Access To Medicine

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...

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...

Gilead Halts Access to Potential COVID-19 Drug Remdesivir

by Samantha McGrail

Biopharmaceutical company Gilead announced that it will temporarily pause access to COVID-19 treatment, remdesivir, outside of clinical trials as demand becomes overwhelming.  For more...

GSK, Chapel-Hill Renew $20M Partnership to Discover HIV Treatment

by Samantha McGrail

Global specialist HIV company ViiV Healthcare, owned by GSK, and UNC-Chapel Hill recently announced a five-year, $20 million renewal of a public-private partnership to discover a possible HIV...

FDA, FTC Warn Companies to Stop Selling Fraudulent COVID-19 Drugs

by Samantha McGrail

The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling false coronavirus (COVID-19) drugs, vaccines, and other products,...

FDA Provides Coronavirus Supply Chain Update

by Samantha McGrail

As the FDA closely monitors the coronavirus supply chain, it has uncovered a drug shortage related to a site affected by the coronavirus, or COVID-19, according to a recent statement from Stephen M....

Gene Therapy, Regenerative Medicine Markets Booming Worldwide

by Samantha McGrail

Globally, companies manufacturing gene therapy, cell therapy, and other regenerative medicines raised nearly $10 billion in 2019, the second-highest year on record, according to a recent analysis from...

Pharma Company Earns $311M for Cannabinoid Medicines

by Samantha McGrail

GW Pharmaceuticals announced last week that its cannabinoid (CBD) prescription medicines brought in total revenue of $109.1 million for the fourth quarter of 2019, and $311.3 million for the full...

Esperion Earns FDA Approval for Cholesterol Lowering Drug Nexletol

by Samantha McGrail

Esperion recently announced that the FDA approved Nexletol an LDL-cholesterol lowering medicine, boosting access to medicine for patients with familial hypercholesterolemia or atherosclerotic...

Children’s Hospitals Team Up to Link Patients to Clinical Trials

by Samantha McGrail

Michigan Medicine’s C.S. Mott Children’s Hospital recently announced that it has joined the top children’s hospitals from the United States, Canada, Australia, and Europe to...

HHS Launches Foundry for American Biotechnology to Spur Innovation

by Ana Mulero

HHS launched on Monday the nation’s first Foundry for American Biotechnology for producing technological solutions that help protect against and respond to health security threats, as well as...

FDA Breaks Down Barriers to Prioritizing Generic Drug Approvals

by Ana Mulero

The Food and Drug Administration issued updates to its policy on prioritization of generic drug applications to make better use of the agency's limited resources. The Manual of Policies and...

Illinois Caps Out-of-Pocket Costs for Insulin at $100 for Insured

by Ana Mulero

Following in Colorado’s footsteps, Illinois became the second state to cap out-of-pocket costs for insulin at $100 for a 30-day supply after Gov. JB Pritzker signed SB 667 into law on January...

FTC, NY Sue to Ban Martin Shkreli From Pharmaceutical Industry

by Ana Mulero

The Federal Trade Commission and the New York Attorney General Letitia James filed a complaint in federal court against Vyera Pharmaceuticals, Martin Shkreli and Kevin Mulleady, seeking to ban the...

Improving Vaccination Efforts Requires Renewed Commitment

by Ana Mulero

A Health Affairs blog post on Tuesday made the argument to invest in vaccine infrastructure and education to “turn the tide” on vaccine-preventable diseases, breaking it down by problem...

GlaxoSmithKline Leads Group Combatting Antimicrobial Resistance

by Ana Mulero

Reliance on just a select few pharmaceutical companies to carry the fight against the growing public health threat that is antimicrobial resistance could be what is holding back real...

Eli Lilly Snags $470M for NC Drug Manufacturing Plant

by Ana Mulero

Eli Lilly will open its first “state-of-the-art” manufacturing facility in North Carolina for the manufacturing of injectable products and delivery devices, the Indianapolis firm said...

USMCA Approval Signals Drug Pricing Changes Ahead

by Ana Mulero

The Senate’s January 16 approval of the US-Mexico-Canada (USMCA) Agreement was well-received by industry groups who argued for it to serve as a template for ongoing trade deal negotiations to...

GAO Flags Lack of 340B Drug Discount Program Oversight

by Ana Mulero

Weakness in the oversight of the 340B Drug Discount Program allowed some hospitals to get discounted drugs they were ineligible for, a Government Accountability Office analysis found.  Hospitals,...

USMCA Makes its Way to Full Senate Vote After Lobbying Win

by Ana Mulero

The Senate Finance Committee passed the US-Mexico-Canada (USMCA) Trade Agreement of 2019 on Tuesday, in a 25-3 vote. Other senate committees are now are set to debate the trade agreement, beginning...