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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The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. Novartis moment blazoned that a Phase II study of investigational iptacopan (LNP023) – a first-in- class, oral, picky factor B asset – in cases with C3 glomerulopathy (C3G) met primary endpoints in both patient cohorts1.

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Drug Target Review

SEPTEMBER 25, 2024

Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment. Several patients have experienced disease stabilisation, and one NSCLC patient showed a confirmed partial response. 2021 Oct 11 [cited 2024 Sep 4];13(20):5081. 2021 Apr [cited 2024 Sep 4];2(4):377–91.

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The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. was approved by the European Commission in February 2021. 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. About LIBRETTO-001.

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Drug Discovery World

OCTOBER 13, 2022

Not to mention, this year’s meeting was double the size of Drug Discovery 2021. . Drug Discovery 2022 also saw its largest non-UK attendance, with 25% of delegates travelling from abroad to attend the show. Presentations .

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products. billion per year 3.

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The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. About Inozyme Pharma.

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The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In June 2021, Lilly announced the U.S. vice president of pain and neurodegeneration, Lilly.

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The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 The US FDA granted Fast Track Designation in February 2021.

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The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. controlled trial had not received previous systemic therapy for metastatic disease. © 2021 Regulatory Affairs Professionals Society.

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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. 4] , [5] , [6]. months (range, 1.6–9.9).

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Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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The Pharma Data

JANUARY 3, 2021

The topline data from the trial is expected to be available in January 2021. Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. The pharmacokinetics of nasally administered Foralumab will also be evaluated.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

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Agency IQ

DECEMBER 1, 2023

About one year after its initial publication, FDA updated the guidance in February 2021. However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. Like the first version, the updated guidance was issued as direct-to-final.

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Drug Discovery World

FEBRUARY 20, 2023

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022. The post What are the top disease areas for clinical drug trials?

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The Pharma Data

DECEMBER 28, 2020

NASH, which is a severe form of non-alcoholic fatty liver disease affects approximately 17 million people in the U.S. The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. and is a leading cause of liver transplantation.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

MARCH 16, 2021

These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021. PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Editor’s Note: a.

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The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

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The Pharma Data

JULY 11, 2021

years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5

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The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). Kenilworth, N.J.,

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The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. This seemed likely until the FDA pushed back the ide-cel review.

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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. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., Cortexyme’s approach is based on the theory that P.

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The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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The Pharma Data

JULY 23, 2021

We also continue to identify, develop and support potential therapies which can play a role in treating the disease. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations. The impact of COVID-19 goes beyond those who contract it.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S., The full U.S.

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The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Gallen will be published in a supplement issue of The Breast, available on March 17, 2021. Available on-demand on March 10, 2021.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. The Phase 2b trial is expected to begin during the second half of 2021. Summary of New PXL770 Phase 2a Study Results.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity. billion for pseudoephedrine. “We

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The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. We are also expanding our odronextamab program with multiple pivotal trials in 2021.” Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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The Pharma Data

OCTOBER 27, 2020

INCREASE sNDA under FDA review with April 2021 action date; Remunity launch preparations continue. Tyvaso in pulmonary hypertension due to interstitial lung disease (PH-ILD). In August 2020 , the FDA accepted the sNDA for review, which we expect will be complete in April 2021. SILVER SPRING, Md. SILVER SPRING, Md.

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The Pharma Data

APRIL 14, 2021

This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Food and Drug Administration. patients who recovered from COVID-19.

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