Regulatory approval news - the latest biotech news from Labiotech

Endometrial cancer drug receives breakthrough therapy designation in China

Jim Cornall — Thu, 20 Jul 2023 15:36:06 +0000

HUTCHMED (China) Limited has announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to the combination of fruquintinib and sintilimab (a PD-1 antibody) for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed at least one line of platinum-based […]

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FDA approves Beyfortus ahead of 2023-24 RSV season

Jim Cornall — Tue, 18 Jul 2023 08:28:06 +0000

The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The approval also covers children up to 24 months of age who remain vulnerable to severe […]

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FDA approves Alzheimer’s treatment

Jim Cornall — Fri, 07 Jul 2023 09:15:00 +0000

Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use. The decision makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression […]

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Narcolepsy drug gets Chinese approval

Jim Cornall — Wed, 05 Jul 2023 10:31:12 +0000

RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, has announced that the Chinese National Medical Products Administration (NMPA) has approved pitolisant (Wakix) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. In China, pitolisant is the first approved innovative drug for […]

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Innovent and IASO Bio obtain approval for CAR-T multiple myeloma treatment

Jim Cornall — Tue, 04 Jul 2023 09:32:25 +0000

Innovent Biologics, Inc. and IASO Biotechnology have announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel). FUCASO is the first fully-human BCMA-directed chimeric antigen receptor (CAR) T-cell therapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior […]

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FDA approves BioMarin gene therapy for hemophilia A

Jim Cornall — Fri, 30 Jun 2023 08:21:23 +0000

BioMarin Pharmaceutical Inc. has announced that the United States Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test. The […]

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FDA gives Orphan Drug Designation to CellCentric multiple myeloma drug

Jim Cornall — Thu, 29 Jun 2023 10:09:31 +0000

CellCentric, a UK-based biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inobrodib in the treatment of multiple myeloma. Delivered as an oral capsule, inobrodib can be used at home without requiring intensive monitoring. It is a first-in-class drug, with a new mechanism of action. It […]

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UCB myasthenia gravis drug given FDA approval

Jim Cornall — Tue, 27 Jun 2023 09:21:34 +0000

UCB has announced RYSTIGGO (rozanolixizumab-noli) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. Rozanolixizumab-noli injection for subcutaneous infusion is a humanized IgG4 monoclonal antibody that binds to the neonatal […]

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AbbVie takes step forward in Europe with migraine drug

Jim Cornall — Mon, 26 Jun 2023 15:19:13 +0000

AbbVie says the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CMHP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral […]

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Sarepta gets approval for first gene therapy for Duchenne muscular dystrophy

Jim Cornall — Fri, 23 Jun 2023 08:45:00 +0000

Sarepta Therapeutics, Inc. has announced U.S. Food and Drug Administration (FDA) accelerated approval of ELEVIDYS (delandistrogene moxeparvovec-rokl), an Adeno-associated virus (AAV)-based gene therapy for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval […]

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FDA approves type 2 diabetes drug for children 10 and older

Jim Cornall — Thu, 22 Jun 2023 08:22:47 +0000

The U.S. Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) 10 mg and 25 mg tablets to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company have announced. “As the burden of type 2 diabetes increases among young […]

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Clearance for anti-tumor bispecific antibody trial

Jim Cornall — Tue, 20 Jun 2023 08:22:48 +0000

TG ImmunoPharma Co., Ltd. (TGI), which focuses on the development of novel immuno-oncology therapies, says the FDA has granted clearance for the clinical trial of TGI-6, its bispecific antibody. TGI-6 targets unique tumor-associated antigens (TAA) and CD3 molecules simultaneously, enabling potent anti-tumor responses. TGI said the antibody demonstrates exceptional anti-tumor activity, favorable safety profiles, and […]

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Nordic Bioscience cancer biomarker gets FDA go ahead

Jim Cornall — Thu, 15 Jun 2023 11:06:15 +0000

Danish biomarker company Nordic Bioscience says its PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). The letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies. Nordic Bioscience has a successful track record of developing and […]

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CellCentric receives FDA Fast Track designation for relapsed refractory multiple myeloma drug

Jim Cornall — Tue, 13 Jun 2023 10:27:45 +0000

CellCentric has announced that the U.S. Food and Drug Administration (FDA) has granted its novel cancer drug, inobrodib, Fast Track designation for the treatment of patients with relapsed or refractory multiple myeloma. The FDA’s Fast Track designation is designed to aid the development of new treatments, expediting the review of drugs to treat serious conditions […]

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How will European Commission proposals on data exclusivity and the bolar exemption affect pharma companies?

External Contributor — Tue, 13 Jun 2023 07:16:25 +0000

By Andrew Sharples, co-head of EIP’s UK litigation team In April, the European Commission published proposed legislation (specifically a new Regulation and a new Directive) aimed at reforming EU legislation in relation to pharmaceuticals. These proposals, if adopted, will affect pharmaceutical regulation in several ways. In relation to IP specifically, they will affect the periods […]

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von Willebrand disease treatment gets FDA orphan drug designation

Jim Cornall — Fri, 02 Jun 2023 08:50:00 +0000

The U.S. Food and Drug Administration (FDA) has granted Vega Therapeutics, Inc. orphan drug designation for its antibody therapy, VGA039, for the treatment of the rare bleeding disorder, von Willebrand disease (VWD). Vega Therapeutics is a clinical stage biotechnology company developing novel therapies for rare blood disorders. VGA039 is a first-in-class antibody therapy with a […]

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Assessing the EU Pharmaceutical Package – Positives, negatives and the impact on smaller pharma and biotech companies

External Contributor — Tue, 30 May 2023 08:00:05 +0000

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Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

Jim Cornall — Fri, 26 May 2023 07:50:00 +0000

Rocket Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-L301, the company’s investigational lentiviral-based gene therapy for pyruvate kinase deficiency (PKD). PKD is a rare blood disorder characterized by severe anemia and excessive red blood cell breakdown. RMAT designation was granted based […]

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FDA approves first topical gene therapy for dystrophic epidermolysis bullosa wound treatment

Jim Cornall — Mon, 22 May 2023 15:23:26 +0000

The U.S. Food and Drug Administration has approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. The approval of Vyjuvek was granted to […]

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SiSaf siRNA therapy gets FDA designations to treat autosomal dominant osteopetrosis

Jim Cornall — Tue, 16 May 2023 09:00:00 +0000

SiSaf Ltd, an RNA delivery and therapeutics company, has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis Type 2 (ADO2), has been granted orphan drug designation by the U.S. FDA. Also, due to the serious manifestations of this rare skeletal disorder in children, SIS-101-ADO has been granted rare pediatric disease designation […]

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