XTalks

JANUARY 9, 2023

Sunlenca received New Drug Application (NDA) approval based on the results of the CAPELLA trial, in which it demonstrated high rates of sustained virological suppression. The CAPELLA Clinical Trial Evaluated the Antiviral Activity of Sunlenca. The primary endpoint was the proportion of participants achieving ≥0.5

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XTalks

JANUARY 25, 2021

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. ATLAS and FLAIR Phase III Trials. Patients in the studies were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) prior to initiation of treatment with Cabenuva. Updated data from the trial showed 86.6

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. The approval was built on the Phase III ATLAS and FLAIR trials. Janssen is a Johnson & Johnson company.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology. The Utility of cfDNA for Cancer Management and Predicting Outcomes.

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The Pharma Data

JANUARY 22, 2021

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Before initiating Cabenuva treatment, study participants were virologically suppressed (HIV-1 RNA <50 copies/mL).

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The Pharma Data

NOVEMBER 18, 2020

The simple nasal swab test, developed by Lucira Health, requires a prescription and people under the age of 14 can’t perform the test on themselves, the FDA said in a statement. The California company said that clinical trials showed 100% of patients were able to perform the Lucira test in about two minutes.

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XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Read more about the vaccine, including clinical trial results on its efficacy and safety.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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XTalks

JUNE 14, 2023

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinical trials underscored the favorable tolerability profile of Vevye.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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Drug Discovery World

DECEMBER 21, 2023

In a record year for gene therapy approvals, it isn’t surprising that cell & gene therapy (CGT) has been a hot topic. Regulatory issues and diversity in clinical trials were also important in 2023, as well as the role that artificial intelligence tools like ChatGPT might play.

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pharmaphorum

DECEMBER 23, 2021

At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. Third-quarter sales of Leqvio were just $5 million, although that will reflect the lag between regulatory approval and reimbursement negotiations in European markets.

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pharmaphorum

APRIL 5, 2022

AstraZeneca’s take on the PCSK9 inhibitor – an antisense drug licensed from Ionis six years ago – has cleared a proof-of-concept trial in high-risk patients with high blood cholesterol, but it remains to be seen where it will fit into the increasingly busy category. billion in sales by 2027, ahead of Repatha at $2.2

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STAT News

MARCH 6, 2023

Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines  can be greenlighted.

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The Pharma Data

DECEMBER 8, 2020

Silverback’s lead candidate is currently in a Phase I trial in adults with HER2-expressing solid tumors. BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021. Laying down a new track for RNA processing, Remix launched with $81 million in financing.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Initial doses are expected to be limited as manufacturing ramps up.

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pharmaphorum

DECEMBER 23, 2020

The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. In the 500 patient trial, patients treated with Trodelvy lived for a median of 12.1

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Drug Discovery World

AUGUST 1, 2023

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

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The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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Roots Analysis

DECEMBER 18, 2023

Unfortunately, the initial success was short-lived as the products did not progress beyond phase III clinical trials, leading to the delisting of the products from the market and, consequently termination of their partnership with Merck. Pluvicto® received the FDA approval in March 2022 and the EMA approval in December 2022.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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Drug Discovery World

MARCH 7, 2023

In 2023, the company revealed data from a Phase III trial which showed that its vaccine candidate DCVax-L more than doubled overall survival in glioblastoma patients. She founded Neuroute in 2019, with the aim of empowering patients from diverse backgrounds to participate in drug trials. Dr Loubna Bouarfa, Founder and CEO, OKRA.ai

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The Pharma Data

NOVEMBER 29, 2020

The submission was based on the safety and efficacy data of the pivotal Phase II trials 201 and 12-230. The FDA approved the drug on November 24. It is an RNA interference (RNAi) therapeutic. The drug was developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs.

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XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

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Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. In phase II clinical trial, led by Steven A. Rosenberg, M.D.

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XTalks

DECEMBER 22, 2021

The RNA Revolution: From mRNA Vaccines to RNA Editing. The age of RNA is officially here, and it’s here to stay as more than a passing life science trend. RNA technology is not new nor has its potential been surprising. RNA in the Making. So why did this perceived RNA ‘revolution’ take so long?

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The Pharma Data

JANUARY 21, 2021

In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ?50 50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ?50

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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pharmaphorum

DECEMBER 23, 2022

Gilead Sciences has claimed FDA approval for Sunlenca, a therapy from Gilead Sciences for people with multidrug-resistant (MDR) HIV infection that only needs to be taken twice a year, at the second time of asking. The post FDA approves twice-yearly resistant HIV therapy from Gilead appeared first on.

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pharmaphorum

JANUARY 5, 2022

The year 2020 ended on a note of hope, with the 8th December vaccination of 91-year-old Margaret Keenan, the world’s first person to receive a COVID-19 vaccine outside clinical trials. For example, Eli Lilly’s donanemab has a rolling FDA submission, and a 2022 phase III readout, with possible FDA approval in H2/2022.

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The Pharma Data

DECEMBER 10, 2020

Both vaccination regimens resulted in complete protection from subsequent viral ‘challenge’ as reflected by reductions in viral RNA levels that were below the level of detection by day seven post-challenge compared to controls. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

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The Pharma Data

AUGUST 19, 2021

Food & Drug Administration (FDA) approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. log 10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine was 94.1%

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XTalks

JUNE 5, 2023

RSV belongs to the family of negative-strand RNA viruses and was first identified in 1955. Today’s FDA approval of Abrysvo recognizes significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease,” said Edward E.

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Delveinsight

DECEMBER 13, 2020

and ribavirin, were officially approved for HCV GT1 treatment. Even though clinical trial results were promising, adverse events and serious complications were observed. In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir? First DAAs (telaprevir and boceprevir), used in combination with PegINF-?

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