Insight on submission of USFDA sBLA of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)
Posted on18 Sep 2019
TagsJanssen, Janssen Biotech, Janssen Pharma, MorphoSys AG, sBLA, supplemental Biologics License Application, Tremfya
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MorphoSys AG, a clinical-stage biopharmaceutical company, announced that its licensee Janssen Research & Development, submitted a supplemental Biologics License Application (sBLA) to... Read More
Insight on Boehringer Ingelheim’s new indication approval for Ofev to slow the rate of decline in pulmonary function in patients with Ssc-ILD
Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) approved Ofev (nintedanib) as the first and only medicine to slow... Read More
Takeda recalled of NATPARA (a parathyroid hormone) in US
Takeda Pharmaceutical Company Limited, on 6 Sep 2019, announced that the company is issuing a US recall for all doses of NATPARA®... Read More
Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab
Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a... Read More
Insight on USFDA approval of new add-on drug, Nourianz (istradefylline), to treat off episodes in adults with Parkinson’s disease
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s... Read More
Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)
U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment... Read More
Turalio: USFDA approval of first therapy for rare joint tumor
U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell... Read More
Take a Self Competency Test in European Drug Regulatory Affairs
Posted on07 Aug 2019
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Effective regulatory strategic planning is a challenging as different regions and countries need to follow different regulatory requirements for Marketing Authorization Application... Read More
Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals
The U.S. Food and Drug Administration (FDA) inspected drug manufacturing facility, Strides Pharma Science Limited at Unit-II, R. S. No.: 32, 33... Read More
Case Study : Rituxan – A Brand which Pharma Industry reckon
Brand Name: Rituxan Company: Roche 2017 U.S. sales: $4.41 billion Disease: Blood cancers, rheumatoid arthritis Dosage form: Injection for Intravenous Use Rituxan (rituximab) is a... Read More