Pharmaceutical drug discovery, development, and access news and insights

FDA Launches New Advisory Committee for Genetic Metabolic Diseases

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Adding to the lengthy list of advisory committees under its belt, the United States Food and Drug Administration (FDA) announced its plans to create a new advisory committee to specialize in genetic...

FDA Approves First CRISPR-Based Gene Therapy

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Last week marked a monumental regulatory decision for CRISPR-based gene editing technologies. The United States Food and Drug Administration (FDA) approved the first two cell-based gene therapies for...

EPA Proposes Lead Pipe Removal to Minimize Human Exposure

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Under the guidance of the Biden–Harris administration, the Environmental Protection Agency (EPA) announced its plans to strengthen the Lead and Copper Rule as part of the Lead Pipe and Paint...

34% of Conventional Baby Food Contains Pesticides

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Earlier this month, the Environmental Working Group (EWG) published an updated version of their 1995 study on pesticides in baby food. Data revealed that while some threats have been eliminated, there...

Roche Expands Obesity Portfolio Through $2.7 Billion Carmot Acquisition

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On December 4, 2023, Roche revealed that it entered into definitive merger agreements with Carmot Therapeutics. According to the company’s press release, it will acquire Carmot and its gamut of...

FDA Publishes Drug Safety Communication for Antiseizure Drugs

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Earlier this week, the United States Food and Drug Administration (FDA) published a drug safety communication warning patients about potentially life-threatening side effects linked to levetiracetam...

FDA Approves First Therapy for Progressing Desmoid Tumors

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On Monday, November 27, 2023, the United States Food and Drug Administration (FDA) approved Ogsiveo (nirogacestat), making it the first FDA-approved treatment for desmoid tumors. The drug is intended...

Biden Leverages DPA to Strengthen Pharmaceutical Supply Chain

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On Monday, November 27, 2023, the White House released a fact sheet from the Biden administration outlining plans to strengthen domestic supply chains, reduce consumer costs, and secure key supply...

US States, Cities Sue Insulin Makers Over Shortages, High Prices

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In recent weeks, a wave of lawsuits has emerged as more states and cities in the United States take legal action against insulin makers and pharmacy benefit managers (PBMs). These lawsuits allege that...

WHO Urged Actions to Stop Antimicrobial Resistance

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The World Health Organization (WHO) recognizes World Antimicrobial Resistance Week from November 18, 2023, to November 24, 2023. Throughout this week, the organization highlights data on antimicrobial...

FDA Approves Truqap, Faslodex for HR-Positive Breast Cancer

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On November 16, 2023, the United States Food and Drug Administration approved AstraZeneca’s Truqap (capivasertib) to be administered in combination with fulvestrant for adults with hormone...

FDA Announces Kilitch Healthcare India Eyedrop Recall

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On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through...

FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

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On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven...

FDA Approves New Weight Loss Drug: Zepbound

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On November 8, 2023, the United States Food and Drug Administration (FDA) approved Eli Lilly’s newest weight loss drug, Zepbound. The newly approved drug uses the same active ingredient as...

Sage Therapeutics Announces Wholesale Cost of Zuranolone, $15,900

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On November 7, 2023, Sage Therapeutics, the manufacturer of ZURZUVAE (zuranolone), announced that the wholesale acquisition cost of the postpartum depression drug would be $15,900 for a 14-day...

Psychiatrists Prescribe or Recommend Ozempic, Other Weight Loss Drugs

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On November 3, 2023, the New York Times broke a story analyzing the role of Ozempic and other weight loss drugs in mental health or psychiatric care. Upon reaching out to 13 psychiatric departments at...

Researchers Reveal Positive Data on New Antibiotic for Super Gonorrhea

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On November 1, 2023, the Global Antibiotic Research and Development Partners (GARDP) and Innoviva Specialty Therapeutics, a subset of Innoviva Inc, issued a co-authored press release announcing that a...

26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

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On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health,...

Pharmacy Workforce Conditions Drive 3-Day CVS, Walgreens Staff Walkout

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Through Wednesday, November 1, 2023, patients may have more difficulty obtaining prescriptions or getting vaccinated at their local pharmacy. According to a CNN report, CVS and Walgreens pharmacy...

FDA Issues Warning About Probiotics Sold for Preterm Infants

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On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to...