Teva Pharmaceuticals and mAbxience recently announced a strategic licensing agreement for a biosimiliar candidate that is in development for treating multiple oncology indications. The licensing agreement covers multiple global markets, including Europe and the U.S., expanding mAbxience’s global expansion strategy. The new partnership also supports Teva’s “Pivot to Growth” strategy that will expand its biosimiliar…

All companies in the pharmaceutical industry are under pressure for time, quality, compliance, and innovation. These pressures create imperatives to be both paperless and flexible to protect profitability. The stresses and imperatives apply to small-molecule pharmaceuticals, active ingredients (API), contract drug manufacturers (CDMOs), large-molecule biotechnology, and gene and cell therapy makers. Fortunately, a manufacturing execution…

Merck & Co. has announced its third quarter results, projectings its full-year 2023 revenue to be in the range of $59.7 billion to $60.2 billion. That’s roughly in line with the guidance from Pfizer, which recently adjusted its revenue forecast from $58 billion to $61 billion.  As Pfizer deals with reduced demand for COVID-19 products,…

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…