Aurobindo Pharma Ltd.

Acadia Pharmaceuticals Secures Patent Victory for Parkinson's Drug Nuplazid Until 2038

6 days ago

• The U.S. District Court for the District of Delaware ruled in favor of Acadia Pharmaceuticals, upholding their '721 formulation patent for Nuplazid against Aurobindo Pharma's generic challenge. • Judge Gregory B. Williams determined that Aurobindo's proposed generic pimavanserin capsules would infringe Acadia's patent, which provides protection for the 34 mg capsule formulation until August 2038. • The ruling represents a significant win for Acadia, securing long-term market exclusivity for their FDA-approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis.

EU Approves Aurobindo Pharma's Dyrupeg: New Pegfilgrastim Biosimilar for Chemotherapy Patients

2 months ago

• The European Commission has granted marketing authorization for Dyrupeg™, a pegylated filgrastim biosimilar developed by CuraTeQ Biologics, a subsidiary of Aurobindo Pharma. • Dyrupeg™ is indicated for reducing neutropenia duration and febrile neutropenia incidence in adult cancer patients undergoing cytotoxic chemotherapy, offering a cost-effective alternative to existing treatments. • The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January 2025, marking a significant expansion of Aurobindo's biosimilar portfolio in Europe.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

5 months ago

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

Aurobindo Pharma's Biosimilar Bevqolva Receives MHRA Approval for Cancer Treatment

5 months ago

• CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has secured MHRA approval in the UK for Bevqolva, a biosimilar of bevacizumab, expanding cancer treatment options. • Bevqolva is indicated for multiple cancers, including metastatic colorectal cancer, non-small cell lung cancer, renal cell carcinoma, cervical cancer, and ovarian cancers. • The biosimilar will be available as a 25 mg/mL concentrate in 4 mL and 16 mL single-use vials, administered intravenously, offering a cost-effective alternative. • This approval follows a positive opinion from the EMA's CHMP for Aurobindo Pharma's filgrastim biosimilar Zefylti, further strengthening its biosimilar portfolio.

Alzheimer's Disease and Gene Therapy Clinical Trials Show Promise with Novel Approaches

8 months ago

• Over 120 Alzheimer's Disease treatment therapies are under development globally, targeting various mechanisms of action and routes of administration. • Gene therapy is emerging as a potential treatment strategy, with over 300 gene therapy drugs in the pipeline for various diseases, including neurological disorders. • Several companies are advancing Alzheimer's therapies through clinical trials, including Phase 3 studies for small molecule candidates and Phase 1 trials for novel muscarinic agonists. • Recent FDA approval of Leqembi marks a significant milestone, highlighting the potential of amyloid beta-directed antibodies in treating Alzheimer's disease.

Acadia Pharmaceuticals Secures Two Key Patent Victories for Parkinson's Drug NUPLAZID

a year ago

• The U.S. District Court for Delaware ruled in favor of Acadia Pharmaceuticals on all disputed claim construction points for its NUPLAZID formulation patent, which extends protection until 2038. • In a separate ruling on the same day, the court granted Acadia summary judgment confirming the validity of its composition of matter patent for NUPLAZID against obvious-type double patenting challenges. • These legal victories strengthen Acadia's patent estate for NUPLAZID (pimavanserin), the only approved treatment for hallucinations and delusions associated with Parkinson's disease psychosis.