Rheumatoid arthritis

RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren's Syndrome

Retrieved on: 
Wednesday, April 3, 2024

The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.

Key Points: 
  • The FDA grants FTD to accelerate the development and review of new drugs that have the potential to treat life-threatening conditions and address unmet medical needs.
  • Telitacicept prevents abnormal differentiation and maturation of B-cells through a two-pronged approach, thereby treating various autoimmune diseases mediated by B-cells.
  • In December 2023, Telitacicept was granted Investigational New Drug (IND) by the FDA for the treatment of active pSS in adults.
  • Dr. Jianmin Fang, CEO of RemeGen, commented, "As the first fusion protein drug of its kind independently developed by RemeGen, we are delighted the FDA has recognized Telitacicept for fast track designation.

Viatris Announces the Launch of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% in the United States

Retrieved on: 
Monday, April 1, 2024

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States.

Key Points: 
  • PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States.
  • The onset of action of RYZUMVI generally occurs in 30 minutes.
  • In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours.
  • To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Open Call: Vilcek Foundation to Award $150,000 in Prizes to Immigrant Scientists in 2025

Retrieved on: 
Monday, March 25, 2024

NEW YORK, March 25, 2024 /PRNewswire/ -- The Vilcek Foundation has announced an open call for applications for the 2025 Vilcek Prizes for Creative Promise in Science. Three prizes of $50,000 each will be awarded to young immigrant scientists in the United States whose early career work represents a significant contribution to their field. Applications will be accepted through June 10, 2024, at 5:00pm ET.

Key Points: 
  • The Vilcek Foundation will accept applications for the 2025 Vilcek Prizes for Creative Promise in Biomedical Science through June 10, 2024.
  • NEW YORK, March 25, 2024 /PRNewswire/ -- The Vilcek Foundation has announced an open call for applications for the 2025 Vilcek Prizes for Creative Promise in Science .
  • The Vilcek Prizes for Creative Promise are awarded to immigrant professionals living and working in the United States.
  • The Vilcek Prizes for Creative Promise are a part of the Vilcek Foundation Prizes program.

healthŌme and GalenusRx Forge Strategic Partnership to Launch Genomics-based Personalized Medication Safety Program

Retrieved on: 
Wednesday, March 20, 2024

HUNTSVILLE, Ala., March 20, 2024 /PRNewswire/ -- healthŌme®, Inc., a leading genomics-based, precision health management company serving the life and critical illness industries, and GalenusRx, Inc., the world's most advanced medication safety organization, today announced a strategic partnership to elevate individual health outcomes, optimize medication use and improve medication safety. The partnership marks a critical advancement for healthŌme policyholders to access life-changing personalized medicine and proactive health management.

Key Points: 
  • Partnership Aims to Reduce Adverse Drug Events by Combining Pharmacogenomic Testing and Precision Medication Consultation to Provide Personalized Medication Support Plans for healthŌme Policyholders.
  • HUNTSVILLE, Ala., March 20, 2024 /PRNewswire/ -- healthŌme®, Inc., a leading genomics-based, precision health management company serving the life and critical illness industries, and GalenusRx, Inc., the world's most advanced medication safety organization, today announced a strategic partnership to elevate individual health outcomes, optimize medication use and improve medication safety.
  • Partnership elevates individual health outcomes, optimizes medication use and improves medication safety.
  • Together, healthŌme and GalenusRx refine the standards of medication management, merging personalized medication plan safety with genomics-driven insights for a comprehensive and engaging policyholder experience.

Remission Medical Partners with Sentara Health to Expand Access to Rheumatology Care

Retrieved on: 
Wednesday, March 20, 2024

RICHMOND, Va. , March 20, 2024 /PRNewswire/ --Remission Medical announced a partnership with Sentara Health to increase access to Rheumatology care for adult patients.For 130 years, Sentara has pursued its mission - "we improve health every day."  Part of improving health is ensuring swift access to specialists, with maximum convenience including video visits.According to the CDC, one in four US adults have a rheumatic condition, especially arthritis, which is characterized by joint pain and stiffness.  Rheumatic disease can affect quality of life, both at home and work, and can be hard to diagnose, given there are some 150 disease varieties."The medical literature shows that the time to diagnosis and treatment matters for certain conditions in rheumatology such as rheumatoid arthritis," says Steven Pearman, MD, Vice President and Chief Medical Officer of Medical Specialties from Sentara Health. "Starting treatment with the right therapy can avoid the damage to joints that comes with these conditions. In addition, access to Rheumatology is limited by increasing demand and a dwindling supply of specialists. Telehealth is well-suited for rapid triage and timely access to care."

