BD announced today that it has secured ISO certification for its enterprise-level Information Security Management System. The Franklin Lakes, New Jersey–based company said the ISMS meets a rigorous set of independently audited international standards. BD says the ISO/IEC 27001:2022 certification demonstrates its commitment to protecting the company, customers and patients from cybersecurity threats. The International…

A New York federal judge has frozen the assets of several individuals and entities for their alleged role in distributing counterfeit versions of Gilead Science’s (Nasdaq:GILD) HIV medications. Presiding over the U.S. District Court for the Eastern District of New York, Judge Ann M. Donnelly also denied the defendants’ motion to dismiss the case for…

Demand for the attention-deficit/hyperactivity disorder drug Adderall (mixed amphetamine salts) has skyrocketed in the past decade. In 2021, physicians prescribed the medication and its generic equivalents 41.4 million times. Supplies of generic Adderall XR, however, remain scarce. Amneal Pharmaceuticals, Rhodes Pharmaceuticals, Par Pharmaceutical, Sandoz and Teva had the drug on backorder in late August, according…

Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril.  Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure.  N-nitroso-quinapril, which can be frequently found in…

Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization. The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants. Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin —  to prevent contamination…

Roche (SIX:RO,ROG) has announced that it has completed the repurchase of 53.3 million shares held by Novartis (NYSE:NVS) for a total consideration of $20.7 billion. In early November, the companies had announced that they had agreed to a bilateral transaction related to the sale of the shares. Roche intends on canceling the repurchased shares after…

With new cases of COVID-19 increasing 14% in the past two weeks, President Biden is aiming to convince unvaccinated Americans to get their first dose of the vaccine. CDC data show that the highly transmissible Delta variant now dominates the U.S., driving close to 52% of COVID-19 cases in the U.S. from June 19 to…

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts. Also in the plan are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential. The “full-scale, wartime” plans have considerable relevance…

About 6.4 million doses of the COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) will ship to U.S. states in mid-December, as long as the vaccine soon receives an FDA EUA. There are also plans to quickly distribute vaccine from rival COVID-19 vaccine developer Moderna (NSDQ:MRNA), which could soon apply for an EUA, officials at the…

Medical supply firm McKesson (NYSE:MCK) announced in a quarterly report that it and two other drug distributors could pay as much as $21 billion in opioid lawsuit settlements over 18 years. Under the new proposal, McKessons’s share of the settlements could be $8 billion. Rivals AmerisourceBergen (NYSE:ABC) and Cardinal Health (NYSE:CAH) would pay the remainder…