and Mekinist gets FDA breakthrough status
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation after complete resection.
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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).
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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.
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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.
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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).
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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).
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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).
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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.
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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.
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