NICE UK recommends Keytruda with carboplatin and paclitaxel for metastatic squamous non-small-cell lung cancer – Merck Inc

NICE (UK): Keytruda (pembrolizumab), from Merck Inc. with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if their tumours express PD?L1 with a tumour proportion score of 0% to 49%, if their tumours express PD?L1 with a tumour proportion score of 50% or more and they need urgent clinical […]

Sandoz launches generic lenalidomide in 19 countries across Europe

Sandoz has announced the launch of generic oncology medicine lenalidomide, indicated for several haemato-oncology conditions as recommended by the latest European Society for Medical Oncology (ESMO) guidelines. The medicine will become available to patients in 19 countries across Europe. The cost of treating multiple myeloma patients is high and continues to rise. Affordability of and access to new multiple myeloma […]

Three-drug combination prolongs survival in men with metastatic, hormone-sensitive prostate cancer

Results from an international, randomized, double-blind, placebo-controlled, phase 3 clinical trial indicate that adding the androgen-receptor inhibitor darolutamide to androgen-deprivation therapy and chemotherapy prolongs the survival of men with metastatic, hormone-sensitive prostate cancer, a disease that is fatal in most cases. The study, which was conducted by a team led by investigators at Massachusetts General Hospital (MGH), is published in […]

UK rolls out new drug approval pathway

Effective 1 January 2022 Pharmaceutical companies can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). The new approval pathway marks a collaboration by multiple UK government entities, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency (MHRA), the Scottish Medicines Consortium and the […]

EMPEROR-Preserved phase III trial of Jardiance shows efficacy in heart failure – Eli Lilly + Boehringer

Jardiance (empagliflozin), from Eli Lilly and Boehringer, reduced the risk for the composite primary endpoint of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease status at baseline, according to findings from a new prespecified sub-analysis of the EMPEROR-Preserved […]

EMA gives green light for six new medicines

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory body, the Committee on Human Medicinal Products (CHMP). The newly approved products are: Trodelvy (sacituzumab govitecan) for the treatment of unresectable or metastatic triple-negative breast cancer. Rybrevant (amivantamab), conditionally approved for the treatment of […]

The Bristol-Myers Squibb-Pfizer Alliance welcomes the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis Patents

The Bristol-Myers Squibb-Pfizer Alliance issued the following statement: We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August 2020 decision finding the composition of matter (COM) patent (US 6,967,208) and formulation patent (US 9.326,945) covering Eliquis valid and infringed. Given today’s decision, the earliest that generic manufacturers are permitted to […]

Shorter course of antibiotics is effective for men with urinary tract infection

Researchers report that, for treatment of afebrile (non-feverish) men with a urinary tract infection (UTI), a 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole is a non-inferior alternative to a 14-day course of treatment. The findings were published on July 27, 2021 in JAMA/Journal of the American Medical Association. “The findings support the use of a 7-day course of ciprofloxacin or trimethoprim/sulfamethoxazole […]

Using artificial intelligence for early detection and treatment of illnesses

Artificial intelligence (AI) will fundamentally change medicine and healthcare: Diagnostic patient data, e.g. from ECG, EEG or X-ray images, can be analyzed with the help of machine learning, so that diseases can be detected at a very early stage based on subtle changes. However, implanting AI within the human body is still a major technical challenge. TU Dresden scientists at […]