Pharmaceutical drug discovery, development, and access news and insights

Study Links Stimulant Prescription Rates to Teen Drug Misuse

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On April 18, 2023, JAMA Network Open published an article linking stimulant prescription rates for ADGD to teen drug misuse. The study analyzed the medical and nonmedical use of prescription stimulants...

FDA Updates EUA for Bivalent mRNA COVID-19 Vaccines to Simplify Use

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On April 18, 2023, the FDA issued an announcement, updating the emergency use authorization (EUA) for the bivalent mRNA COVID-19 vaccines. Attempting to simplify use for healthcare professionals, the...

FDA Guidance Won’t Recommend Another Booster for Most Individuals

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In a news release published Tuesday, the FDA announced that most individuals who already received a bivalent booster vaccine would not be eligible for another dose. FDA officials said they intend to...

GSK Acquires Bellus Health for $2 Billion

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On Tuesday, GSK announced that it had reached an agreement to acquire Bellus Health Inc. for nearly $2 billion. Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant,...

Merck Plans to Acquire Prometheus Biosciences in a $10.8 Billion Deal

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On April 16, 2023, Merck announced plans to expand its immunology portfolio by acquiring Prometheus Biosciences, a biotechnology company focused on immune-mediated diseases. The deal, valued at $10.8...

Vertex and CRISPR Submit BLA for Sickle Cell Disease Treatment

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On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...

DEA Issues Public Safety Alert for Fentanyl Mixed with Xylazine

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On Wednesday, April 12, 2023, the United States Drug Enforcement Administration (DEA) issued a public safety alert on fentanyl mixed with xylazine. Linked to a press release by the Biden...

Project NextGen Leverages $5 Billion for COVID Vaccine Development

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This week federal officials announced the $5 billion successor to Operation Warp Speed, dubbed Project Next Gen. The program will seek to address the growing threat of coronaviruses and the possibility...

NIH Study Finds That Post-Exposure Doxycycline Reduces STI Rate

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An article published in the New England Journal of Medicine found that post-exposure doxycycline reduces sexually transmitted infection (STI) rates by two-thirds. The study found that men who have sex...

FDA Withdraws Approval of a Premature Birth Drug After 12 Years

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On April 6, 2023, the FDA Commissioner Robert M. Califf, MD, and Chief Scientist Namandjé Bumpus, PhD, announced the organization’s decision to withdraw the approval of Makena...

Federal Judge Rules to Reverse FDA Approval of Abortion Pill

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On Friday, April 7, 2023, a federal judge in Texas ruled to reverse the approval of mifepristone, the abortion pill. The Trump-appointed judge, Mathew Kacsmaryk, was assigned to the Alliance for...

FDA Requires Mail-Back Envelops with Opioid Analgesics Dispensation

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As a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS), the FDA will now require mail-back envelops with opioid analgesic dispensation in outpatient settings to...

HHS Releases National Cancer Plan to Further Cancer Moonshot

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On April 3, 2023, the United States HHS released detailed information for a National Cancer Plan. The plan aims to facilitate the Cancer Moonshot initiative. The Biden administration reignited the...

FDA Details Manufacturing Conditions That Led to Eye Drop Recall

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After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...

HHS Relaunched Health Sector Climate Pledge

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In March 2023, the United States HHS announced plans to relaunch the Health Sector Climate Pledge, proposed by the White House in 2022. According to the press release, the healthcare sector accounts...

Canadian Province Restricts Ozempic Sales to United States Citizens

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On March 28, 2023, British Columbia (BC), a Canadian Province, announced it would restrict Ozempic sales to United States citizens. The release from government officials notes that US citizens crossing...

WHO Updates COVID-19 Vaccination Guidance After March SAGE Meeting

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The WHO Strategic Advisory Group of Experts on Immunization (SAGE) announced the results of its March meeting, updating its COVID-19 vaccination guidance. According to the news release, the...

FDA Grants Approval to Emergent BioSolutions for Over-the-Counter Narcan

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On Wednesday, the FDA approved Narcan nasal spray for non-prescription over-the-counter use, making it available to consumers across various markets and retail locations. The approval went to Emergent...

FDA Issues Draft Guidance on Accelerated Approval for Oncology Drugs

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On March 24, 2023, the FDA issued a draft guidance on the clinical trial considerations for the accelerated approval of oncology drugs. The proposed recommendations include guidelines to fortify and...

Ohio Attorney General Sues Pharmacy Benefit Managers Due to Collusion

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On Monday, March 27, 2023, Ohio Attorney General Dave Yost sued pharmacy benefit managers (PBMs) from multiple organizations for collusion on drug prices. The lawsuit names numerous defendants,...