Pharmaceutical drug discovery, development, and access news and insights

FDA Issues Draft Recommendation for Updated Blood Donation Guidelines

by

On January 27, 2023, the FDA issued a press release linking its new draft recommendation for updated blood donation guidelines. These updated guidelines take a more modern and individual approach to...

NIH Published Draft Recommendation for Pandemic Pathogen Research

by

As public health officials become increasingly concerned about potential pandemic pathogen (PPP) research, the NIH has published a draft recommendation to guide future research policies and practices....

Flexible Prescribing Did Not Increase Buprenorphine Overdose Deaths

by

Despite common misconceptions, researchers published an article in JAMA Network Open noting that buprenorphine overdose-related deaths did not increase during the COVID-19 pandemic when providers were...

Takeda One Ups Pfizer, Moderna with 600,000 SF R&D Office in Cambridge

by

Kendall Square is a round table of the largest pharmaceutical companies in the world, and Tokyo-based Takeda will soon have a seat at that table with its massive new workspace. Takeda, the largest life...

COVID Vaccine Uptake Among Immunocompromised Individuals Is Low

by

A cohort study published in JAMA Network Open determined that COVID vaccine uptake among immunocompromised individuals was low, implying that many people did not adhere to the CDC guidelines. According...

Hybrid Immunity Provides Better Protection Against Omicron Variant

by

In a systematic review and meta-regression published in The Lancet Infectious Diseases, researchers determined that hybrid protection — the combination of SARS-CoV-2 infection and vaccination...

HIV Vaccine Study Discontinued at Phase 3 Due to Inadequate Results

by

In a recent press release, the HIV Vaccine Trials Network (HVTN) announced that the Mosaico study, an investigational HIV vaccine study, was discontinued at phase 3 after an interim review by the Data...

The FDA Modernization Act 2.0 Allows Animal Trials Alternatives

by

On December 29, 2022, President Biden signed the FDA Modernization Act 2.0 into law, allowing clinical trial leaders to use animal trial alternatives before human clinical trials. Senators Rand Paul,...

Pfizer Acquires Abzena’s Biologic Manufacturing Facility

by

The contract development and manufacturing organization (CDMO) Abzena and Pfizer’s CDMO arm CenterOne reached an agreement last week, under which Pfizer will take control of Abzena’s...

Nutrient Intake Is Inversely Related to Metabolic Syndrome Incidence

by

A publication in JAMA Network Open found that folate, vitamin B6, and vitamin B12 intake and serum levels are inversely related to metabolic syndrome (MetS) incidence, with higher intake levels...

Developing Next-Generation Respiratory Virus Vaccines, Considerations

by

In an article published in Cell Host and Microbe, NIH researchers — including Anthony Fauci, David Morens, and Jeffery Taubenberger — discuss necessary considerations for scientists to...

Clinical Guidelines for Pediatric Obesity Encourage Early Intervention

by

On January 9, 2023, the American Academy of Pediatrics (AAP) released its clinical practice guidelines for evaluating and treating pediatric obesity. These updated practices encourage comprehensive...

AstraZeneca Purchases CinCor Pharma Inc. in $1.8 Billion Acquisition

by

This week, AstraZeneca announced its acquisition of Massachusetts-based CinCor Pharma as part of a transaction worth $1.8 billion. CinCor will support AstraZeneca’s mission to accelerate...

Scientists at the University of Washington Study Breast Cancer Vaccine

by

Early phase studies by scientists at the University of Washington found that a plasmid DNA breast cancer vaccine may produce favorable outcomes, generating anti-tumor immunity. The study, published in...

FDA Accelerates Approval of a New Alzheimer’s Disease Drug, Leqembi

by

Based on the results of a double-blind, placebo-controlled, the FDA granted the accelerated approval of Leqembi for Alzheimer’s disease, making it the second approved medication targeting the...

EPA to Propose National Drinking Water Regulations

by

Earlier this year, the United States Environmental Protection Agency (EPA) announced plans to propose, establish, and enforce national drinking water regulations for perfluorooctanoic acid (PFOA),...

Measles Outbreak Fueled by Low Vaccination Rates

by

Over the past few years, healthcare professionals and public health experts have seen the resurgence of many diseases that were once obsolete or nearly obsolete. In part, these rising rates have been...

Moderna to Buy Japanese Firm OriCiro in Its First-Ever Acquisition

by

Moderna Inc and Japan-based OriCiro Genomics K.K. reached an agreement on Wednesday wherein Moderna will acquire OriCiro and its suite of biopharmaceutical applications for $85...

FDA Expands Access to Abortion Pills in Retail Pharmacies

by

In a step towards widening access, the FDA made a regulatory change, allowing the abortion pill, mifepristone, to be distributed by retail pharmacies with a valid prescription. Mifepristone is one...

Naloxone Vending Machines Prevented Almost 1,000 Deaths

by

Based on data from the CDC, since 1999, there have been nearly one million overdose-related deaths. In 2020, the United States reported 91,799 overdose deaths, a 31% increase from the previous year....