Regulatory approval Archives

News and Trends 27 Jun 2023

UCB myasthenia gravis drug given FDA approval

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 […]

June 27, 2023 - 5 minutesmins - By Jim Cornall

News and Trends 26 Jun 2023

AbbVie takes step forward in Europe with migraine drug

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 […]

June 26, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 23 Jun 2023

Sarepta gets approval for first gene therapy for Duchenne muscular dystrophy

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 […]

June 23, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 22 Jun 2023

FDA approves type 2 diabetes drug for children 10 and older

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 […]

June 22, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 20 Jun 2023

Clearance for anti-tumor bispecific antibody trial

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 […]

June 20, 2023 - 2 minutesmins - By Jim Cornall

News and Trends 15 Jun 2023

Nordic Bioscience cancer biomarker gets FDA go ahead

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 […]

June 15, 2023 - 3 minutesmins - By Jim Cornall

News and Trends 13 Jun 2023

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

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 […]

June 13, 2023 - 3 minutesmins - By Jim Cornall

Opinion 13 Jun 2023

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

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 […]

June 13, 2023 - 5 minutesmins - By External Contributor

blood bleeding disorders von Willebrand disease

News and Trends 2 Jun 2023

von Willebrand disease treatment gets FDA orphan drug designation

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 […]

June 2, 2023 - 2 minutesmins - By Jim Cornall

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

May 30, 2023 - 7 minutesmins - By External Contributor

News and Trends 26 May 2023

Rocket Pharmaceuticals receives FDA designation for pyruvate kinase deficiency gene therapy

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 […]

May 26, 2023 - 4 minutesmins - By Jim Cornall

News and Trends 22 May 2023

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

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 […]

May 22, 2023 - 3 minutesmins - By Jim Cornall

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