The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma.

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The Pharma Data

AUGUST 1, 2021

to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9

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The Pharma Data

AUGUST 3, 2021

Revenue in the second quarter of 2021 increased 23 percent, driven by volume growth of 22 percent. – Revenue from all key products grew in the quarter and 2021 year-to-date. . – Revenue from all key products grew in the quarter and 2021 year-to-date. – 2021 EPS guidance updated to be in the range of $6.73

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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. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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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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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. reported in 2021. However, searching for broader applicability and personalized approaches continues, as not all patients respond to these treatments. billion by 2030.

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The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

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The Pharma Data

SEPTEMBER 29, 2021

Presentations: 535P, 536P, 534P, 104P, 1534P, 444P, 630P, LBA26, 623P, 603P, 593P, 594P, 1309P, 606P, 590P, 826O, 530P, LBA58, 1520O, 48P, 508TiP, 505TiP, 509TiP, 1438TiP Bayer will present new data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.

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The Pharma Data

JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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The Pharma Data

AUGUST 3, 2021

Breakthrough results in the treatment of a type of heart failure, which is extremely difficult to manage Strong progress in mental health pipeline Good business performance in all areas, despite ongoing impact of COVID-19. Our strong R&D pipeline has made further, decisive progress in the first half of 2021.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. The company is set to charge between $32 and $37 per dose.

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The Pharma Data

AUGUST 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. Key results include: Total revenues increased 5% to $6.5 on a non-GAAP basis.

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The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”.

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The Pharma Data

NOVEMBER 23, 2021

Roche moment blazoned that new data from its expansive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021. 2 FL is the most common idle ( slow growing) form ofnon-Hodgkin carcinoma, a type of blood cancer, which frequently returns after original remedy.4

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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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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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The Pharma Data

SEPTEMBER 8, 2021

Phase 3 data from RELATIVITY-047 demonstrate prolonged benefit beyond initial treatment of the LAG-3 blocking antibody relatlimab and PD-1 inhibitor nivolumab fixed-dose combination for patients with previously untreated unresectable or metastatic melanoma. Summary of Presentations. All times noted are Central European Summer Time (CEST).

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The Pharma Data

SEPTEMBER 6, 2021

The primary efficacy outcome was met showing a statistically significant reduction in the 24-hour cough count (average hourly cough frequency based on 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment.

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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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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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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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The Pharma Data

AUGUST 30, 2021

ALXN1840 demonstrated approximately three times greater copper mobilisation from tissues than standard-of-care treatments. The trial enrolled 214 patients, including treatment-naïve participants and those who have been on SoC therapy for an average of ten or more years.

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Vial

DECEMBER 5, 2023

NGS has expanded the scope of genomics research to include studies and clinical trials on rare genetic diseases, cancer genomics, microbiome analysis, infectious diseases, and population genetics. 2021) concluded that machine learning (ML) and network-based approaches can add valuable insights and build highly accurate models.

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

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The Pharma Data

AUGUST 22, 2021

Alexion is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). The IDMC recommended that the trial be discontinued due to lack of efficacy. Data from the trial will be provided to inform ongoing research. CHAMPION-ALS.

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The Pharma Data

OCTOBER 14, 2021

The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). These data are being presented as ePosters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on October 13 – 15, 2021.

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The Pharma Data

SEPTEMBER 28, 2021

Data from the IMpower010 trial were published simultaneously within the Lancet. Data from the IMpower010 trial were published simultaneously within the Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the danger of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88)

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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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The Pharma Data

NOVEMBER 18, 2021

– CHALLENGE-MIG is the first and only clinical trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines, Emgality and Nurtec ODT, which work differently – The study’s primary endpoint is the percentage of patients with ?50% 75% and 100% reductions from baseline in monthly migraine headache days.

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The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

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The Pharma Data

NOVEMBER 11, 2021

The positive CHMP opinion is based on results from the STEP phase 3a clinical trial programme. Across the trials in people with obesity or overweight without type 2 diabetes, an average weight loss of 17-18% 1 sustained over 68 weeks was reported for those treated with Wegovy. Food and Drug Administration (FDA).

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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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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. The typical cost of developing a biosimilar ranges from $100 million to $300 million, with clinical trials accounting for more than half of the budget. Harvard Kennedy School.

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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. Actemra/RoActemra is not U.S.

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The Pharma Data

AUGUST 31, 2021

The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator – the AstraZeneca/Oxford University COVID-19 vaccine. GSK commitment to tackling COVID-19. About SK bioscience.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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