Eye on FDA

FEBRUARY 10, 2021

Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. The collection of letters issued by OPDP during 2020 can be found here. We instead see the same pace as we have the past several years – that is anemic levels of enforcement.

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Drug Target Review

OCTOBER 30, 2024

8 With the widespread use of induced pluripotent stem cells (iPSCs), organoids can now be generated from the skin or blood cells of both healthy volunteers and disease patients, opening the door to studying various diseases and creating individually customised potential treatments. MedComm (2020). 2009;459(7244):262-5. 2023;4(3):e274.

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Drug Discovery Today

APRIL 26, 2020

To mark the 30th Anniversary of World Haemophilia Day, Sobi have released the 2020 Haemophilia Index which examines the quality of life for people with haemophilia in Europe, including the UK and the reach of humanitarian aid across the globe.

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The Pharma Data

NOVEMBER 1, 2020

Vancouver-based Algernon Pharmaceuticals plans to conduct a late-stage study to evaluate an orally delivered drug, NP-120 (ifenprodil), as a COVID-19 treatment. The drug was originally developed in the 1990s by Sanofi to treat peripheral circulatory disorders and it is still used in generic form in Japan.

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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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SCIENMAG: Medicine & Health

JULY 5, 2023

But a study published by The BMJ today finds that less than half of approved first indications for new drugs in the US and Europe between 2011 and 2020 add substantial therapeutic value over existing treatments […]

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The Pharma Data

NOVEMBER 9, 2020

DAEGU, KOREA, November 09, 2020 /24-7PressRelease/ — South Korean religious group Shincheonji Church of Jesus has announced their third convalescent plasma donation drive to take place for 3 weeks starting November 16th at an Indoor Athletics Center in Daegu. Approximately 4,000 members of the group are expected to participate.

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Eye on FDA

MARCH 5, 2023

By contrast, already in 2023 there have been eight AdComm meetings scheduled by FDA for the purpose of considering a new medical treatment, three of which have occurred and all resulting in votes in favor of the sponsor, so perhaps 2023 is heading to less negative territory. There are a lot of variables that factor in.

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Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.

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Broad Institute

JUNE 18, 2024

By Allessandra DiCorato June 18, 2024 Credit: Jon Arizti-Sanz SHINE, a rapid diagnostic test developed by Pardis Sabeti's lab in 2020, uses paper strips and CRISPR enzymes to identify specific sequences of viral RNA in samples.

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Common Sense for Drug Policy Blog

NOVEMBER 29, 2023

Receipt of Opioid Use Disorder Treatments Prior to Fatal Overdoses and Comparison to No Treatment "The findings revealed that exposures to MOUD, even if not continued throughout the six-month exposure period was associated with reduced risk of a fatal poisoning compared to non-MOUD forms of treatment and no treatment exposure.

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. Over time, the frequency of resistance gene variants in the population will continue increasing because only the bacteria lacking those variants will die with treatment.

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Drug Target Review

OCTOBER 5, 2023

This innovative approach involves the extraction of a patient’s own stem cells from either their bone marrow or blood , followed by a course of chemotherapy and antibody treatment. The research team identified 231 individuals diagnosed with relapsing-remitting MS, with 174 of them having undergone aHSCT treatment before the year 2020.

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National Drug & Alcohol Research Centre Blog

NOVEMBER 12, 2023

Professor Shane Darke NDARC's Professor Shane Darke discusses the findings of a new study published in Addiction journal, which found that 610 people died from heroin overdose between 2020-22. In order to examine the situation regarding fatal heroin overdose in Australia in the early 2020s, we examined all cases over the period 2020 to 2022.

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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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The Pharma Data

MARCH 9, 2022

Few treatments currently exist for COVID-19 and the ones that do primarily focus solely on preventing the virus from replicating. This new potential treatment inhibits replication but also protects or repairs tissue, which is important because COVID-19 can cause symptoms that affect patients long after the viral infection has been cleared.

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National Institute on Drug Abuse: Nora's Blog

FEBRUARY 8, 2023

Pregnant People With Substance Use Disorders Need Treatment, Not Criminalization mfleming Wed, 02/08/2023 - 15:33 Nora's Blog February 15, 2023 Image ©Getty Images/ Caia Image This blog was also published in STAT on February 8, 2023. People seeking treatment for addictions face additional obstacles, especially if they have children.

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Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options.

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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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The Pharma Data

APRIL 15, 2022

The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. This work was originally reported in 2020 in the journal Science. Just last month, the FDA paused several monoclonal antibody treatments, for example, due to their failure against the BA.2

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NIOSH Science Blog: Drugs

JANUARY 10, 2024

Unintentional overdose from the nonmedical use of drugs resulted in 388 worker deaths in 2020, an increase of nearly 500 percent from 2012. It is now clearer than ever that employers can play a critical role in preventing drug-related deaths and helping workers access treatment and maintain recovery from substance use

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SCIENMAG: Medicine & Health

AUGUST 14, 2023

Similarly, cancer was the primary cause of death in 2020. Among the various types of cancer, lung cancer stands out as the most prevalent, posing significant challenges in terms of treatment due […]

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The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is not indicated for the treatment of patients with severe combined immunodeficiency (SCID). Today, the U.S. Rethymic is the first thymus tissue product approved in the U.S.

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Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. How does SRP-001’s safety profile, especially concerning hepatotoxicity and nephrotoxicity, compare to other common pain medications?

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The Pharma Data

FEBRUARY 22, 2022

Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. “Many people living with major depressive disorder struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment.

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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

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. DURYSTA ® Consumer Indications and Usage and Important Safety Information.

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The Pharma Data

OCTOBER 14, 2021

COBRA study subgroups results presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). There’s historically limited clinical safety data for babies who are breastfed by maters witnessing treatment for MS including during the gestation period. NYSE and TASE TEVA) andSt.

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The Pharma Data

APRIL 7, 2022

It may also limit coverage for any future approved treatment in the class. When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

People with an opioid use disorder (OUD) urgently need treatment not just to protect them from overdosing but also to help them achieve recovery, but highly effective medications like buprenorphine and methadone remain underused. Almost all (99%) of those retained in treatment achieved remission.

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National Institute on Drug Abuse: Nora's Blog

AUGUST 28, 2024

Over the past two decades, substance use treatment admissions have increased among people aged 50 and over. Chronic pain is prevalent among older adults, and treatment for pain is less effective in this age group than it is in younger people; it negatively impacts quality of life and is a risk factor for cognitive decline and premature death.

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Drug Target Review

SEPTEMBER 22, 2023

8 Furthermore, the absence of immune, mesenchymal, or endothelial cells limits the applicability of organoids for the assessment of certain therapies, such as immuno-oncology treatments or drug metabolism studies where more complex models are needed. Elsevier; 2020. 2020 Oct 7;21(10):571–84. 2020 Jun 8;4(9):863–74.

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The Pharma Data

APRIL 26, 2022

This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.

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The Pharma Data

OCTOBER 12, 2021

Positive high- position results from the Paraphernalia Phase III COVID-19 treatment trial showed AstraZeneca’s AZD7442, a long amusement antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo innon-hospitalised cases with mild-to-moderate characteristic COVID-19.

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The Pharma Data

MAY 27, 2022

In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response . to develop and commercialise cilta-cel.[1].

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The Pharma Data

APRIL 27, 2022

ESCC is the most common type of esophageal cancer globally, with an estimated 604,000 new cases and 544,000 deaths from esophageal cancer internationally in 2020. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need.

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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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