JAMA Internal Medicine

APRIL 21, 2024

fold greater risk of serious falls (HR, 1.80 [95% CI, 1.52-2.13]) fold greater risk of syncope (HR, 1.69 [95% CI, 1.30-2.19]). Subgroup analysis revealed an even higher risk of fractures in nursing home residents with dementia (HR, 3.28 [95% CI, 1.76-6.10]), 6.10]), elevated systolic (HR, 3.12 [95% CI, 1.71-5.69])

Nurses 40

Nurses HR Trials 40

Pharmaceutical Technology

SEPTEMBER 26, 2022

The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy. An inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6), palbociclib is administered once a day as a pill.

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HR Drugs Hormones Medicine 130

Scienmag

MARCH 9, 2022

A study led by researchers from The University of Texas MD Anderson Cancer Center showed a significant overall survival benefit with ribociclib plus endocrine therapy for postmenopausal patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.

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HR Hormones Medicine Research 62

The Pharma Data

FEBRUARY 21, 2022

1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. 4 Currently, chemotherapy remains the only treatment option both for patients with HR-positive tumours following progression on endocrine (hormone) therapy, and for those who are HR-negative.5.

HR 52

HR Trials Hormones Antibody 52

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.

HR 52

HR Trials Protein Medicine 52

The Pharma Data

JUNE 26, 2021

Basel, June 23, 2021 — VISION data published today in The New England Journal of Medicine (NEJM) shows that 177 Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52?0.74]; months) and imaging-based progression-free survival (HR = 0.40 [99.2%

Medicine 52

Medicine HR Hormones Protein 52

The Pharma Data

MARCH 27, 2023

“The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of Kisqali to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer,” said Shreeram Aradhye, M.D.,

HR 40

HR Trials Hormones Research 40

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.

Medicine 52

Medicine Sales Marketing Generic Pharmaceutical 52

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 […].

HR 61

HR Hormones Research Clinical Trials 61

BioTech 365

SEPTEMBER 9, 2020

Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving NUBEQA plus androgen deprivation therapy (ADT) had a statistically significant improvement in its secondary endpoint of overall survival (OS) compared to placebo plus ADT (HR=0.69, 95% CI 0.53-0.88;

HR 52

HR Medicine 52

The Pharma Data

NOVEMBER 16, 2020

from the Boston University School of Medicine, and colleagues conducted a nested case-control study using the Health Improvement Network to examine the association between warfarin and risk for knee and hip replacements among adults aged 40 to 89 years with atrial fibrillation. Priyanka Ballal, M.D.,

HR 52

HR Protein Medicine Research 52

The Pharma Data

APRIL 28, 2023

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. maturity, HR of 0.81, 95% CI 0.67-1.00; In exploratory analyses of the BRCAm subgroup, Lynparza plus abiraterone demonstrated improvements in both rPFS (HR of 0.23, 95% CI, 0.12-0.43)

HR 40

HR Trials Medicine Clinical Trials 40

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.,

HR 52

HR Hormones Medicine Trials 52

XTalks

FEBRUARY 7, 2024

The approval of Truqap was the first-in-class approval for AstraZeneca.

Life Science 59

Life Science HR Hormones Marketing 59

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]; 1.09]) and heart failure hospitalization (HR 0.71 [95% CI: 0.56-0.90])

HR 52

HR Cardiology Clinical Trials Clinical Trials 52

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.

HR 105

HR Medicine Trials Drugs 105

The Pharma Data

APRIL 28, 2023

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. In exploratory analyses of the BRCA m subgroup, patients in the LYNPARZA plus abi/pred arm had fewer rPFS (HR=0.23 [95% CI, 0.12-0.43]) 0.43]) and OS (HR=0.29 [95% CI, 0.14-0.56])

HR 40

HR FDA Approval Trials DNA 40

Drug Discovery World

JUNE 2, 2023

Syros to present new clinical data at ASCO 2023 Biopharmaceutical company Syros Pharmaceuticals has announced new clinical data from the Phase I/Ib clinical trial evaluating SY-5609 in patients with relapsed/refractory pancreatic ductal adenocarcinoma (PDAC), HR+ breast cancer and other solid tumours.

Drugs 52

Drugs HR Antibody Clinical Trials 52

The Pharma Data

NOVEMBER 17, 2021

About MPP The Medicines Patent Pool (MPP) is a United Nations- backed public health association working to increase access to, and grease the development of, life- saving drugs for low-and middle- income countries. High and upper-middle income countries will pay further than lower income countries, which will pay a not-for- profit price.

Licensing 52

Licensing Licensing Medicine Manufacturing 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).

