The Pharma Data

MARCH 27, 2023

The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. “There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life.

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pharmaphorum

APRIL 25, 2022

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class.

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The Pharma Data

APRIL 27, 2022

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. 1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.

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Drug Discovery World

MARCH 24, 2023

Regulatory approval The company and the US Food and Drug Administration (FDA) agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application (BLA). The Phase III will have overall survival as the primary objective and may include a specific patient population.

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Trials Immune Response HR Clinical Development 52

The Pharma Data

APRIL 8, 2022

NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.

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The Pharma Data

JUNE 2, 2023

“These additional data on Verzenio and Jaypirca build on the evidence supporting the role each of these medicines play in improving the treatment paradigms for patients with node-positive, high risk early breast cancer and covalent BTK inhibitor pre-treated relapsed or refractory MCL, respectively,” said David Hyman, M.D.,

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The Pharma Data

MARCH 22, 2023

positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma Two statistically significant Phase 3 trials, GLOW and SPOTLIGHT, to serve as the basis for global regulatory submissions Astellas Pharma Inc. In both trials, approximately 38% of these patients had CLDN18.2-positive

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.

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The Pharma Data

OCTOBER 26, 2021

Q3 core¹ operating income grew +9% (cc, +10% USD) Innovative Medicines grew +13% (cc, +14% USD), due to higher sales and productivity programs Sandoz declined -15% (cc, -13% USD), impacted by gross margin Q3 operating income grew +32% (cc, +34% USD) Q3 net income increased +41% (cc, +43% USD) Q3 free cash flow 1 of USD 4.4 About Novartis.

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pharmaphorum

DECEMBER 17, 2021

The EMA’s human medicines committee has said that EU member states can start to offer Pfizer’s oral antiviral Paxlovid as a treatment for people with COVID-19 outside hospital, ahead of a formal approval for the drug. The UK has agreed to purchase 480,000 courses of the drug.

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Drug Discovery World

JUNE 2, 2023

AI-designed monoclonal antibody ‘redirects’ the immune system Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours.

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Drugs HR Antibody Clinical Trials 52

The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56]) 1.00]; p=0.0544). While the observed 7.4-month

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Scienmag

SEPTEMBER 29, 2020

20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].

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HR Hormones Research Clinical Trials 61

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. HR (95% CI): 0.68.

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Trials HR Containment Development 52

pharmaphorum

SEPTEMBER 27, 2021

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. To address this problem, businesses operating in this sector should go back to the beginning of the process and look at how they conduct clinical trials.

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The Pharma Data

AUGUST 30, 2021

Finerenone significantly reduced the risk of the composite primary endpoint of time to first occurrence of CV death or non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization by 13% (relative risk reduction, HR 0.87 [95% CI: 0.76-0.98]; 0.98]; p=0.0264) over a median duration of follow-up of 3.4 0.95]; p=0.0018).

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HR Cardiology Clinical Trials Clinical Trials 52

The Pharma Data

APRIL 16, 2021

Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population 1. 5 (OS HR 0.71; 95% CI: 0.61 5 (OS HR 0.71; 95% CI: 0.61 5: progression-free survival (PFS) HR 0.68; 95% CI: 0.58 PRINCETON, N.J.–(BUSINESS

HR 52

HR Dermatology Trials Clinical Trials 52

pharmaphorum

NOVEMBER 9, 2021

The Scottish Medicines Consortium (SMC) has approved Tagrisso (osimertinib) for use within NHS Scotland as a monotherapy for adjuvant treatment after tumour removal in adult patients with stage IB-IIIA NSCLC whose tumours have epidermal growth factor (EGFR) mutations. to 0.26; P<0.0011).

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pharmaphorum

NOVEMBER 5, 2021

The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.

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Contract Manufacturing DNA HR Manufacturing 116

The Pharma Data

NOVEMBER 8, 2021

In the FIGARO-DKD study, presented at ESC Congress 2021 and published in the New England Journal of Medicine, the prevalence of the first secondary endpoint, a compound of time to order failure, a sustained drop of estimated glomerular filtration rate (eGFR) ? placebo donors (HR = 0.64; 95 CI0.41-0.995; ESKD passed in0.9

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Drug Discovery World

JUNE 1, 2023

6 Also in May 2023, Shanghai-native LaNova Medicines entered into an exclusive license agreement with AstraZeneca for LM-305, a pre-clinical stage ADC targeting G protein-coupled receptor, class C, group 5, member D (GPRC5D).

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pharmaphorum

FEBRUARY 25, 2022

.” The FDA’s decision to expand the indications for Jardiance was based on results from the international, randomised, double-blind EMPEROR-Preserved phase III trial, which evaluated the safety and efficacy of Jardiance 10mg compared to placebo and standard of care therapy. absolute risk reduction, 0.79

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FDA Approval HR Cardiology Drugs 101

pharmaphorum

OCTOBER 14, 2021

Approval follows a phase 3 KEYNOTE-826 trial that evaluated Keytruda administered intravenously as well as chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab. months of overall survival compared to 16.3

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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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Clinical Trials Clinical Trials Trials HR 52

Drug Discovery World

JANUARY 9, 2024

Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year’s Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes.” The 2024 Drugs to Watch, are: 1.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

Antibody 52

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Drug Discovery World

NOVEMBER 24, 2023

7,8 Results from the primary endpoint of the TOPAZ-1 Phase III trial showed that durvalumab, in combination with standard of care gemcitabine plus cisplatin (chemotherapy) demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced BTC.6 months (HR 0.76; 95% CI 0.64-0.91,

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HR Licensing Licensing Trials 52

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

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The Pharma Data

JUNE 22, 2023

” “Pfizer has a legacy of bringing medicines to patients with genitourinary cancers and helping improve outcomes for patients suffering from advanced prostate cancer,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. 0.61; p<0.0001). . Source link: [link]

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The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST].

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pharmaphorum

SEPTEMBER 23, 2022

Now, based on follow-up results from the PALOMA-3 trial and additional data collected on patients treated with Ibrance in the UK, the decision has been taken to move the drug out of the CDF and into routine NHS funding. months in the trial, median overall survival was 6.8 “After a median follow-up of 73.3

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Hormones HR Medicine Drugs 52

Drug Discovery World

FEBRUARY 9, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to AstraZeneca for Imfinzi (durvalumab) in combination with gemcitabine and cisplatin in Great Britain for use as a first-line treatment of adults with locally advanced, unresectable or metastatic biliary tract cancer (BTC). versus 11.5%).

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HR Clinical Research Trials Medicine 52

pharmaphorum

NOVEMBER 10, 2021

Merck has partnered with the UN-backed Medicines Patent Pool (MPP) to grant royalty-free licenses to generic companies who can manufacture molnupiravir in 105 low- and middle-income nations around the world. The US orders now total $2.2 The post US buys another $1 billion-worth of Merck’s COVID capsule appeared first on.

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HR Manufacturing Licensing Licensing 52

The Pharma Data

JUNE 7, 2023

Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma following complete resection.

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The Pharma Data

JUNE 25, 2021

41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; As previously announced , the trial will continue to evaluate OS, a key secondary endpoint. KENILWORTH, N.J.–(BUSINESS months (14.9-41.5),

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The Pharma Data

SEPTEMBER 6, 2021

Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard of care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Lung Cancer Highlights. Abstract title.

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The Pharma Data

JANUARY 15, 2021

This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”. 4.3] (HR=0.47; 95% CI 0.31-0.71)

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