Pharmaceutical drug discovery, development, and access news and insights

Nektar Sues Eli Lilly for Incorrect Clinical Trial Results

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On Monday, Nektar Therapeutics released a scathing public statement that accused its former partner, Eli Lilly, of miscalculating and sharing clinical trial results that underrepresented the...

Red Cross Adopts FDA’s Blood Donation Policies to Expand Eligibility

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On August 7, 2023, the American National Red Cross announced that it would adopt the United States Food and Drug Administration’s new blood donation protocols. This shift will widen donor...

FDA Clears IND for New Parkinson’s Disease Treatment Using IPSCs

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Today, Aspen Neuroscience announced that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a new Parkinson’s Disease gene...

FDA Approves Zuranolone for Postpartum Depression

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Last week, the United States Food and Drug Administration approved the first oral treatment for postpartum depression (PPD). Zuranolone was approved on August 4, 2023, just days after a study in the...

Lupin Pharmaceuticals Recalls Two Lots of Birth Control

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On July 28, 2023, Lupin Pharmaceuticals, a manufacturer based out of Baltimore, MD, voluntarily recalled two lots of Tydemy. The drug is an estrogen and progestin oral contraceptive, also known as a...

New Reagent Delivers Biomolecules to Lung Tissue to Treat Lung Disease

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On August 2, 2023, Altogen Biosystems announced and launched a new targeted reagent that can deliver biomolecules to the lungs, treating pulmonary diseases. According to the announcement, the drug has...

ADHD Medication Shortages Prompt Response from the FDA and DEA

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On August 1, 2023, the United States Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) released a public statement updating Americans on the ongoing shortages of prescription...

FDA Approves Second OTC Naloxone for Opioid Overdose Management

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Four months after approving the first over-the-counter (OTC) naloxone, the FDA has made another harm reduction tool available by supporting a second OTC Naloxone nasal spray, RiVive. The nasal spray...

FDA Issues Draft Guidance on Devices for Opioid Use Disorder

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On July 27, 2023, the United States Food and Drug Administration (FDA) issued a draft guidance titled Clinical Considerations for Studies of Device Intended to Treat Opioid Use Disorder (OUD) as part...

Zuranolone Effectively and Safely Treats Postpartum Depression

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A study published in the American Journal of Psychiatry on July 26, 2023, proved that zuranolone could effectively and safely treat postpartum depression. The study supports the priority review granted...

Only 3.3% of NIH-Funded Pediatric Clinical Trials Data Is Reusable

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In a research letter published in JAMA Network Open on July 25, 2023, scientists evaluated data availability from pediatric clinical trials funded by the National Institutes of Health (NIH). According...

Pfizer Plant Damage May Cause Pharmaceutical Supply Chain Shortages

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A Tornado in Rocky Mount, North Carolina, caused significant damage to a Pfizer manufacturing plant. Experts predict that medication and pharmaceutical supply chain shortages are imminent. The company...

Comparing Merck and Pfizer’s 2022 ESG Ratings

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Environmental, social, and governance assessments, commonly called ESG scores, are emerging metrics that are beginning to shape how pharmaceutical companies do business. MSCI Inc., an American finance...

Newly Approved Monoclonal Antibody Prevents RSV in Babies and Toddlers

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On July 17, 2023, the FDA added to the arsenal of respiratory syncytial virus (RSV) prevention tools by approving Beyfortus, a monoclonal antibody for preventing the infection in children two years old...

Melanoma Drugs Repurposed Can Shrink Rare Brain Tumors

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A study published last week in the New England Journal of Medicine concluded that BRAF–MEK inhibitors — traditionally used in melanoma treatment — can shrink papillary...

Majority of Patients Quit Weight-Loss Drugs Like Wegovy Within First Year

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A recent cost analysis shared with Reuters showed that only a third of patients continued to use popular glucagon-like peptide-1 (GLP-1) compounds a year after initial prescription. Healthcare costs...

FDA Approves Over-the-Counter, Nonprescription Birth Control

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After months of deliberation, the United States Food and Drug Administration (FDA) approved the first hormonal oral contraceptive for non-prescription over-the-counter (OTC) sale. This historical...

White House National Response Plan Addresses Xylazine, Fentanyl Risk

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A statement issued by the White House on July 11, 2023, outlined a national response plan to address the ongoing risk of fentanyl laced with xylazine. As more illicit drug overdoses are linked to...

Cipla Albuterol Sulfate Inhalation Aerosol Voluntarily Recalled

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On July 6, 2023, Cipla US recalled six batches of its albuterol sulfate inhalation aerosol, 90 mcg (200 MI). According to the release published by the FDA on July 7, 2023, the company cited a container...

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