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.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Omaveloxolone Clinical Trials Skyclarys is an oral medication that contains omaveloxolone, an activator of the nuclear factor-erythroid 2 related factor 2 (Nrf2) pathway.

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FDA Approval Engineer Clinical Trials Clinical Trials 52

XTalks

DECEMBER 2, 2022

As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Rebyota is not indicated for the first occurrence of C.

FDA Approval 59

FDA Approval Bacteria Containment Clinical Trials 59

XTalks

SEPTEMBER 28, 2023

a Texas-based pharmaceutical firm specializing in psychotropic drug development, revealed that its groundbreaking antidepressant, Exxua (gepirone extended release) for treating major depressive disorder (MDD), received US Food and Drug Administration (FDA) approval on September 22, 2023. Fabre Kramer Pharmaceuticals, Inc.,

FDA Approval 105

FDA Approval Clinical Trials Clinical Trials Trials 105

XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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FDA Approval Trials Antibody DNA 105

XTalks

DECEMBER 22, 2023

Glaukos Corporation, a leader in ophthalmic medical technology and pharmaceuticals with a focus on novel treatments for glaucoma, corneal disorders and retinal diseases, has secured US Food and Drug Administration (FDA) approval for iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog intended for one-time use per eye.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 18, 2023

After Johnson & Johnson’s US Food and Drug Administration (FDA) approval last week for its second multiple myeloma bispecific, Talvey (talquetamab), Pfizer received an FDA nod for its B-cell maturation antigen (BCMA)-directed therapy Elrexfio (elranatamab) in the same indication.

FDA Approval 98

FDA Approval Drugs Antibody Trials 98

XTalks

JUNE 6, 2023

Posluma is now the first and only radiohybrid PSMA-targeted PET imaging agent to receive FDA approval. Posluma contains a radioactive imaging agent, fluorine-18 ( 18 F), that is designed to specifically bind to the PSMA over-expressed on prostate cancer cells. Gauden, CEO of Blue Earth Diagnostics, in the company’s news release.

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FDA Approval Clinical Trials Clinical Trials Marketing 96

XTalks

JANUARY 25, 2021

GlaxoSmithKline’s (GSK) ViiV Healthcare — which focuses on HIV treatments and prevention — has received approval from the US Food and Drug Administration (FDA) for its highly anticipated injectable HIV treatment. Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.

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FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

JUNE 29, 2022

The new FDA approval gives Breyanzi (lisocabtagene maraleucel) the broadest patient eligibility of any CAR T-cell therapy in relapsed or refractory LBCL. Outcomes of Clinical Trials for Breyanzi. Product logo and product image courtesy of Bristol Myers Squibb. Lymphoma is one of the most aggressive types of cancer.

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FDA Approval Gene Therapy Antibody Gene 52

XTalks

MAY 24, 2022

More than two dozen antiretroviral drugs are approved by the US Food and Drug Administration (FDA) to treat HIV infection. The FDA has allowed clinical trials assessing the injectable lenacapavir, an investigational long-acting HIV-1 capsid inhibitor in development by Gilead Inc., Clinical Trials of Lenacapavir.

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Clinical Trials Clinical Trials Drugs Trials 98

XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

Sales 52

Sales Insulin FDA Approval Drugs 52

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. The solution of Vevye does not contain water, anti-microbial preservatives, oils or surfactants.

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Gene Silencing Drug Delivery FDA Approval RNA 97

XTalks

APRIL 25, 2024

The efficacy of the Revivent TC system is being evaluated through clinical trials, namely the LIVE trial and the ongoing ALIVE trial. The LIVE trial showcased the system’s potential to reduce ventricular volumes by approximately 25 percent and improve left ventricular ejection fraction by about 16 percent.

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Development Trials Clinical Trials Clinical Trials 111

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. Lastly, we look to our life science partners themselves, who have undoubtedly spearheaded ECAs for their own pipelines. Myth 1: There are too many challenges with adopting an ECA.

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Clinical Trials Clinical Trials Life Science Trials 70

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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Gene Therapy Gene Trials Clinical Trials 95

XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. After the vote, the FDA extended the decision date by one month due to concerns it raised in briefing documents before the committee meeting.

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Gene Therapy Gene Protein FDA Approval 98

XTalks

MAY 1, 2023

Today marks an important moment in ALS research as Qalsody is the first ALS treatment approved based on a biomarker,” said Jean Swidler, chair of Genetic ALS & FTD: End the Legacy, in Biogen’s press release. In recent years, several other medications have entered Phase II/III clinical trials for the treatment of ALS.

