•  12/2/2020 08:58 AM

Today, the Food and Drug Administration issued a draft guidance for industry, “Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.” The guidance assists sponsors of investigational new drug applications and new drug applications during drug development in evaluating the need for and design of drug-drug interaction (DDI) studies involving acid-reducing agents (ARAs).

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  •  12/2/2020 08:37 AM

On December 1, 2020, the Food and Drug Administration approved pralsetinib (GAVRETO, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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  •  11/30/2020 08:41 AM

The U.S. Food and Drug Administration approved Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes considered pathogenic (causing disease), likely pathogenic, or of uncertain significance. Imcivree is the first FDA-approved treatment for these genetic conditions.

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  •  11/30/2020 07:25 AM

On November 27, 2020, the Food and Drug Administration approved the Sonalleve MR-HIFU system (Profound Medical Inc.) for the treatment of osteoid osteoma in the extremities. MR-guided High Intensity Focused Ultrasound (MR-HIFU) treatment is an image guided technique combining high intensity focused ultrasound ablation with real time monitoring of temperature change during the sonication.

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  •  11/27/2020 09:19 AM

For so many, 2020 has been a bleak year filled with uncertainty and anxiety directly related to the COVID-19 pandemic that has surged across the globe and led to the deaths of more than 1.4 million people, including close to 260,000 in the United States.

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  •  11/27/2020 07:33 AM

Prairie Farms has issued a limited voluntary recall of its Prairie Farms Premium Flavored Chocolate Milk gallons and Prairie Farms 1% Lowfat Chocolate Milk gallons (Best by Date: Dec. 4, 2020) that were not labeled for an egg allergen that may be present. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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  •  11/26/2020 09:11 AM

On November 24, 2020, the Food and Drug Administration granted accelerated approval to naxitamab (DANYELZA, Y-mAbs Therapeutics, Inc.) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.

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  •  11/26/2020 07:00 AM

In the antiseptic world of drug manufacturing, cleanliness is key and outside contamination is a drugmaker’s worst enemy.

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  •  11/25/2020 12:43 PM

Pharma major Lupin Limited announced the launch of tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received an approval for its ANDA from the United States Food and Drug Administration (FDA).

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  •  11/25/2020 08:51 AM

The University of Sheffield and Pfizer have launched a new consortium which aims to standardise and accelerate the development of Advanced Therapy Medicinal Products (ATMPs), allowing potentially transformative treatments to reach patients sooner.

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  •  11/25/2020 06:46 AM

On November 24, 2020, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” This guidance describes the enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an abbreviated new drug application

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  •  11/24/2020 01:57 AM

Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level.

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