National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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Drug Discovery Today

AUGUST 16, 2021

Manchester, UK, August 11, 2021: Monument Therapeutics, a stratified medicine company, today announced Monument Therapeutics the appointment of Dr Julian Gilbert to its Board as a Non-Executive Director.

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The Pharma Data

AUGUST 7, 2021

In June 2021, Wegovy , semaglutide 2.4 For the 2021 outlook, sales growth is now expected to be 10-13% at CER (previously 6-10%), and operating profit growth is now expected to be 9-12% at CER (previously 5-9%). ?? Lars Fruergaard Jørgensen, president and CEO: “We are pleased with the sales growth in the first half of 2021.

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International Treatment FDA Therapies 52

Eye on FDA

JANUARY 9, 2022

In that respect, 2021 was not a banner year. Digital and social media are a primary resource for getting healthcare information and discussing treatment, especially now in the age of COVID. The Numbers: Looking first at the quantity of enforcement, the numbers were low. This year there were 5 regulatory action letters issued by OPDP.

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FDA Pharma Companies Pharmaceutical Companies Treatment 64

Drug Target Review

SEPTEMBER 21, 2023

The findings supported the possibility put forward by Cotton et al (2016) concerning the chance of repurposing these drugs for adulticidal treatment. The available treatment for that is minor surgery -to remove the nodules. With accessible and effective treatments, this is feasible. doi: 10.1002/14651858.CD011146.pub2.

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Drugs Treatment Disease Research 105

The Pharma Data

JULY 6, 2021

Sanofi highlights scientific innovations in the field of rare blood disorders at I STH 2021. At ISTH, we are sharing data across all our innovative approaches and collectively, the data reinforce how our pipeline and portfolio may unlock new possibilities in the treatment of rare blood disorders.”. ePoster Abstract # OC48.2

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al. Abstract 744.

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Pharmacokinetics Clinical Trials Trials Treatment 52

Drug Channels

NOVEMBER 19, 2021

Carolyn describes how oncology pathways were developed to help standardize treatment and ensure quality care. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. She argues, however, that these pathways often shut manufacturers out of the market. Read on for Carolyn’s insights. d/b/a Drug Channels Institute.

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Treatment Marketing Drugs 98

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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International Disease Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 29, 2021

Presentations: 535P, 536P, 534P, 104P, 1534P, 444P, 630P, LBA26, 623P, 603P, 593P, 594P, 1309P, 606P, 590P, 826O, 530P, LBA58, 1520O, 48P, 508TiP, 505TiP, 509TiP, 1438TiP Bayer will present new data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.

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Research Clinical Trials Therapies Trials 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

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Treatment FDA Approval Pharmacokinetics FDA 52

Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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Treatment Therapies Clinical Development Cell Biology 98

Drug Target Review

DECEMBER 16, 2024

Despite challenges as a woman in the field, Dr Hingorani built a career focused on advancing treatments for pediatric and adult cancers. Despite the progress we are making in curing children with cancer, there remains an unmet need for new treatments that are more effective and safer.

Medical Schools 52

Medical Schools Clinical Research Drug Development Trials 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 55. Complaint ¶ 58. Complaint ¶ 59.

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Pharmacy Government Treatment Compliance 139

Common Sense for Drug Policy Blog

OCTOBER 7, 2023

Given that the median duration of prison stay was only 16 days, excess risk of infection-related hospitalization after release may also reflect people seeking treatment outside prison for infections that initially developed before or during incarceration ( Lloyd et al., 2012 ; Joudrey et al., 2019 ; Treloar et al., times the risk, 95% CI 1.22-1.72)

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Hospitals Treatment International Drugs 52

The Pharma Data

JULY 25, 2021

Allergan, an AbbVie company, today announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Most side effects were mild and transient in nature with only 1.2%

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Treatment Production Disease FDA 52

The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Drug Target Review

SEPTEMBER 25, 2024

4 Another related and well described non-oncogene resistance mechanism is the histological transformation of EGFR-mutated non-small cell lung cancer (NSCLC) to small-cell lung cancer upon treatment with an EGFR inhibitor. Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment.

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Small Molecule Therapies Regulations Treatment 105

The Pharma Data

APRIL 4, 2022

The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., If approved, Actemra/RoActemra would be the first U.S. Roche also partnered with Gilead Sciences, Inc.,

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Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

NOVEMBER 11, 2021

Wegovy was launched in the US in June 2021 following approval by the U.S. In September 2021, Wegovy was approved by the UK Medicines and Health products Regulations Agency (MHRA). mg injection is approved for the treatment of adults with obesity or overweight in the US and UK, as an adjunct to diet and exercise.

