Month: February 2024

Arshad M. Khanani, MD, MA, FASRS. Image Credit: Opthea Limited Opthea Limited, a clinical-stage biopharma company that creates novel therapies for the treatment of retinal diseases, including wet age-related macular degeneration (AMD), has appointed Arshad M. Khanani, MD, MA, FASRS, as its chief medical advisor. He currently serves as a managing partner, director of clinical research, […]

Image credit: appledesign | stock.adobe.com. The FDA has approved AstraZeneca’s Tagrisso (osimertinib) for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.1,2 Tagrisso was previously approved as a monotherapy […]

Image credit: adragan | stock.adobe.com. Prescription drug pricing has become a major concern in the United States, with patients and their employer-sponsored health plans facing exorbitant costs even after factoring in rebates. In this article, we delve into the intricacies of the pharmaceutical industry, shedding light on issues related to transparency, consumer behavior, and potential […]

Image Credit: Adobe Stock Images/NewAfrica.com Earlier this week, Masimo announced the FDA clearance of the MightySat Fingertip Pulse Oximeter, representing the first FDA-cleared fingertip pulse oximeter for over-the-counter (OTC) sale directly to consumers without a prescription. According to the company, the new device is equipped with Masimo SET pulse oximetry technology, known for accuracy and […]

Image Credit: DHL Supply Chain DHL Supply Chain, a logistics company that operates within Deutsche Post DHL Group, has made a $200 million investment toward growing its life sciences and healthcare offerings.1 This decision features the construction of new, state-of-the-art warehouse facilities in Pennsylvania and North Carolina, expanding their footprint to over 13 million square feet. […]

Image credit: photon_photo | stock.adobe.com. Researchers are beginning to realize the potential of artificial intelligence to predict the safety and efficacy of drugs across different indications and disease states. In a recent study published by Amsterdam University Medical Center, investigators found that a multimodal machine learning approach accelerated the time in which they could determine […]

Image credit: iDoPixBox | stock.adobe.com. EMD Serono, Merck KGaA’s biopharmaceutical business, scored a traditional approval for Tepmetko (tepotinib) to treat adults with metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.1 The oral MET inhibitor was developed to inhibit oncogenic MET receptor signaling that is caused by alterations to the MET gene, including METex14 […]

There is one certainty about health care supply chain in 2024: smart executives will challenge the status quo and think differently about strategy. Fraught with a perfect storm of challenges in recent years—including the highest number of drug shortages in nearly a decade—success going forward will be defined by a laser-focused approach to overcoming logistical […]

Image credit: bit24 | stock.adobe.com. Food allergy. Allergic food on wooden background. The FDA has approved an expanded indication for Novartis’ and Roche’s Xolair (omalizumab) as the first medication indicated to reduce allergic reactions from exposure to one or more food allergens in individuals over 1 year of age with immunoglobulin E (IgE)-mediated food allergy.1 Xolair […]

Image Credit: Adobe Stock Images/Faustasyan.com Abbott has announced that an FDA advisory committee officially voted in favor of its TriClip System, designed to address tricuspid regurgitation (TR). Abbott describes TR as a condition in which the heart’s tricuspid valve fails to close properly, leading to backward blood flow. According to a company press release, the […]

Image Credit: Adobe Stock Images/Nobeastsofierce.com Rapid cell proliferation or spreading is a staple of cancer, especially when it is combined with therapeutic sensitivity that can result in DNA replication stress (RS). This issue with tumors lies in their ability to become resistant to medications known as RS-inducing (RSi) agents, also known as chemotherapy. In a […]

Image credit: Matthieu | stock.adobe.com. The FDA has approved Ipsen’s Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (mPDAC). The FDA initially approved an Onivyde treatment combination for mPDAC in 2015 in combination with fluorouracil and leucovorin for patients who experienced […]

Image credit: peterschreiber.media | stock.adobe.com. Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) has been granted Priority Review status by the FDA for patients aged 12 years and older with solid tumors that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic, and for whom surgical resection will likely cause […]

Image Credit: Adobe Stock Images/Rost9.com Given the severity of terminal and chronic diseases, the regulatory agencies that are responsible for verifying that novel biotherapeutics are as safe and effective as possible often find themselves under pressure to provide quick public access to these products, noted the authors of an analysis published in Cytotherapy.1 Some could […]

Image credit: diy13 | stock.adobe.com Roche has halted its worldwide license and collaboration agreement with Repare Therapeutics Inc. to develop and commercialize camonsertib (RP-3500). The rights to camonsertib, an oral small molecule Ataxia-Telangiectasia and Rad3-related (ATR) protein kinase inhibitor, now revert back to Repare, who plan to continue development of the agent across tumor types.1 “Camonsertib […]

Image credit: Destina | stock.adobe.com. The FDA has granted Fast Track designation to GSK’s novel antisense oligonucleotide (ASO) bepirovirsen to treat chronic hepatitis B (CHB).1 The drug was designed to specifically recognize the RNA used by hepatitis B virus (HBV) to replicate in infected liver cells. Bepirovirsen, a triple action investigational ASO, has been found […]