XTalks

JUNE 23, 2022

The drug has become the first approved systemic treatment for the autoimmune disorder that causes patchy hair loss. Ayesha also discussed the FDA approval of Alnylam’s RNAi therapeutic Amvuttra for the treatment of polyneuropathy associated with a rare protein disorder called hereditary transthyretin-mediated (ATTR) amyloidosis.

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BioPharma Reporter

MARCH 22, 2022

Fujifilm Irvine Scientific, Inc, has announced the acquisition of Shenandoah Biotechnology, a company supplying recombinant proteins to the drug discovery, life science research, and cell and gene therapy markets.

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Gene Therapy Life Science Protein Gene 98

XTalks

MARCH 31, 2023

By growing high quality crystal structures of protein-based therapeutics under microgravity, researchers can gain better insights into their complex structures and stability. This can help guide better drug formulations, delivery of higher therapeutic doses and improved biomanufacturing processes.

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Protein Research Development Manufacturing 97

pharmaphorum

JULY 26, 2021

The most complete database of protein structures ever assembled, developed with the help of Google’s artificial intelligence unit DeepMind, has been made freely available to researchers around the world. Around a third of the structures are considered to be detailed and precise enough to allow drug design.

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Protein Genomics Genome Life Science 130

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. In 2024, Deciphera was acquired by ONO Pharmaceutical for $2.4

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XTalks

JULY 20, 2022

It is also the first protein-based COVID-19 vaccine to be authorized in the country. Ayesha also talked about the expanded label approval of Horizon Therapeutics’ gout medication Krystexxa to include its co-administration with arthritis and chemotherapy drug methotrexate. Krystexxa Chronic Gout Medication Gets Expanded FDA Approval.

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Life Science Vaccination Vaccine Drugs 52

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. Datroway leverages DXd technology to precisely target cancer cells.

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XTalks

APRIL 2, 2025

Along the way, Dr. Fordyce has built a world class team of drug developers and raised over $1 billion in capital. Dr. Fordyce previously worked in clinical development leadership roles at Gilead Sciences in the 2010s, driving innovation in treatments for HIV and hepatitis.

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pharmaphorum

JANUARY 11, 2023

A slow journey to drug discovery. Asked about the impetus behind Verseon’s work in the sector, Prakash explained that he began the company “to change the way the world finds new drugs”. Today’s pharmaceutical drug discovery process essentially relies on trial and error,” he expanded. “To Not an unambitious goal.

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XTalks

JANUARY 7, 2025

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. When an artery is damaged, restoring blood flow quickly is crucial.

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XTalks

MAY 29, 2024

Cocrystal Pharma leverages a unique structure-based drug discovery platform, complemented by Nobel Prize-winning expertise, to develop leading-edge antiviral drugs that are both first-in-class and best-in-class. Dr. Lee brings over 25 years of experience in anti-infective drug discovery research to his role.

Life Science 52

Life Science FDA Approval Drugs Development 52

XTalks

DECEMBER 26, 2024

The BROADWAY trial tested obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor, as a monotherapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD). Unlike CETP inhibitors, PCSK9 inhibitors block a protein that regulates cholesterol levels.

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Trials Life Science Clinical Trials Clinical Trials 52

XTalks

OCTOBER 24, 2024

Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA). This drug may significantly improve psoriasis care by offering effective long-term control with fewer side effects.

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Research Dermatology Clinical Trials Clinical Trials 105

XTalks

OCTOBER 22, 2024

Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The drug is specifically indicated for patients whose tumors are HER2-negative and express claudin 18.2 months from 15.5

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XTalks

NOVEMBER 30, 2022

The approval was awarded to CSL Behring’s Hemgenix, a single-dose gene therapy that delivers a working copy of the gene that codes for the Factor IX protein that is deficient, or made in insufficient amounts, in patients with Hemophilia B. The therapy is now officially the world’s most expensive drug at $3.5 million per dose.

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Gene Therapy Life Science Gene FDA Approval 52

XTalks

NOVEMBER 23, 2021

The reliance of COVID-19 vaccine manufacturing on only a handful of countries globally has made many nations realize the need for large-scale, domestic biomanufacturing facilities for drugs and vaccines as preparation for potential disease outbreaks and health emergencies in the future.

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pharmaphorum

NOVEMBER 6, 2022

In 2021, five out of the top 10 selling drugs were mAbs and this trend is forecasted to remain the same over the next five years. Artificial Intelligence (AI) and deep learning have already transformed several aspects of small molecule drug design. The potential of monoclonal antibodies (mAbs) as therapies is indisputable.

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Antibody Drugs Protein Life Science 123

XTalks

APRIL 22, 2025

The postpandemic era has accelerated demand across healthcare and life sciences, rewarding companies that address emerging patient and provider needs. Seer (Absolute Growth: 2,439.8%) Seers proteomics diagnostics platform uses proprietary nanoparticles to enrich lowabundance proteins.

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XTalks

NOVEMBER 8, 2024

Top Hospital-Based Healthcare Innovations Google DeepMind AlphaFold 3: Rendering Molecules in HD Drug discovery often hinges on predicting how proteins interact with each other. Understanding these interactions is like solving a three-dimensional puzzle with thousands of pieces.

