The Pharma Data

NOVEMBER 14, 2021

Roche follows a holistic approach when managing sustainability: In addition to improving access to products, the company’s strategy also focuses on achieving continuous progress in areas such as social responsibility, environmental protection, supply chain sustainability, people attraction and retention.

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The Pharma Data

OCTOBER 14, 2021

The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). Roche’s Chief Medical Officer and Head of Global Product Development. This is especially important given the ongoing challenges for healthcare systems around the world brought about by the COVID-19 pandemic.[1].

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The Pharma Data

OCTOBER 9, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).

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FDA Law Blog

MAY 25, 2022

It is not uncommon for some in vitro diagnostic tests to suffer from poor positive predictive value, in part due to the rarity of the disease. The VALID Act would give FDA authority to regulate laboratory developed tests and fundamentally change the regulatory paradigm for all in vitro diagnostic tests. (As

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The Pharma Data

OCTOBER 14, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

DECEMBER 2, 2020

Progenity”) (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced the pricing of its previously announced underwritten public offering of 7,645,259 shares of its common stock at a public offering price of $3.27 SAN DIEGO, Dec.

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The Pharma Data

DECEMBER 2, 2020

SAN DIEGO, Dec. 02, 2020 (GLOBE NEWSWIRE) — Progenity, Inc. NASDAQ: PROG) today announced the pricing of its offering of $75.0 The issuance and sale of the notes are scheduled to settle on December 7, 2020, subject to customary closing conditions. million principal amount of notes. per share of common stock.

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XTalks

SEPTEMBER 30, 2020

In collaboration with clinicians around the world, Casanova’s team studied the genomes of COVID-19 patients, focusing on a set of 13 genes involved in interferon immunity against influenza. The findings reveal a critical role for IFNs in fighting COVID-19 infection, positioning them to be a potential therapeutic target in the disease.

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XTalks

DECEMBER 11, 2023

The combination of water purification and on-demand dialysate production empowers Tablo to function as a mobile dialysis clinic. Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. In 2021, Axonics achieved an impressive revenue of $180.3 million, marking a substantial 43.8

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. They can be used in patient selection, stratification, risk mitigation and assessment of safety and efficacy endpoints.

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The Pharma Data

NOVEMBER 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. “ Roche’s Chief Medical Officer and Head of Global Product Development. “ Results from three vital studies will be featured First Donation of efficacity and safety data from the phase III POLARIX study as a late- breaking abstract and in the ASH press programme.

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The Pharma Data

SEPTEMBER 16, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. “As New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme.

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The Pharma Data

SEPTEMBER 6, 2020

Roche’s Chief Medical Officer and Head of Global Product Development. “We Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States. In NSCLC, RET fusions represent approximately 1-2% of patients. months, not reached).

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The Pharma Data

MAY 4, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study. Tecentriq approval offers an alternative to chemotherapy for all eligible patients. months compared with chemotherapy (median OS=20.2

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Pharmaceutical Technology

AUGUST 26, 2008

It started to emerge in the mid 1990s, incrementally gathering speed as more products were approved in the last ten years,” says Reilly. “The pharmaceutical industry is increasingly embracing large molecule products and concepts.” “Biotechnology has exploded across the industry. .

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Pharmaceutical Technology

FEBRUARY 20, 2023

He says these issues must be urgently addressed over the next few years as advancing medical knowledge and the role of genomics in treating disease ushers in a new era of precision medicine and new potential to address diseases that affect certain populations. This may sound obvious, but it is still a major hurdle in drug development.

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The Pharma Data

JULY 23, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

JULY 21, 2021

I’m particularly excited about the significant progress we made in our product pipeline, including very promising study results for Tecentriq in early-stage lung cancer, as well as additional positive data for Evrysdi in spinal muscular atrophy and for COVID-19 medicines. Outlook for 2021 confirmed. Group results.

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XTalks

FEBRUARY 28, 2025

Anbio offers an extensive portfolio of in vitro diagnostics (IVD) products tests performed outside the human body to address diverse diagnostic needs. The company is gathering documentation for registration under the In Vitro Diagnostic Regulation, anticipating approvals for various device classes by the end of the 2020s.

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The Pharma Data

NOVEMBER 11, 2021

Roche’s Chief Medical Officer and Head of Global Product Development.”People Roche’s Chief Medical Officer and Head of Global Product Development.”People A final decision regarding the blessing of Ronapreve is anticipated from the European Commission in the near future.

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The Pharma Data

NOVEMBER 12, 2021

This decision follows one day after the positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the EMA and the European Commission’s precedence to dock review timelines for safe, effective and high- quality rectifiers during the COVID-19 public health exigency. “

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The Pharma Data

JUNE 26, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche’s Chief Medical Officer and Head of Global Product Development. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies.

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FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

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The Pharma Data

NOVEMBER 17, 2021

Streamlined in vitro data, published in bioRxiv, demonstrate that sotrovimab retains exertion against all current variants of concern and interest of the SARS-CoV-2 contagion as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), 1.617.2), Delta Plus (AY.1 2) and Mu (B.1.621).

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XTalks

JANUARY 6, 2025

Medical device manufacturers are leveraging these technologies to enhance their products, supporting healthcare providers and improving patient outcomes. Read on to explore the innovations shaping the biotech landscape and gain a glimpse into the exciting developments on the horizon for 2025 and beyond.

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