Pharmaceutical drug discovery, development, and access news and insights

45% of Drinking Water Samples in the United States Contain PFAS

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An analysis of 716 tap-water samples revealed that 45% of drinking water samples in the United States contained at least one tested per- and poly-fluoroalkyl substance (PFAS), also called forever...

Biogen and Eisai Secure Traditional FDA Approval for Lequembi

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On July 6, 2023, the FDA granted Biogen Inc and Eisai Co’s Lequembi traditional FDA approval. The approval was based on a supplemental Biologics License Application (sBLA) and prior accelerated...

Older and Immunocompromised Adults Advised to Get RSV Vaccine

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The Centers for Disease Control and Prevention (CDC) advised older and immunocompromised adults in the United States to get the newly available respiratory syncytial virus (RSV) vaccine. The CDC...

FDA Adds Another Frozen Fruit to Recall List: Listeria Contamination

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On June 22, 2023, the Scenic Fruit Company issued a voluntary recall on frozen pineapple and fruit blends, including frozen pineapple, due to potential contamination with Listeria monocytogenes. This...

GSK Receives Fast Track from FDA for Gonorrhea Vaccine

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On Thursday, the FDA announced that it would grant GSK a fast track designation for its gonorrhea vaccine. The fast track process expedites the review process for drugs used to treat serious conditions...

Retatrutide Helps Patients Achieve 17.5% Weight Reduction at 24 Weeks

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A phase 2 clinical trial published in the New England Journal of Medicine revealed that retatrutide, Eli Lilly’s newest weight loss drug, helped patients achieve a 17.5% weight reduction in 24...

FDA Issues Guidance on Psychedelic Drug Use in Clinical Trials

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On June 23, 2023, the United States Food and Drug Administration issued its first draft guidance on using psychedelic drugs in clinical trials. Marking a pivot in the clinical trial landscape, these...

FDA Launches Programs to Reduce Risk of Cancer Biomarker Testing

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Last week, on June 20, 2023, the United States Food and Drug Administration (FDA) launched a pilot program to reduce the risk of laboratory-developed tests to identify cancer biomarkers. The program...

Eli Lilly Announces $2.4B Acquisition of Immunology Company Dice Therapeutics

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Monday, Eli Lilly announced that it would acquire Dice Therapeutics for $2.4 billion in cash, representing a 40% premium on the recent trading value of the smaller firm. Lilly’s purchase...

FDA Grants Bluebird Bio Priority Review of BLA for SCD Treatment

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On June 21, 2023, Bluebird Bio issued a press release announcing that the FDA had granted its biological license application (BLA) for a new sickle cell disease (SCD) treatment priority review...

FDA Approves New Pediatric Medication for Type 2 Diabetes

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Adding to the arsenal of tools providers have to manage type 2 diabetes (T2D), the FDA has approved a new pediatric medication for managing the condition. The approval of Jardiance and Synjardy to...

FDA Announce Additional Frozen Fruit Recall: Hepatitis A Contamination

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Last week, the FDA issued an announcement recalling multiple kinds of frozen fruit by Willamette Valley Fruit Co. The company is recalling the Great Value sliced strawberries, mixed fruit, and...

Men in the US Are More Likely to Have a Fatal Overdose Than Women

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As the opioid epidemic in the United States continues to progress, a recent study revealed that men are more likely to have a fatal overdose than women. Data from a study — led by researchers...

FDA Provides Guidance for Preventing Contamination in Tattoo Ink

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On June 12, 2023, United States Food and Drug Administration officials provided guidance for reducing microbial contamination in tattoo ink. The draft recommendation, now open for public commentary,...

Mississippi Study Indicates COVID Vaccines Reduce Myocarditis Risk

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At the start of COVID-19 vaccinations, myocarditis rates in Mississippi dropped 14% from pre-vaccination COVID-induced myocarditis rates. The Mississippi-based study was published by a researcher at...

Mallinckrodt Shareholders Doubt Company Will Pay $200M Opioid Settlement

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United Kingdom-based Mallinckrodt is considering repeat bankruptcy as its $200 million opioid payment comes due. A Security and Exchange Commission (SEC) filing from June 5 showed that company...

Government Health Leaders Request Additional Data on Drug Test Strips

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Although drug-checking tools such as fentanyl test strips have been championed as critical harm-reduction tools in the opioid epidemic, additional data and research are required to assess their...

Research Explores the Harmful Health Effects of Recycled Plastics

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Despite the narrative that recycled plastic is better for the environment and overall health, years of research have explored the harmful health effects linked to recycled plastics. In a report...

Top Challenges Facing Biosimilar Adoption and Manufacturing

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Biosimilar adoption by the healthcare industry can incentivize pharmaceutical development and increase options for patients, payers, and providers by offering a less expensive alternative to biologic...

Sackler Family Granted Legal Immunity Despite Opioid Epidemic

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The Sackler family is getting away with falsely marketing OxyContin, a highly addictive opioid manufactured by their company, Purdue Pharma, as non-addictive. The United States Court of Appeals for the...