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Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday approved Abrysvo (respiratory syncytial virus vaccine). 23 October 2024
Biotechnology
Shares in Sangamo Therapeutics surged around 40% on Tuesday, following the announcement that the US Food and Drug Administration has granted the company a faster path to approval for its gene therapy ST-920 (isaralgagene civaparvovec) for Fabry disease. 23 October 2024
Pharmaceutical
Shares of Swedish drugmaker Camurus fell almost 10% to 588.50 kroner yesterday after it revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. 23 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Biotechnology
Biotech firm Gilead Sciences has announced plans to voluntarily withdraw the US accelerated approval for Trodelvy (sacituzumab govitecan-hziy) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. 21 October 2024
Biotechnology
The US Food and Drug Administration has approved Vyloy (zolbetuximab-clzb), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine and platinum-containing chemotherapy, from Japanese drug major Astellas Pharma. 19 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has placed a partial clinical hold on the two-stage, open-label, randomized Phase III trial, PRESERVE-003 (NCT05671510). 18 October 2024
Biotechnology
The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
Biotechnology
UK pharma major AstraZeneca said today that its Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. 5 January 2023
Biotechnology
The Food and Drug Administration (FDA) has now approved TG Therapeutics’ Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 31 December 2022
Biotechnology
Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab). 30 December 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Olpruva (sodium phenylbutyrate; ACER-001) for oral suspension for the treatment of certain patients living with urea cycle disorders (UCDs). 28 December 2022
Biosimilars
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Pharmaceutical
Following marketing authorization by the European Commission in August for the same indication, the US Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. 23 December 2022
Biotechnology
Ahead of the expected December 29 action date, and adding to European approval in June, the US Food and Drug Administration (FDA) yesterday granted marketing authorization for Swiss pharma giant Roche subsidiary Genentech’s Lunsumio (mosunetuzumab-axgb). 23 December 2022
Generics
Indian generics major Zydus Lifesciences, formerly known as Cadila Healthcare, subsidiary Zydus Worldwide has received final approval from the US Food and Drug Administration (FDA) to market Selexipag Tablets, 200mcg, 400mcg, 600mcg, 800mcg, 1,000mcg, 1,200mcg, 1,400mcg, and 1,600mcg. 22 December 2022
Biotechnology
Roche company Genentech has won US approval for its intravenous Actemra (tocilizumab) product, for adults that have been hospitalized with COVID-19. 22 December 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Applications (sBLAs) for Seagen and Astellas’ Padcev (enfortumab vedotin-ejfv) and Merck & Co’s Keytruda (pembrolizumab). 20 December 2022
Pharmaceutical
Switzerland-based Idorsia today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. 20 December 2022
Biotechnology
Chinese biopharma Hutchmed has started the filing of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib. 19 December 2022
Biotechnology
The US Food and Drug Administration has approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. 19 December 2022
Pharmaceutical
Big pharma pairing AstraZeneca and Merck & Co announced a rare setback with their blockbuster PARP inhibitor Lynparza (olaparib) in prostate cancer on Thursday. 16 December 2022
Biotechnology
As the year draws to a close, this article presents some of the wins of the orphan drug community in terms of US FDA approvals, while highlighting challenges faced by the sector and looking ahead to the expectations of the next year. 15 December 2022
Pharmaceutical
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Biotechnology
A second KRAS blocker has won US approval, opening further a market in oncology based on a target that was once thought undruggable. 13 December 2022
Biotechnology
On December 9, the US Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), from Genentech, a USA-based subsidiary of Swiss pharma giant Roche, for adult and pediatric patients two years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). 12 December 2022
Biosimilars
The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen for BIIB800, a biosimilar candidate referencing Roche’s Actemra, an anti-interleukin-6 receptor monoclonal antibody. 12 December 2022
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