Broad Institute

OCTOBER 3, 2024

Largest-ever genetic study of epilepsy finds possible therapeutic targets By Ari Navetta October 3, 2024 Breadcrumb Home Largest-ever genetic study of epilepsy finds possible therapeutic targets Scientists have uncovered new genetic links to different types of epilepsy, which could lead to more tailored treatments.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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Common Sense for Drug Policy Blog

OCTOBER 7, 2023

2014 ; Joudrey et al., 2014 ; Joudrey et al., 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., 2023.104218.

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Drug Target Review

AUGUST 29, 2024

However, these treatments will eventually fail for the majority of patients, so there is a strong need for better CAR therapies. How might the CD5 knockout approach impact the treatment of other types of cancers beyond T-cell lymphoma?

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The Pharma Data

JUNE 18, 2025

By combining Neoclease’s AI-designed gene-editing platform with our technologies, regulatory expertise, and process support, we aim to help accelerate new treatments that minimize side effects and maximize effectiveness for patients.”

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The Pharma Data

JUNE 18, 2025

This leadership transition arrives at a pivotal moment in Alnylam’s evolution, as the company builds upon the recent commercial success of AMVUTTRA® (vutrisiran) —a landmark treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

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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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FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Drug Target Review

JANUARY 8, 2024

Our lead program utilises OSK for the treatment of age-related optic neuropathies. acquired by Teva Pharmaceuticals in 2014. What evidence is there that we can reverse aging with drugs? Before that, he served as president and CEO of AgeneBio, Inc.,

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Drug Target Review

OCTOBER 17, 2023

To improve its treatment, early diagnosis and appropriate therapeutic strategies are very important. Metabolic changes such as increased arginine levels could serve as biomarkers for detecting cancer at an early stage, which is essential for successful cancer treatment and patient survival. This research was published in Cell.

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Common Sense for Drug Policy Blog

DECEMBER 20, 2023

Juvenile Drug Courts "As shown in Figure 13, a total of 420 JDCs were operating across the United States in 2014. Overall, between 2014 and 2021, the number of JDCs in the United States decreased by 30%." Data Digest Issue 2: Treatment Court Counts. This number decreased to 305 by 2019 and again to 296 by the end of 2021.

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Drug Patent Watch

JANUARY 14, 2025

The stakes are higher than ever, with billions of dollars and potentially life-saving treatments on the line. The collapsed talks between Pfizer and AstraZeneca in 2014 highlight the need for flexibility, realistic valuations, and a deep understanding of regulatory hurdles in cross-border deals.

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Drug Target Review

NOVEMBER 17, 2023

Only three of the CAR-NK studies were for the treatment of solid tumours. By themselves, the NK cells showed limited efficacy, but anti-tumour efficacy was observed with co-treatment regimens (eg, monoclonal antibodies, haematopoietic stem cell transplants, whole body irradiation) and multiple dosing (tolerated well by patients).

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New Drug Approvals

JUNE 25, 2025

Consequently, a GK activator may provide therapeutic treatment for NIDDM and associated complications, inter alia, hyperglycemia, dyslipidemia, insulin resistance syndrome, hyperinsulinemia, hypertension, and obesity. Frequent use of these drugs may lead to weight gain and may induce edema and anemia. (E) For example, U.S.

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The Pharma Data

JUNE 24, 2025

We look forward to this strategic alliance continuing to expand the frontiers of cutting-edge science and translating groundbreaking discoveries into transformative treatments for patients.” Since 2009, Bayer has actively cultivated academic partnerships with major Chinese institutions, including Peking University (since 2014).

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The Pharma Data

DECEMBER 30, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine.

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Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Prior to the founding of IN8bio, from 2014 to 2017, Mr Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Mr Ho has worked in the biotechnology industry for almost 20 years.

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Therapies Engineering Molecular Biology Science 105

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

As a second and more challenging test, the researchers reconfigured the BOC by placing a multi-drug resistant vulva cancer cell line in one chamber and, in another, a breast cancer cell line that responded to drug treatment. Both tamoxifen alone and the combination treatment showed some off-target effects on heart cells.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020 — For colon cancer patients, Medicaid expansion is associated with earlier diagnosis, enhanced access to treatment, and improved surgical care, according to a study published online Nov. Patients in nonexpansion states were compared to those in expansion states in January 2014. MONDAY, Nov. Hoehn, M.D., © 2020 HealthDay.

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Eye on FDA

JUNE 14, 2023

The numbers plummet in 2014 until the record low last year of only 4 letters. The latest letter was issued for a website that promoted a treatment for hypercortisolemia in patients with Cushings Disease. That is the record high for a single year since that time and means that they were coming out a rate of over 12 a month on average.

