The Pharma Data

JANUARY 19, 2021

Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

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The Pharma Data

AUGUST 31, 2020

About the cobas HIV-1/HIV-2 Qualitative Test cobas HIV-1/HIV-2 Qualitative for use on the cobas 6800/8800 Systems is an in vitro nucleic acid amplification test for the qualitative detection and differentiation of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma. .

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The Pharma Data

SEPTEMBER 1, 2020

Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Antigen test accurately screens individuals with known exposure to infected SARS-CoV-2 patients, providing fast answers regarding their infection status. Food and Drug Administration (FDA).

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The Pharma Data

AUGUST 18, 2020

If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

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The Pharma Data

AUGUST 6, 2020

Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified. This includes studies evaluating Tecentriq both alone and in combination with other medicines. OS follow-up is planned to continue until final analysis.

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The Pharma Data

AUGUST 9, 2020

Roche is studying additional investigational medicines in inflammatory bowel diseases. Roche is studying additional investigational medicines in inflammatory bowel diseases. Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies.

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The Pharma Data

DECEMBER 2, 2020

The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. (NASDAQ: PROG) today announced the pricing of its offering of $75.0 million principal amount of notes. The notes will mature on December 1, 2025, unless earlier repurchased, redeemed or converted.

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The Pharma Data

DECEMBER 2, 2020

Progenity expects to use the net proceeds from the offering to support its operations, to invest in its molecular testing research and development program, to invest in research and development with respect to its precision medicine platform and for working capital and general corporate purposes. SAN DIEGO, Dec. About Progenity.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

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The Pharma Data

SEPTEMBER 19, 2020

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy. Roche’s Chief Medical Officer and Head of Global Product Development. from 41.1% (95% CI: 33.6–48.9)

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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XTalks

DECEMBER 11, 2023

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Let’s examine the list of the top ten fastest growing medical device companies in 2023, ranked by their compound annual growth rate (CAGR). In 2021, Axonics achieved an impressive revenue of $180.3

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pharmaphorum

DECEMBER 15, 2022

Boehringer Ingelheim taps new head of medicine. As we reported 4th November, Boehringer Ingelheim brought on former Novartis neurosciences head Lykke Hinsch Gylvin (pictured below) into the role of head of medicine and chief medical officer. Read on for a round-up of some of the biggest moves that crossed our desks.

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy. Food and Drug Administration (FDA).

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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

SEPTEMBER 6, 2020

Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States. It is jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the US and will be commercialised by Roche outside of the US, excluding Greater China*. “We months, not reached). months, not reached).

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The Pharma Data

SEPTEMBER 9, 2020

The longer-term data for ENSPRYNG further reinforce the previously observed efficacy of this medicine for this debilitating disorder that is often mistaken for multiple sclerosis,” said Levi Garraway, M.D., ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. ENSPRYNG was recently approved by the U.S.

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The Pharma Data

AUGUST 16, 2020

“Today’s FDA approval of ENSPRYNG, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with OCREVUS to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., with placebo.

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The Pharma Data

APRIL 27, 2021

The FDA’s Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MAY 18, 2021

If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks.

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The Pharma Data

MAY 18, 2021

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

SEPTEMBER 3, 2020

As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients. Test for use on high-throughput cobas 6800/8800 Systems will continue to support high volume testing .

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The Pharma Data

APRIL 23, 2021

These results were published in the New England Journal of Medicine in August 2020. Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. The VIALE-A study showed Venclyxto plus azacitidine significantly improved overall survival compared to azacitidine alone.

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The Pharma Data

MAY 18, 2021

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. About 90,000 women globally die from endometrial cancer each year 1. Endometrial cancer is the most common gynecologic cancer in the U.S.

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The Pharma Data

SEPTEMBER 18, 2020

Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall survival and progression-free survival compared with the previous standard of care. Chief Medical Officer and Head of Global Product Development. Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MAY 4, 2021

This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types. Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study.

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The Pharma Data

AUGUST 4, 2020

This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. FDA granted de novo class II for cobas EBV test following the agency’s Breakthrough Device designation. Test meets World Health Organization standards for consistent result reporting among laboratories across the U.S.,

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pharmaphorum

DECEMBER 16, 2020

There were companies that allowed their staff to volunteer to deliver medicines to vulnerable people, and many HCPs that work in the industry have gone back to frontline care. We’ve also seen a very mixed picture in the market for pharmaceuticals,” he says. We had companies collaborating to develop laboratories.

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The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. These gold standard biomarkers³ have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks? NT-proBNP).

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The Pharma Data

JUNE 25, 2021

Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the trial, said: “The results of STORM CHASER suggest that AZD7442 may be useful in preventing symptomatic COVID-19 in individuals not already infected. AZD7442 was well tolerated in the trial.

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XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

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The Pharma Data

JULY 21, 2021

Group sales up 8% 1 at constant exchange rates (CER); 5% in Swiss francs. Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. [Ad hoc announcement pursuant to Art.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of hospitalisation and death. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

FEBRUARY 25, 2021

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine. The publication of the data in the New England Journal of Medicine reinforces the value of Evrysdi as an important treatment option for SMA.”.

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The Pharma Data

SEPTEMBER 7, 2020

The test provides standardised, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options. BK virus (BKV) is a member of the polyomavirus family that can cause severe transplant-associated complications.

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The Pharma Data

SEPTEMBER 27, 2020

Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Exploratory efficacy data showed 88% of infants treated with Evrysdi were alive and did not require permanent ventilation at two years. No new safety signals were identified.

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