The Pharma Data

NOVEMBER 24, 2020

25, 2020 /CNW/ – On August 21, 2020 , Health Canada approved Lynparza® (olaparib), for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent (NHA).

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Drug Target Review

SEPTEMBER 4, 2023

7,9 Dihydrofolate reductase-thymidylate synthase (DHFR) have been successfully exploited for the therapy of bacterial infections and other parasitic diseases such as malaria. 2018): Ubiquitin Proteasome pathway proteins as potential drug targets in parasite Trypanosoma cruzi, Scientific Reports. (8):8399. link] Ojewale Kayode (2018).

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The Pharma Data

SEPTEMBER 9, 2020

CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment. The announcement was made during the virtual European Society of Minimally Invasive Neurological Therapy (ESMINT). Stroke Research and Treatment, Hindawi, 27 Nov.

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Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. He said: “This will discuss priorities in the clinical development of drugs for children, in particular in areas of unmet medical need, and coordinate studies relating to paediatric treatments.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Sponsors should plan to justify the inclusion of a psychotherapy component.”

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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Drug Discovery World

APRIL 30, 2024

Reece Armstrong explores the potential and future opportunities for mRNA-based therapies. For instance, consider how at the end of 2018, the mRNA therapies market was valued at $3.43 We can see this versatility in the various treatments that are currently being researched.

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Drug Target Review

APRIL 3, 2024

Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy. Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.

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Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

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The Pharma Data

JUNE 18, 2021

“The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment,” said Mohamed Zaki , M.D., vice president and head, global oncology development, AbbVie.

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The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Both treatments were administered subcutaneously at week 0, 2, and 4.

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The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. I work on a rare disease called primary mitochondrial myopathy, for which there is currently no approved treatment.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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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. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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The Pharma Data

OCTOBER 26, 2020

On 14 May 2018, the Company announced a collaboration with GlobalCo to work on its CDX antibody. ” Market Abuse Regulation (MAR) Disclosure. This additional extension of the collaboration will allow us to choose the best CDX antibody for pre-clinical and clinical development.” [link]. .

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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The Pharma Data

MARCH 23, 2022

In fact, antiviral therapies designed to treat viruses such as hepatitis C (Sofosbuvir/SOVALDI) work by blocking viral polymerase. Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase.

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The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

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Agency IQ

JULY 21, 2023

As for the second challenge, potential confounders present at the time of treatment initiation can be controlled for using randomization, but it may be more difficult for sponsors to detect and adjust for factors that arise after the investigational product’s administration (e.g., years before they would have been available otherwise.

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The Pharma Data

NOVEMBER 8, 2020

Following the data releases in 2018 and 2019, this will be the third time that Ascentage Pharma has presented updated clinical data of HQP1351 at the ASH Annual Meeting. HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. Qian Jiang , M.D.,

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The Pharma Data

OCTOBER 15, 2020

It demonstrates that flexible Blue Light Cystoscopy helped resolve a substantial amount of cases by complete removal on-site or direct referral to intravesical treatment, providing increased efficacy to manage non-muscle-invasive bladder cancer (NMIBC) in the office setting. OSLO, Norway , Oct. Here is a link to the poster.

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The Pharma Data

NOVEMBER 9, 2020

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. Psychedelic compounds are emerging as a new class of drug with potential for significant impact in the treatment of mental health related medical indications such as depression, anxiety, addiction, anorexia and post-traumatic stress disorder.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . 10% of patients 1,3. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

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The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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The Pharma Data

NOVEMBER 10, 2020

We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. Grand View Research August 2018 ( [link] ). Cited References: 1.

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The Pharma Data

NOVEMBER 2, 2020

If approved, 1st Therapy in U.S. for the Treatment of Achondroplasia. This acceptance by the FDA marks the first marketing application accepted for a treatment for achondroplasia in the United States. The study will be followed by a subsequent open-label extension trial when all subjects receive active treatment.

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The Pharma Data

APRIL 28, 2021

Food and Drug Administration (FDA) and for SKYRIZI ® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis. “We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.” cough.

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Agency IQ

JULY 7, 2023

regulators have previously discussed , using RWE “for regulatory decision-making is already a reality, and there is increasing interest in using big data and advanced analytics as a complementary source of evidence.” Regulators have been investing in ways to understand better how RWE can be used and how RWD is generated.

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The Pharma Data

JANUARY 13, 2021

Dr. Lederman continued, “Despite the recognized promise of anti-CD40-ligand mAb therapy, first generation anti-CD40-ligand mAbs were limited because their crystallizable fragment (Fc) domain interacted with a cell surface receptor called Fc?RII, RII, which resulted in an increased risk of thrombosis. 1 Lederman, S. 1 Lederman, S.

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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The Pharma Data

JUNE 18, 2021

In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group). NORTH CHICAGO, Ill. percent and 4.5 percent and 3.4

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Codon

JANUARY 21, 2024

yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Scientists studied black men infected with syphilis for several decades while withholding known treatments. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.”

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Drug Discovery World

AUGUST 24, 2023

Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken. For instance, though psilocybin remains illegal in Maryland, The Johns Hopkins Center for Psychedelic and Consciousness Research continues to explore innovative treatments using psilocybin and its potential for mental illnesses 3.

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