clinical trials

Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts–based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg…

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 (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…

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…

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…

Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection. New Brunswick, N.J.–based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young…

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…

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.…

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 (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…

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…

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…

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…

Focused on antibody-based cancer therapies, Zymeworks (NYSE:ZYME) believes bi- and multi-specific antibodies offer significant potential in oncology. Such therapies could provide new biological avenues for cancer treatment and extend immunotherapy to patients with few options. The FDA has approved three bispecific antibodies, and more than one hundred others are in development across the industry. Zymeworks…

Novartis (NYSE:NVS) has announced that the FDA has granted priority review for its application for allosteric inhibitor asciminib (ABL001) in chronic myeloid leukemia (CML). The drug targets the ABL myristoyl pocket (STAMP). The priority review status could trim four months off the review time, dropping the review period to eight months from 12 months under a…

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate…

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime…

Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease…

The biotech platform company Humacyte is merging with Alpha Healthcare Acquisition Corp. (NSDQ:AHAC) (“AHAC”), a special purpose acquisition company (SPAC). AHAC’s shareholders approved the deal today and plan to submit results from the meeting to the SEC via a Form 8-K document. The two organizations expect the merger to finalize on August 26 and stock…

The investigational antibody ​​AZD7442 from AstraZeneca (LON:AZN) fared well in the PROVENT study, reading the risk of developing symptomatic COVID-19 by 77% compared to placebo. More than three-quarters of participants in the trial had comorbidities that could potentially reduce their immune response to vaccination. “We need additional approaches for individuals who are not adequately protected by COVID-19…

For all of the varied work on COVID-19 vaccine candidates, the majority of vaccines to win emergency use authorization have fallen into a handful of categories, including mRNA, viral vector and inactivated vaccines. Zydus Cadila (NSE: CADILAHC) is adding more diversity to the pool with its ZyCoV-D vaccine, which recently received emergency use authorization (EUA)…

Jazz Pharmaceuticals (NSDQ:JAZZ) has announced that its Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution has won FDA approval for treating idiopathic hypersomnia in adults. Idiopathic hypersomnia is a rare chronic disorder involving chronic excessive daytime sleepiness. Previously, the drug was FDA approved for treating cataplexy or excessive daytime sleepiness (EDS) in patients seven years…

Theratechnologies (NSDQ:THTX) announced that the peer-reviewed journal Cancer Science had published its preclinical research related to TH1902, a peptide linked to the chemotherapeutic agent docetaxel. The research tested the investigational drug as a sortilin-positive triple-negative breast cancer (TNBC) treatment. TNBC lacks the expression or amplification of targetable biomarker. The prognosis for this cancer subgroup tends…

The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.” WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients: Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year,…

The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month. BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.” Pfizer CEO Dr. Albert Bourla has made similar recommendations.  Pfizer…