Posts in category: Uncategorized

FDA Approves Capvaxive™ for Prevention of Invasive Pneumococcal Disease and
Pneumococcal Pneumonia in Adults

Merck has announced that the U.S. Food and Drug Administration (FDA) approved Captative™ (Pneumococcal 21-valent Conjugate Vaccine) for:

• Active immunization for the prevention of invasive disease caused by Streptococcus
  pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
• Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. Capvaxive is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases.
• The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is expected to meet later this month to discuss and make recommendations for the use of Capvaxive in adults.

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FDA Grants Accelerated Approval to Iqirvo for the Treatment of Primary Biliary Cholangitis

Ipsen has announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

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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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