HR 105

HR Licensing Licensing Medicine 105

pharmaphorum

APRIL 25, 2022

The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice of endocrine therapy for previously-treated hormone receptor (HR)-positive, HER2-negative breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

Trials 68

Trials Hormones HR Sales 68

The Pharma Data

APRIL 16, 2021

In the trial of this patient population, Opdivo plus chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients (OS HR 0.80; 95% CI: 0.71 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

HR 52

HR Dermatology Trials Clinical Trials 52

pharmaphorum

OCTOBER 14, 2021

The approved treatment regime demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; 0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; 0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, where tumours expressed PD-L1 (CPS ?1).

HR 45

HR Containment Protein Clinical Development 45

The Pharma Data

APRIL 8, 2022

This analysis reported after a median follow-up of three years, LORBRENA continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded independent central review (BICR), the primary endpoint, compared to XALKORI (HR, 0.27; 95% CI, 0.18–0.39),

Trials 52

Trials HR Development Medicine 52

The Pharma Data

JUNE 7, 2022

increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. RSMs are the raw materials that are chemically converted into API, which is the active ingredient in a medicine. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S.,

Manufacturing 40

Manufacturing HR Production Vaccination 40

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.

Contract Manufacturing 115

Contract Manufacturing DNA HR Manufacturing 115

pharmaphorum

FEBRUARY 25, 2022

chairman, Department of Medicine, University of Mississippi. chairman, Department of Medicine, University of Mississippi. Endpoint analysis from EMPEROR-Preserved shows that in 5,988 adults with heart failure with LVEF over 40%, the once-daily dose of Jardiance demonstrated a 21% relative risk reduction (3.3%

FDA Approval 100

FDA Approval HR Cardiology Drugs 100

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.

Drugs 69

Drugs Antibody Gene Editing Medicine 69

The Pharma Data

MARCH 22, 2023

Specifically, zolbetuximab plus CAPOX reduced the risk of progression or death by 31.3% (n=507; hazard ratio [HR]=0.687; [95% confidence interval [CI]: (0.544-0.866)]; p=0.0007) compared to placebo plus CAPOX, meeting GLOW’s primary endpoint. Median PFS was 8.21 months (95% CI: 7.46–8.84) 8.84) in the treatment arm and 6.80 months (95% CI: 6.14–8.08)

Trials 40

Trials HR Development Clinical Development 40

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. Gavreto is being jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the U.S.

HR 52

HR Medicine Hormones Trials 52

The Pharma Data

NOVEMBER 17, 2021

Food and Drug Administration (FDA) includes clinical data from the Phase2/3 EPIC-HR ( Evaluation of Protease Inhibition for COVID-19 in High- Threat Cases) interim analysis. This submission to theU.S. Rolling submission ofnon-clinical data for PAXLOVID was initiated with theU.S. FDA in October 2021.

HR 52

HR Manufacturing Contract Manufacturing Licensing 52

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).

Antibody 98

Antibody Marketing Drugs Licensing 98

pharmaphorum

SEPTEMBER 23, 2022

. “Today’s decision is fantastic news for up to 2,400 people with advanced breast cancer who have already had endocrine treatment,” according to Helen Knight, interim director of medicines evaluation at NICE, who also said it showed that that CDF approach is working well.

Hormones 52

Hormones HR Medicine Drugs 52

Drug Discovery World

NOVEMBER 24, 2023

months in the gemcitabine and cisplatin plus placebo group (hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.66-0.97, months (HR 0.76; 95% CI 0.64-0.91, Press release: First Innovation Passport awarded to help support development and access to cutting-edge medicines. 6 Initial data reported a median overall survival of 12.8

HR 52

HR Licensing Licensing Trials 52

pharmaphorum

SEPTEMBER 27, 2021

In 2020, 53 novel medicines were approved by the FDA and of the patients who took part in trials, just 8% were black and 6% were Asian. Diversity and inclusion has often been stuck with human resources (HR) and focused too much on ticking a box. There isn’t a one-size-fits-all approach.

Clinical Trials 121

Clinical Trials Clinical Trials Trials Vaccination 121

The Pharma Data

SEPTEMBER 14, 2020

Trodelvy is also being investigated for efficacy in third-line HR+/HER2- breast cancer at Phase 3 and bladder cancer at Phase 2, with other ongoing studies in non-small cell lung cancer and other solid tumours, with data also planned for reveal at ESMO 2020.

HR 52

HR Antibody Medicine Drugs 52

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]

FDA Approval 40

FDA Approval Gene HR Medicine 40