Drug Development

Project NextGen Leverages $5 Billion for COVID Vaccine Development

by Hayden Schmidt

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...

A New Era in Medicine: The Therapeutic Promise of HMO-Based Medications

by Alivia Kaylor

Human breast milk has long been recognized as the optimal source of infant nutrition, providing essential nutrients and antibodies that promote growth and protect against infection. However, research has revealed that breast milk contains...

Meteoric Rise of Weight-Loss Drug Wegovy Brings Pushback to Novo Nordisk

by Hayden Schmidt

In June of 2021, the FDA approved Novo Nordisk’s Wegovy to aid in weight management in overweight adults with weight-related chronic conditions like high blood pressure, type 2 diabetes, or high...

Analyzing Returns on Investment from Pharmaceutical Innovation

by Veronica Salib

In an annual report focused on the return on investment (ROI) from pharmaceutical innovation, Deloitte analyzed research and development (R&D) in the pharmaceutical industry and the resulting outcomes throughout 2022. Considering the...

Sanofi Acquires Provention Bio for $2.9 Billion

by Hayden Schmidt

On Monday, the European healthcare company Sanofi announced a $2.9 billion acquisition deal with US-based Provention Bio. Under the terms of the agreement, Sanofi will pay $25 per share in cash,...

Regulating and Authorizing Medicines: A Comparison of the FDA and EMA

by Veronica Salib

Medicine regulation, review, and authorization are critical tools for bringing drugs to market, monitoring patient safety, and ensuring the best health outcomes. While regulatory guidance can vary globally, comparing protocols can help...

Sun Pharmaceutical Industries Acquires Concert Pharma for $576M

by Hayden Schmidt

Last month, Sun Pharma announced that it would pay $8 per share to acquire Concert for a total of $576 million in cash. During the first three quarters of 2022, Concert recorded a net loss of nearly...

Developing Clinical Trial Budgets, Considerations, and Best Practices

by Veronica Salib

Despite having a high risk of failure, the clinical trial process can cost millions of dollars to complete. For clinical research organizations and sponsors, a clinical trial budget is critical in determining whether a clinical trial is...

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

by Hayden Schmidt

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...

Developing and Launching Drugs, Considerations, and Best Practices

by Veronica Salib

Like developing, launching, and marketing any product, drug development and launching is a complex, costly, and intricate process. However, unlike other markets, the pharmaceutical industry has an added layer of complexity associated with...

The FDA Modernization Act 2.0 Allows Animal Trials Alternatives

by Veronica Salib

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 Hayden Schmidt

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...

AstraZeneca Purchases CinCor Pharma Inc. in $1.8 Billion Acquisition

by Hayden Schmidt

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...

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

by Hayden Schmidt

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 Grants Approval for HIV Treatment to Fight Drug Resistance

by Hayden Schmidt

Last week, the FDA approved Gilead Science’s Sunlenca (lenacapavir), the first and only capsid inhibitor-based HIV treatment. The treatment is intended for adult patients whose HIV cannot be...

Merck and Moderna Find Success with Cancer Vaccine Clinical Trial

by Hayden Schmidt

Pharmaceutical companies Merck & Co and Moderna Inc announced positive clinical trial results for their investigational melanoma vaccine candidate last week. The personalized cancer treatment that...

Projected Shortage of Non-Human Primates May Impact Drug Development

by Veronica Salib

Over the past few weeks, the pharmaceutical industry — drug development in particular — has faced a new issue regarding drug development and the animal models typically used to model...

Amgen’s $27.8 Billion Rare Disease Drug Acquisition

by Hayden Schmidt

On Monday, Amgen Inc announced its acquisition of the rare disease pharmaceutical company Horizon Therapeutics PLC, building on its portfolio of key drugs for treating uncommon conditions. Amgen...

FDA Grants IND Approval for Prostate Cancer Clinical Trial

by Veronica Salib

Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of...

FDA Clears Clinical Trials on Investigational New Drug for ALS

by Veronica Salib

Amyotrophic lateral sclerosis, ALS, is a life-threatening neurodegenerative disease that can lead to paralysis and death. Over 5,000 individuals in the United States are diagnosed with ALS each year,...