Supply Chain Management

FDA Seeks to Clarify Evidence for Intended Use Determinations

by Samantha McGrail

FDA recently proposed updates to its regulations to clarify the types of evidence the agency considers when determining the “intended use” of FDA-regulated products.  The proposed...

Immunotherapy Combo from Bristol Myers Squibb Improves Survival

by Samantha McGrail

Bristol Myers Squibb recently announced that more than half (53.4 percent) of advanced renal cell carcinoma patients treated with an immunotherapy combination of Opdivo (nivolumab) and Yervoy...

Microsoft Alliance Targets Real-Time Visibility for Supply Chains

by Samantha McGrail

Microsoft and C.H. Robinson recently partnered to transform supply chains of the future and enable real-time visibility for C.H. Robinson customers. To meet the demands of evolving global supply...

Is Germany’s Drug Pricing Strategy An Option for the US?

by Samantha McGrail

The German Pharmaceutical Market Restructuring Act (AMNOG) is an example of how a drug pricing strategy can be designed to better align prices with clinical benefit and is an approach the US can take...

Gilead Hints at Remdesivir’s Potential as a COVID-19 Treatment

by Samantha McGrail

Gilead Sciences recently found that using remdesivir as a COVID-19 treatment for severe coronavirus patients produced positive results in a Phase 3 clinical trial. Severe coronavirus patients receiving...

PBM Reimbursement Significantly Varies for Generic Drugs

by Samantha McGrail

Pharmacy benefit manager (PBM) reimbursement for generic drugs significantly varies by medication and plan, and does not respond to price hikes, according to a study from 3 Axis Advisors. Researchers...

Alynlam, Dicerna Partner on RNAi Therapeutics for Liver Disease

by Samantha McGrail

Alnylam and Dicerna recently announced the development and commercialization of investigational RNAi therapeutics for the treatment of alpha-1 liver disease. The pharmaceutical companies have also...

FDA Issues Guidance on Conducting Clinical Trials During COVID-19

by Samantha McGrail

FDA recently announced that it issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 pandemic. For more coronavirus updates,...

Suppliers Unable to Meet Orders for Potential COVID-19 Drugs

by Samantha McGrail

Vizient recently announced it has sent recommendations to the White House Coronavirus Task Force and FDA to improve access for two potential COVID-19 drugs: chloroquine and hydroxychloroquine. For...

Pharma Companies Spent $985M On New Drug Development

by Samantha McGrail

Biopharmaceutical companies spent an estimated $985 million on new drug development and research over a decade, counting expenditures on failed trials, according to researchers from the London School...

Feds Charge Sandoz for Fixing Generic Drug Prices

by Samantha McGrail

The Department of Justice recently announced that it has charged generic pharmaceutical company Sandoz Inc. for fixing generic drug prices, rigging bids, and other antitrust...

CA Firm Files Wrongful Death Lawsuit Over Opioid Dependence Drug

by Samantha McGrail

Law firm Lieff Cabraser, Heimann & Bernstein recently filed a wrongful death lawsuit against biopharmaceutical manufacturer Alkermes, for its alleged misrepresentation of an opioid dependence drug,...

GSK Sells 15 Consumer OTC Products to German Pharma Company STADA

by Samantha McGrail

Germany-based pharmaceutical company, Stada, announced it acquired 15 well-established local and regional consumer over-the-counter (OTC) products from GlaxoSmithKline (GSK).  The proposed...

Machine Learning Supports Effective Antibiotic Discovery

by Samantha McGrail

With the prevalence of antibiotic resistance rapidly rising, a new study published in Cell is offering a more efficient, cost-efficient strategy for antibiotic discovery using machine learning. There...