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16-30 of 1906 results
FDA committee votes in favor of Pfizer's Xeljanz for ulcerative colitis
By PBR Staff Writer
Pfizer has received a positive response from the Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) on Xeljanz (tofacitinib) to treat adult patients with moderately to severely active ulcerative colitis (UC).
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FDA grants priority review to Shionogi's lusutrombopag
Shionogi's new drug application (NDA) for lusutrombopag (S-888711) has been accepted for filing and granted priority review by the US Food & Drug Administration (FDA).
Production & Manufacturing > Process & Production > News
EMA to review GW Pharmaceuticals' MAA for antiepileptic drug Epidiolex
The European Medicines Agency (EMA) has accepted for review GW Pharmaceuticals' marketing authorization application (MAA) for Epidiolex (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
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EMA to review Teva's MAA for migraine prevention drug fremanezumab
By PBR Staff Writer
Teva Pharmaceutical Industries' marketing authorization application (MAA) for fremanezumab has been accepted by the European Medicines Agency (EMA) for the prevention of episodic and chronic migraine in adults.
Production & Manufacturing > Process & Production > News
FDA grants fast track status to Takeda’s Zika virus vaccine candidate
By PBR Staff Writer
Takeda Pharmaceutical has secured fast track designation from the US Food and Drug Administration (FDA) for its Zika virus vaccine candidate, TAK-426.
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Synthon’s SYD985 granted FDA fast track status for pre-treated HER2-positive metastatic breast cancer
Synthon Biopharmaceuticals has secured has granted Fast track designation from the US Food & Drug Administration (FDA) for its investigational anti-HER2 antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985).
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CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease
Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).
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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).
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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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16-30 of 1906 results