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Doctors Doctor Protein Nurses 104

XTalks

AUGUST 17, 2020

Viltepso (viltolarsen), an injectable drug developed by NS Pharma, has gone through the US Food and Drug Administration’s (FDA) accelerated approval process, but the company has yet to confirm that the drug has a true clinical benefit.

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XTalks

NOVEMBER 21, 2024

The US Food and Drug Administration (FDA) has granted Breakthrough Device clearance to Ultromics’ EchoGo Amyloidosis device through its Total Product Lifecycle Advisory Program (TAP). Cardiac amyloidosis, a serious and often underdiagnosed heart condition, poses significant diagnostic challenges even for experienced clinicians.

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Production Protein Life Science Trials 105

Delveinsight

JULY 29, 2021

Biogen-Ionis’ experimental drug meets primary goal in Alzheimer’s trial. Biogen and Ionis Pharmaceuticals have demonstrated that their experimental drug, BIIB080 (IONIS-MAPT), fulfilled the primary goal of safety and tolerability in the Phase Ib multiple ascending doses (MAD) clinical trials in mild Alzheimer’s disease patients.

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Drugs Protein Life Science Development 98

XTalks

JULY 28, 2020

Excipients can take many forms, such as bulking agents, binders, coatings and colourants, and they are chosen based on their ability to aid in drug delivery, administration and even in pill identification and prevention of counterfeiting.

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Protein Drugs In-Vitro Scientist 103

XTalks

FEBRUARY 26, 2024

The US Food and Drug Administration (FDA) has granted expanded approval to Genentech’s (part of Roche) Xolair (omalizumab) to help reduce allergic reactions to various foods after accidental exposure. This amount is equivalent to about two and a half peanuts or half a teaspoon of regular peanut butter.

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Allergies FDA Approval Drugs Protein 100

Pharmaceutical Technology

MARCH 1, 2023

According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Gene Editing DNA Cosmetics Life Science 100

Pharmaceutical Technology

MARCH 1, 2023

According to GlobalData, Phase I drugs for Head And Neck Cancer Squamous Cell Carcinoma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Gene Editing DNA Cosmetics Life Science 100

XTalks

MARCH 11, 2025

Vepdegestrant, an investigational oral therapy, utilizes PROteolysis TArgeting Chimera (PROTAC) technology a mechanism that harnesses the bodys natural protein disposal system to selectively target and degrade the estrogen receptor. From a business perspective, Arvinas fourth quarter financial highlights report that revenue surged to $263.4

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Trials Clinical Trials Clinical Trials Protein 59

XTalks

JANUARY 6, 2021

One nanobody in particular, called NIH-CoVnb-112, was shown to be able to prevent COVID-19 infection from the novel coronavirus by targeting both the spike protein on SARS-CoV-2, as well as the angiotensin converting enzyme 2 (ACE2) receptor that it binds to on human cells. The study was led by neuroscientists Thomas J. “TJ”

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Antibody Protein Bacteria In-Vitro 105

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

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FDA Approval Drugs Gene Trials 99

XTalks

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). Overall, the drug has been well-tolerated, Hirawat said. “We The FDA approved 2.5 The FDA approved 2.5

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FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

FEBRUARY 22, 2022

Microlyse is a thrombolytic fusion protein that targets von Willebrand factor (vWF), a glycoprotein in the blood that is a carrier protein for Factor VIII and is part of the process that causes platelets to stick together in clot formation. The post TargED Bio raises €39m for new clot-busting drug appeared first on.

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Drugs Protein Clinical Development Antibody 59

pharmaphorum

MARCH 23, 2021

US biotech Aura Biosciences has closed an oversubscribed financing, raising $80 million to help take its lead virus-like drug conjugate (VDC) for a cancer that affects the eye into late-stage development. The post Aura raises $80m to develop its virus-like cancer drugs appeared first on.

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Development Drugs Immune Response Life Science 71

XTalks

MARCH 9, 2023

Travere Therapeutics recently announced that their medication Filspari (sparsentan) received accelerated approval from the US Food and Drug Administration (FDA). The approval was granted for its use as a non-immunosuppressive therapy for the reduction of proteinuria (protein in urine) in IgA nephropathy in adults.

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FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

JULY 20, 2021

The vaccine – now dubbed Vidprevtyn – is based on a recombinant protein antigen developed by Sanofi’s vaccines unit Sanofi Pasteur, and also includes an immune-boosting adjuvant developed by GSK that aims to boost its efficacy. 1.351) variant first identified in South Africa.

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Vaccination Vaccine Protein Immune Response 98

XTalks

MARCH 18, 2025

By inhibiting this protein, povorcitinib reduces the inflammatory signals that contribute to abscess and nodule formation. As reported by Investors.com , RBC Capital Markets analyst Brian Abrahams stated, The drug did hit on statistical significance and could be a viable entrant.

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XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

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FDA Approval Sales Antibody Protein 66

XTalks

NOVEMBER 1, 2024

The neurology drug market continues to be dynamic with novel treatments that cater to a broad range of neurological and psychiatric conditions. In this blog, we highlight the top 20 best-selling neurology drugs to watch in 2024, based on 2023 sales statistics. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1.

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FDA Approval Drugs Botox Sales 85