Bio Pharma Dive

APRIL 14, 2022

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

Drugs 361

Drugs Antibody Trials 361

Bio Pharma Dive

MARCH 23, 2023

The two companies gained billions of dollars in market value after their antibody drug succeeded against a disease that’s been difficult to treat with biologic medicines.

Antibody 293

Antibody Trials Medicine Marketing 293

Pharmaceutical Technology

JUNE 21, 2024

Trial investigators anticipate that the FDA will decide on approval for linvoseltamab in relapsed/refractory multiple myeloma by the end of 2024.

Antibody 246

Antibody Trials 246

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

Nurses 293

Nurses Antibody Clinical Trials Clinical Trials 293

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.

Clinical Trials 312

Clinical Trials Clinical Trials Antibody Medicine 312

Bio Pharma Dive

OCTOBER 23, 2023

A combination of Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s Keytruda dramatically improved survival in first-line bladder cancer.

Antibody 288

Antibody Trials Drugs 288

XTalks

DECEMBER 10, 2024

In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5

Trials 104

Trials Protein Clinical Development Drugs 104

Pharmaceutical Technology

MARCH 20, 2023

BioNTech has signed an exclusive worldwide licence and collaboration agreement with OncoC4 to co-develop and commercialise a new checkpoint antibody in multiple solid tumour indications. A randomised Phase III trial of ONC-392 as monotherapy is planned to commence this year.

Antibody 246

Antibody Development Trials Production 246

XTalks

APRIL 14, 2025

The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods.

Antibody 59

Antibody Drugs Development Medicine 59

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.

Antibody 105

Antibody FDA Approval HR Trials 105

Bio Pharma Dive

MARCH 25, 2024

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

Antibody 293

Antibody Drugs Trials Development 293

Pharmaceutical Technology

OCTOBER 20, 2023

The company plans to initiate the Phase II trial of anti-IL-6 antibody in atherosclerotic cardiovascular disease in 2024.

Antibody 147

Antibody Development Trials 147

Bio Pharma Dive

OCTOBER 9, 2020

The medicine, a concentrated infusion of blood antibodies, is different than the convalescent plasma that was recently cleared for emergency use by the FDA.

Antibody 242

Antibody Trials Medicine 242

Pharmaceutical Technology

DECEMBER 6, 2022

The three leading Alzheimer’s disease (AD) drugs currently in development are all monoclonal antibodies—donanemab by Eli Lilly , lecanemab by Eisai and Biogen , and gantenerumab by Roche. Monoclonal antibodies make up half of these, with an 11% share of all AD approvals.

Antibody 147

Antibody Marketing Drugs Trials 147

Pharmaceutical Technology

AUGUST 22, 2022

The World Health Organization (WHO) has made new recommendations for the usage of two monoclonal antibodies to treat the Ebola virus in its first published guideline. mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb) are the two monoclonal antibody treatments recommended by the WHO.

Antibody 147

Antibody Clinical Trials Clinical Trials Trials 147

Bio Pharma Dive

MAY 4, 2021

Pfizer halted a key trial of one of the most advanced bispecific antibody drugs in development for the blood cancer after several cases of peripheral neuropathy.

Drugs 272

Drugs Antibody Trials Development 272

Pharmaceutical Technology

FEBRUARY 17, 2023

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best. However, in some cases, fewer patients could be needed.

Clinical Trials 289

Clinical Trials Clinical Trials Trials Drugs 289

Bio Pharma Dive

AUGUST 25, 2020

The British pharma has started a Phase 1 trial amidst reports that competing programs from Regeneron and Eli Lilly haven't met their projected timelines.

Antibody 208

Antibody Drugs Trials 208

Pharmaceutical Technology

JULY 31, 2023

US FDA and China’s NMPA have approved the Phase I trial of anti-GPRC5D/CD3 bispecific antibody (LBL-034) by Leads Biolabs.

Antibody 130

Antibody FDA Approval Trials 130

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.

Clinical Trials 237

Clinical Trials Clinical Trials Antibody Drugs 237

Bio Pharma Dive

OCTOBER 13, 2022

The findings, which were disclosed in a press release without specific data, are the first immune response results in humans for the reformulated shot targeting the BA.4 5 substrains.

Immune Response 176

Immune Response Antibody Trials 176

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.

Antibody 130

Antibody Development Sales Clinical Trials 130

Bio Pharma Dive

JULY 23, 2024

The drug, a rival to Sanofi and AstraZeneca’s fast-selling Beyfortus, met its main goals in a Phase 3 trial. But undisclosed study results leave its full potential unclear.

Antibody 167

Antibody Trials Drugs 167

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. .

Antibody 130

Antibody Clinical Trials Clinical Trials Licensing 130

Fierce Pharma

MAY 31, 2024

Just one week after Summit Therapeutics and Akeso’s bispecific antibody ivonescimab passed muster with Chinese regulators, the drug has pulled off another feat by staring down the PD-1 king Keytrud | In the phase 3 HARMONi-2 trial, solo ivonescimab delivered a statistically significant and clinically meaningful improvement in progression-free survival (..)

Antibody 95

Antibody Trials Regulation Drugs 95

STAT News

DECEMBER 10, 2022

Now, the results of a Phase 2 study on a bispecific antibody targeting this protein offers confirmation. NEW ORLEANS — Researchers had hoped in recent years that a protein called GPRC5D might offer a new way to get the immune system to hunt down and destroy multiple myeloma cells.

Antibody 132

Antibody Protein Trials Research 132

Worldwide Clinical Trials

OCTOBER 14, 2024

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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

Research 147

Research Clinical Trials Clinical Trials Immune Response 147

Pharmaceutical Technology

JULY 9, 2024

iTeos will receive $35m from GSK as the first patient is dosed in the Phase III trial of the jointly developed monoclonal antibody EOS-448.

Trials 130

Trials Antibody Development 130

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

Antibody 263

Antibody Trials Medicine Drugs 263

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). Currently, CSPC is investigating CRB-701 in a Phase I dose escalation clinical trial to treat advanced solid tumours in China.

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Worldwide Clinical Trials

OCTOBER 14, 2024

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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

Research 130

Research Clinical Trials Clinical Trials Immune Response 130

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccine Vaccination Trials 59

Pharmaceutical Technology

MARCH 1, 2024

US FDA placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.

Trials 130

Trials Antibody 130

Bio Pharma Dive

MAY 15, 2024

Uniquity Bio emerged from stealth mode ready to begin Phase 2 trials of an antibody targeting the protein TSLP in asthma and COPD.

Protein 184

Protein Antibody Drugs Trials 184

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.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

Pharmaceutical Technology

OCTOBER 4, 2024

Two years after the FDA placed partial clinical hold, Avidity can resume research of del-desiran as a treatment for myotonic dystrophy type 1.

Antibody 130

Antibody Trials Research 130

BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

Antibody 98

Antibody Drug Trials Clinical Research Trials 98