The FDA has granted accelerated approval to the first-in-class antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) from Genmab and Seagen to treat adults with recurrent or metastatic cervical cancer. Specifically, the approval covers cancer with disease progression on or after chemotherapy. The drug targets protein tissue factor (TF), which is abnormally expressed in cervical cancer. Historically, physicians…
FDA backs stem cell therapy for COVID-19 under compassionate use program
The Global Institute of Stem Cell Therapy and Research (GIOSTAR) has announced that the FDA has authorized emergency use of its stem cell therapy for hospitalized COVID-19 patients. The San Diego–based organization has offered stem cell therapy for COVID-19-related symptoms since April 2020. The compassionate use authorization will enable GIOSTAR to offer stem cell therapy…
AUA2021: Gemtesa effective in overactive bladder wet and dry
Urovant’s Gemtesa (vibegron) was the subject of two positive presentations at the Annual Meeting of the American Urological Association (AUA2021). The first explained that vibegron is effective in patients with ‘dry’ overactive bladder (OAB) based on a post-hoc analysis of the pivotal EMPOWUR trial. The second presentation explained that vibegron had a negligible impact on ambulatory…
Ivy Brain Tumor Center sees promise in sonodynamic therapy for glioblastoma
Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients. Sonalasense has developed a noninvasive sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive. Data from the trial indicate that SDT swiftly causes…
Cell logistics firm Cellbox sets up shop in the U.S.
Live cell shipping specialist Cellbox Solutions GmbH (Hamburg, Germany) has now formally entered the North American market after setting up an office in Rockville, Maryland. The company is the developer of patented Cellbox technology, a transportable CO2 incubator that hit the European market in 2019. The company has also developed packaging compliant with UN3373 standards…
CDC study finds waning immunity in Pfizer-BioNTech vaccine recipients after four months
CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions. The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that interval was 92%. The CDC also concluded that, from March 11…
FDA advisory panel recommends boosters only for older and high-risk individuals
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…
FDA grants expanded EUA to Lilly’s COVID-19 antibody cocktail
FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis. Earlier in the year, federal authorities had counseled against the use of the monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351). Meanwhile, demand for…
How Lilly Oncology is aiming to improve clinical trial diversity
Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…
An inside look at Insmed
Many large drug developers employ individual groups or teams independently working on discrete steps in the drug development process. Rare disease biopharma Insmed (NSDQ:INSM) differentiates itself through its focus on patients with rare diseases. To that end, the company works to ensure collaboration between various departments to consider questions related to the applicability of a…
Amylyx Pharmaceuticals preps NDA filing for ALS drug AMX0035
Cambridge, Massachusetts–based Amylyx Pharmaceuticals intends to submit a New Drug Application (NDA) to FDA for AMX0035 (sodium phenylbutyrate and taurursodiol) to treat amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig’s disease. The company decided to file after a series of meetings with the FDA, including a pre-NDA meeting on July 15. AMX0035…
A closer look at Urovant’s vibegron blood pressure study
In recent years, regulators including FDA have increased their focus on the potential of drugs to cause blood pressure increases. To that end, the agency asked Urovant (Irvine, California) to study the impact of the beta-3 adrenergic receptor agonist vibegron on blood pressure. The study, recently published in the Journal of Urology, found no significant change…
Hookipa Pharma announces oncology partnership with Merck
Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC). Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.…
Theravance cuts 75% of staff after ampreloxetine failure
Theravance Biopharma (NSDQ:TBPH) has announced today that it is laying off 75%, or roughly 270, of its employees. The South San Francisco, California–based company employed 359 people in 2020, according to its most recent annual report. The company plans on making the bulk of the cuts in November, with more to follow in early 2022.…
Urovant shares positive data at the annual meeting of the American Urological Association
Urovant Sciences (Irvine, California) is upbeat about the prospects of beta-3 adrenergic receptor agonist Gemtesa (vibegron) in treating overactive bladder (OAB). This week, the drug was featured in two presentations at the virtual American Urological Association (AUA) Annual Meeting. Historically, the primary treatment for OAB involved a type of anticholinergics known as muscarinic receptor antagonists. In…
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. Two departing senior FDA vaccine officials recently co-wrote…
QurAlis selects development candidate for ALS
Privately-held biotech QurAlis plans to begin clinical development for the first-in-class molecule QRL-201 for amyotrophic lateral sclerosis (ALS) in the second half of 2022. QRL-201 is now the subject of IND-enabling studies. The drug candidate targets the restoration of STATHMIN-2 (STMN2) expression in ALS. STMN2 is a protein encoded by the STMN2 gene that is involved in…
Why pulmonary fibrosis deserves more attention
This September is Pulmonary Fibrosis Awareness Month, which the Pulmonary Fibrosis Foundation (PFF) and allies have launched to educate the public about the disease family. Involving scarring of the lungs, pulmonary fibrosis gradually robs the breath from patients it affects. Some 250,000 Americans live with idiopathic pulmonary fibrosis, according to PFF. At present, two drugs…
Why the pandemic is a crucible for clinical trial innovation
The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations. To get a clearer sense of what the ramifications of this accelerated development will…
Medable’s CSO opens up on rethinking clinical drug development
Direct-to-patient clinical trial company Medable (Palo Alto, California) has recently hired MaryAnne Rizk as its chief strategy officer. Rizk was IQVIA’s former senior vice president, digital R&D strategy. Rizk was also recently named a PharmaVoice 100 leader. Rizk is also a graduate advisor and an adjunct professor for the school of engineering at the Stevens Institute of…
AstraZeneca’s Imfinzi and tremelimumab show promise in non-small cell lung cancer study
AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON. Imfinzi and tremelimumab are immune checkpoint…
Key clinical trial considerations for the new normal and the future
A great many new and varied approaches to clinical trial management have gained ground during the COVID-19 pandemic through the help of virtualization tools, strong partnerships, and regulatory guidance. Despite the upheaval this year and last, there appears to be a silver lining. The systemic changes have enabled remarkably quick development in adapting trials to…
FDA rejects EUA for Humanigen’s monoclonal antibody for COVID-19
FDA determined it couldn’t conclude that the benefits of lenzilumab from Humanigen (NSDQ:HGEN) outweigh the risks for patients hospitalized with COVID-19. Lenzilumab is the company’s lead product candidate. The drug works by neutralizing granulocyte-macrophage colony-stimulating factor (GM-CSF), which is implicated in the so-called cytokine storm. The drug is the subject of 16 clinical trials spanning…
How Janssen’s twice-yearly schizophrenia drug could help patients
Traditionally, one of the most challenging aspects of treating schizophrenia is medication adherence. Patients who neglect to take their medicine have an elevated risk of relapse, hospitalization and suicide. “There’s a higher likelihood of an exacerbation of the illness occurring,” said Dr. Gustavo Alva, medical director at ATP Clinical Research (Costa Mesa, California). The problem…
FDA could soon greenlight COVID-19 vaccine boosters
While President Biden initially announced that COVID-19 boosters would be available by September 20, media reports suggested that the announcement caught FDA off guard. White House chief medical advisor Dr. Anthony Fauci recently suggested in an interview with CBS’s “Face the Nation” that the U.S. government is scaling back its booster plan for the broader…