The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization. FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests. SQI intends to submit RALI-dx for EUA to FDA in late Q4 2020.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. GAITHERSBURG, Md., and Australia.

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Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. The current Myasthenia Gravis therapeutics market has many FDA-approved drugs for the treatment of Myasthenia Gravis.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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XTalks

MAY 1, 2023

Tofersen was discovered by Ionis Pharmaceuticals, and Biogen licensed tofersen from Ionis under a collaborative development and license agreement. While the exact causes of ALS are not fully understood, research suggests that the mutation of SOD1 may be linked to the development of the condition. What is SOD1 -ALS?

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XTalks

JUNE 28, 2023

The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. After the vote, the FDA extended the decision date by one month due to concerns it raised in briefing documents before the committee meeting.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Senior Vice President and Head of Global Clinical Development at Regeneron. Yancopoulos , M.D.,

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. These allow for the creation of bispecific antibodies that closely resemble natural human antibodies with no linkers or artificial sequences.

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The Pharma Data

JUNE 17, 2022

At Sandoz, we are constantly looking for ways to meet the changing needs of patients and health care providers,” said Florian Bieber, Global Head Biopharmaceuticals Development, Sandoz. “By About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a).

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The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer.

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pharmaphorum

SEPTEMBER 8, 2022

Ben Hargreaves examines what advantages radiopharmaceuticals offer in the treatment of cancer and why there has been interest from big pharma in developing these types of therapies. This is why the recent surge in development for radiopharmaceuticals is drawing attention. The drug was added to Novartis’ portfolio through a $2.1

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The Pharma Data

DECEMBER 30, 2020

billion acquisition of immuno-oncology company Forty Seven and its lead asset, magrolimab, a monoclonal antibody in the clinic for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL). It began in May with the $4.9 Magrolimab targets CD47. But the U.K.-based

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The Pharma Data

APRIL 4, 2023

It has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). Our ambition is to be the world’s leading and most valued generics company.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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The Pharma Data

DECEMBER 8, 2020

As we continue to progress the development of mRNA-1273, our COVID-19 vaccine candidate, we appreciate the continued confidence and support shown by the Swiss Federal Government as they increase their supply agreement with us,” said Stephane Bancel, Moderna’s Chief Executive Officer. “As .–(BUSINESS WIRE)–Dec. million to 7.5

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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The Pharma Data

FEBRUARY 23, 2022

Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S. induces protective antibodies against the three most prevalent subtypes of the TBEV circulating globally.

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The Pharma Data

DECEMBER 10, 2020

The goal of targeting both S and N was to both activate virus-specific T cells and generate anti-SARS-CoV-2-neutralizing antibodies. ImmunityBio’s hAd5 vaccine generated robust neutralizing antibody activity that was present 14 days post-final vaccination. This feature of the hAd5 vaccine distinguishes it from other vaccines.

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The Pharma Data

OCTOBER 30, 2020

NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. and Roche will develop, manufacture and distribute it outside the U.S. TARRYTOWN, N.Y. ,

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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XTalks

OCTOBER 14, 2022

Prior to the development of vaccinations for the condition, whooping cough was thought to be a childhood disease. Since infant immune systems are still developing, they are more susceptible to complications. Initially, Boostrix was approved by the FDA in 2005 as a single booster Tdap vaccine for individuals aged 10 to 18.

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The Pharma Data

DECEMBER 13, 2020

Although we are disappointed by the delay in timing to bring omidubicel to patients after a potential FDA approval, we are encouraged by the FDA’s reaction to our Phase 3 data as the pivotal trial of omidubicel achieved pre-specified primary and secondary endpoints. chief executive officer of Gamida Cell. About Omidubicel.

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XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Another method to isolate CTCs is by antibody targeting of white blood cells for removal, followed by collection of untagged CTCs.

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pharmaphorum

JANUARY 5, 2022

New vaccines, specifically developed for Omicron, may be required, and Moderna, BioNTech, and Johnson&Johnson have all announced they are in the process of creating these, with availability possible in the first half of 2022. Lagevrio was approved by the FDA, MHRA and EMA before the end of 2021. CNS’s moment of truth.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

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XTalks

JANUARY 5, 2021

There will also be more focus on digitization of research and development and manufacturing spaces to increase efficiencies and interconnectivity in the pharma, biotech and medical device industries. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity.

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Roche’s Chief Medical Officer and Head of Global Product Development. receptors.

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The Pharma Data

JANUARY 15, 2021

Enhertu is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicityEnhertu. Enhertu is the first antibody drug conjugate to receive approval in the U.S. is a HER2 directed antibody drug conjugate (ADC). months [95% CI 9.6-14.3] months [95% CI 6.9-10.7] with chemotherapy.

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XTalks

AUGUST 17, 2020

Immunotherapy continues to be a burgeoning field, with immune-based therapies being among the leading treatments being developed in oncology and autoimmunity. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. Immune system modulators (i.e.

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The Pharma Data

NOVEMBER 20, 2020

The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making. The information contained in this release is as of November 20, 2020.

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pharmaphorum

NOVEMBER 2, 2021

Dr Laura Moriarty, senior marketing manager at Bio-Rad, looks at the impressive immuno-therapeutic potential of bispecific antibodies (bsAbs). Though their bispecific nature complicates large-scale production and purification workflows, with challenges such as antibody chain mispairing, bsAbs have come a long way since first developed.

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