Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy. CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

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PLOS: DNA Science

MARCH 28, 2024

FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. A gene-based treatment would have to alter many cells to exert a noticeable effect.

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Drug Discovery World

DECEMBER 27, 2023

There have been some ground-breaking advances in women’s health this week, with new treatments for hot flushes and pregnancy sickness, and a discovery that could aid in development of treatments for secondary breast cancer. The post New DDW Highlights podcast for 27 December 2023 appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 10, 2023

A new class of antidepressants In July 2023, AlzeCure Pharma published the results of a preclinical study supporting the antidepressive effects ACD856, the first in a new class of antidepressants. Treatment for PPD was previously only available as an IV injection given by a health care provider in certain health care facilities.

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Drug Discovery World

AUGUST 14, 2023

Emeritus Professor Ian Frazer, University of Queensland and Director of Microba, has been announced as the Millis Oration keynote speaker for AusBiotech 2023. The title of his presentation will be ‘Navigating the future: Predictions and potential of Australian biotechnology’.

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Drug Discovery World

OCTOBER 11, 2023

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA). More than five million people worldwide suffer from GA, of which more than 40% are legally blind.

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Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. Business updates Pfizer reported second quarter 2023 revenues totalling $12.7 billion, a decrease of $15.0 at CER and business EPS growth of 8.1% Specialty care grew 11.8% Vaccines were up 9.1%

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Drugs.com

DECEMBER 8, 2023

8, 2023 -- The U.S. 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. Casgevy, developed by Vertex.

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Drugs.com

DECEMBER 8, 2023

8, 2023 -- The U.S. 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.

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Drugs.com

JULY 24, 2023

MONDAY, July 24, 2023 -- The U.S. 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). Ycanth uses a.

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Drug Discovery World

SEPTEMBER 14, 2023

6,7 “For patients with advanced UC, including FGFR-driven tumours, outcomes remain poor and treatment options are limited; therefore, there is a need for novel, targeted therapies,” said Martin Vogel, EMEA Therapeutic Area Lead Oncology, Janssen-Cilag GmbH. “We Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.

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Drug Discovery World

AUGUST 9, 2023

The new acquisition gives Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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Drugs.com

JUNE 14, 2023

WEDNESDAY, June 14, 2023 -- The U.S. 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.

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Drug Discovery World

MARCH 16, 2023

Overcoming Resistance to FLT3 Inhibitors in the Treatment of FLT3-Mutated AML. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome. and Leung, A. International Journal of Molecular Science, 21(4): 1537. and Wang, H-G.

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Drug Discovery World

MARCH 18, 2024

The US Food and Drug Administration (FDA) has granted orphan drug and paediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in paediatric patients. Paediatric exclusivity extends that period by another six months.

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Drug Discovery World

SEPTEMBER 12, 2024

Childhood cancers often have a different biology than those in adults, yet targeted treatment options are mostly based on adult therapies. In contrast, 14 new cancer medicines for adults received FDA approval in 2023 alone. The current pipeline of potential new medicines being developed for childhood cancers is sparse.

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Drugs.com

JUNE 23, 2023

FRIDAY, June 23, 2023 -- The U.S. 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:

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Drugs.com

AUGUST 17, 2023

17, 2023 -- The U.S. 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.

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Drug Discovery World

FEBRUARY 22, 2024

trillion in 2023, according to data analysts GlobalData. The top 20 global biopharmaceutical companies experienced varied year-on-year (YoY) market capitalisation shifts in 2023 amid the macroeconomic headwinds, steep patent cliffs and the commencement of US drug price negotiations under the Inflation Reduction Act (IRA).

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The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. prescribing in August 2023. NYSE: PFE) and OPKO Health Inc. NASDAQ: OPK) announced today that the U.S. NGENLA is expected to become available for U.S.

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Drugs.com

JUNE 23, 2023

FRIDAY, June 23, 2023 -- The U.S. 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:

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Drugs.com

JULY 28, 2023

FRIDAY, July 28, 2023 -- The U.S. 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.

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Drugs.com

AUGUST 3, 2023

3, 2023 -- The U.S. 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. We know naloxone is a powerful tool to.

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Drug Discovery World

MAY 1, 2024

Many of the best-selling drugs in 2023 were monoclonal antibody (mAB) therapies, including Keytruda (pembrolizumab), Humira (adalimumab), and Dupixent (dupilumab) 1. This won’t come as a surprise when you look at industry milestones achieved in 2023 and looking ahead, this shows no signs of slowing down.

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Drugs.com

AUGUST 9, 2023

9, 2023 -- The U.S. Food and Drug Administration has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration. The approval was based on two. WEDNESDAY, Aug.

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Drugs.com

JULY 18, 2023

TUESDAY, July 18, 2023 -- People living with the pain, bloody diarrhea and sometimes urgent need to use the toilet that comes with ulcerative colitis may soon have a new treatment option that’s already been given the go-ahead in Europe.

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata.

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Drug Discovery World

NOVEMBER 14, 2023

billion by 2031, growing at a CAGR of 7% from 2022 to 2031 2 , but is also reflected in data by The Antibody Society, which shows that of the over 100 approved mAbs, around 40% are for cancer 3. Earlier in 2023, a mAb to prevent Covid-19 in vulnerable patients, AZD3152, entered clinical trials less than 12 months after its discovery.

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Drug Discovery World

JUNE 1, 2023

According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1. A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2.

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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. By contrast, in 2023, the number of recommendations for approval was over three times the number of negative outcomes.

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The Pharma Data

MARCH 22, 2023

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Head of North America.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. million treatment courses of PAXLOVID have been prescribed in the U.S. “Today marks a monumental milestone as PAXLOVID became the first COVID-19 oral treatment to be approved by the U.S.

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Drug Discovery World

MARCH 12, 2024

Advancements in antibody-drug conjugates are also expected, enhancing targeted delivery for cancer treatments.” Carole Nicco, CSO, BioSenic “mAb immunotherapy is the most widely used approach and has achieved tremendous success. Other ACTs such as TIL, TCR, NK cell, Treg, and MDSC therapies are now emerging.

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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B. Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas.

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Drug Discovery World

FEBRUARY 3, 2023

The US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat) for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) approved in the US.

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Drug Discovery World

MARCH 1, 2024

Approval was withdrawn as the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and Pepaxto has not been proved to be safe or effective under its conditions of use. The FDA has now suspended enrolment in all ongoing Pepaxto clinical trials.

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Drug Discovery World

APRIL 10, 2023

Beckley Psytech has initiated a Phase IIa study investigating its lead candidate, BPL-003, as a potential treatment for alcohol use disorder (AUD). BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

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