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]

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XTalks

AUGUST 6, 2020

The US Food and Drug Administration (FDA) has approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients aged one year and older. Epidiolex is the only FDA-approved formulation that contains CBD derived from the cannabis plant.

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FDA Approval Protein Containment Genetic Disease 64

Pfizer

AUGUST 3, 2022

mitogen activated protein kinase pathway, which demonstrated improvement in functional capacity (6-minute walk test; 6MWT) in a 48-week, open-label, Phase 2 study among patients with symptomatic LMNA-related DCM. The information contained in this release is as of August 3, 2022. Disclosure Notice.

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Development Vaccination Vaccine Production 101

pharmaphorum

NOVEMBER 9, 2021

Opdivo is a PD-1 inhibitor that works against the protein, Programmed Death-Ligand 1 (PD-L1), which is found on the surface of many cells throughout the body. Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system. These patients had a median overall survival (OS) of 24.6

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The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

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. Casirivimab and imdevimab injection is not FDA approved for any use.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

JANUARY 29, 2021

Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of trial data from the primary analysis of the Phase III programme led by the University of Oxford. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

FEBRUARY 23, 2022

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. Figure 1a – Pre- vs post-booster neutralizing antibody titers in 18-55-yr old participants.

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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. Myasthenia Gravis Approved Therapies. Some of the approved drugs are: Prograf (Tacrolimus).

Marketing 85

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XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. protein-based biologics) : are those which bind to specific components (i.e. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. chimeric receptor antigen [CAR] T cell) immune modulators (i.e. Immune system modulators (i.e.

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Protein Engineer Immune Response In-Vivo 98

Delveinsight

DECEMBER 13, 2020

This discovery led to the development of diagnostic tests and an effective vaccine, and Blumberg was awarded the Nobel Prize in Physiology or Medicine in 1976 for this discovery. The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). in January 2019.

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Genotype FDA Approval DNA Drugs 52

The Pharma Data

JANUARY 6, 2021

” AstraZeneca has already submitted a substantial data package to support a conditional marketing authorisation for its COVID-19 vaccine to the European Medicines Agency (EMA), as part of an ongoing rolling review process and will continue to work closely with the EMA to seek approval in the coming weeks. Source: AstraZeneca.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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The Pharma Data

APRIL 15, 2022

With this proposed acquisition, we have the opportunity to potentially bring meaningful new benefits to patients and further strengthen our portfolio of specialty medicines.” Patients were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor.

Sales 52

Sales Protein FDA Approval Trials 52

The Pharma Data

NOVEMBER 16, 2020

Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval. mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. About mRNA-1273.

Vaccination 52

Vaccination Vaccine Containment Pharmacy 52

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

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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. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings.

Medicine 52

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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. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

DECEMBER 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), marking a significant milestone for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC).

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. ImmunityBio’s platform is based on the foundation of three separate modalities: antibody cytokine fusion proteins, synthetic immunomodulators, and second-generation human adenovirus (hAd5) vaccine technologies.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

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).

Antibody 52

Antibody Vaccination Vaccine Trials 52

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. “We 1 TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer.

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Medicine In-Vitro Antibody Development 40

The Pharma Data

JANUARY 15, 2021

This approval represents the first time a HER2 directed medicine has demonstrated a significant improvement in survival compared to chemotherapy for patients following initial treatment in the metastatic setting and it has the potential to become the new standard of care for this patient population.”. Sammons Cancer Center and the W.W.

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. It is approved in the U.S. See the full Prescribing Information here.

Antibody 52

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The Pharma Data

NOVEMBER 16, 2020

I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. .–(BUSINESS WIRE)–Nov.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

AUGUST 25, 2020

In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is the first and only FDA-approved therapy for patients with R/R AML and positive for an IDH2 mutation, which represents up to 19 percent of AML patients. About IDHIFA.

Trials 52

Trials FDA Approval Development Clinical Trials 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Vaccination Vaccine FDA Approval Containment 52

The Pharma Data

DECEMBER 5, 2020

BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator. All patients were triple-refractory, with 57% being penta-refractory,” said Deepu Madduri , M.D.,

Antibody 40

Antibody Production Trials Medicine 40

The Pharma Data

OCTOBER 30, 2020

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

NOVEMBER 30, 2020

GPCR – G protein-coupled receptors. We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. About Sosei Heptares. Sosei Group Forward-looking statements.

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Licensing Licensing Production Development 40

Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

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Production Gene Protein Vaccination 52

The Pharma Data

SEPTEMBER 1, 2020

Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

Trials 52

Trials Clinical Trials Clinical Trials Vaccination 52

The Pharma Data

MAY 13, 2021

Fiber and protein will make you feel full faster, while carbs increase insulin level making you hungry. Every capsule is manufactured in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. They do not contain any dangerous stimulants or toxins, and they are not habit forming.

Production 52

Production Doctors Doctor Sales 52

XTalks

AUGUST 2, 2023

With each passing year, pharmaceutical companies around the globe strive to deliver cutting-edge medicines, therapies and vaccines that impact the lives of millions. In this in-depth article, we embark on a captivating journey to uncover the top 30 pharma and biotech companies that have been instrumental in shaping the future of medicine.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. P-gp, BCRP or OATP1B1 Substrates — Apalutamide is a weak inducer of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide 1B1 (OATP1B1) clinically.

HR 52

HR Hormones Development Production 52

XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

JANUARY 12, 2021

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52