Pharmaceutical Technology

APRIL 21, 2023

In a statement emailed to Endpoints News , AstraZeneca (AZ) disclosed intentions to terminate its clinical program for its daily glucagon-like peptide-1 receptor glucagon co-agonist (GLP-1RA/GCGR) cotadutide, in favour of focusing on the development of AZD9550, its once-weekly injectable GLP-1RA/GCGR. Of the 71 patients, only 10.6%

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Drug Discovery World

MARCH 8, 2024

News round-up for 4-8 March by DDW Digital Content Editor Diana Spencer. FDA advisory committee meeting delays approval of donanemab The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

More than double the volume of Fennec’s shares were traded on the day of the approval news in comparison to 19 September. Pedmark clinical trials. Fennec Pharmaceuticals assessed Pedmark in the two multicentre clinical trials SIOPEL 6 (NCT00652132) and COG ACCL0431 (NCT00716976).

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XTalks

FEBRUARY 20, 2024

Safety assessments of sibeprenlimab have revealed no evidence of adverse toxic effects or clinically significant immunosuppression. At month 12, the percentage of patients achieving clinical remission was 7.9 How Does Sibeprenlimab Work? percent (three of 38 patients), 12.2 percent (five of 41 patients), 26.3

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Drug Discovery World

JUNE 16, 2023

News round-up for 5-9 June by DDW Multimedia Editor Megan Thomas. Patient dies in cell therapy clinical trial A Phase I clinical trial testing a CAR-T cell therapy treatment in children with acute myeloid leukaemia (AML) has been paused due to a patient’s death.

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Drug Discovery World

JULY 21, 2023

News round-up for 17-21 July by DDW Digital Content Editor Diana Spencer. The most impactful drug discovery news this week is all linked with scientific research data. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Discovery World

MARCH 24, 2023

News round-up for 20-24 March by DDW Digital Content Editor Diana Spencer. There have also been positive trial results announced in prostate cancer, pancreatic cancer and breast cancer. This week we have seen a number of developments in the treatment of solid tumours hitting the headlines.

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Pharmaceutical Technology

DECEMBER 12, 2022

In this last 2022 edition of the series, which started in June , Pharmaceutical Technology is tracking major trial announcements and decisions by regulators and reimbursement agencies that have occurred since mid-October, as well as their potential impact on manufacturing plans. Regulatory decisions and clinical trial news.

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Drug Discovery World

NOVEMBER 1, 2023

Durvalumab and olaparib, AstraZeneca A primary analysis of the DUO-E Phase III trial investigating durvalumab and olaparib in advanced or recurrent endometrial cancer showed an improvement in PFS compared to chemotherapy, reducing the risk-of disease progression or death by 45%. months for amivantamab plus chemotherapy vs. 6.7

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Drug Discovery World

AUGUST 12, 2022

News round-up by DDW’s Reece Armstrong for 8-12 August . New insights into melanoma, a company transition into life sciences and a Lyme disease vaccine are some of the stories in this week’s news round-up. Pfizer launches Phase III trial for Lyme disease vaccine?? .

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Pharmaceutical Technology

DECEMBER 23, 2022

This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacapavir plus an optimised background regimen. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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Drug Discovery World

JUNE 12, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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Drug Discovery World

JUNE 12, 2023

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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XTalks

JULY 17, 2023

“Astellas is committed to bringing innovative therapies to patients with hard-to-treat cancers, including gastric cancer,” said Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, in the news release. In both trials, approximately 38 percent of the screened patients had CLDN18.2-positive

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Drug Discovery World

JULY 4, 2023

Shares in AstraZeneca fell by 6% on July 3 when the company published the first results from its Phase III trial for datopotamab deruxtecan (Dato-DXd) and continued to fall throughout the day, though there was some recovery on July 4. The companies say the trial will continue as planned to assess OS with greater maturity.

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Drug Discovery World

AUGUST 11, 2023

The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

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XTalks

FEBRUARY 19, 2024

The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. The comparison is particularly important as gB/MF59 demonstrated promise in Phase II clinical trials but did not advance to Phase III.

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XTalks

MAY 24, 2023

Leading health solutions company CVS Health recently disclosed that its clinical trial business will shut down just two years after its initiation in May 2021. The company will gradually wind down its CVS Health Clinical Trial Services unit with full exit by December 31, 2024.

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XTalks

JUNE 16, 2023

Our goals are completely aligned with the National Kidney Foundation, making this partnership a natural fit,” said Navdeep Tangri, co-founder of Klinrisk, in the news release. New and Promising Drugs for CKD Numerous drugs are currently being investigated for CKD and its associated conditions.

