clinical trials

The task of extracting health insights from electronic health records (EHRs) has taken longer to materialize than some pundits projected a decade or so ago. But the situation is quickly changing with continued advances in data science, said Sujay Jadhav, CEO of Verana Health (San Francisco), which has created a real-world data network in partnership…

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020. Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe…

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).  The COVID-19 pandemic previously interrupted the study for more than one year.  In 2019, IntelGenx initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a…

Soon after taking the reins of Zymeworks (NYSE:ZYME), new Chair and CEO Kenneth Galbraith has decided to sharpen the company’s focus and reduce the firm’s headcount. To free up cash, the company plans to lay off at least one-quarter of its staff, including 10 members (50%) of its senior management team. The Vancouver–headquartered company also intends to…

FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…

The use of decentralized clinical trials (DCTs) exploded during the pandemic, but quantifying their financial benefits has been elusive.  Medable (Palo Alto, California), the maker of a cloud-based DCT platform, has announced that DCTs can accelerate clinical trial timelines and lead to significant cost savings.  Medable and its research partner, the Tufts Center for the Study…

Janssen (NYSE JNJ) and Leyden Labs (Amsterdam) have signed a licensing agreement that gives the latter rights to develop CR9114, an antibody protecting against influenza A and B. Leyden hopes to commercialize CR9114 as a nasal spray. Under the terms of the deal, Janssen will get an upfront payment and could receive milestone payments tied…

Focusing on insights based on real-world data (RWD) related to drug lifecycle and medical practice, Verana Health (San Francisco) has just hauled in $150 million Series E funding. Verana Health’s current fundraising total is $288.8 million, according to CrunchBase. Johnson & Johnson Innovation (JJDC) and Novo Growth led the most recent funding round. Also joining…

Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD). In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales…

FDA has approved Rinvoq (upadacitinib) from AbbVie (NYSE:ABBV) to treat moderate to severe atopic dermatitis in individuals at least 12 years old. AbbVie anticipates 2025 risk-adjusted sales for Rinvoq to top $7.5 billion. The most common type of eczema, atopic dermatitis, can be managed with various therapies, including corticosteroids, topical calcineurin inhibitors and immunosuppressants. Nevertheless, the…

While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market.  “We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,”…

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab. Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of…

The pharmaceutical industry appears to have addressed a decade-long decline in R&D productivity, according to a recent analysis from Deloitte. In 2021, the projected R&D return on investment (ROI) rose 7%. For comparison, the ROI level in 2010 was 2.7%. Forecast peak sales per asset hit $521 million, up more than 23% over the $422 million…

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary. Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron…

Psoriatic arthritis (PsA) is a complex heterogeneous disease involving the peripheral joints, affecting between 7% and 26% of psoriasis patients. Among the popular treatment options for psoriasis are tumor necrosis factor (TNF) inhibitors. A significant portion of psoriatic arthritis patients, however, fail to respond to TNF inhibitors.  Janssen announced last month that Tremfya (guselkumab) fared…

Pfizer (NYSE:PFE) aims to have an omicron-specific version of its vaccine available by March. However, it still isn’t sure if the tweaked version will be necessary, said CEO Dr. Albert Bourla in an interview with CNBC’s Squawk Box. The “new version” of its COVID-19 vaccine, which it developed jointly with BioNTech (NSDQ:BNTX), should hopefully offer better…

Idorsia Ltd (SIX:IDIA) has received FDA approval for 25- and 50-mg doses of Quviviq (daridorexant), a dual orexin receptor antagonist. Quiviviq is the first compound in its pipeline to win FDA approval. The drug works differently from traditional benzodiazepines, which modulate neuronal activity. By contrast, daridorexant inhibits the binding of orexins to reduce excessive wakefulness.…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

Eli Lilly (NYSE:LLY) has acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix proteolipid vehicle (PLV) drug-delivery technology for central and peripheral nervous system applications. Indianapolis-based Lilly plans on using the platform to discover and develop nucleic acid products. Entos said Fusogenix brings together the best features of viral and lipid-based delivery approaches while avoiding their respective downsides.…

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate. The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30. The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.…

Zymeworks (NYSE:ZYME) will install Ken Galbraith as chairman and CEO, replacing the company’s outgoing leader Ali Tehrani on or before February 1.  Galbraith has more than 30 years of experience working in life sciences, venture capital and global commercialization.  “Ken Galbraith is an outstanding global leader who brings more than 30 years of life science…

Pfizer Inc. (NYSE:PFE) and mRNA vaccine specialist BioNTech SE (NSDQ:BNTX) will collaborate to develop an mRNA-based vaccine to prevent the herpes zoster virus (shingles). Roughly one million people in the U.S. get shingles each year, according to the CDC. Currently, the two-dose Shingrix shingles vaccine from GSK (NYSE:GSK) is the only such product available in the U.S. market.…

High-quality clinical trial data serves as the foundation for analysis, submission, approval, labeling and marketing of a compound under study. Widely used throughout the industry, data cleaning ensures that the process deployed to collect data is consistent and accurate. Challenges in collection include data errors during manual data entry, i.e., spelling and transcription mishaps, range,…

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.   But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron.  In October, the Moscow-based…

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which…