Pharmaceutical Technology

SEPTEMBER 19, 2022

bluebird bio was granted a rare paediatric priority review voucher following approval. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. 1) in Skysona-treated and untreated subjects. “For thalassemia.

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XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

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Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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FDA Approval Cardiology Clinical Trials Clinical Trials 246

Pharmaceutical Technology

AUGUST 8, 2022

The companies will co-market the therapy in the region and will be made available soon. The latest approval is based on one-year efficacy and safety findings, including 24-week data from the Phase III SPIRIT 1 and SPIRIT 2 clinical, as well as the first 28 weeks of an open-label extension study in those who completed either SPIRIT 1 or 2. .

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FDA Approval Drugs Trials Marketing 189

XTalks

JANUARY 2, 2025

(ATGC) has gone public with its initial public offering (IPO), marking a significant milestone in its journey to transform the heart valve market. Trading began on the Nasdaq Global Market on December 13, 2024, under the ticker symbol “AVR,” with the offering closed on December 16, 2024. The company offered 14.8

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Pharmaceutical Technology

MAY 1, 2023

The approval of Uzedy is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. The regulatory approval is based on the data obtained from the Risperidone Subcutaneous Extended-Release Study (RISE) and the SHINE Phase III trials.

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FDA Approval Clinical Trials Clinical Trials Trials 189

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

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XTalks

FEBRUARY 19, 2025

In the MOTION study a double-blind , multicenter, randomized (2:1) trial patients with measurable TGCT received either vimseltinib at a recommended dose of 30 mg orally twice weekly (with a minimum 72-hour interval between doses) or placebo for 24 weeks. Patients also reported improvements in pain, physical functioning and range of motion.

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Pharmaceutical Technology

FEBRUARY 1, 2023

The FDA IND clearance allows the company to expand its ongoing first-in-human Phase I/II clinical trial of EP0042. This will enable the addition of US trial sites, as well as the recruitment of eligible patients in the country to the trial.

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World of DTC Marketing

AUGUST 27, 2021

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient. 78 % of all subjects were enrolled outside the U.S.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

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Bio Pharma Dive

APRIL 27, 2023

The drugmaker will use a priority review voucher in a bid to secure FDA approval of Mounjaro in obesity by late this year or early next.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. After assessing the New Drug Application (NDA) under priority review, the FDA granted the approval based on the data obtained from a Phase II/III clinical trial.

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Pharmaceutical Technology

MAY 23, 2023

Indivior CEO Mark Crossley said: “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids such as fentanyl. Indivior will begin offering Opvee in the market in the fourth quarter of 2023.

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Pharmaceutical Technology

AUGUST 25, 2022

The latest approval is mainly based on positive findings from the single-arm, open-label, multicentre Phase I/II iMAGINE clinical trial of Imbruvica to treat moderate or severe cGVHD in paediatric and young adults aged one year to under 22 years. It is co-developed and co-marketed by AbbVie company, Pharmacyclics, and Janssen Biotech.

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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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Pharmaceutical Technology

MAY 25, 2023

It is already the first proposed high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar in the world to receive marketing authorisation from the European Commission. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

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FDA Approval Dermatology Sales Clinical Trials 264

Pharmaceutical Technology

FEBRUARY 8, 2023

The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 Pfizer maintained its third-place position in the market in 2022, reporting a market capitalization of $287.6 witnessed the biggest market capitalization growth of 45.3% trillion to $3.61 billion on Dec 31, 2022.

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Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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XTalks

APRIL 3, 2024

While Soliris had its market launch 17 years ago with $3.2 billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Competitors in the PNH market include Novartis, which won approval for its factor B inhibitor Fabhalta (iptacopan), the first oral pill for PNH treatment, late last year.

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Pharmaceutical Technology

FEBRUARY 10, 2023

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310).

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Pharmaceutical Technology

JUNE 19, 2023

The FDA’s review will take into account data from the Phase III MOMENTUM trial (NCT04173494). The double-blinded study investigated the efficacy of momelotinib compared to danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor.

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Pharmaceutical Technology

AUGUST 5, 2022

In addition, for doctors who do use Lucentis, there will be added pressure from payers to switch to Cimerli with its direct interchangeability with Lucentis approved. The post FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity appeared first on Pharmaceutical Technology.

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XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

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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. Elahere is said to be the first ADC to receive FDA approval for platinum-resistant disease. The ADC comprises an FR?-binding

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Antibody FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

SEPTEMBER 6, 2022

By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. . This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

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Drugs FDA Approval Clinical Trials Clinical Trials 246

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. times its initial investment.

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FDA Approval Drugs Gene Trials 99

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years.

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Pharmaceutical Technology

APRIL 7, 2023

Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. The results of the trial neither reduced preterm births nor demonstrated any improvement in the health of newborn babies.

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Drugs FDA Approval Clinical Trials Clinical Trials 243

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

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Drugs FDA Approval Development Marketing 246

XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. Biohaven’s Nurtec ODT is the first and only FDA-approved CGRP receptor antagonist available in a quick-dissolve ODT formulation.

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XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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FDA Approval Trials Clinical Trials Clinical Trials 101

pharmaphorum

DECEMBER 30, 2021

Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. The post J&J goes after another FDA approval for a cancer bispecific appeared first on.

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FDA Approval Antibody Drugs Production 122

Pharmaceutical Technology

APRIL 7, 2023

Makena was approved by the FDA under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. The results of the trial neither reduced preterm births nor demonstrated any improvement in the health of newborn babies.

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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