Bispecific antibody startup Bambusa raises $90m to fund clinical trials
Pharmaceutical Technology
FEBRUARY 17, 2025
Two of Bambusas bispecific antibody candidates for immunological and inflammatory disorders are set to enter the clinic in 2025.
AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland
Pharmaceutical Technology
JULY 21, 2022
AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca.
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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s
Pharmaceutical Technology
JANUARY 9, 2023
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.
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GSK, Vir build case for COVID-19 antibody drug with new study data
Bio Pharma Dive
JUNE 21, 2021
Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.
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Merck, facing threat to Keytruda, buys into new kind of cancer immunotherapy
Bio Pharma Dive
NOVEMBER 14, 2024
The company is paying China-based biotech LaNova Medicines $588 million for the type of dual-pronged antibody drug that recently bested Keytruda in a clinical trial.
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Lilly's antibody drug prevents COVID-19 in study, but hurdles to use remain
Bio Pharma Dive
JANUARY 20, 2021
Results from a clinical trial in nursing home residents and staff offered the first evidence Lilly's bamlanivimab could protect against, as well as treat, COVID-19
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New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials
BioPharma Reporter
DECEMBER 13, 2021
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
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AZ’s COVID jab tackles delta variant, but antibody fails clinical trial
pharmaphorum
JUNE 15, 2021
Antibody flunks post-exposure prevention study. Eli Lilly meanwhile reported positive results with its bamlanivimab antibody in the BLAZE-2 study carried put in nursing homes, which found a 57% reduction in the risk of infection compared to placebo.
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Disc wins orphan drug tag for rare blood cancer
Pharmaceutical Technology
FEBRUARY 12, 2024
The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.
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Innovation in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes
Worldwide Clinical Trials
OCTOBER 14, 2024
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes
Worldwide Clinical Trials
OCTOBER 14, 2024
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
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Datroway’s Approval in Breast Cancer Solidifies Daiichi Sankyo’s Leadership in ADCs
XTalks
JANUARY 21, 2025
The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. Datroway leverages DXd technology to precisely target cancer cells.
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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma
Pharmaceutical Technology
MAY 22, 2023
SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.
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WHO grants emergency use listing to SK bioscience’s SKYCovione
Pharmaceutical Technology
JUNE 20, 2023
In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain. The vaccine is based on recombinant protein vaccine technology and is suitable for storage between 2°C and 8°C.
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COVID-19: Some ignored facts
World of DTC Marketing
APRIL 11, 2021
The CDC says “neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States can cause you to test positive on viral tests , which are used to see if you have a current infection.? But again 90% is not 100%.
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TORL BioTherapeutics raises funds to develop new oncology therapies
Pharmaceutical Technology
APRIL 14, 2023
Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients. CLDN 18.2).
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Looking back at 2022: The top healthcare stories
Pharmaceutical Technology
DECEMBER 27, 2022
Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced. Still, the country’s clinical trials sector remains insular. Tracking the news.
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Flow cytometry: advantages in immunotherapy clinical trials
Pharmaceutical Technology
AUGUST 24, 2022
The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.
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Gilead partners with MacroGenics for bispecific antibody development
Pharmaceutical Technology
OCTOBER 18, 2022
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.
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Lilly’s antibody therapy cuts hospitalisation rates in COVID-19
pharmaphorum
SEPTEMBER 17, 2020
Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. The double-blind placebo-controlled antibody study involved patients with symptoms outside hospitals, who were treated with four different dose strengths.
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Monoclonal antibody treatment for malaria shows encouraging results
STAT News
AUGUST 3, 2022
An experimental antibody treatment prevented malaria in the majority of participants in a small but important new study , providing a measure of hope in the effort to lower the burden of the disease worldwide.
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Brii Bio introduces Covid-19 combination therapy in China
Pharmaceutical Technology
JULY 7, 2022
Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. 2 subvariants.
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Feinstein Institutes researchers discover new protein for sepsis treatment
Pharmaceutical Technology
FEBRUARY 6, 2023
It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy. These anti-pCTS-L monoclonal antibodies may help in providing effective treatments for human sepsis as well as other infectious diseases, such as Covid-19.
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US FDA grants fast track designation for Jasper’s antibody to treat SCID
Pharmaceutical Technology
SEPTEMBER 16, 2022
The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . The antibody was also analysed in a total of more than 110 healthy subjects and patients. .
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Food Allergy Awareness Week 2024: How can new treatments target an unmet need?
Pharmaceutical Technology
MAY 16, 2024
IgGenix is planning to initiate a clinical trial later this year investigating its peanut allergy monoclonal antibody IGXN001.