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FDA Approval Gene Genetics Protein 89

Drug Discovery World

SEPTEMBER 28, 2023

In fact, the endometrial fluid contains peptides that may protect against a variety of fungi, bacteria, viruses, and other pathogens 4. Ongoing impactful trials are investigating the potential for microbiome-based diagnostic tests for endometriosis 5 and PCOS 6 using blood, faecal, vaginal, and/or endometrial samples.

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Clinical Trials Clinical Trials Regulation Bacteria 64

pharmaphorum

OCTOBER 2, 2020

It’s the same indication targeted by Janssen with another medicine that drew inspiration from an illegal recreational drug – Spravato is an FDA-approved nasal spray containing esketamine, an isomer of ketamine. New partnership tests low-dose psilocybin.

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Medicine Life Science FDA Approval Development 118

XTalks

MARCH 12, 2024

XTALKS WEBINAR: Engaging Patient Communities: A Pathway to Clinical Trial Success Live and On-Demand: Tuesday, April 16, 2024, at 11am EDT (4pm BST/UK) Register for this free webinar to explore best practices for engaging with patient communities to enhance recruitment, retention and overall success of a trial.

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Drugs Production Trials Containment 105

XTalks

DECEMBER 5, 2022

The CBD prodrug will be going up against Jazz Pharma’s Epidiolex, the first FDA approved CBD drug formulation. Approved in 2018, Epidiolex is a CBD oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, rare and severe forms of epilepsy, in patients two years of age and older.

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Bioavailability FDA Approval Trials Drugs 97

pharmaphorum

APRIL 13, 2021

Dr Cindy Jacobs, chief medical officer of Achieve Life Sciences discusses the potential of cytisinicline therapy for smoking cessation. . Higher rates occur with FDA-approved treatment therapies developed for users of combustible cigarettes. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

Life Science 106

Life Science FDA Approval Trials Development 106

XTalks

MARCH 3, 2021

Today’s action marks the first FDA approval for a therapy to treat this devastating disease,” said Hylton V. Joffe, MD, director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research, in a press announcement from the FDA. Nulibry Trial Results.

FDA Approval 64

FDA Approval Genotype Clinical Trials Clinical Trials 64

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. ’s berdazimer gel, containing 10.3

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. The vaccine is protein-based and contains an adjuvant (MM), a component that helps generate a stronger immune response, that was developed by Novavax. Malaria Vaccine Phase II Trial.

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Vaccination Vaccine Immune Response Trials 105

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. There are five categories, each containing five cannabis scientists.

Medicine 52

Medicine Scientist Production Regulation 52

XTalks

DECEMBER 26, 2022

has obtained US Food and Drug Administration (FDA) approval of an expanded indication for the use of Cytalux (pafolacianine) for the detection of lung cancer during surgery. Clinical Trials of Cytalux (pafolacianine). On Target Laboratories, Inc. Live and On-Demand: Wednesday, January 25, 2023, at 1pm EST (10am PST).

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL.

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Protein Engineer Immune Response In-Vivo 98

XTalks

MAY 26, 2023

Brixadi is specifically indicated for patients who have already started treatment with a single dose of a transmucosal buprenorphine product (that enters across a mucous membrane) or are currently receiving treatment with a transmucosal buprenorphine-containing product. It is offered in two regimens: weekly and monthly.

FDA Approval 97

FDA Approval Containment Clinical Trials Clinical Trials 97

XTalks

MAY 15, 2023

Chiesi Global Rare Diseases in collaboration with Protalix BioTherapeutics announced the US Food and Drug Administration (FDA) approval of their new medication Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease. The initial half-life of Elfabrio was determined to be 78.9 ± 10.3

FDA Approval 98

FDA Approval Gene Genetics Clinical Trials 98

XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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Sales Manufacturing FDA Approval Life Science 98

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

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Manufacturing Vaccination Vaccine RNA 130

XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

Insulin 98

Insulin Hormones FDA Approval Sales 98

XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

JANUARY 9, 2021

RECONCILIATION OF NON-GAAP MEASURES (unaudited) This press release contains two financial measures (Adjusted Net Income and Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization)) that are considered “non-GAAP” financial measures under applicable Securities and Exchange Commission rules and regulations. .

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Production Manufacturing Vaccination Vaccine 52