Posts in category: News

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.

Ream more…

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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FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first and only drug approved for the treatment of Rett syndrome.

Rett syndrome is a complex, rare, neurodevelopmental disorder typically caused by a genetic mutation on the MECP2 gene. It is characterized by a period of normal development until six to 18 months of age, followed by significant developmental regression with loss of acquired communication skills and purposeful hand use. Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Rett syndrome is believed to affect 6,000 to 9,000 patients in the U.S.,with a diagnosed population of approximately 4,500 U.S. patients. Daybue is not recommended for patients with moderate or severe renal impairment.

Daybue™ is expected to be available in the U.S. by the end of April, 2023.

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