Clinical Research Informer

FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The submission of the NDA was based on the findings of the CAPItello-291 Phase III trial.

HR

HR Hormones Trials Protein

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Pharmaceutical Technology

JUNE 6, 2023

It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials. The therapy has also received orphan drug designation and breakthrough therapy designation from the US Food and Drug Administration.

Genetics

Genetics Life Science Trials Clinical Development

Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

JANUARY 13, 2023

Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy. Enhertu’s safety profile was consistent with the previous clinical trials.

HR

HR Trials Engineer Clinical Trials

Eisai and National Cancer Center partner for tazemetostat clinical research

Pharmaceutical Technology

APRIL 3, 2023

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

Clinical Research

Clinical Research Research Clinical Trials Clinical Trials

US FDA grants fast track status for CellCentric’s inobrodib

Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. The therapy can be utilised by patients who have failed to progress on other therapies and along with existing standard-of-care drugs.

Protein

Protein Antibody Gene Trials

FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

Trials

Trials Drugs Production Development

FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC

Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. positive platinum-resistant ovarian cancer.

FDA Approval

FDA Approval Antibody Clinical Trials Clinical Trials

Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Pharmaceutical Technology

NOVEMBER 25, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive unresectable or recurrent breast cancer in adults. The treatment is indicated for usage in such patients following previous chemotherapy, comprising trastuzumab and a taxane.

Antibody

Antibody Trials Medicine Drugs

Eli Lilly achieving significant gains in obesity results

Pharmaceutical Technology

JUNE 7, 2023

The recent rallying of Lilly’s market value has come as the result of two major announcements: its blockbuster type 2 diabetes (T2D) drug Mounjaro (tirzepatide) successfully completed its second final-stage trial for obesity, and its experimental treatment for Alzheimer’s disease completed its Phase III trial.

Marketing

Marketing Sales Trials Drugs

FDA accepts Bristol Myers Squibb’s repotrectinib NDA for review

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s new drug application (NDA) for repotrectinib for priority review. Repotrectinib is a tyrosine kinase inhibitor (TKI) intended to treat patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Trials

Trials Drugs Medicine Development

Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

JANUARY 6, 2023

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.

Clinical Trials

Clinical Trials Clinical Trials Trials Marketing

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. In these subjects, the median progression-free survival (PFS) following Enhertu treatment was 9.9

FDA Approval

FDA Approval HR Clinical Trials Clinical Trials

Astellas Pharma files NDA for zolbetuximab to Japan’s MHLW

Pharmaceutical Technology

JUNE 12, 2023

Astellas Pharma has submitted a new drug application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab as a treatment option for advanced gastric and gastroesophageal cancer. The drug will become the first CLDN18.2-targeted 38% of the screened patients in both trials had CLDN18.2-positive

Clinical Trials

Clinical Trials Clinical Trials Trials Antibody

FDA pushes Daiichi Sankyo’s quizartinib approval date by three months

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1% months , compared to 15.1

Branding

Branding Drugs Medicine Trials

China’s NMPA approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

FEBRUARY 27, 2023

China’s National Medical Products Administration (NMPA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive metastatic breast cancer. Being jointly developed and commercialised by the two companies, it is a specifically engineered HER2-directed antibody-drug conjugate (ADC).

Clinical Trials

Clinical Trials Clinical Trials Trials Engineer

Byondis receives CRL from US FDA for SYD985 BLA

Pharmaceutical Technology

MAY 16, 2023

Dutch biopharmaceutical company Byondis has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). SYD985 showed a statistically significant improvement of 2.1

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

Current and future players in the lupus market

Pharmaceutical Technology

JANUARY 23, 2023

The term LN refers to a major predictor of poor prognosis in SLE patients, with inflammation of the kidney that encompasses diverse patterns of renal disease, including glomerular and vascular pathology. In previous years, Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9m

Marketing

Marketing Production Drugs Trials

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The trial demonstrated that after a median follow-up of 5.2

FDA Approval

FDA Approval HR Drugs Hormones

This week in drug discovery (15-19 April)

Drug Discovery World

APRIL 19, 2024

The headline news this week all concerns clinical trials for new drugs that could have a significant impact on future patient treatment, including trials testing therapeutics for ALS, cystic fibrosis, gonorrhoea, TB and Parkinson’s. News round-up for 15-19 April by DDW Digital Content Editor Diana Spencer.

Gene Therapy

Gene Therapy Drugs Clinical Trials Clinical Trials

Elevar submits new drug application for uHCC combo therapy

Pharmaceutical Technology

MAY 18, 2023

HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer.

Drugs

Drugs Trials Production Development

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

Pharmaceutical Technology

APRIL 3, 2023

The regulatory approval comes after a positive opinion was issued by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) in January this year. It also decreases the number of injections needed by patients who require a dose of 80 mg/mL or above.

