XTalks

APRIL 9, 2025

Primary IgAN is a rare autoimmune disease in which deposits of IgA provoke glomerular inflammation and excessive protein leakage into the urine. This oral, oncedaily, nonsteroidal therapy targets the endothelin A receptor, a key driver of inflammation and scarring in the kidneys filtering units.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

Pharmaceutical Technology

APRIL 11, 2023

The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response. Zydus has manufacturing sites and research facilities across five Indian states, including Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim.

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FDA Approval Drugs Immune Response Manufacturing 130

XTalks

JANUARY 21, 2025

The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology. The FDA approval sent Daiichi Sankyos shares soaring by 8.7% to 4,437 yen, reflecting investor confidence.

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Antibody FDA Approval HR Trials 105

Pharmaceutical Technology

NOVEMBER 14, 2022

Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial. binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4. The ADC comprises an FR?-binding

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Antibody FDA Approval Clinical Trials Clinical Trials 246

XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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Botox FDA Approval Cosmetics Clinical Trials 98

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. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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FDA Approval Genetics Gene Therapy Gene 105

XTalks

JUNE 2, 2021

KRAS mutations have previously been considered ‘undruggable’ targets, but they have been a big focus in cancer research as they are one of the most common gene mutations across all cancers. The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

Scienmag

MARCH 26, 2021

Discovery opens door to testing more effective drugs for treating COVID-19 patients University of Maryland School of Medicine (UMSOM) researchers have identified the most toxic proteins made by SARS-COV-2–the virus that causes COVID-19 – and then used an FDA-approved cancer drug to blunt the viral protein’s detrimental effects.

Protein 71

Protein FDA Approval Drugs Medicine 71

XTalks

OCTOBER 4, 2022

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

FDA Approval 98

FDA Approval Antibody Drugs Protein 98

XTalks

JUNE 8, 2022

These autoantibodies include rheumatoid factor and antibodies against post-translational modified proteins such as carbamylation (anti-CarP antibodies) and citrullination (anti-citrullinated protein antibodies [ACPA]). This marks a new indication for Riabni, the fifth FDA-approved biosimilar by the biopharma Amgen.

FDA Approval 96

FDA Approval Antibody Clinical Trials Clinical Trials 96

pharmaphorum

SEPTEMBER 16, 2022

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. The companies hope that in the year to come those data targets will be entered for validation, hit generation, and lead selection. Human-first precision health. AI relies on data.

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Development Research Drugs Clinical Trials 135

XTalks

AUGUST 19, 2022

Beta thalassemia is a rare inherited blood disorder caused by mutations in the beta-globin gene leading to a reduced amount, or complete absence, of the beta chains of the oxygen-carrying hemoglobin protein in red blood cells. XTALKS WEBINAR: How Agile Clinical Trials Unlock Universal Access to Rare Disease Research.

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Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

FEBRUARY 26, 2024

After a 16- to 20-week treatment period, among those who received Xolair, 68 percent were able to eat at least a single 600-mg dose of peanut protein without moderate to severe allergic symptoms (such as whole-body hives, persistent coughing or vomiting) compared to six percent who received placebo.

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Allergies FDA Approval Drugs Protein 100

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Tyrosine Kinase Inhibitors for Cancer Treatment Tyrosine kinases, or TKs, are a group of signaling molecules that affect multiple downstream proteins.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Related: Cancer Blood Test Developed by University of Oxford Researchers Can Detect Metastasis. Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore.

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FDA Approval Development Containment Licensing 98

pharmaphorum

NOVEMBER 12, 2021

Researchers in the US have developed an artificial intelligence-based tool that is able to predict COVID-19 symptoms and suggest which FDA-approved drugs might be used to treat patients. The tool meanwhile could also be applied to new outbreaks of other novel viral infections as they emerge, according to the scientists.

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Doctors Doctor Drugs Gene Expression 135

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Lerner researchers developed a novel artificial intelligence platform to identify potential drugs for COVID-19, finding melatonin to be a promising candidate.