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Pharmaceutical Technology

MAY 26, 2023

In response to the approval news, some pointed concerns about long-term safety. Paxlovid’s approval was based on results from the Phase III EPIC-HR clinical trial (NCT04960202). However, other studies found that the relapse in symptoms occurs in patients independent of Paxlovid use.

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BioTech 365

DECEMBER 13, 2021

DGAP-News: Biotest AG / Key word(s): Research Update 14.12.2021 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASE Biotest treats first CMV-positive pregnant woman in Phase III clinical trial to prevent transmission of CMV … Continue reading →

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XTalks

MAY 31, 2023

Headquartered in California, Acelyrin is a late-stage clinical biopharmaceutical company dedicated to expediting the development and delivery of groundbreaking medicines in the field of immunology. The success of Acelyrin can be attributed to its industry-leading immunology portfolio and a robust pipeline of clinical and preclinical programs.

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BioTech 365

AUGUST 25, 2021

DGAP-News: Biotest AG / Key word(s): Study 26.08.2021 / 07:00 The issuer is solely responsible for the content of this announcement. PRESS RELEASE Biotest receives approval for phase III clinical trial in pregnant women for prevention of CMV infection of … Continue reading →

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Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

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Drug Discovery World

DECEMBER 9, 2022

News round-up for 5-9 December by DDW Digital Content Editor Diana Spencer. Teamwork makes the dream work’ this week, with the launch of new partnerships to further the development of precision drugs in neurodevelopmental disorders, lung cancer and rare paediatric diseases. Encouraging trial findings renew hope for HIV vaccine .

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XTalks

JANUARY 3, 2024

Polydefkis, professor of Neurology at Johns Hopkins University School of Medicine and an investigator in the Phase III NEURO-TTRansform study on which Wainua’s FDA approval was grounded on, in the news release. Safety and Efficacy of Wainua The FDA’s approval of Wainua is underpinned by compelling clinical data.

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XTalks

FEBRUARY 22, 2024

“We are encouraged by the FDA’s acceptance of the BLA as we endeavor to make datopotamab deruxtecan the first TROP2-directed ADC approved to treat patients with nonsquamous NSCLC after disease progression on prior systemic therapy,” said Susan Galbraith, executive VP of Oncology R&D at AstraZeneca, in the company’s news release.

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Pharmaceutical Technology

JULY 6, 2022

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Inflation also adds pressure to research activities, says Skillington, adding that the cost of preclinical and clinical studies will likely encounter a knock-on impact in the longer term.

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The Pharma Data

OCTOBER 25, 2020

It was another busy week for clinical trial updates and news. Army Medical Research and Development (USAMRDC ) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The trials won’t begin until early 2021 and are expected to finish in May 2021. Here’s a look. COVID-19-Related.

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ACRP blog

SEPTEMBER 27, 2023

Food and Drug Administration’s (FDA’s) Rare Disease Endpoint Advancement (RDEA) Pilot Program , the clinical research enterprise gains new support for efforts aimed at efficacy endpoint (or clinical outcome) development and the timely approval of drugs and biological products that treat rare diseases, including rare diseases in children.

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Delveinsight

JULY 28, 2020

Daiichi’s DS-1062 , a trophoblast cell-surface antigen 2 (TROP2) directed DXd antibody-drug conjugate (ADC) is currently in Phase I clinical trial for multiple cancer types including the majority of non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). Daiichi holds exclusive rights to the drug in Japan.

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XTalks

NOVEMBER 14, 2023

Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals. In trial data shared by Novo in August, Wegovy (2.4 The SELECT trial began in 2018 and is Novo’s largest trial to date.

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XTalks

AUGUST 21, 2023

The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release. Safety and Effectiveness of Sohonos The Phase III MOVE trial evaluated the safety and efficacy of palovarotene in decreasing new HO in participants with FOP.

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XTalks

SEPTEMBER 16, 2022

Approval was based on results from their Phase III clinical trials which demonstrated the superior efficacy and acceptable safety profile of Sotyktu compared to placebo and a comparator therapy. XTALKS WEBINAR: How to Maximize Clinical Trial Value for Patients and Sponsors Alike.

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look.

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XTalks

NOVEMBER 30, 2023

XTALKS WEBINAR: Unique Sourcing Solutions to Optimize Time and Budget in Clinical Trials Live and On-Demand: Friday, January 19, 2024, at 2pm EST (11am PST) Register for this free webinar to learn about innovative sourcing strategies for commercially available medications.

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Drug Discovery World

SEPTEMBER 16, 2022

News round-up for 12-16 September by DDW Digital Content Editor Diana Spencer. A slightly quieter week for news in light of national events in the UK, but the vital work of the international drug discovery community goes on and new discoveries are being made all the time. . New treatment hope for patients with rare tumours .

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