Access To Medicine

HHS Doles Out Additional $227M for COVID-19 Vaccine Preparedness

by Samantha McGrail

HHS recently announced that the CDC will award an additional $227 million for COVID-19 vaccine preparedness and response activities. Specifically, $140 million will be used for vaccine preparedness...

US Govt Purchases Additional 650,000 Doses of COVID-19 Antibody

by Samantha McGrail

Eli Lilly & Company recently announced that the US government has purchased 650,000 additional doses of its neutralizing COVID-19 antibody, LY-CoV555, for $812.5 million. The doses will be...

UK Approves COVID-19 Vaccine from Pfizer, BioNTech

by Samantha McGrail

Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary emergency use authorization to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2. This is the...

HHS to Allocate Doses of Regeneron’s COVID-19 Antibody Therapy

by Samantha McGrail

HHS recently announced that it will allocate initial doses of Regeneron’s investigational monoclonal COVID-19 antibody therapy immediately. Weekly allocations to state and territorial health...

Rare Disease Drug from Alnylam Gets FDA Approval

by Samantha McGrail

FDA recently approved Alnylam Pharmaceutical’s rare disease drug Oxlumo (lumasiran) for the treatment of primary hyperoxaluria type 1 (PH1).  Oxlumo is now the first approved targeted...

J&J COVID-19 Vaccine Shows Promise in Preclinical Trial

by Samantha McGrail

Johnson & Johnson recently announced that its lead COVID-19 vaccine candidate, Ad26.COV2.S, showed positive outcomes in preclinical studies using hamsters.   The data, published in Nature...

Trump Pursues Most Favored Nation Strategy for Lower Drug Prices

by Samantha McGrail

President Trump signed an executive order yesterday to lower prescription drug prices by “putting America first,” but experts are unsure if this move will have a direct impact on rising...

Steps to Implement a Successful COVID-19 Vaccination Program

by Samantha McGrail

Premier recently released four recommendations on how the US can implement a successful COVID-19 vaccination program once a vaccine becomes available to the public.   Currently, various...

Mylan, Biocon Biologics Launch Diabetes Biosimilar in the US

by Samantha McGrail

Mylan and Biocon Biologics recently announced the US launch of biosimilar Semglee in vial and pre-filled pen presentations, to help control high blood pressure in pediatric patients with type 1...

NIH Challenges Use of Convalescent Plasma to Treat COVID-19

by Samantha McGrail

After substantial review, NIH’s COVID-19 Treatment Guidelines Panel found that there were insufficient data to recommend either for or against the use of convalescent plasma for the treatment of...

FDA Expands Remdesivir Use to All Hospitalized COVID-19 Patients

by Samantha McGrail

FDA recently broadened an emergency use authorization for remdesivir to include all hospitalized adult and pediatric patients with COVID-19. For more coronavirus updates, visit our resource page,...

Early Positive Data for Pfizer’s mRNA COVID-19 Vaccine Candidate

by Samantha McGrail

Pfizer and BioNTech recently shared early Phase 1 safety and immunogenicity data from the ongoing US study of their mRNA COVID-19 vaccine candidate, BNT162b2, which has advanced into Phase 2/3...

Remdesivir May Not Greatly Help Moderately Ill COVID-19 Patients

by Samantha McGrail

Although remdesivir showed clinical benefit in patients with severe COVID-19, it showed little benefit on clinical status for moderately ill COVID-19 patients , a recent JAMA Network Open study...

Roche, Regeneron to Boost Supply of COVID-19 Antibody Combo

by Samantha McGrail

Roche and Regeneron recently announced a partnership to develop, manufacture, and distribute Regeneron’s investigational COVID-19 antibody combination. For more coronavirus updates, visit...

GSK Launches Phase 3 Trial for 5-in-1 Meningitis Vaccine

by Samantha McGrail

GSK recently announced that the first patients have been dosed in a Phase 3 clinical trial investigating its 5-in-1 meningitis vaccine candidate, MenABCWY. The initial Phase 3 tiral will be enroll...

FDA Authorizes Use of Convalescent Plasma as COVID-19 Treatment

by Samantha McGrail

FDA announced yesterday that it issued an emergency use authorization (EUA) for investigational convalescent plasma as a COVID-19 treatment in hospitalized patients. For more coronavirus updates,...

HHS Authorizes Pharmacists to Administer Childhood Vaccines

by Samantha McGrail

HHS recently issued a third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to lifesaving childhood vaccines during the COVID-19...

Sanofi Inks $3.4B Pharma Acquisition Deal with Principia Biopharma

by Samantha McGrail

Sanofi recently announced that it will acquire biopharmaceutical company, Principia Biopharma Inc, in a pharma acquisition deal of $100 per share in cash. Principia Biopharma focuses on developing...

EU Launches Initiative to Accelerate COVID-19 Therapy Development

by Samantha McGrail

The Corona Accelerated R&D in Europe (CARE) recently launched to quicken COVID-19 therapy development leveraging both public and private companies. For more coronavirus updates, visit...

HHS, DoD Tap McKesson to Help with COVID-19 Vaccine Distribution

by Samantha McGrail

HHS and the Department of Defense (DoD) recently announced that McKesson Corporation will be a central distributor of future COVID-19 vaccines and related supplies needed to administer the drug. For...