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Research Hormones Protein Regulation 98

Pharmaceutical Technology

JUNE 28, 2022

Researchers at the Rensselaer Polytechnic Institute in the US have received a five-year, $3.5m The latest research is part of the consortium of a new antiviral drug development centre named Center for Antiviral Medicines and Pandemic Preparedness (CAMPP), to be led by Scripps Research. Meanwhile, the NIH also granted a $2.7m

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Development Bioinformatics Drugs Allergies 147

XTalks

MAY 10, 2022

Researchers at the University of Manchester have developed a new blood test that can help diagnose ovarian cancer faster and more accurately in women, particularly those under the age of 50, using a newer ovarian cancer biomarker. The test includes the use of the emerging ovarian cancer biomarker, human epididymis protein 4 (HE4).

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Research Development Clinical Trials Clinical Trials 105

XTalks

AUGUST 2, 2022

B cells require a specific protein for growth called BLyS (B-lymphocyte stimulator), which is implicated in the pathogenesis of SLE. Register for this free webinar to learn why patient-centricity is important in rare disease research. When this behaviour is prolonged, it results in inflammation. Managing Lupus Nephritis.

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FDA Approval Antibody Bacteria Protein 94

XTalks

JUNE 5, 2023

Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains. “A Research indicates that RSV can interfere with the functioning of dendritic cells, vital for initiating an antiviral response. percent and severe RSV-associated LRTD by 94.1

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Vaccination Vaccine FDA Approval Protein 98

The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

FDA Approval 52

FDA Approval Drugs Protein In-Vitro 52

The Pharma Data

APRIL 26, 2022

A drug used to treat asthma and allergies can bind to and block a crucial protein produced by the virus SARS-CoV-2, and reduce viral replication in human immune cells, according to a new study by researchers at the Indian Institute of Science (IISc). Targeting Nsp1 could therefore reduce the damage inflicted by the virus.

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Protein Drugs Allergies FDA Approval 52

XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

Pfizer

JANUARY 27, 2023

Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.

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Research Vaccine Vaccination Drugs 112

XTalks

MARCH 18, 2025

Standard treatment strategies include combinations of antibiotics, hormonal therapies and biologic agents most notably adalimumab (Humira), the only FDA-approved biologic for moderate to severe cases while surgery remains an option for advanced disease.

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Trials Clinical Trials Clinical Trials Hormones 59

Delveinsight

FEBRUARY 9, 2021

Deerfield and Dana-Farber Establish Links in USD 130 Million Cancer Research Deal. Deerfield Management has entered into a research agreement with Dana-Farber Cancer Institute to fuel the development of therapeutics and diagnostics for cancer. Breyanzi, BMS’ Blood Cancer CAR-T Therapy Receives FDA Nod.

FDA Approval 52

FDA Approval Marketing Research Protein 52

The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

FDA Approval 52

FDA Approval Drug Delivery Development Doctors 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Vaccination Vaccine Protein Immune Response 111

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. According to the Centers for Disease Control and Prevention (CDC) , 45.8 GlobalData is the parent company of Pharmaceutical Technology.

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Vaccination Vaccine Antibody Development 162

XTalks

DECEMBER 29, 2023

. “The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy,” said David M.

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Clinical Trials Clinical Trials FDA Approval Trials 119

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. point reduction in the placebo arm.

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Drugs Gene Hormones Clinical Trials 317

XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Khanani, director of clinical research at Sierra Eye Associates, Reno, Nevada, in Iveric Bio’s news release. The recommended dosage of Izervay is 2 mg (equivalent to 0.1

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 11, 2023

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

Protein 105

Protein Regulation FDA Approval Licensing 105

Worldwide Clinical Trials

MAY 30, 2024

These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Researchers established efficacy of edaravone in a 24 week, randomized, placebo-controlled double-blind study in 137 Japanese patients.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

XTalks

JULY 29, 2024

World Lung Cancer Day, observed annually on August 1, serves as a global platform to raise awareness about lung cancer, honor those affected and highlight advancements in research and treatment. New FDA-approved therapies have been found to be more effective and have fewer side effects than traditional chemotherapy.

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Research Clinical Trials Clinical Trials FDA Approval 59