FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Causedby 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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mRESVIA®

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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ONYDA XR

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

FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris.

  • Bkemv is approved for the following treatment indications, which are also currently approved for
    Soliris:
    o the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce
    hemolysis; and
    o the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit
    complement-mediated thrombotic microangiopathy.
  • Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).

Source: FDA

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YESAFILI AND OPUVIZ

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

IMDELLTRA™

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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GENERIC DRUG APPROVALS

May 2024

  • Edaravone Intravenous Solution 30mg/100mL and 60mg/100mL
    Approved: May 6, 2024 – Gland Pharma Limited; Hikma Pharmaceuticals USA Inc. (30mg/100mL
    only); Long Grove Pharmaceuticals, LLC (30mg/100mL only); Dr. Reddy’s Laboratories Limited
    (60mg/100mL only)
    Treatment for: Amyotrophic Lateral Sclerosis
    Generic for: Radicava
  • Emtricitabine and Tenofovir Alafenamide Fumarate Tablets 120mg/15mg (base) and 200mg/25mg
    (base)
    Approved: May 17, 2024 – Apotex Corp.
    Treatment for: HIV Infection
    Generic for: Descovy
  • Halcinonide Topical Solution 0.1%
    Approved: May 29, 2024 – Encube Ethicals Private Limited
    Treatment for: Inflammatory Skin Diseases
    Generic for: Halog Solution

Scientists May Have Located Your Brain’s ‘Neural Compass’

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 Issues Recall of Sapropterin Dihydrochloride Powder

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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MYHIBBIN™

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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