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Treatment Disease Clinical Trials Trials 52

The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Robinson , M.D., Linked to ASCRS program. . Presentation Details.

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Treatment Doctors Production FDA Approval 52

KIF1A

OCTOBER 14, 2023

The 2021 Natural History Study found that about 20% of KAND patients experience cerebral visual impairment , but the incidence is likely higher. Understanding how these symptoms cluster may inform clinicians as they perform additional testing or recruit additional experts in the treatment of patients with cerebral visual impairment.

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Disease Treatment Research Production 105

Chemical Biology and Drug Design

OCTOBER 2, 2023

Abstract Despite the successful reduction in the malaria health burden in recent years, it continues to remain a significant global health problem mainly because of the emerging resistance to first-line treatments.

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The Pharma Data

SEPTEMBER 27, 2021

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe regional enteritis. Topline results of the studies were shared in January 2021, and extra analyses were presented at Digestive Disease Week® (DDW) Virtual Conference 2021.

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Treatment FDA Therapies Disease 52

SugarCone Biotech

MARCH 24, 2025

Other mechanisms that cancer cells use to escape from TCE treatment are less expected. This provides ample flexibility to optimize the treatment modality to attack specific cancers. doi: 10.1136/jitc-2021-004348 6. CD58 is a protein that interacts with the CD2 protein that is expressed on T cells to upregulate T cell activation.

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Immune Response Therapies Treatment Disease 67

The Pharma Data

NOVEMBER 18, 2021

Eli Lilly and Company blazoned that registration is now open for the CHALLENGE-MIG clinical trial, the first and only head-to- head trial comparing twoanti-calcitonin gene- related peptide (CGRP) drugs for the preventative treatment of episodic migraine in grown-ups.1 gepants) may help people achieve the pretensions that count most to them.

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The Pharma Data

AUGUST 27, 2020

The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. There is hope that Moderna’s vaccine could be available by early 2021. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. Conor Kavanagh. Source link.

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Vaccine Immune Response Clinical Trials Virus 90

Drug Patent Watch

DECEMBER 10, 2024

This growth is driven by the increasing demand for affordable biologic treatments and the loss of patent exclusivity for several blockbuster biologics. link] What Are Biosimilars, and How Do They Expand Treatment Options for Patients? link] An inflection point for biosimilars. link] Biosimilars advancements: Moving on to the future.

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Drug Channels

NOVEMBER 5, 2021

To learn more about the risk-based care approach, download the free whitepaper: Risk-Based Care Helps Cancer Treatment Adherence. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. Read on for Ashleigh’s insights. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Specialty Pharmacies Pharmacy Treatment Drugs 75

The Pharma Data

NOVEMBER 17, 2021

They also identified potential targeted treatments based on the findings, as reported in Science Advances in November. Patient similarity network of newly diagnosed multiple myeloma identifies patient subgroups with distinct genetic features and clinical implications, Science Advances, 2021. doi: 10.1126/sciadv.abg9551.

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Treatment RNA DNA Science 52

KIF1A

MARCH 16, 2024

Whole genome sequencing can identify additional mutations that aren’t included on CMT panels, providing patients with a more accurate diagnosis to find resources and treatments. billion people were affected by neurological disorders in 2021, making them a leading cause of disability worldwide.

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Disease Clinical Development Research Treatment 105

New Drug Approvals

APRIL 25, 2025

8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. Combining inavolisib with palbociclib and fulvestrant might improve treatment of breast cancer. [14] Vanhaesebroeck B, Perry MW, Brown JR, Andr F, Okkenhaug K (October 2021). 22 June 2021.

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FDA FDA Approval Therapies Trials 57

The Pharma Data

AUGUST 7, 2021

Food and Drug Administration (FDA) has approved Nexviazyme® (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder that impairs a person’s ability to move and breathe. Sanofi also filed avalglucosidase alfa in Japan in January 2021.

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FDA Approval Disease FDA Treatment 52

The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Vaccine Therapies Immune Response Disease 52

New Drug Approvals

MAY 8, 2025

1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] 7] [12] In the European Union, pirtobrutinib is indicated for the treatment of mantle cell lymphoma. [2] 27 January 2023.

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FDA Approval FDA Therapies Trials 52

The Pharma Data

NOVEMBER 29, 2021

Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, would be the first TYK2 inhibitor approved for the treatment of any disease. Bristol Myers Squibb moment blazoned that theU.S. The FDA has assigned a Tradition Medicine Stoner Figure Act (PDUFA) thing date of September 10, 2022.

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