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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.
  • textsms

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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70% of Major Pharmaceutical Companies and CROs Surveyed Have Adopted Digital Pathology

Proscia's new survey reveals that approximately 70% of life science organizations have invested in digital pathology to advance drug research and development. Over half of these organizations still use legacy software systems, primarily for basic image viewing, despite the growing adoption of artificial intelligence (AI) to accelerate the introduction of breakthrough therapeutics. The survey als..

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

The Truth About Unlimited PTO

Unlimited PTO policies have become increasingly popular in recent years, with companies encouraging staff to take time off as needed instead of limiting the number of days they can take. However, this policy may not be truly unlimited, and many employees are hesitant to take advantage of it due to cultural factors like peer pressure and workload demands. Employers may also be wary of the policy ..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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Catalent Finally Reports Earnings: Despite Losses, Revenue Beat Projections

Catalent, a healthcare product technology provider, has finally released its Q3 financial report for fiscal 2023 after delays in May. The company's revenue of $1.04 billion beat Wall Street projections despite being 19% below last year's Q3 revenue. However, the company reported an adjusted net loss of $17 million due to operational challenges and unexpected cost increases at some manufacturing ..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 14.
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Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race

French company Valneva has released positive results from a Phase III study of its chikungunya vaccine candidate VLA1553, following Merck's exit from the race earlier this year. The vaccine showed a 28-day seroprotection rate of 98.9% in participants given the inoculation, according to results published in medical journal The Lancet. However, more than half of those vaccinated developed at least..

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

Seagen Touts Adcetris Early-Stage Lymphoma Data with 93% Complete Remission

Seattle Genetics, known as Seagen, has announced positive results from its Phase II trial for early-stage classical Hodgkin lymphoma. The company reported that Adcetris, in combination with Bristol Myers Squibb’s PD-1 inhibitor and standard chemotherapy agents, led to complete remission in 93% of patients. In Part C of the three-part study, which involved 150 patients, Adcetris showed a 98% over..

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