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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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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Eye on FDA

AUGUST 4, 2021

Each committee is comprised of a number of experts, diverse for their expertise, geography and specialty – with some focused on statistics while others may be focused on areas of concentration within the category, such as the treatment of pediatric patients. Fewer meetings – more approvals. That gets us to the issue of vacancies.

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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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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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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. For instance, in 2021, the U.S.

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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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Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. His mother had a presentation of the disease that suggested her immune system was already on the job.

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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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SCIENMAG: Medicine & Health

AUGUST 14, 2023

According to data from Statistics Korea, cancer accounted for the majority of deaths in Korea in 2021, constituting 26% of all recorded cases. 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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International Treatment 77

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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Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. Ultimately, flexibility in dual-payload ADC development means better treatments could reach patients sooner. Biomaterials 273 , 120817 (2021).

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Drugs.com

JULY 18, 2023

TUESDAY, July 18, 2023 -- While nursing home residents are at high risk for bad outcomes if they get COVID-19, use of antiviral treatments, such as monoclonal antibodies, was low through most of 2021 and 2022. The authors of a new study, led by.

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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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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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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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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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Broad Institute

MARCH 20, 2024

In 2021, we reported the discovery of a network of immune cells in colorectal cancer. By Broad and Mass General Communications March 20, 2024 Credit: Chen JH et al. Nature Immunology. doi: 10.1038/s41590-024-01792-2 (2024) Scientists used a microscope to visualize an immunity hub (yellow and green) in human lung tumor tissue (blue).

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The Pharma Data

MARCH 28, 2022

Kerendia ™ (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis. Finerenone is different to existing CKD in T2D treatments. In Japan, an estimated 13.3

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The Pharma Data

MARCH 29, 2022

Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer. Food and Drug Administration approved Opdivo in combination with chemotherapy for the treatment of adult patients with resectable (tumors ? CT, in New Orleans, Louisiana. Based on the results of CheckMate -816, the U.S.

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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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The Pharma Data

MARCH 9, 2022

The most common treatment-emergent adverse events (>5% of participants overall) were headache, arthralgia, fall, and back pain. Dietmar Berger, MD, PhD Global Head of Development and Chief Medical Officer , Sanofi “While advances have been made in the treatment of hemophilia, unmet medical needs still exist.

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Science Daily: Pharmacology News

JUNE 20, 2023

New research analyzed data from 11 studies of over 5,000 women around the world between 1980 and 2021, to evaluate how common it is to get pregnant naturally after having a baby conceived by fertility treatment.

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Treatment Research 66

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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DrugBank

AUGUST 9, 2024

reported in 2021. However, searching for broader applicability and personalized approaches continues, as not all patients respond to these treatments. In 2021, an estimated 537 million adults were living with diabetes, a number projected to reach 643 million by 2030. billion in 2021, is projected to reach 231.7

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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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Drug Target Review

JULY 7, 2023

In pregnant individuals, maternal autoantibodies can even attack the organs and tissues of the foetus, 1-9 Many of these diseases are rare, with no safe, targeted, advanced and effective treatment options approved for patients in need. 16,17 There are currently no approved therapeutics for the treatment of HDFN.

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PLOS: DNA Science

MARCH 21, 2024

million price tag for the one-time infusion, and for the older siblings who contributed to developing the gene treatment, but were too sick to receive it. The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. million, a lot less than the MLD treatment.

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FDA Law Blog: Drug Discovery

SEPTEMBER 10, 2023

This finalized a draft guidance issued in December 2021, largely similar in substance. Even though the draft guidance was issued in 2021 after the onset of the COVID-19 pandemic, the Agency’s thinking now appears to be more reflective of this recent experience. Non-interventional studies thus do not require an IND.

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Eye on FDA

AUGUST 27, 2023

there has been a significant uptick – more in fact than any other previous mid-year check-in with the exception of 2021. There are still many decisions and publicly available PDUFA dates with many novel treatments among them, including investigative treatments for sickle cell disease and ALS.

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Common Sense for Drug Policy Blog

DECEMBER 20, 2023

This number decreased to 305 by 2019 and again to 296 by the end of 2021. These data indicate a 3% decrease in JDCs between 2019 and 2021. Overall, between 2014 and 2021, the number of JDCs in the United States decreased by 30%." Data Digest Issue 2: Treatment Court Counts.

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Eye on FDA

APRIL 13, 2022

The medicine that was the subject of these communications was DUOBRII (halobetasol propionate and tazarotene) a topical lotion indicated for the treatment of plaque psoriasis in adults. Also of note, the treatment of pain, in particular migraine, was the subject of 3 of these 11 letters. There are a couple of things of note.

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Broad Institute

JUNE 10, 2024

In 2021, Liu’s lab reported a key step towards this goal and developed a prime editing approach called twinPE that installed recombinase “landing sites” in the genome, and then used natural recombinase enzymes such as Bxb1 to catalyze the insertion of new DNA into the prime edited target sites.

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National Institute on Drug Abuse: Nora's Blog

OCTOBER 6, 2023

According to a 2021 survey from the Substance Abuse and Mental Health Services Administration, about one in five of all full-time employed adults in the US reported having a substance use disorder. Stigma against people with substance use disorders can keep them from seeking treatment.

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Broad Institute

MAY 2, 2024

She aims to better understand how cancers evolve during treatment and throughout a patient’s lifetime. In 2021, Martin competed in the US Olympic trials in a lightweight double, and won the world-renowned Head of the Charles regatta in lightweight single sculls. Tell us a bit about your research.

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New Drug Approvals

SEPTEMBER 29, 2024

Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). Gingipains also were reported to degrade ApoE, and 28 days of treatment with COR388 was claimed to reduce CSF ApoE fragments ( 2020 AAIC abstract ). gingivalis DNA and gingipains in CSF, blood, and saliva, before and after treatment. 2017 ; Ilievski et al.,

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