Drug Discovery World

OCTOBER 4, 2022

“Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018. billion in 2013 to less than $3 billion in 2018) due to loss of patent protection for the five FDA approved pharmacologic treatments available for AD, none of which slow or stop the damage from the disease. .

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The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. 2018)2: Menter MA, Armstrong AW, Gordon KB, Wu JJ. 2018 Feb;37(2S):S48-S51. For more information please visit: www.uniontherapeutics.com. Sources 1: Li et al.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. The Antimicrobial and the Cellular, Tissue, and Gene Therapy each met three times.

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Drug Discovery World

AUGUST 10, 2022

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

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The Pharma Data

DECEMBER 9, 2020

This acquisition will significantly strengthen Boehringer Ingelheim’s focus on targeted cancer cell therapies, gaining the company access to NBE’s innovative immune-stimulatory iADC platform. . The FDA approved the first ADC just this year – Immunomedics’ Trodelvy, for treating adult and pediatric glioblastoma. .

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

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Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

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The Pharma Data

SEPTEMBER 28, 2021

The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to 6 weeks aged and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne dystrophy (DMD).

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Eye on FDA

JANUARY 16, 2023

Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. Looking at the second chart below, one can see that the number of AdComms since 2018 peaked in the same year FDA approved a record number of new molecular entities (NMEs).

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done.

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The Pharma Data

AUGUST 19, 2021

3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] RYBREVANT TM (amivantamab-vmjw) received accelerated approval by the U.S.

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The Pharma Data

DECEMBER 30, 2020

That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. Andexxa, was approved by the U.S.

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The Pharma Data

JANUARY 31, 2021

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. For more information, please visit our website: www.cloverbiopharma.com.

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The Pharma Data

SEPTEMBER 9, 2020

The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018. 0.86, p=0.015). Europe and Japan.

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The Pharma Data

FEBRUARY 8, 2021

In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.

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The Pharma Data

JUNE 28, 2021

Million People in Japan[1],[2] Aimovig is the First and Only Approved Treatment in Japan to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R) That Plays an Important Role in Migraine[3] Aimovig Continues to be the Most Utilized Anti-CGRP Pathway Therapy, With More Than Half a Million Patients Prescribed Worldwide[4].

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The Pharma Data

DECEMBER 3, 2020

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines. For more information, please visit our website: www.cloverbiopharma.com.

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Drug Discovery World

JULY 8, 2024

While mRNA vaccines and RNA interference therapies have garnered much attention, a new class of RNA therapeutics known as aptamers is gaining momentum, particularly to address acute diseases. The most developed RNAi is small interfering ribonucleic acid (siRNA)-based therapies.

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Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. Using gene therapy, their approach was beautifully straightforward – “Missing an important gene?

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The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg. 1,2,8-13 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

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Agency IQ

JANUARY 19, 2024

Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. However, BeiGene announced that it is seeking approval in the U.S. Inaqovi (cedazuridine/decitabine; Otsuka Pharmaceuticals) is approved in the E.U.

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The Pharma Data

AUGUST 31, 2021

Janssen will share four data presentations highlighting clinical advances for two therapies from our solid tumor portfolio. FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. DRUG INTERACTIONS.

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Agency IQ

JULY 21, 2023

subsequent superior/inferior supportive care, lifestyle changes, and/or use of additional therapies). That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors.

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. While stimulant use disorder is increasing, there are currently no FDA-approved medications. What’s next?

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Codon

JULY 14, 2024

While this departs from the reductionist, single-component therapies that have dominated transfusion medicine since World War II, emerging data underscores that whole blood transfusions—blood with all its parts—yield better outcomes following severe blood loss than transfusions involving discrete blood components. Always free.

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The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. In short, all studies found no significant difference between phenylephrine and placebo.

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Drug Discovery World

JANUARY 17, 2024

This, coupled with a growing understanding of the heterogeneity of cancer as the basis for treatment resistance, tumour evolution and therefore the main source of therapeutic failure, 6 has highlighted the importance of developing personalised therapy. Tumour heterogeneity and resistance to cancer therapies. 15 , 81–94 (2018).

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Agency IQ

OCTOBER 20, 2023

A study found that, of 23 FDA-approved biosimilar products, 21 had comparative efficacy established through one or more phase 3 clinical trials , which included “both an initial comparative efficacy period and additional follow-up, during which a subset of patients was switched between the biosimilar and reference products.”

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Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. Fewer meetings – more approvals.

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