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MONARCH 2 clinical trial results : Verzenio, fulvestrant combo improves overall survival in metastatic breast cancer

MONARCH 2 clinical trial results : Verzenio, fulvestrant combo improves overall survival in metastatic breast cancer

MONARCH 2 clinical trial results : Eli Lilly and Company (Lilly) said that Verzenio (abemaciclib) in combination with fulvestrant delivered a statistically significant improvement in overall survival in the phase 3 MONARCH 2 clinical trial held for a type of metastatic breast cancer. The US pharma giant said that the MONARCH 2 clinical trial results […]

Mylan Upjohn merger : Pfizer to merge off-patent drugs unit with Mylan

Mylan Upjohn merger : US pharma giant Pfizer will spin off Upjohn, its off-patent branded and generic established medicines business, and merge it with Dutch pharma company Mylan, to form a new global pharma company. As per the terms of the all-stock, Reverse Morris Trust transaction, each of Mylan shares will be converted into one […]

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Janssen’s Ponesimod OPTIMUM trial in MS meets primary endpoint

Ponesimod OPTIMUM trial results :  Johnson & Johnson’s Janssen Pharmaceutical said that the phase 3 OPTIMUM clinical trial evaluating ponesimod yielded positive results compared to Aubagio (teriflunomide) in adults having relapsing multiple sclerosis (MS). The OPTIMUM clinical trial, which enrolled 1,133 participants, assessed the efficacy and safety of the selective sphingosine-1-phosphate receptor 1 (S1P1) modulator […]

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Boehringer Ingelheim secures Ofev FDA approval recommendation for SSc-ILD

Ofev FDA approval recommendation: The US FDA’s Arthritis Advisory Committee has recommended approval of Boehringer Ingelheim’s kinase inhibitor Ofev (nintedanib) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The committee’s Ofev FDA approval recommendation was driven by the findings of the phase 3 SENSCIS trial, held in patients with SSc-ILD, a disease for […]

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Kodiak Sciences reports positive KSI-301 phase 1b results

KSI-301 phase 1b results : Kodiak Sciences, a California-based retinal medicines development company, said that a phase 1b clinical trial evaluating its investigational intravitreal anti-VEGF antibody biopolymer conjugate KSI-301 has yielded positive interim results. KSI-301 is being studied in patients with anti-VEGF treatment-naïve neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular […]

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NeuroVive secures NeuroSTAT FDA fast track designation for TBI

NeuroSTAT FDA fast track designation : Swedish mitochondrial medicine company NeuroVive Pharmaceutical has secured Fast Track designation from the US Food and Drug Administration (FDA) for NeuroSTAT for the treatment of moderate to severe traumatic brain injury (TBI). NeuroVive said that NeuroSTAT FDA fast track designation will enable the drug’s clinical development and a direction […]

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Italian pharma company Zambon acquires Breath Therapeutics for €140m

Zambon acquisition of Breath Therapeutics : Italian pharma company Zambon has acquired German biopharma company Breath Therapeutics and its subsidiaries for €140 million, which can potentially go up to total €500 million based on the latter’s achievement of certain regulatory and sales milestones. Breath Therapeutics, which is based in Munich as well as Menlo Park […]

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Aptar wins FDA approval for Unidose Powder System for nasal spray of hypoglycemia drug

AptarGroup (Aptar) said that its Unidose Powder System has been approved by the US Food and Drug Administration (FDA) for the intranasal, needle-free rescue treatment drug – Lilly’s Baqsimi nasal powder, which was indicated for the treatment of severe hypoglycemia in people with diabetes. (Read Baqsimi FDA approval) The announcement marks the first approval by […]

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Proteostasis begins dosing in phase 2 cystic fibrosis trial

Boston-based biopharma company Proteostasis Therapeutics has dosed the first patient in a phase 2 clinical trial of its cystic fibrosis transmembrane conductance regulator (CFTR) modulator combinations in F508del homozygous and heterozygous cystic fibrosis patients. The 28-day phase 2 study has been initiated after getting positive results from the 14-day phase 1 clinical studies of the […]

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Lilly secures Baqsimi FDA approval for severe hypoglycemia

Baqsimi FDA approval : Eli Lilly and Company (Lilly) has secured the US Food and Drug Administration (FDA) approval) for Baqsimi nasal powder for the treatment of severe hypoglycemia in patients with diabetes aged four years and older. According to the FDA, Baqsimi is the first glucagon therapy approved for the emergency treatment of the […]

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