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Biogen Teams with NeuroSense to Explore ALS Neurofilament Biomarker

Biogen has partnered with NeuroSense Therapeutics to conduct a study on the effects of PrimeC on neurofilament levels in patients with ALS. The study will be funded by Biogen and use blood samples from 69 PARADIGM patients provided by NeuroSense. The collaboration includes data sharing and joint evaluation of correlations among endpoints. PrimeC is an investigational combination therapeutic comp..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 15.
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Kura Hopes to Raise $100M in Public Offering on Heels of Clinical Data

Kura Oncology has announced plans for a $100 million underwritten public offering to fund the development of its three candidate drugs, invest pipeline research and development, and provide general working capital. The company has approximately $406 million in cash, cash equivalents and investments, which it expects will fund current operations until Q4 2025. However, Kura's pre-market share val..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 15.
  • textsms

2seventy bio's CAR-T Trial Halted After Pediatric Death

2seventy bio has paused its Phase I CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. The trial was being conducted in partnership with Seattle Children’s, and the company's DARIC technology is used to regulate CAR T-cell responses and enable "on-demand" control of engineered T-cells. The child who died was the first to receive the second dose level of 2seventy..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 15.
  • textsms

Self-Sampling Using Colli-Pee® Device for HPV Screening Is Both Cost Effective and Could Improve Patient Access, Study Concludes

OraSure Technologies has conducted a study that suggests self-sampling with its Colli-Pee® device is a cost-effective alternative to clinician-collected sampling and other self-sampling methods for routine human papillomavirus (HPV) primary cervical cancer screening. The study, published in the biomedical journal “BMJ Open,” indicates that if self-screening led to a 15% increase in women accessi..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
  • textsms

Heligenics Unveils A First-Of-Its-Kind Precision Prescription Test For Breast Cancer Therapeutics

Heligenics, a biotech company based in Las Vegas, has developed a first-of-its-kind precision genetic test that can select among drugs to treat breast cancer. The test uses Heligenics' proprietary GigaAssay technology to identify which of the 10,000 potential mutations in a cancer gene would make a patient susceptible to a drug they would want to take and which variants produced resistance to th..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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U.S. FDA Approves Bylvay® for Patients Living with Cholestatic Pruritus Due to Alagille Syndrome

Ipsen has received approval from the US Food and Drug Administration (FDA) for Bylvay, a drug used to treat cholestatic pruritus in patients with Alagille syndrome aged 12 months or older. This marks the second rare cholestatic liver disease indication for Bylvay in the US after progressive familial intrahepatic cholestasis related pruritus in 2021. The approval was based on positive data from t..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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Brand Institute Partners on Brand Name Development for FDA-Approved Eye Drops for the Treatment of the Signs and Symptoms of Dry Eye Disease

Brand Institute partners with Novaliq to develop the brand name VEVYE for their FDA-approved cyclosporine ophthalmic solution, which is designed to treat dry eye disease. VEVYE is a water-free cyclosporine eye drop formulation approved by the FDA for this purpose and was developed to address unmet needs in the market. The Brand Institute also worked on logo and packaging design for the product. ..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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OliX Pharmaceuticals Begins Phase 1 Clinical Study of RNAi Therapeutic for Androgenic Alopecia

OliX Pharmaceuticals has announced the start of a Phase 1 clinical trial for its RNAi therapeutic, OLX72021, which is being developed to treat male-pattern baldness. The study will assess the drug's safety, tolerability and pharmacokinetics in single intradermal injections in up to 30 healthy males with androgenic alopecia over an eight-week period. Participants will be split into five cohorts a..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
  • textsms

Vistagen Announces European Patent Office Intention to Grant New PH80 Nasal Spray Patent for the Treatment of Migraine

Late clinical-stage biopharmaceutical company Vistagen has announced that the European Patent Office (EPO) plans to grant a patent for its PH80 nasal spray, which is designed to treat migraines. The patent claims include treatment administered at the onset of migraine symptoms and treatment of migraines associated with traumatic brain injury. PH80 nasal spray initiates neural impulses in the olf..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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Kalderos' 2023 Annual Report Highlights Costs of Systemic Challenges in Drug Discount Programs and Their Impact on Drug Manufacturers, Covered Entities, Payers and Patients

Kalderos, a data infrastructure and analytics company, has released its annual report highlighting the costs of systemic challenges in drug discount programs and their impact on all stakeholders. The report outlines a new paradigm of cooperation among drug discount program stakeholders that benefits everyone, particularly patients. The Medicaid Drug Rebate Program (MDRP), 340B Drug Pricing Progr..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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