Latest Posts Under: Pharma Industry News

Eiger bags FDA breakthrough therapy status for HDV drug candidate Lambda

US biopharma company Eiger BioPharmaceuticals said that peginterferon lambda (Lambda) has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of hepatitis delta virus (HDV) infection. Breakthrough therapy designation enables expedition of the development and review of drugs intended for the treatment of a serious condition and where […]

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NKMax America launches SNK01-MX03 clinical trial in plaque psoriasis

SNK01-MX03 clinical trial : NKMax America, a US biotech company, has initiated a phase 1 trial called SNK01-MX03 to investigate its ex vivo expanded autologous natural killer cell therapeutic SNK in plaque psoriasis. In this connection, NKMax America treated the first patient in the SNK01-MX03 clinical trial, which is a single center, dose-escalation study for […]

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Mexican pharma company Sanfer secures $500m investment from CDPQ

CDPQ investment in Sanfer : Mexican pharma company Sanfer has secured a $500 million minority investment from Canadian long-term institutional investor Caisse de dépôt et placement du Québec (CDPQ) to help it execute its continued expansion plans across Mexico and the Latin American region. In the last 20 years, Sanfer claims to have closed more than […]

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Nabriva secures Xenleta FDA approval for community-acquired pneumonia

Xenleta FDA approval : Irish pharma company Nabriva Therapeutics has bagged approval from the US Food and Drug Administration for its semi-synthetic pleuromutilin antibiotic Xenleta (lefamulin) for the treatment of community-acquired bacterial pneumonia in adults. Community-acquired pneumonia is caused when someone develops pneumonia in the community, that is not in a hospital. Pneumonia is a […]

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Celgene bags Inrebic FDA approval for myelofibrosis

Inrebic FDA approval : Celgene’s subsidiary Impact Biomedicines, has bagged approval for its oral kinase inhibitor Inrebic (fedratinib) capsules from the US Food and Drug Administration (FDA) for the treatment of certain types of myelofibrosis, a rare bone marrow cancer. Fedratinib FDA approval is for the treatment of adult patients with intermediate-2 or high-risk primary […]

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Alfasigma USA launches IBS-C drug ZELNORM in US

Alfasigma USA has launched ZELNORM (tegaserod) tablets in the US as a prescription drug for irritable bowel syndrome with constipation (IBS-C) in adult women aged under 65 years. ZELNORM was acquired by Alfasigma USA in July 2019 from Sloan Pharma, a subsidiary of US WorldMeds. Bryan Downey – president and CEO of Alfasigma USA said: “We […]

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AbbVie secures Rinvoq FDA approval for rheumatoid arthritis

Rinvoq FDA approval : US biopharma company AbbVie has bagged approval from the US Food and Drug Administration (FDA) for its 15mg, daily once oral, small molecule Janus kinase (JAK) inhibitor – Rinvoq (upadacitinib) for the treatment of moderately to severely active rheumatoid arthritis (RA). The FDA approval for Rinvoq is for the treatment of […]

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FDA approves CVRx Barostim Neo System for advanced heart failure symptoms

CVRx, a Maple Grove-based medical device company, has secured approval for its implantable technology – Barostim Neo System from the US Food and Drug Administration (FDA) to improve symptoms in patients with advanced heart failure. As per the FDA approval for the CVRx Barostim Neo System, the medical device has to be used in patients […]

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Bio-Thera Solutions begins phase 1 trial for Simponi biosimilar BAT2506

Chinese biotech company Bio-Thera Solutions has started dosing in a phase 1 clinical trial to study the pharmacokinetics and safety of BAT2506, a proposed biosimilar of Janssen Biotech’s Simponi (golimumab). The early-stage clinical study is a randomized two-arm, parallel-group trial that will have nearly 182 healthy volunteers. Each of the patients will be subjected to […]

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Neuropore gets FDA orphan drug designation for NPT520-34 for ALS

Neuropore Therapies has secured orphan drug designation for NPT520-34 from the US Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS). The California-based biopharma company said that the orphan drug designation will enable the development of NPT520-34 in the treatment of the debilitating medical condition for which there are not many […]

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