Drug Development

Pharma Manufacturing Industry Ranks Second in R&D Intensity

by Samantha McGrail

Despite investing a much larger share of its revenue in research and development (R&D), the pharmaceutical industry retains a smaller share of total spending on its products than other...

Clinical Trial Finds Hydroxychloroquine Does Not Prevent COVID-19

by Samantha McGrail

A new clinical found that high doses of hydroxychloroquine did not prevent illness compatible with COVID-19 when initiated within four days after a high-risk or moderate-risk exposure. For more...

FDA OKs Roche’s First-Line Treatment for Some Lung Cancers

by Samantha McGrail

FDA recently approved Roche’s first-line treatment, Tecentriq (atezolizumab), for adult patients with metastatic non-small cell lung cancer. Atezolizumab is the fourth indication in metastatic...

FDA Rejects Bristol Myers Cell Squibb’s CAR T-Cell Therapy

by Samantha McGrail

FDA recently issued a Refusal to File letter to Bristol Myers Squibb (BMS) and Bluebird Bio regarding the Biologics License Application (BLA) for idecabtagene vicleucel, a chimeric antigen receptor...

HHS Reveals Plan for Shipping Remdesivir to Hospitals for COVID-19

by Samantha McGrail

Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS recently announced the allocation plan for remdesivir, a COVID-19 treatment for hospitalized patients.  For more...

Pfizer, Valneva Commercialize Lyme Disease Vaccine Candidate

by Samantha McGrail

Pfizer and specialty vaccine company, Valneva SE, recently announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate. For more coronavirus updates, visit...

COVID-19 Clinical Trial Questions High Doses of Chloroquine

by Samantha McGrail

A recent COVID-19 clinical trial found that higher dosages of 2 chloroquine diphosphate should not be recommended for critically ill coronavirus patients because of its potential safety...

Gilead Hints at Remdesivir’s Potential as a COVID-19 Treatment

by Samantha McGrail

Gilead Sciences recently found that using remdesivir as a COVID-19 treatment for severe coronavirus patients produced positive results in a Phase 3 clinical trial. Severe coronavirus patients receiving...

BARDA Gives $483M to Moderna for COVID-19 Vaccine Development

by Samantha McGrail

Moderna recently received $483 million from the Biomedical Advanced Research and Development Authority (BARDA) to bolster COVID-19 vaccine development using the company’s mRNA vaccine...

BARDA Director Rick Bright Leaves Agency Amid COVID-19 Pandemic

by Samantha McGrail

HHS has replaced Rick Bright as the director of the US agency charged with developing potential COVID-19 drugs and vaccines, according to national news sources. For more coronavirus updates, visit...

Pfizer, BioNTech Team Up to Advance COVID-19 Vaccine Development

by Samantha McGrail

Pfizer and BioNTech recently disclosed additional details on their COVID-19 vaccine development plans through BioNTech’s and mRNA vaccine program. For more coronavirus updates, visit...

Novartis Donates 130M Doses of Hydroxychloroquine to Combat COVID-19

by Samantha McGrail

Novartis recently announced its commitment to donate up to 130 million doses of generic hydroxychloroquine, a potential COVID-19 treatment.  For more coronavirus updates, visit our resource...

Premier Presses FDA, FTC for Biosimilar Marketplace Competition

by Samantha McGrail

In response to an FDA and FTC open docket regarding biosimilar marketplace competition, Premier submitted comments and recommendations to further promote a robust biosimilars marketplace.  The...

Sanofi, GSK Partner to Develop Adjuvanted COVID-19 Vaccine

by Samantha McGrail

Sanofi and GSK recently announced that they signed a letter of intent to develop an adjuvanted COVID-19 vaccine.  For more coronavirus updates, visit our resource page, updated twice daily...

Alynlam, Dicerna Partner on RNAi Therapeutics for Liver Disease

by Samantha McGrail

Alnylam and Dicerna recently announced the development and commercialization of investigational RNAi therapeutics for the treatment of alpha-1 liver disease. The pharmaceutical companies have also...

Henry Ford to Study Use of Hydroxychloroquine to Prevent COVID-19

by Samantha McGrail

Henry Ford Health System will lead the first large-scale study in the US to determine the effectiveness of hydroxychloroquine in preventing COVID-19 among healthcare workers and first...

Key Prescription Drugs Being Used to Treat COVID-19 Patients

by Samantha McGrail

As the number of confirmed COVID-19 cases continues to grow, pharmaceutical companies are boosting their efforts to combat the virus. There are currently over 245,000 cases of coronavirus in the US, a...

Gilead Expands Access to Potential COVID-19 Treatment, Remdesivir

by Samantha McGrail

Gilead will expand access to potential COVID-19 treatment, remdesivir, for patients with the greatest need, according to an official letter from Daniel O’Day, Gilead chairman and CEO. For more...

FDA Accelerates Review of COVID-19 Diagnostic Tests

by Samantha McGrail

FDA Commissioner Stephen M. Hahn, MD, recently provided an update on the review processes and procedures for the authorization of COVID-19 diagnostic tests. For more coronavirus updates, visit...

Bristol Myers Scores FDA Approval for Celgene’s MS Drug Ozanimod

by Samantha McGrail

The FDA finally approved Zeposia (ozanimod), a multiple sclerosis (MS) drug developed by Celgene, according to a recent announcement from the Bristol-Myers Squibb Company. Bristol-Myers acquired...