Marketing

Marketing Medicine Packaging Packaging

EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

JANUARY 27, 2023

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. It has been developed using the DXd ADC technology from Daiichi Sankyo.

HR

HR Engineer Antibody Medicine

China’s NMPA conditionally approves two oral drugs for Covid-19

Pharmaceutical Technology

JANUARY 29, 2023

The National Medical Products Administration (NMPA) of China has granted conditional approval for two domestically developed oral drugs to treat Covid-19. Simcere Pharmaceutical Group and Shanghai Junshi Biosciences’ subsidiary have submitted the applications for the two drugs Xiannuoxin (SIM0417) and VV116, respectively.

Drugs

Drugs Clinical Trials Clinical Trials Trials

Panbela obtains rights to develop and commercialise Flynpovi to treat FAP

Pharmaceutical Technology

APRIL 12, 2023

Panbela Therapeutics has regained the global rights for the development and commercialisation of Flynpovi (a combination of CPP-1X [eflornithine] and sulindac) to treat familial adenomatous polyposis (FAP) patients. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

Development

Development Trials Clinical Trials Clinical Trials

China approves Medivir’s patent application for Fostrox

Pharmaceutical Technology

JUNE 19, 2023

The drug has been designed for the selective treatment of liver cancers and for minimising the treatment’s side effects. It is being developed as an orally administrated drug to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

Medicine

Medicine Drugs Trials Marketing

China accepts Junshi’s sNDA for TNBC combination therapy

Pharmaceutical Technology

MAY 24, 2023

China’s National Medical Products Administration (NMPA) has accepted Shanghai Junshi Biosciences ’ supplemental new drug application (sNDA) for toripalimab in combination with chemotherapy to treat advanced triple-negative breast cancer (TNBC).

Clinical Trials

Clinical Trials Clinical Trials Antibody Trials

What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. Dr. Morrison and Dr. Vidal shared their insights from the 2023 ESMO conference which occurred in Madrid.

Clinical Trials

Clinical Trials Clinical Trials Trials Gene Therapy

Treatment options for Crohn’s disease expand after Rinvoq approval

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval

FDA Approval Dermatology Sales Clinical Trials

Late-stage ulcerative colitis pipeline continues to innovate

Pharmaceutical Technology

JULY 28, 2022

Ulcerative colitis (UC), an inflammatory bowel disease, is characterised by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life, including diarrhoea, abdominal pain and cramping, fatigue, weight loss and pain.

Trials

Trials Marketing RNA Development

US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. in trial subjects versus those who received ADT plus docetaxel.

Hormones

Hormones Clinical Trials Clinical Trials Licensing

Emalex raises $250m for Tourette syndrome drug development

Pharmaceutical Technology

NOVEMBER 3, 2022

Emalex Biosciences has raised Series D funds worth $250m led by Bain Capital Life Sciences to progress the development of an investigational new drug for Tourette syndrome. The funding will be used for the Phase III clinical trial and potential marketing of the investigational compound, ecopipam, for treating Tourette syndrome patients.

Development

Development Drugs Clinical Trials Clinical Trials

Viking’s weight loss drug enters an already crowded arena

Pharmaceutical Technology

MARCH 29, 2023

The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days. The Phase I study is an extension of a previously completed Phase I trial that evaluated the subcutaneous administration of VK2735.

Drugs

Drugs In-Vivo Marketing Trials

GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

OCTOBER 31, 2022

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

Vaccination

Vaccination Vaccine Marketing Trials

First tumour agnostic HER2 directed ADC gets US approval

Drug Discovery World

APRIL 12, 2024

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumours. This latest approval means that Enhertu now has five approved indications, including for breast cancer.

Antibody

Antibody Clinical Trials Clinical Trials Trials

Amylyx to Discontinue ALS Drug Relyvrio After Failure in Confirmatory Trial

XTalks

APRIL 5, 2024

Amylyx Pharmaceuticals announced yesterday that it will be pulling its ALS (amyotrophic lateral sclerosis) drug Relyvrio from the market after failing in a confirmatory trial. Last month, Amylyx reported results from the global PHOENIX Phase III clinical trial that were unable to confirm the drug’s effectiveness.

