Procter & Gamble (NYSE:PG) recently received a warning letter from FDA for failing to meet the agency’s requirements in the drug listing. The warning related to Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (National Drug Code (NDC): 58933-541), a powdered medicine intended to be dissolved in hot water before use. The FDA’s…
California partners with manufacturer to make affordable generic insulin
The state of California has established a $50 million collaboration over a decade with the generic drug manufacturer Civica. The goal of the collaboration is to create affordable state-branded generic insulin. Qualified individuals may obtain a 10-mL vial of generic insulin for $30 or less. California plans to provide a pack containing five prefilled 3…
FDA releases guidance on pharmaceutical supply chain security
The FDA recently published guidance to help the pharma industry detect suspicious and illegitimate products within the pharmaceutical supply chain. These regulations, established under the Drug Supply Chain Security Act (DSCSA), concentrate on product tracing, verification, and identification for specific drug products distributed in the U.S. So far this year, the agency has released more than…
Sanofi joins Lilly and Novo Nordisk in drastic insulin price reductions
Paris-based Sanofi (Nasdaq:SNY) is the fastest company to reduce insulin prices. The pharmaceutical behemoth said it would cut the list price of Lantus (insulin glargine injection) by 78%. Lantus is its most commonly prescribed insulin in the U.S. Moreover, Sanofi will implement a $35 cap on out-of-pocket expenses for users of the insulin. Sanofi has also…
Seven security considerations for cloud-based plant process management
Cloud-based plant process management systems are gaining ground. Here’s what pharmaceutical companies should know about cloud software security. Moving to a cloud-based plant process management (PPM) system can be an important part of digital transformation for pharmaceutical companies. Digital PPM systems centralize the knowledge captured, allowing process manufacturers to better manage and share data. A cloud-based…
The pros and cons of membrane-based WFI generation and distillation for biopharma
The pharma industry is in the process of moving toward ambient water for injection (WFI). Despite changes to regulations almost five years ago that allowed for alternative methods of generating WFI, the industry has been slow to fully embrace the shift away from traditional distillation despite the significant advantages of membrane-based WFI generation. For companies…
Sanofi to acquire diabetes treatment developer Provention Bio for $2.9B
Sanofi announced that it agreed to acquire Provention Bio, which develops therapeutics for immune-mediated diseases, for approximately $2.9 billion. Paris, France-based Sanofi agreed to acquire Provention Bio for $25 per share in cash. If the companies complete the acquisition, Sanofi expects a wholly-owned subsidiary to merge with and into Provention Bio. It intends to fund…
Pfizer to acquire Seagen for $43B
Pfizer and Seagen announced today that they entered into an agreement under which Pfizer acquires Seagen for $43 billion. The price of the acquisition comes to $229 in cash per Seagen share, totaling $43 billion. Both companies’ boards unanimously approved the transaction. Seagen develops antibody-drug conjugate (ADC) technology. Four of the 12 total FDA-approved and…
Drug shortage Alert: Millions of patients affected as FDA reports shortfalls of essential drugs
Millions of U.S. patients are facing medication shortages, according to recent FDA data. The Adderall drug shortage in particular has received significant attention in recent months. Other notable drugs currently facing shortages include the bronchodilator Albuterol and the popular antibiotics amoxicillin and azithromycin. The pandemic and supply chain challenges are partly to blame for the…
White House mulls mass vaccination campaign for poultry to combat bird flu outbreak
The Biden administration is considering a mass vaccination campaign for poultry. Such an initiative could counter the deadly H5N1 bird flu outbreak, which has also fueled a shortage of eggs while spiking their price. Researchers at the U.S. Department of Agriculture (USDA) are exploring the development of novel poultry vaccines. The agency is also discussing…