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Avidity, Kymera raise fresh funds; Walgreens partners with BARDA
Bio Pharma Dive
AUGUST 20, 2024
In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.
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EC approves Briumvi to treat relapsing forms of multiple sclerosis
Pharmaceutical Technology
JUNE 2, 2023
Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody. The therapy targets a unique epitope on CD20-expressing B-cells.
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Tiziana Life Sciences plans to assess intranasal foralumab for long Covid
Pharmaceutical Technology
APRIL 14, 2023
Foralumab is a fully human anti-CD3 monoclonal antibody, which works by binding to the T-cell receptor and regulating T-cell function to reduce pulmonary inflammation. Tiziana Life Sciences chief medical officer Matthew Davis said: “We anticipate entering into a Phase 2a placebo-controlled clinical trial upon successful feedback from the FDA.
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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery
XTalks
MAY 4, 2023
A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine. However, there are ongoing clinical trials for celiac disease to investigate potential new treatments. How does Beyond Celiac spread awareness about research and clinical trials for celiac disease?
Former Novartis exec joins ADC Therapeutics as CEO after brief stint as Rafael head
Bio Pharma Dive
MAY 9, 2022
Ameet Mallik takes over for founder Chris Martin at helm of the antibody drug developer after a seven-month run leading Rafael Holdings, which reported a clinical trial setback last October.
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STAT+: Argenx antibody drug benefits patients with platelet-destroying autoimmune disorder
STAT News
DECEMBER 11, 2022
NEW ORLEANS — An antibody treatment developed by the Belgian drugmaker Argenx raised platelet counts and stopped bleeding episodes in patients with a rare autoimmune disorder that causes the body to attack and destroy its own blood-clotting platelets.
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US FDA approves Provention Bio’s Tzield to delay diabetes
Pharmaceutical Technology
NOVEMBER 18, 2022
The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D. Tzield was evaluated in the placebo-controlled, double-blind, randomised, event-driven TN-10 clinical trial, for delaying T1D (Stage 3, or clinical T1D) in Stage 2 T1D patients.
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STAT+: Roche’s experimental Alzheimer’s treatment fails to slow cognitive decline across two clinical trials
STAT News
NOVEMBER 13, 2022
Roche reported negative results Monday from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease.
FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC
Pharmaceutical Technology
NOVEMBER 14, 2022
The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.
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STAT+: Still hoping for looser FDA rules, Regeneron says it will test durable antibody for Covid
STAT News
JANUARY 10, 2023
SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.
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Eisai signs agreement with Bliss Biopharmaceutical to develop BB-1701
Pharmaceutical Technology
MAY 8, 2023
Ei s ai and Bliss Biopharmaceutical have entered into a joint development agreement for antibody-drug conjugate (ADC), BB-1701, to treat cancers. Currently, BB-1701 is being evaluated in Phase I/II trials in China and the US. Currently, BB-1701 is being evaluated in Phase I/II trials in China and the US.
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Health Canada gives approval to Enhertu for breast cancer treatment
Pharmaceutical Technology
JANUARY 13, 2023
Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.
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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer
Pharmaceutical Technology
AUGUST 8, 2022
The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4
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Analysis reveals adverse effects of complex cancer therapies called antibody drug conjugates
Medical Xpress
NOVEMBER 21, 2022
Over the past two decades, numerous complex cancer therapies called antibody drug conjugates (ADCs) have been tested in clinical trials and approved for use in patients. Their findings are published online in Cancer.
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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer
Pharmaceutical Technology
AUGUST 12, 2022
The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4
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Covid vaccine booster raises antibody levels in fight against Omicron
pharmaphorum
JANUARY 21, 2022
Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5 The post Covid vaccine booster raises antibody levels in fight against Omicron appeared first on.
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Antibody combination provides strong protection against severe COVID-19 in large international trial
Medical Xpress
APRIL 19, 2023
A treatment combining two antibodies against the coronavirus SARS-CoV-2 strongly protected high-risk people with early COVID-19 symptoms from hospitalization and death in an international Phase 2/3 clinical trial conducted in the first half of 2021 and co-led by researchers at Weill Cornell Medicine and NewYork-Presbyterian.
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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine
Pharmaceutical Technology
AUGUST 15, 2022
The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints. In baseline seronegative subjects, the updated vaccine offered a superior neutralising antibody response against Omicron (BA.1) 1) versus the 50µg mRNA-1273 booster dose.
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Clinical trial: Monoclonal antibody may be an effective alternative to cisplatin in treatment of head and neck cancers
Medical Xpress
NOVEMBER 22, 2024
Head and neck cancers are the seventh most common type of cancer worldwide, according to the 2020 World Cancer Report. Smokers and drinkers, as well as those with HPV infections, are disproportionately affected.
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