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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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. Uzedy reduced the risk of schizophrenia relapse by up to 80% compared to placebo in a Phase III clinical trial.

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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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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 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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BioPharma Reporter

MAY 5, 2022

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

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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

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.

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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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World of DTC Marketing

OCTOBER 21, 2021

SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

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Delveinsight

AUGUST 13, 2021

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual Clinical Trials?

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XTalks

FEBRUARY 19, 2025

XTALKS WEBINAR: Key Strategies for Successful Orphan Drug Launch in Europe Live and On-Demand: Friday, March 28, 2025, at 1pm EDT (5pm GMT) Register for this free webinar to learn about optimizing pricing and reimbursement strategies and leveraging patient advocacy for a successful market launch of orphan drugs.

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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 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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pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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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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XTalks

MAY 5, 2022

There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.

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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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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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Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. However, extended market exclusivity is often associated with high drug pricing and limited patient access.

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pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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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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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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XTalks

MAY 2, 2022

This is the very first approval for a medication for the chronic version of VVC. The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need. For Mycovia Pharmaceuticals , Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections.

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XTalks

MARCH 19, 2025

Elevidys is the first FDA-approved gene therapy for DMD a rare genetic disorder characterized by progressive muscle degeneration. To date, over 800 patients have received the therapy in clinical trials and real-world settings. This drop likely reflects market concerns over the therapys safety profile.

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pharmaphorum

MAY 16, 2022

The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinical trials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.

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XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

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XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

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XTalks

JUNE 26, 2023

The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021. Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release.

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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. Another noteworthy contender is Novan Inc.’s

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Pharmaceutical Technology

AUGUST 18, 2022

The latest approval is based on findings from the Phase III clinical trials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?

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XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. Both shots are indicated for adults aged 18 years and older.

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XTalks

JANUARY 13, 2023

According to Polarean, Xenoview is the first and only inhaled hyperpolarized MRI contrast agent to reach the market. FDA approval represents achievement of a major milestone for Polarean’s technology. Two More Devices Approved by the FDA Alongside Xenoview. Xenoview Clinical Studies.

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Pharmaceutical Technology

MARCH 14, 2023

The agreement is intended for providing commercial support for CTx-1301, after receiving the US Food and Drug Administration (FDA) approval. Additionally, it intends to start a fixed-dose, placebo-controlled, pivotal Phase III trial in ADHD paediatric and adolescent patients in the middle of this year.

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XTalks

MAY 25, 2022

Only three drugs are approved by the US Food and Drug Administration (FDA) to treat fibromyalgia: Pfizer’s Lyrica (pregabalin), Eli Lilly’s Cymbalta (duloxetine) and Forest Laboratories’ and Cypress Bioscience’s Savella (milnacipran). Some of the clinical trial results were published in the Journal of Pain Research last year.

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World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.”

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Pharmaceutical Technology

SEPTEMBER 5, 2022

AstraZeneca’s cardiovascular, renal, and metabolism (CVRM) portfolio includes 18 marketed drugs and an investigational cardiovascular disease drug, eplontersen. The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. In 2019, AstraZeneca entered a $6.9

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