The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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FDA Law Blog

SEPTEMBER 27, 2022

The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements. The program is currently not accepting applications for antibody tests (HPM has blogged previously about FDA’s Monkeypox Policy here ).

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The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. The companies will collaborate on developing and manufacturing REGN-COV2. Regeneron will distribute REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

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Delveinsight

JANUARY 12, 2021

It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences. million after Birinapant successfully becomes a part of the Phase I trials.

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. months, 39.4%

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The Pharma Data

MAY 17, 2021

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests. .

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XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. “We understand that diagnostic manufacturers often have diverse needs. Banczyk has expertise in medical and IVD filtration devices. Xu joined Sartorius in 2002.

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FDA Law Blog

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection. Javitt & Jeffrey N.

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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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pharmaphorum

JANUARY 17, 2023

In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed. In addition, the construction of a specialised manufacturing facility for mRNA vaccines was agreed. The intracellular barriers include endosomal escape, RNA sensors, and endonucleases.

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The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S.

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Roots Analysis

AUGUST 15, 2023

Overview of Cell Free Systems Cell-free systems are ­in-vitro platforms which allow occurrence of biochemical reactions in the absence of living cells. These expression systems utilize bio machinery harvested from the lysate of disrupted cells for the manufacturing of a wide array of macromolecular and small molecule products.

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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The Pharma Data

JANUARY 16, 2021

It has become the de facto standard equipment for high titer transient protein expression platforms used by many leading Chinese antibody drug pharmaceutical companies and IVD (In Vitro Diagnostics) companies since its launch in Oct. Etta Biotech is a leading cell electroporation technology and equipment supplier.

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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 is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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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. Outlook for 2021 confirmed. Group results.

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The Pharma Data

JANUARY 12, 2021

INCHEON, South Korea–( BUSINESS WIRE )– Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. days quicker compared to placebo. days; 95% C.I, days compared to placebo [5.7

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The Pharma Data

MARCH 16, 2021

The cobas SARS-CoV-2 Variant Set 1 Test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the cobas ® SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the UK (B.1.1.7),

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FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. There is also a wide variety of tests, including PCR assays, antigen tests, and antibody tests, and at least 16 over-the-counter assays (4 of which were authorized in the past month).

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FDA Law Blog

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. There is also a wide variety of tests, including PCR assays, antigen tests, and antibody tests, and at least 16 over-the-counter assays (4 of which were authorized in the past month).

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The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement.

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XTalks

JUNE 12, 2023

Medtronic, the leading global medical device manufacturer, reported a revenue growth of 5 percent in the last fiscal year, affirming its position as the top global medical technology company by revenue. This article takes a comprehensive look at the top 10 medical device companies that are leading the charge in this rapidly evolving field.

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Pfizer

JANUARY 27, 2023

This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In addition, to meet U.S. and around the world.

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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

NOVEMBER 29, 2021

First Combination of Immunotherapy With Tyrosine Kinase Inhibitor Approved in Europe for Adult Patients With Advanced or Recurrent Endometrial Carcinoma With Disease Progression on or Following Prior Treatment With a Platinum-Containing Therapy in Any Setting and Who Are Not Candidates for Curative Surgery or Radiation.

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The Pharma Data

MAY 15, 2023

If approved, this would be the third indication for Vabysmo, the first bispecific antibody available for the treatment of retinal conditions that can cause blindness.” 1,2 Vabysmo’s safety profile was consistent with previous trials. Roche’s Chief Medical Officer and Head of Global Product Development. In BALATON, vision gains were +16.9

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The Pharma Data

JUNE 26, 2021

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Roche’s Chief Medical Officer and Head of Global Product Development. FDA in this setting, but the U.S.

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The Pharma Data

APRIL 12, 2023

4-7 Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

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Roots Analysis

OCTOBER 22, 2023

In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent. It is important to highlight that IVT mRNAs are structurally similar to natural mRNAs and can be used to express proteins through genetic engineering.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. per share amounts). Reported Diluted EPS (1).

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XTalks

DECEMBER 6, 2024

Zenocutuzumab-zbco is a first-in-class bispecific antibody that targets NRG1 fusions, a rare genetic driver implicated in several tumor types. Zenocutuzumab-zbco is a first-in-class bispecific antibody that targets NRG1 fusions, a rare genetic driver implicated in several tumor types. percent of NSCLC and 0.3 months to 16.6

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FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.

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XTalks

SEPTEMBER 14, 2020

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. The price of that prize is incalculable.

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FDA Law Blog

NOVEMBER 8, 2022

To put it into perspective, these were the numbers (so far) for in vitro diagnostics EUAs: 304 molecular, 84 antibody, 51 antigen, and 5 other. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications. In response, Ms.

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