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The Pharma Data

AUGUST 12, 2020

The first trial compared Opdivo combined with chemotherapy to chemotherapy alone as a treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma. Opdivo was first approved for use in July 2014, and is now approved in more than 65 countries. Conor Kavanagh. Source link.

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Clinical Trials Trials Therapies Treatment 52

Drug Target Review

APRIL 3, 2024

This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

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The Pharma Data

SEPTEMBER 23, 2020

Avigan has been approved in Japan since 2014 as a treatment for influenza in emergency cases, and generic versions of the therapy are already available. The company said it aims to submit a regulatory filing as early as October, following an additional analysis of the data, with approval possible within a month. Matt Fellows.

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The Pharma Data

AUGUST 1, 2021

Takeda Pharmaceutical Company Limited today announced the receipt of a decision by the Irish Tax Appeals Commission on July 30, 2021 (IST) to uphold the Irish Revenue Commissioners’ position related to the treatment of a break fee received by Shire plc (“Shire”) in October 2014 from AbbVie Inc.

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The Pharma Data

DECEMBER 15, 2020

from the Oregon Health & Science University in Portland, and colleagues updated the 2014 HBV screening review in nonpregnant adolescents and adults. Antiviral therapy compared with placebo or no treatment was associated with an increased likelihood of achieving intermediate outcomes based on 18 trials. Roger Chou, M.D., Editorial.

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New Drug Approvals

AUGUST 21, 2023

5] Medical uses Palovarotene is indicated for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. [4] 19] In January 2023, the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for palovarotene for the treatment of fibrodysplasia ossificans progressiva. [20]

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New Drug Approvals

SEPTEMBER 13, 2024

2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7] 2] Aticaprant is taken by mouth. [1] nM vs. 24.0 13] [14] Occupancy was 35% for a 0.5 nM vs. 24.0

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The Pharma Data

NOVEMBER 10, 2020

from Harvard Medical School in Boston, and colleagues developed machine learning models to predict antibiotic susceptibility using electronic health record data and built a decision algorithm for recommending the narrowest possible antibiotic to which a specimen is susceptible for the treatment of uncomplicated UTI. Sanjat Kanjilal, M.D.,

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Medical Schools Science Therapies Trials 52

The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). 1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (A?) Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?)

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The Pharma Data

JUNE 28, 2021

mg, 5 mg, and 10 mg is approved for the treatment of patients with chronic heart failure who are receiving standard treatment for chronic heart failure. Vericiguat is the first sGC stimulator to be approved for the treatment of chronic heart failure. Verquvo (vericiguat) 2.5 in the U.S.

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The Pharma Data

OCTOBER 27, 2021

Kymriah was preliminarily granted orphan medicinal product designation by the European Commission (EC) forFL.However, Kymriah would have the occasion to present an important treatment option for those cases with r/ r FL in need of potentially definitive issues, If approved in this implicit third suggestion.

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FDA Treatment Trials FDA Approval 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] It is taken by mouth. [1] 11] SYN ACS Med. 11] SYN ACS Med. 11] SYN ACS Med.

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The Pharma Data

JULY 22, 2021

Researchers in the field of parasitology celebrated for contributions early in their scientific careers Together with scientific publisher Parasites & Vector, Boehringer Ingelheim has sponsored the award since its founding in 2014 Award serves to foster career growth in parasitology as well as keep memory of parasitologist Odile Bain alive.

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Research Disease Science Treatment 52

Common Sense for Drug Policy Blog

JANUARY 1, 2024

Multiplying the lifetime costs of HIV treatment per person ($229,800) 25 by the average number of diagnoses averted annually in both cities yields an estimated annual saving of $243.4 million in 2014, 13 allowing for greater coverage of injection events and more opportunities for disease prevention. "By million for Baltimore.

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The Pharma Data

APRIL 27, 2023

We are encouraged by the CHMP’s positive recommendation, which puts us one step closer to offering patients in the EU a first-in-class treatment for obstructive HCM, and reinforces our commitment to delivering transformative cardiovascular therapies to patients worldwide.”

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The Pharma Data

MARCH 3, 2022

There is no current oral treatment for this disease. In 2014, Shalev’s UAB research lab reported that verapamil completely reversed diabetes in animal models, and she announced plans to test the effects of the drug in a human clinical trial. director of the Comprehensive Diabetes Center at the University of Alabama at Birmingham.

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RNA Treatment Disease Regulations 52

The Premier Consulting Blog

OCTOBER 21, 2024

The FDA’s 2014 guidance for the industry titled Expedited Programs for Serious Conditions highlights the importance of addressing serious conditions and unmet medical needs. Recent case studies Ocaliva® (Obeticholic Acid) : This drug received an initial accelerated approval on May 27, 2016, for the treatment of primary biliary cholangitis.

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