Cary, North Carolina–based Thread has introduced a consultative service known as Thread Adopt to support change management in decentralized clinical trials. The service encompasses processes, tools, templates and educational functionality. “Thread Adopt guides and empowers customers to analyze their pipeline, with a view to match decentralized solutions and services to the specific needs of their…
FDA hands Kaleido Biosciences a warning letter
The FDA notified Kaleido Biosciences (NSDQ:KLDO) determined that the Lexington, Massachusetts-based company did not submit investigational new drug (IND) applications for clinical trials related to the investigational drug KB109, a microbiome modulator. The two clinical trials in question, dubbed “Protocol K031-120” and “Protocol K032-120,” are testing KB109 in adults with mild-to-moderate COVID-19. KB109 is a synthetic…
University of Minnesota announces clinical trial for opioid vaccine
The University of Minnesota Medical School has developed a therapeutic vaccine for opioid use disorder that is the subject of a new Phase 1 randomized placebo-controlled clinical trial. The trial, which recently begun enrollment, will be conducted at the Columbia University Irving Medical Center in New York. Sandra Comer, a professor of neurobiology at the College of Physicians and…
Medable installs new chief strategy officer
Direct-to-patient clinical trial company Medable (Palo Alto, California) has added MaryAnne Rizk to its executive team. Rizk formerly worked at IQVIA as a senior vice president, digital R&D strategy. She is also an adjunct professor at the Steven Institute of Technology (Hoboken, New Jersey) and a managing partner at Rizk Management Consulting. In August, Rizk…
Novartis wins FDA fast track designation for investigational osteoarthritis drug
Novartis (NYSE:NVS) has received FDA fast track designation for LNA043, a potential treatment for osteoarthritis of the knee. LNA043 is a modified version of the human angiopoietin-like 3 (ANGPTL3). The drug would be a potential first-in-class disease-modifying osteoarthritis therapy. Osteoarthritis is a common joint disorder. In 2017, more than 300 million people internationally had either hip…
Impel NeuroPharma wins FDA approval for migraine nasal spray
Impel NeuroPharma (NSDQ:IMPL), a biopharma founded in 2008, has won FDA approval for Trudhesa (dihydroergotamine mesylate) nasal spray as an acute migraine therapy. The Seattle-based company intends to launch the drug, formerly known as INP104, in early October 2021. Impel plans to price the drug between $600 and $850 for a package with four doses.…
AstraZeneca and European Commission settle COVID-19 vaccine supply lawsuit
AstraZeneca (LON:AZN) and the European Union have agreed to end litigation related to the supply of its COVID-19 vaccine Vaxzevria (ChAdOx1-S). AstraZeneca had initially contracted with the European Commission to provide 300 million doses of its vaccine with an option for another 100 million, but fell short of its commitment. The level of vaccine doses,…
Caribou Biosciences announces positive CRISPR hybrid RNA-DNA data
Caribou Biosciences (NSDQ:CRBU) has announced the publication of data showing that its CRISPR hybrid RNA-DNA (chRDNA) guide technology supports better CRISPR associated protein 9 (Cas9) specificity compared with all-RNA guides. The Berkeley, California–based company’s technology thus enabled accuracy in intended genomic edits in cells while minimizing off-target events. High Cas9 specificity is useful in the…
FDA advisory panel to discuss potential Pfizer vaccine boosters in mid-September
The FDA has scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss Pfizer’s supplemental application for a COVID-19 vaccine booster. While President Biden has embraced the concept of boosters as early as five months post-second dose, other experts within the government have recommended a more cautious approach. In addition, WHO has…
ConcertAI and Janssen deepen data-science collaboration
A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types. ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together…
Assembly Bio discontinues development of hepatitis drug ABI-H2158
Assembly Biosciences (NSDQ:ASMB) is halting the development of the hepatitis drug ABI-H2158 (2158) after observing elevated alanine aminotransferase (ALT) in participants in a Phase 2 trial. High ALT levels can indicate liver damage. “Patient safety is always our priority, which is why we have elected to discontinue the development of 2158,” said Dr. John McHutchison,…
Janssen wins FDA approval of twice-yearly schizophrenia treatment
Janssen (NYSE:JNJ) has won FDA approval for the long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), which will be the first six-month injectable on the U.S. market. Titusville, New Jersey–based Janssen announced that patients who intend to obtain Invega Hafyera must receive Invega Sustenna (one-month paliperidone palmitate) four at least four months beforehand. Alternatively, they can…
Could COVID-19 vaccines guard against dementia?
COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ. COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings. Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced…
An inside look at Pardes Biosciences’ oral coronavirus protease inhibitor
Two months after exiting stealth mode via a SPAC merger, the early-stage biopharma Pardes Biosciences (Palo Alto, California) has launched a first-in-human trial for its investigational COVID-19 pill PBI-0451. The origins of the company stretch back to the early days of the pandemic, said Dr. Uri Lopatin, CEO and co-founder of the company. A visiting…
Study finds Moderna’s COVID-19 vaccine drives a stronger antibody response than Pfizer’s
Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s. Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter. The study involved 1,647…
Janssen’s pulmonary hypertension division leader is upbeat about the future of PH treatment
A few decades ago, an HIV diagnosis was akin to a death sentence. But with proper treatment including antiretroviral therapy, HIV patients can often expect to have a normal life expectancy. David Jimenez, former president of Johnson & Johnson’s Janssen Infectious Diseases, is confident that similar breakthroughs can happen in pulmonary hypertension. “We’re not there…
Pfizer’s abrocitinib goes head-to-head with Sanofi’s Dupixent
Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD). Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant…
Third dose of Pfizer COVID-19 vaccine boosts protection in people over 60
Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older. The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel).…
BioAegis announces promising data in case study involving critical COVID-19 patient
BioAegis (North Brunswick, NJ) is evaluating data from a Phase 2 clinical trial related to recombinant human plasma gelsolin (rhu-pGSN) along with standard of care in treating patients with severe COVID-19 pneumonia. In the interim, the company has announced the results of a compassionate use case study involving a hospitalized patient with critical COVID-19 pneumonia.…
NIH to study third dose of COVID-19 vaccine in people with autoimmune disease
The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination. The Phase 2 study will also test the impact of pausing immunosuppressive…
Roche withdraws approval application for Tecentriq in mTNBC
Roche (OTCQX:RHHBY) has voluntarily withdrawn its application for FDA accelerated approval for the monoclonal antibody Tecentriq (atezolizumab) in combination with chemotherapy to treat unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) with tumors expressing programmed death-ligand 1 (PD-L1). Earlier this month, Roche won priority review for Tecentriq for people with non-small cell lung cancer…
Pardes Biosciences launches first-in-human trial for SARS-CoV-2 antiviral
A handful of companies may have a lock on COVID-19 vaccines, but competition is heating up in antivirals targeting the novel coronavirus. One of the latest entrants is Pardes Biosciences (Carlsbad, Calif.), which recently announced a Phase 1 trial for PBI-0451, an oral antiviral targeting SARS-CoV-2. Other companies developing antivirals for COVID-19 include Pfizer as well as…
Aria Pharmaceuticals announces positive in vivo data for two idiopathic pulmonary fibrosis candidates
Small molecule drug developer Aria Pharmaceuticals (Palo Alto, Calif.) has announced that two investigational treatments for idiopathic pulmonary fibrosis (IPF), TXR-1002 and TXR-1007, demonstrated efficacy and tolerability in preclinical research. The two drug candidates reduced fibrosis and lung collagen staining. The company used Boehringer Ingelheim’s nintedanib as a control in the research. TXR-1002 and TXR-1007…
iBio bolsters immuno-oncology pipeline with RubrYc Therapeutics alliance
Biopharma iBio, Inc. (NYSEA:IBIO) has entered into a definitive global exclusive license agreement with RubrYc Therapeutics for RTX-003, an immunotherapy candidate targeting regulatory T cells. In addition, the deal includes an option for iBio to license additional antibodies designed with RubrYc’s antibody discovery platform based on machine learning and computational biology. iBio made an upfront $5 million…
Appeals court invalidates $1.2 billion fine against Gilead Sciences
The U.S. Court of Appeals for the Federal Circuit tossed a $1.2 billion fine against Gilead Sciences after invalidating portions of a Memorial Sloan Kettering Cancer Center patent licensed to a Bristol Myers Squibb subsidiary. The patent was the basis for the previous ruling against Foster City, Calif.–based Gilead, which related to patent infringement claims…