Industry News

FDA Issues Emergency Authorization for Merck’s COVID-19 Treatment

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FDA recently issued an emergency use authorization for Merck’s COVID-19 treatment, molnupiravir, for adults 18 years of age and older. The agency authorized the treatment for adults with high...

Pfizer to Amend Clinical Study of COVID-19 Vaccine in Children

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Pfizer and BioNTech recently announced that they will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their COVID-19 vaccine in children. The Phase 1/2/3 trial...

FDA Approves Pfizer’s Drug to Treat Adult Patients With AS

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FDA recently approved Pfizer’s Xeljanz (tofacitinib) to treat adults with active ankylosing spondylitis (AS). The agency approved the drug specifically for individuals who have had an inadequate...

SAGE, WHO Support Johnson & Johnson COVID-19 Vaccine Booster

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The Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) recently supported using Johnson & Johnson’s COVID-19 vaccine booster shot in...

GSK Welcomes Gavi Decision to Fund Routine Malaria Vaccines for Kids

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GSK recently welcomed the decision of the Gavi Board to fund the procurement and introduction of malaria vaccines into routine child immunization programs in eligible countries. GSK developed its...

FDA Approves Imaging Drug to Identify Ovarian Cancer

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FDA recently approved imaging drug Cytalux to assist surgeons in identifying ovarian cancer lesions.   Cytalux is approved for use in adult patients with ovarian cancer to help identify...

J&J Considers Licensing COVID-19 Vaccine to South African Company

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Johnson & Johnson recently announced a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, based in South Africa.  The companies will work towards a...

Specialty Drugs Accounted for Half of Medicaid Spending in 2020

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Specialty drugs accounted for 51.4 percent of the net cost in Medicaid and 1.3 percent of utilization in 2020, according to a Magellan Health trend report. The Medicaid Pharmacy Trend Report looked at...

GSK Appoints Phil Dormitzer Global Head of Vaccines, Research

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GSK recently appointed Phil Dormitzer, MD, PhD, as global head of vaccines research and development and a member of the vaccines leadership team. Previously, Dormitzer was vice president and chief...

CVS, Walgreens & Walmart Helped Fuel Opioid Crisis in Ohio Counties

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A federal jury recently held CVS, Walgreens, and Walmart pharmacies accountable for their role in an opioid crisis in two Ohio counties, according to a report from the Associated Press. Between 2012...

FDA Grants Designation For Early-Stage Breast Cancer Blood Test

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FDA recently granted breakthrough device designation for Datar Cancer Genetics’ blood test to detect early-stage breast cancer. The test, TriNetra, uses proprietary technology to detect...

FDA Approves Rare Blood Disease Injection For Adults

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FDA recently approved PharmaEssentia’s injection to treat adults with polycythemia vera, a rare blood disease that causes overproduction of red blood cells.  The monopegylated, long-acting...

Improved Diagnostic Testing Boosts Patient Experience, Study Finds

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Abbott recently released research from its multi-year global research program, which found that advancing diagnostic testing for vascular diseases can help hospitals and physicians improve the patient...

Abbott, ADA Initiative Addresses Diabetes Care Management in POC

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Abbott and the American Diabetes Association (ADA) recently launched a joint community health partnership to address diabetes care management among people of color (POC) living with the...

CHMP Recommends Approval Of Roche’s COVID-19 Antibody Combination

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of Roche’s COVID-19 antibody combination, Ronapreve. CHMP...

FDA Approves Novartis’ Chronic Myeloid Leukemia Treatment

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FDA recently approved Novartis’ Scemblix to treat chronic myeloid leukemia (CML) for adult and pediatric patients with Philadelphia chromosome-positive CML in chronic phase. Scemblix is the...

Feds Purchases More Doses of Lilly’s COVID-19 Antibody Treatment

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The US government recently purchased additional doses of Eli Lilly and Company’s combination COVID-19 antibody treatment. Under the agreement, Eli Lilly and Company will supply 614,000 doses of...

FDA Authorizes Thermo Fisher’s COVID-19 New Test Collection Method

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FDA recently granted emergency use authorization to Thermo Fisher Scientific to run new saliva sample collection methods on its COVID-19 tests. The company’s molecular diagnostics Spectrum...

FDA Accepts Application for Novartis’ Diabetic Macular Edema Drug

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FDA recently accepted Novartis’ biologics license application for Beovu, the company’s diabetic macular edema (DME) drug.  Specifically, FDA accepted the application for six...

FDA Approves Expansion of Gilead’s HIV Drug in Pediatric Patients

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FDA recently approved a new low-dose tablet dosage form of Gilead’s HIV-1 drug, Biktarvy, in pediatric patients. The agency approved the new dosage for children weighing at least 30 pounds who...