Aeglea BioTherapuetics announced that it had failed to secure a biologics license application (BLA) from the FDA after administrators issued a refusal to file for the company’s biologic...
The FDA announced guidance Thursday that allows manufacturers and distributors of dietary supplements to submit late new dietary ingredient (NDI) notifications if they have failed to do so. Directors...
ViiV Healthcare, GSK, and Shionogi recently entered a $1.25-billion settlement over the global patent infringement litigation with Gilead concerning its HIV drug combined with three HIV integrase...
PhRMA member companies encourage Congress to abandon old partisan ideas on drug pricing and pursue policies that address patients out of pocket costs, according to a new official letter.
The...
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...
FDA recently accepted Roche’s biologics license application and granted priority review for Tecentriq as an adjuvant treatment following surgery and platinum-based chemotherapy for individuals...
Roche recently announced that FDA granted breakthrough therapy designation for its combination myelodysplastic syndromes (MDS) treatment.
The treatment combination of Venclexta and azacitidine is...
Denmark-based Orphazyme recently announced that FDA issued a complete response letter regarding its heat shock protein amplifier, arimoclomol, intended for Niemann-Pick disease type C (NPC), a rare...
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...
FDA recently updated its letter of authorization for Johnson & Johnson’s COVID-19 vaccine to help facilitate potential export to other countries.
Under the revised letter, FDA...
The Biden Administration recently announced that the US government will procure nearly 1.7 million courses of Merck’s investigational antiviral COVID-19 treatment,...
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...
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 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...
Janssen Pharmaceuticals of Johnson & Johnson recently announced that FDA has granted Breakthrough Therapy Designation (BTD) for its refractory T-cell therapy for multiple myeloma,...
CMS recently proposed delaying Medicaid value-based drug payment requirements for state purchasing agreements with drug manufacturers until July 2022.
The rule, called “Medicaid Program...
Several companies are filing a lawsuit against CVS Health, claiming that the retail pharmacy chain intentionally overcharged plaintiffs for prescription drugs by submitting claims for payment at...
Abbott recently announced that it received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, for individuals with severe aortic stenosis in...
JAMA Network Open study found that change in brand-name medication prices for most commercially insured patients correlated with changes in out-of-pocket costs.
In the study, nearly 53.7 percent of...
United States Trade Representative Katherine Tai announced the Biden-Harris Administration’s support for waiving COVID-19 vaccine intellectual property in order to speed up vaccine distribution...
