Events, Licensing, Pharmacokinetics and Treatment

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment

Treatment FDA Approval Pharmacokinetics FDA

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone.

Treatment

Treatment Hospitals Long-Term Care Facilities Virus

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University.

Clinical Trials

Clinical Trials Trials Treatment FDA

Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

JULY 20, 2023

He gave the example of GLP-1 receptor agonist Ozempic, a diabetes treatment, which was successfully repurposed for weight loss as Wegovy. It is important for researchers to have a clear proof of concept before they begin clinical trials, he explained, which would allow them to avoid expensive studies that will ultimately fail.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Trials

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

Government

Government Long-Term Care Facilities Hospitals Treatment

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

Therapies

Therapies Hospitals FDA Approval Long-Term Care Facilities

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

FDA

FDA Trials Regulations Therapies

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

Disease

Disease FDA Clinical Trials Licensing

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.

Production

Production Clinical Trials Government Disease

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 “As these data continue to mature, we look forward to assessing whether responses will further deepen and remain durable with ongoing REGN5458 treatment.” TARRYTOWN, N.Y. ,

Production

Production Trials Treatment Pharmaceuticals

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). The BREEZE study (NCT03950739) seeks to evaluate 45 patients on a stable dose of Tyvaso after switching to our new dry powder inhaler (DPI) form of treprostinil, which we licensed from MannKind Corporation. .

FDA

FDA Production Licensing Licensing

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata. The presentation highlighted that in the open label extension study, treatment with CTP-543 shows continued maintenance of hair regrowth relative to the hair growth shown in the Company’s previously conducted Phase 2 trials in patients with alopecia areata.

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Small Molecule

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

Hospitals

Hospitals Treatment Long-Term Care Facilities Trials

ATUZAGINSTAT

New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). The pharmacokinetic profiles of COR388 in AD and controls were reported to be similar. Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). and Europe.

Small Molecule

Small Molecule DNA Disease Trials

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S., Read full announcement here: [link].

FDA Approval

FDA Approval Treatment RNA FDA

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development

Clinical Development Disease Treatment Licensing

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

When delivered using AAV9 in mice, the treatment significantly improved motor function and extended average lifespan. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Read 🏘️ Events Send me your events. Nature Communications.

DNA

DNA RNA Engineering Licensing

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. 12)AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. About AstraZeneca. Griffin MP, et al. 2017; 61(3): e01714-16.

Trials

Trials Virus Vaccine Pharmacokinetics

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

The Pharma Data

NOVEMBER 22, 2020

MP0420 is subject to an option and license agreement with Novartis AG to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells.

Trials

Trials Clinical Trials Licensing Licensing

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure. The prophylactic steroid treatment was also changed from 1 mg/kg to an intermediate dose of 2mg/kg.

Vaccine

Vaccine Therapies Trials Clinical Trials

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease. nM and 13.81

Clinical Trials

Clinical Trials Disease Treatment Trials

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3

Treatment

Treatment Hospitals Long-Term Care Facilities Therapies

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). Patients and physicians can visit lillyantibody.com to learn more, including how to find a potential treatment location.

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

Drug Discovery Digest

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

Trending Sources

Inozyme Pharma Announces Authorization to Proceed in U.S. and U.K. with Phase 1/2 Clinical Trial of INZ-701 for the Treatment of ENPP1 Deficiency

Drug repurposing: The benefits, risks and what we learned from Covid-19

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease

Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

ATUZAGINSTAT

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

Codon Digest: Injected Gene Editors

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

Stay Connected