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Process & Production

Neos resubmits ADHD drug application for FDA review By PBR Staff Writer
Neos Therapeutics has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its amphetamine XR orally disintegrating tablet (XR-ODT) product candidate, NT‐0202, to treat attention deficit hyperactivity disorder (ADHD).
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Juno IND application given FDA nod for leukemia drug candidate JCAR015 By PBR Staff Writer
The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of biopharmaceutical firm Juno Therapeutics for its product candidate JCAR015 to treat adults with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
Production & Manufacturing > Process & Production > News AbbVie's Humira gets European approval to treat hidradenitis suppurativa By PBR Staff Writer
US-based biopharmaceutical firm AbbVie has received approval from the European Commission (EC) to market Humira (adalimumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS treatment.
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KaloBios' IND application for KB003 gets FDA clearance to treat patients with CMML
By PBR Staff Writer
KaloBios Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for KB003, an anti-GM-CSF monoclonal antibody (mAb), to treat patients with chronic myelomonocytic leukemia (CMML).
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Lightlake partner Adapt Pharma submits NDA to FDA for Narcan nasal spray
Lightlake Therapeutics announced that Adapt Pharma Limited (Adapt), Lightlake's partner for treating opioid overdose with intranasal naloxone, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray, an investigational drug intended to treat opioid overdose.
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FDA accepts ZS Pharma's ZS-9 NDA to treat hyperkalemia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for filing ZS Pharma's new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia.
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ZIOPHARM gets FDA orphan drug status for Ad-RTS-hIL-12 to treat malignant glioma
ZIOPHARM Oncology, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for Ad-RTS-hIL-12 + veledimex in the treatment of patients with malignant glioma.
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AbbVie's Technivie gets FDA approval to treat genotype 4 chronic hepatitis C
By PBR Staff Writer
AbbVie has received approval from the US Food and Drug Administration (FDA) for Technivie (ombitasvir, paritaprevir, and ritonavir tablets) in combination with ribavirin (RBV) to treat adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection who do not have cirrhosis.
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EMA accepts Merck's MAA for grazoprevir/elbasvir to treat chronic hepatitis C infection
Merck, known as MSD outside the US and Canada, announced the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for grazoprevir/elbasvir (100mg/50mg), an investigational, once-daily, single-tablet combination therapy for the treatment of adult patients with chronic hepatitis C (HCV) genotypes (GT) 1, 3, 4 or 6 infection.
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Janssen submits sNDA for Olysio in combination with Sofosbuvir to treat CHC infection
By PBR Staff Writer
Janssen Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor.
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EMA validates Bristol-Myers's two type II variation applications to extend Opdivo indication
By PBR Staff Writer
The European Medicines Agency (EMA) has validated two of Bristol-Myers Squibb's type II variation applications, which seek to extend the current indication for its Immuno-Oncology agent, Opdivo.
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Amgen submits sNDA to FDA for Kyprolis to treat relapsed multiple myeloma
By PBR Staff Writer
Amgen has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) seeking approval for an expanded indication of Kyprolis (carfilzomib) for Injection to treat patients with a form of blood cancer, relapsed multiple myeloma.
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Cardiome submits supplemental new drug submission for Aggrastat to Health Canada
Cardiome Pharma announced that it has submitted a supplemental new drug submission (sNDS) to Health Canada's Therapeutic Products Directorate for Aggrastat (tirofiban hydrochloride).
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