Key Points: 
  • RICHMOND, Va. , March 20, 2024 /PRNewswire/ --Remission Medical announced a partnership with Sentara Health to increase access to Rheumatology care for adult patients.
  •  Part of improving health is ensuring swift access to specialists, with maximum convenience including video visits.
  • "The medical literature shows that the time to diagnosis and treatment matters for certain conditions in rheumatology such as rheumatoid arthritis," says Steven Pearman, MD, Vice President and Chief Medical Officer of Medical Specialties from Sentara Health.
  • "We're a Virginia company," said Blake Wehman, Founder & CEO of Remission Medical, "and we've witnessed how Sentara innovates in patient access, digital health and value-based care.

Study Links Key Gene to Protection from Severe Illness and Death From Covid Infections in Men Under Age 75

Retrieved on: 
Wednesday, March 13, 2024

NEW YORK, March 13, 2024 /PRNewswire/ -- A certain variant of a key anti-inflammatory gene protects men under age 75 from severe illness and death when hospitalized from Covid-19, a genetic analysis of their blood shows.

Key Points: 
  • NEW YORK, March 13, 2024 /PRNewswire/ -- A certain variant of a key anti-inflammatory gene protects men under age 75 from severe illness and death when hospitalized from Covid-19, a genetic analysis of their blood shows.
  • According to the study authors, the protective gene in question, an interleukin-1 receptor antagonist (IL1RN) variant, appears to tamp down inflammation.
  • Overall, more men than women (240 men, at 60.5%; and 157 women, at 39.5%) died from their disease, with women 20% less likely to die than men.
  • Funding support for this study was provided by National Institutes of Health grants P30CA016087 and R21AR078466.

Early Pulmonary Fibrosis Detection Holds the Key to Better Health Outcomes for Canadians Living with COVID-19 and Rheumatoid Arthritis

Retrieved on: 
Wednesday, February 28, 2024

Canadians who have had COVID-19, and other chronic diseases, are experiencing Pulmonary Fibrosis (PF) at significantly higher rates than others, seemingly providing a causal link that researchers are investigating.

Key Points: 
  • Research is shedding light on the growing rate of pulmonary fibrosis (PF) being found in people suffering from long-term COVID-19.
  • One study, Post COVID-19 pulmonary fibrosis; a meta-analysis study , found that almost 45% (44.9%) of study participants began suffering from PF after contracting COVID-19.
  • Canadians suffering from long COVID are encouraged to watch for the early signs of pulmonary fibrosis, a disease that is growing in this population.
  • Dr. Janet Pope's webinar includes explanations for both physicians and thousands of people living with connective tissue diseases of what pulmonary fibrosis symptoms to watch for.

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024

“We will have a number of important events in 2024 including the top-line data readout of ANB032's Phase 2b trial in atopic dermatitis by year end,” adds Faga. “We also plan to move our third and fourth ICMs -- ANB033, our anti-CD122 antagonist, and ANB101 -- into the clinic this year, with IND filings planned for Q2 and H2, respectively.”

Key Points: 
  • “Enrollment is ongoing in three global Phase 2 trials for ANB032, our BTLA agonist, in atopic dermatitis and rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ulcerative colitis.
  • The decrease relates primarily to cash used for operating activities and the $50 million stock repurchase program.
  • The change is due primarily to increased royalties recognized for sales of Jemperli offset by one development milestone achieved for cobolimab in 2022.
  • Acquired in-process research and development of $7.3 million for the three and twelve months ended December 31, 2023 related to the exclusive licensing agreement with Centessa Pharmaceuticals.