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Tag: clinical trials


FDA, Regulations

FDA clears Keytruda for first-line cervical cancer

October 14, 2021

Via: Pharma Times

The FDA has cleared Keytruda in combination with chemotherapy – with or without bevacizumab – for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1. In the Phase III KEYNOTE-826 trial in this patient population, Keytruda plus […]


News

Boston biotech backers quit Dana-Farber board after U-turn on investment policy: report

October 12, 2021

Via: FierceBiotech

The Dana-Farber Cancer Institute has reportedly barred trustees from newly investing in biotechs created to license its science, leading to the resignation of board members including a co-founder of C4 Therapeutics. Under the old policy, trustees could invest in startups […]


Clinical Trials, Research and Development

FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

October 4, 2021

Via: PMLiVE

The FDA granted BTD based on data from the DESTINY-Breast03 phase 3 trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the phase 3 trial showed that Enhertu reduced the risk of disease progression […]


Cell and Gene Therapy, Industry

ViroCell Biologics and GOSH to address gene and cell therapy “logjam”

September 28, 2021

Via: European Pharmaceutical Review

ViroCell Biologics and Great Ormond Street Hospital for Children (GOSH) have today announced a new partnership that will immediately address the global viral vector manufacturing bottleneck for clinical trials. Viral vectors are high-value delivery vehicles used to make cell and […]


Clinical Trials, Research and Development

Bad news for Biohaven as verdiperstat flunks first phase 3 test

September 28, 2021

Via: Pharmaphorum

Myeloperoxidase (MPO) inhibitor verdiperstat was no better than placebo in the M-STAR trial in patients with MSA, and looks likely to be abandoned for this indication. It’s not the end of the line for the drug, which Biohaven picked up […]


News

YonaLink, TrialJectory get $1m grant for patient recruitment tool

September 27, 2021

Via: Pharmaphorum

The grant from the Israel-US Binational Industrial Research and Development (BIRD) Foundation will go towards the further development of the platform, which automates the conduct of trials in a bid to reduce the cost, time, and resources used running them. […]


Clinical Trials, Research and Development

Trials Show COVID Vaccines Well Worth It for Cancer Patients

September 24, 2021

Via: Drugs.com

If you have cancer and you think coronavirus vaccines may do you little good, don’t let your hesitation stop you from getting the shots: A pair of clinical trials finds that patients’ immune systems ramped up after vaccination. The findings […]


FDA, Regulations

FDA Grants Accelerated Approval for Recurrent or Metastatic Cervical Cancer Treatment to Tivdak

September 23, 2021

Via: Biopharm International

FDA granted accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, according to a Sept. 20, 2021, FDA press release. According to the Seagen company press release, Tivdak is the first and […]


Clinical Trials, Research and Development

Excision’s CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

September 17, 2021

Via: FierceBiotech

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according […]


Cell and Gene Therapy, Industry

Obsidian bags $115M to untether cell therapy from toxic sidekick

September 9, 2021

Via: FierceBiotech

Obsidian Therapeutics has raked in $115 million to realize the long-unfulfilled therapeutic promise of tumor-infiltrating lymphocytes (TILs). The series B gives Obsidian a shot at showing whether freeing TILs from IL-2 can finally unleash power that research has hinted at […]


Mergers and Acquisitions

Roche bets on T-cell therapies with Adaptimmune deal

September 8, 2021

Via: PMLiVE

The deal with see Adaptimmune receive $150m upfront, another $150m over the next five years and then milestone payments potentially exceeding $3bn in aggregate sales, as well as royalties. Unlike other leaders in next-generation cell therapies, the partners will use […]


Industry, Vaccines

Vaccine Study Explores COVID-19 and Autoimmune Disease

August 30, 2021

Via: Genetic Engineering and Biotechnology News

An estimated 8% of Americans have an autoimmune disease, including a disproportionate number of people in the minority communities most severely impacted by COVID-19. In addition, higher rates of severe COVID-19 and death have been reported in people with autoimmune […]