Access To Medicine

FDA Authorizes Moderna, J&J Booster COVID-19 Vaccine Dose

by Samantha McGrail

FDA recently granted emergency use authorization to both the Moderna and Johnson & Johnson respective COVID-19 vaccine booster doses.  The agency specifically approved Moderna’s booster...

FDA Recommends Authorization For J&J’s COVID-19 Vaccine Booster

by Samantha McGrail

FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) recently recommended emergency use authorization for a booster dose of Johnson & Johnson’s COVID-19 vaccine. VRBPAC...

FDA Grants Designation For Daiichi Sankyo’s Breast Cancer Treatment

by Samantha McGrail

FDA recently granted Daiichi Sankyo’s Enhertu breakthrough therapy designation in the US to treat adult patients with unresectable or metastatic HER2-positive breast cancer.  Enhertu is an...

ViiV Healthcare Submits FDA Application for HIV Regimen

by Samantha McGrail

ViiV Healthcare recently announced it made a regulatory submission to FDA for approval of a new dispersible tablet regimen for children living with HIV. The tablet formulation, Triumeq, includes...

Marketing Strategies to Boost Access to Prescription Medications

by Samantha McGrail

The pharmaceutical supply chain is the means through which prescription medications are manufactured and delivered to patients. There are many ways that patients can obtain a prescription,...

Thermo Fisher Launches System to Scale Gene Therapy Workflows

by Samantha McGrail

Thermo Fisher Scientific recently launched the integrated Gibco AAV-MAX Helper Free AAV Production System to enable scalable gene therapy workflows. The solution aims to simplify AAV vector production...

Biden Administration Unveils Plan to Lower Prescription Drug Prices

by Samantha McGrail

HHS Secretary Xavier Becerra recently released a comprehensive plan to lower prescription drug prices. The Drug Pricing Plan, part of a broader initiative from Joe Biden’s Executive Order on...

Novartis Boosts Access to Cholesterol-Lowering RNA Therapy

by Samantha McGrail

Novartis and NHS England recently reached a commercial agreement to enable broad access to Novartis’ RNA therapy, Leqvio, which helps lower LDL cholesterol (LDL-C) in eligible patients with...

GoodRx, Boehringer Increase Affordable Drug Access for Patients

by Samantha McGrail

GoodRx and Boehringer Ingelheim recently collaborated to increase affordable drug access for patients with type 2 diabetes or chronic obstructive pulmonary disease (COPD).   Under the...

Gavi Signs Agreement for Sinopharm, Sinovac COVID-19 Vaccine Doses

by Samantha McGrail

Gavi recently signed an advance purchased agreement with Sinopharm and Sinovac for their respective COVID-19 vaccines. The purchase agreements for Sinopharm’s “BBIBP-CorV” and...

Biden Invests Over $3B to Boost COVID-19 Antiviral Development

by Samantha McGrail

The Biden Administration will invest over $3 billion to accelerate the discovery, development, and manufacturing of COVID-19 antiviral medicines. The initiative, called the Antiviral Program for...

Congress Reintroduces PASTEUR Act to Combat Antimicrobial Resistance

by Samantha McGrail

US Senators Michael Bennet and Todd Young, and Representatives Mike Doyle and Drew Ferguson recently reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to...

Pfizer, BioNTech Give US 500M Doses of COVID-19 Vaccine

by Samantha McGrail

Pfizer and BioNTech will provide the US government with 500 million doses of their COVID-19 vaccine; the allotment includes 200 million doses in 2021 and 300 million doses in 2022 at a not-for-profit...

Breaking Down the Approval of Biogen’s Aducanumab

by Samantha McGrail

FDA has approved Biogen’s drug for Alzheimer’s disease, Aduhelm (aducanumab), despite ongoing debate over the drug’s efficacy.  Aducanumab is a monoclonal antibody selected from...

Prescription Drug Spending Expected to Reach $400B in 2025

by Samantha McGrail

Total net prescription drug spending is expected to reach $380 billion to $400 billion in 2025, an increase from $359 billion in 2020, according to an IQVIA analysis.  This forecast is fairly...

EU Approves AstraZeneca’s Non-Small Cell Lung Cancer Drug

by Samantha McGrail

The European Union (EU) has  AstraZeneca’s Tagrisso for the treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer...

Moderna, UNICEF to Supply COVID-19 Vaccine on Behalf of COVAX

by Samantha McGrail

Moderna and UNICEF recently signed a long-term agreement for the supply of COVID-19 vaccine on behalf of the COVAX Facility, part of the agreement announced in May.  UNICEF and its procurement...

FDA Approves First Targeted Non-Small Cell Lung Cancer Therapy

by Samantha McGrail

FDA recently approved Amgen’s Lumakras, the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation and who have received at least...

Northwell, Pear Therapeutics Provide New Opioid Treatment Options

by Samantha McGrail

Northwell Health and Pear Therapeutics recently collaborated to provide new treatment options for patients with opioid and substance-use disorders.  Through the collaboration, patients seeking...

NIH Launches COVID Variant Trial; Pfizer Releases New Data

by Samantha McGrail

NIH recently announced that it has started a Phase 1 clinical trial of Moderna’s variant-specific COVID-19 vaccine candidate, mRNA-1273.351. Researchers will evaluate the safety and...