SCIENMAG: Medicine & Health

DECEMBER 14, 2023

In the fatal world of opioid use disorder (OUD), pharmacotherapy, or using a prescribed medication to treat drug dependence, has emerged as the gold standard of treatment. Among the trio of FDA-approved medications to treat OUD, buprenorphine is the newest highly effective drug that can suppress and reduce cravings for opioids.

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The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. “As director of the FDA’s Center for Drug Evaluation and Research.

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BioPharma Drive: Drug Pricing

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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The Pharma Data

AUGUST 9, 2021

Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. deputy director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research.

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Drugs.com

JULY 24, 2023

Food and Drug Administration has approved the topical solution Ycanth (cantharidin) for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients (aged 2 years and older). MONDAY, July 24, 2023 -- The U.S. Ycanth uses a.

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Drugs.com

DECEMBER 8, 2023

Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.

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Drugs.com

DECEMBER 8, 2023

Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology.Casgevy, developed by Vertex. FRIDAY, Dec. 8, 2023 -- The U.S.

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Policy Prescription

OCTOBER 22, 2024

Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. As the article notes, three in ten American adults struggle to afford prescription drugs.

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The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) gave a greenlight for ViiV Healthcare ’s Cabenuva. 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.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4.

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Drugs.com

JUNE 14, 2023

Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation. The approval was based on data from 328 participants. WEDNESDAY, June 14, 2023 -- The U.S.

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Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.

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The Pharma Data

AUGUST 31, 2021

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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Drugs.com

JUNE 23, 2023

Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD). The groundbreaking treatment will not be cheap: FRIDAY, June 23, 2023 -- The U.S.

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The Pharma Data

OCTOBER 29, 2021

Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. The blessing of Scemblix may offer stopgap to cases by addressing gaps in CML care.” Scemblix nearly doubled the MMR ratevs.

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The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.

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FDA Law Blog: Drug Discovery

MARCH 26, 2024

Sasinowski — On March 21st, FDA announced the approval of the first nonsteroidal therapy for the treatment of Duchenne Muscular Dystrophy (DMD) (FDA press release available here ). The primary basis for approval, like other drugs for DMD, was based on a single placebo-controlled randomized trial.

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BioPharma Drive: Drug Pricing

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

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PLOS: DNA Science

SEPTEMBER 5, 2024

Today for many patients, it is the beginning of taking a series of drugs that specifically target the errant cells by blocking the signals that fuel their runaway cell division, while sparing healthy cells. If deployed early, AI might identify drugs unlikely to work more effectively than can genetic and genomic testing.

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The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S.

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Drugs.com

JUNE 23, 2023

Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD). The groundbreaking treatment will not be cheap: FRIDAY, June 23, 2023 -- The U.S.

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The Pharma Data

APRIL 28, 2023

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya ® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5

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Drugs.com

AUGUST 17, 2023

Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and. THURSDAY, Aug. 17, 2023 -- The U.S.

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The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research. Today, the U.S. Dosing is patient?customized,

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. (the

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Drug Target Review

JUNE 5, 2023

Can you tell us more about ZW191 and its potential as an FRα-targeting antibody-drug conjugate? ZW191 is comprised of a novel fully humanised IgG1 antibody covalently conjugated to a novel topoisomerase 1 inhibitor ZD06519, a camptothecin derivative, via endogenous interchain cysteines with a drug-to-antibody ratio (DAR) of eight.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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Drugs.com

JULY 28, 2023

Food and Drug Administration has approved Xdemvy (lotilaner ophthalmic solution) 0.25 percent for the treatment of Demodex blepharitis, caused by Demodex mites. The approval was based on results from two. FRIDAY, July 28, 2023 -- The U.S.

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The Pharma Data

AUGUST 10, 2020

Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy (SMA), making it the first oral therapy available for the rare hereditary genetic condition in US and the second overall to be approved for the disease. months at launch. with placebo.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. Enzymes involved include CYP1A2, CYP2C8, CYP3A4, CYP4F2, and aldehyde oxidase (AOX).

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Drugs.com

AUGUST 3, 2023

Food and Drug Administration has approved RiVive, an over-the-counter (OTC) naloxone hydrochloride nasal spray for emergency treatment of known or suspected opioid overdose. "We THURSDAY, Aug. 3, 2023 -- The U.S. We know naloxone is a powerful tool to.

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The Premier Consulting Blog

NOVEMBER 12, 2024

For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. In our experience, the conversation on 505(b)(2) pathways commonly focuses on predicate data or bridging strategies to accelerate FDA approval but lacks dialogue on the needs of US payers. Non-preferred coverage. Big picture.

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