Trials

Trials Drugs Marketing FDA Approval

Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024

ACRP blog

JANUARY 3, 2024

Historically, patient recruitment and retention have been pressing issues within the clinical trial space. Eighty-five percent of trials fail to recruit enough patients, while 80% are delayed due to other factors like participant dropouts.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

Japan becomes first country to approve Astellas’ gastric cancer mAb

Drug Discovery World

MARCH 29, 2024

monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. positive population in Japan.” positive patients living with this devastating disease. Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2

Clinical Trials

Clinical Trials Clinical Trials Trials Antibody

AstraZeneca’s Voydeya Scores FDA Approval, Adding to Company’s Multi-Billion Dollar PNH Franchise

XTalks

APRIL 3, 2024

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

FDA Approval

FDA Approval Sales Trials Development

Positive Phase III results for prostate cancer drug

Drug Discovery World

MARCH 21, 2023

Pfizer and Astellas have announcesd positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients in the trial will be followed for a subsequent final OS analysis.

Drugs

Drugs Hormones Trials Development

NeuroSense reports positive results from its ALS trial

Drug Discovery World

MARCH 14, 2024

NeuroSense Therapeutics has reported additional positive data from its six-month double-blind Phase IIb PARADIGM trial of its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS). The PARADIGM trial’s secondary clinical efficacy outcome measure endpoints included Quality of Life and Survival.

Trials

Trials Clinical Trials Clinical Trials Drugs

Non-viral gene therapy shows early efficacy in lung cancer

Drug Discovery World

OCTOBER 9, 2023

Positive Phase I trial data indicates that Reqorsa (quaratusugene ozeplasmid) has shown early efficacy for the treatment of non-small cell lung cancer (NSCLC). The post Non-viral gene therapy shows early efficacy in lung cancer appeared first on Drug Discovery World (DDW).

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

pharmaphorum

FEBRUARY 21, 2022

Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels of HER2 – potentially making it an option for a much broader group of patients.

Trials

Trials Sales Hormones Drugs

Italfarmaco’s Duvyzat Wins FDA Approval as First Nonsteroidal Treatment for All Genetic Variants of DMD

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The global incidence of DMD is approximately one in every 3,500 to 6,000 male births.

FDA Approval

FDA Approval Genetics Gene Therapy Gene

Does CNS Drug Development Need to Evolve to Include Objective, Longitudinal and Broad-Spectrum Data?

XTalks

JANUARY 16, 2024

To date, the lack of objective longitudinal measures in central nervous system (CNS) clinical studies has resulted in less than 6 percent of drugs in this space making it to market. about various aspects of CNS drug development. CJ Barnum, PhD, Vice President of CNS Development, INmune Bio, Inc.

Development

Development Drugs Clinical Trials Clinical Trials

FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol

Trending Sources

Health Canada gives approval to Enhertu for breast cancer treatment

Eisai and National Cancer Center partner for tazemetostat clinical research

US FDA grants fast track status for CellCentric’s inobrodib

FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

FDA grants accelerated approval for ImmunoGen’s ovarian cancer ADC

Japan’s MHLW approves Daiichi Sankyo’s breast cancer treatment

Eli Lilly achieving significant gains in obesity results

FDA accepts Bristol Myers Squibb’s repotrectinib NDA for review

Cell therapies might revolutionise treatment for multiple sclerosis patients

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Astellas Pharma files NDA for zolbetuximab to Japan’s MHLW

FDA pushes Daiichi Sankyo’s quizartinib approval date by three months

China’s NMPA approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Byondis receives CRL from US FDA for SYD985 BLA

Current and future players in the lupus market

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

This week in drug discovery (15-19 April)

Elevar submits new drug application for uHCC combo therapy

EC grants marketing authorisation for Sandoz’s biosimilar Hyrimoz

EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

China’s NMPA conditionally approves two oral drugs for Covid-19

Panbela obtains rights to develop and commercialise Flynpovi to treat FAP

China approves Medivir’s patent application for Fostrox

China accepts Junshi’s sNDA for TNBC combination therapy

What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?

Treatment options for Crohn’s disease expand after Rinvoq approval

Late-stage ulcerative colitis pipeline continues to innovate

US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer

Emalex raises $250m for Tourette syndrome drug development

Viking’s weight loss drug enters an already crowded arena

GSK speeds up the race to bring first RSV vaccine for older adults to market

First tumour agnostic HER2 directed ADC gets US approval

Amylyx to Discontinue ALS Drug Relyvrio After Failure in Confirmatory Trial

Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024

Japan becomes first country to approve Astellas’ gastric cancer mAb

AstraZeneca’s Voydeya Scores FDA Approval, Adding to Company’s Multi-Billion Dollar PNH Franchise

Positive Phase III results for prostate cancer drug

NeuroSense reports positive results from its ALS trial

Non-viral gene therapy shows early efficacy in lung cancer

Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

Italfarmaco’s Duvyzat Wins FDA Approval as First Nonsteroidal Treatment for All Genetic Variants of DMD

Does CNS Drug Development Need to Evolve to Include Objective, Longitudinal and Broad-Spectrum Data?

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