Pharmaceutical Technology

FEBRUARY 28, 2023

Under the deal terms, Chipscreen NewWay will develop and commercialise YH008 in Greater China, including Macau, Mainland China, Taiwan, and Hong Kong. Eucure Biopharma will retain the global rights for the development and commercialisation of the antibody outside Greater China.

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Pharmaceutical Technology

JUNE 6, 2023

Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The rNPV model is a more conservative valuation measure that accounts for the risk of a drug in clinical development failing to progress. Buy the model here.

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The Pharma Data

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. USA) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors to treat inherited eye diseases. MUNICH, Germany, Jan. About ViGeneron.

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The Pharma Data

DECEMBER 22, 2020

Merck will assist with preclinical development and has the option to exclusively develop, manufacture and commercialize the candidate following Phase 1. A2 anticipates that the successful development of its allogeneic Tmod candidate therapy will enable subsequently developed allogeneic Tmod candidates.

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XTalks

DECEMBER 12, 2024

The test builds upon the MeMed BV test, which received FDA clearance in July 2023 and a CE marking under the European In Vitro Diagnostic Devices Regulation (IVDR) in the European Union (EU). The test is currently not approved for sale by any regulatory body.

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The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Continuous professional development. The results demonstrate that regulatory knowledge and qualifications are an advantage and of value in personal and professional development.

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Camargo

FEBRUARY 16, 2021

Many diseases and conditions affect such small numbers of people that a drug or biological product developed to treat these patients generates relatively little return on investment for development costs. Subscribe to our mailing list at the bottom of this page to be notified when Parts 3 and 4 are published. Scientific Rationale.

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XTalks

DECEMBER 11, 2023

Through the utilization of their state-of-the-art technology and substantial investments in research and development (R&D), these med tech/medical device companies persist in driving industry innovation beyond the pandemic, thereby laying the foundation for a more streamlined approach against diseases in the future.

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Camargo

MARCH 25, 2021

Its purpose is to stimulate the development of new drugs for rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products beyond the incentives offered by the ODD program. Criteria for Rare Pediatric Disease Designation. Criteria to Obtain the Designation.

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pharmaphorum

DECEMBER 16, 2020

We had companies collaborating to develop laboratories. Soon the ABPI and the entire industry were facing the ripple effects of COVID-19, including a significant slowdown in non-COVID clinical research, which Torbett says was challenging for the industry to deal with. “We’ve We had companies sourcing consumables for testing machines.

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FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ).

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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

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. Beverley, MA) (“Adeptrix”). I look forward to updating the market when we have definitive clinical performance data.”.

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The Pharma Data

DECEMBER 14, 2020

” Under the license agreement, the development of ABBV-47D11 will be greatly advanced. AbbVie will conduct the clinical development of the product, and if it is successful, it will manufacture and commercialize the product around the globe. million in a Series C round of financing to accelerate the development of its portfolio.

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pharmaphorum

DECEMBER 15, 2022

Woxström, a 26-year veteran of AstraZeneca, will lead sales, marketing, and commercial operations for 30 European countries plus Canada. Prior to 2022, she did sales and marketing at Pfizer, Allergan, DuPont Pharma, and Johnson & Johnson. The month of November saw a number of notable hires and personnel moves in biotech and pharma.

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XTalks

JUNE 12, 2023

These powerhouse organizations have not only distinguished themselves through their cutting-edge devices and technologies but also via their robust research and development (R&D) capabilities, unwavering commitment to quality and extensive global reach. 1) Medtronic 2022 Revenue: Medtronic reported an annual revenue of $31.69

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XTalks

NOVEMBER 15, 2023

Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.” The featured speakers will discuss how innovative technologies and automation contribute to advancing vaccine development. Fever and joint pain are the most common symptoms of chikungunya.

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XTalks

JUNE 30, 2023

But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows. Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers.

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Delveinsight

JANUARY 12, 2021

Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Medivir is also eligible to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales upon the commercial approval of the drug.

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The Pharma Data

JANUARY 19, 2021

TCR 2 is developing novel T-cell therapies for solid tumors and hematological cancers. The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. Ortho Clinical Diagnostics is a leader in in vitro diagnostics. With this kind of a start, 2021 may be scorching.

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The Pharma Data

OCTOBER 27, 2020

The test is planned for commercial launch as a CE-IVD ( in vitro diagnostic) certified product in the European Union in Q1 2021. “Applying 3a’s proprietary enhanced RNA technology to PCR testing was a logical next step in our product development pipeline,” said Dr. .

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The Pharma Data

NOVEMBER 14, 2021

It does so by developing the best diagnostic tests and medicines capable of meeting some of the world’s most pressing medical needs. The ranking acknowledges Roche’s commitment to sustainability as an integral part of its business strategy Roche performed particularly well in Operational Eco-Efficiency, Environmental and Social Reporting.

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The Pharma Data

SEPTEMBER 17, 2020

This is the focus of vaccines in development and convalescent plasma therapy. 2 Measuring antibody levels could also be vital in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19. The test targets antibodies against the spike protein. Food and Drug Administration (FDA).

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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”) (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

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

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Brilacidin is a first-in-class Host Defense Protein (HDP) mimetic with antiviral, anti-inflammatory and antibacterial properties.

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The Pharma Data

DECEMBER 14, 2020

”) platform to transform drug discovery and development, and identify patients who will benefit from its portfolio of targeted oncology therapeutics, announced today new scientific data that substantiates blood brain barrier permeability (BBB) for its drug candidate LP-184. . . DALLAS , Dec. Lantern’s A.I.

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The Pharma Data

AUGUST 18, 2020

The companies will collaborate on developing and manufacturing REGN-COV2. 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. Regeneron will distribute REGN-COV2 in the U.S. and around the world. and around the world.

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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

AUGUST 27, 2020

Roche’s Executive Vice President, Chief Medical Officer, Head of Global Product Development and Co-Founder of Foundation Medicine Inc. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling,” said Levi Garraway, M.D.,

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The Pharma Data

JUNE 25, 2021

In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% (95% confidence interval (CI): -26, 65) compared to placebo, which was not statistically significant (Table 1). The trial did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo.

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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

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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The Pharma Data

AUGUST 6, 2020

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

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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.

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The Pharma Data

MAY 4, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers.

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