Posts in category: Uncategorized

FDA Approves Rytelo for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia June 6, 2024 – Geron Corporation has announced that the U.S. Food and Drug Administration (FDA) has  approved Rytelo™ (imetelstat) for the treatment of adult patients:

• with low- to intermediate-1 risk myelodysplastic syndromes (MDS),

• with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks,

• who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity, and It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Source: Geron Corporation

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FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Caused by RSV

The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

• The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as  the Moderna COVID-19 vaccines.

• Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

Source: Moderna, Inc.

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FDA Approves Onyda XR Non-Stimulant Liquid Treatment for ADHD

The FDA has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

• The FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.
• Onyda XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.
• Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, a
  liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy.

Source: Tris Pharma News and Media

The FDA has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye.

The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Both Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions.
They are used to treat:

• Neovascular (wet) age-related macular degeneration
• Macular edema following retinal vein occlusion
• Diabetic macular edema
• Diabetic retinopathy
  Source: FDA

FDA Grants Accelerated Approval for Imdelltra for the Treatment of Extensive-Stage Small Cell Lung Cancer

The FDA has approved Imdelltra™ (tarlatamab-dlle), manufactured by Amgen, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

• Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the
  patient’s own T cells to attack DLL3-expressing tumor cells.
• Imdelltra is administered as an intravenous infusion over one hour in an appropriate hospital
  setting.

Source: Amgen

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By Dennis Thompson, HealthDay Reporter; Medically reviewed by Drugs.com

Researchers say they’ve identified a human “neural compass” — a pattern of brain activity that helps prevent humans from becoming lost.

This discovery could increase understanding of diseases like Alzheimer’s and Parkinson’s, in which a person’s navigation and orientation are frequently impaired.

Future research will take these findings a step further, to figure out how the brain navigates through time and whether this brain activity is related to memory.

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Dr. Reddy’s Laboratories Ltd. today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency.

• Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.

Source: FDA

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FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

• In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
• Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
• It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

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By Dennis Thompson, HealthDay Reporter; Medically reviewed by Carmen Pope, BPharm

Artificial intelligence (AI) might be able to identify patients who have rare diseases years earlier than they would typically be diagnosed, a new study says.

• A newly developed AI program was able to successfully identify people at risk of developing a rare immune disorder, researchers report in Science Translational Medicine.
• Out of a group of 100 people judged at highest risk by the AI program, 74 very likely have the disorder, researchers found. This shows that AI could potentially improve the outcomes of these folks by getting them earlier treatment.

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Based on sample testing performed, there is no material patient risk associated with the level of contamination found. The detected amount of the ingredient was confirmed to be extremely small and significantly below the permitted daily exposure (PDE) established by the U.S. FDA.

The Abilify® (aripiprazole) Tablets affected are the 5 mg, 10 mg, 15 mg, and 30 mg doses. The 2 mg and 20 mg doses are not affected. The recall will not affect product availability as there are other sources of aripiprazole tablets available in the U.S. market for patient use, including 2 mg and 20 mg.

Source: Otsuka America Pharmaceutical, Inc

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