Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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Gene Therapy Gene Protein FDA Approval 98

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). .

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 27, 2023

Chiesi Global Rare Diseases recently announced in a press release that Lamzede (velmanase alfa-tycv) received US Food and Drug Administration (FDA) approval for the treatment of non-neurological manifestations of alpha-mannosidosis in both adult and pediatric patients.

FDA Approval 52

FDA Approval Life Science Containment Genetics 52

XTalks

MAY 24, 2022

Antiretroviral drugs for HIV are classified as integrase strand transfer inhibitors (INSTIs), nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), cytochrome P4503A (CYP3A) inhibitors, protease inhibitors (PIs) and others. Lenacapavir: A Treatment Candidate for HIV.

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Drugs Clinical Trials Clinical Trials Trials 98

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. How Does Qalsody Work?

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FDA Approval Gene Genetics Protein 89

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. Related: GW Pharmaceuticals’ CBD Drug Gains Second Approval.

FDA Approval 64

FDA Approval Protein Containment Genetic Disease 64

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells.

Drugs 52

Drugs Clinical Trials Clinical Trials Containment 52

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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FDA Approval Production Research Doctors 52

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

Marketing Antibody Drugs Sales 85

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. COVID-19, Vaccines. 07.19.2022.

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Development Vaccination Vaccine Production 101

pharmaphorum

NOVEMBER 9, 2021

Lung cancer drug Opdivo administered with chemotherapy has been shown to boost survival rates in patients with resectable non-small cell lung cancer (NSCLC). 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.

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FDA Approval Trials Containment Medicine 58

The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Posted: November 2020.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

AUGUST 17, 2020

protein-based biologics) and vaccine treatments. Immune checkpoint inhibitors : these are drugs that block immune checkpoints, allowing immune cells to elicit enhanced responses to cancer cells. protein-based biologics) : are those which bind to specific components (i.e. Immune system modulators (i.e.

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Protein Engineer Immune Response In-Vivo 98

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

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Immune Response Vaccination Vaccine FDA Approval 52

Delveinsight

DECEMBER 13, 2020

alcohol, certain drugs) and autoimmune diseases can also cause hepatitis. The first approved treatment for hepatitis C was a series of protein-based injections called recombinant interferon-alfa (IFNa). 2b) was developed to maintain a steady level of an active drug and reduce the frequency of administration.

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Genotype FDA Approval DNA Drugs 52

Delveinsight

JANUARY 4, 2021

The prophylactic vaccine against HBV contains the S envelope protein of the virus, which is mainly produced in yeast S. cerevisiae containing a recombinant DNA plasmid expressing S antigen. Other treatment options present in the Chronic Hepatitis B market are Antiviral drugs, Immunomodulator drugs, and Liver Transplantation.

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Marketing Vaccination Vaccine DNA 52

The Pharma Data

NOVEMBER 30, 2020

CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax’ proprietary Matrix?M. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The award is funding the U.S.

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Clinical Development Vaccination Vaccine Development 52

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. ’s berdazimer gel, containing 10.3

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FDA Approval Dermatology Clinical Trials Clinical Trials 98

XTalks

OCTOBER 14, 2022

This week, GSK announced in a press release that the US Food and Drug Administration (FDA) had approved Boostrix as an immunization for pregnant women for the prevention of whooping cough in newborn infants. Boostrix is the first vaccine in the US indicated for the protection of newborns under two months of age from pertussis.

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FDA Approval Vaccination Vaccine Protein 98

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

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. Director of the FDA’s Center for Biologics Evaluation and Research.

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Vaccination Vaccine Production Manufacturing 52

pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. This is an accelerated approval based on response data and GSK may need survival data from a larger trial to keep the drug on the market in the longer term.

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FDA Approval Antibody Packaging Packaging 87

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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Antibody Vaccination Vaccine Trials 52

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. The hAd5-COVID-19 liquid drug substance was dried (lyophilized) and encapsulated to create the thermally-stable oral version of the vaccine. hAd5-COVID-19 Oral Formulation.

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Vaccination Vaccine Immune Response Protein 52

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Children have been the focus of malaria vaccine and drug trials because over 90 percent of deaths attributable to malaria are in African children under the age of five. Developing an efficacious vaccine against malaria has been a huge challenge.

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Vaccination Vaccine Immune Response Trials 105

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. The Utility of cfDNA for Cancer Management and Predicting Outcomes.

Clinical Trials 98

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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Protein FDA Approval Medicine Trials 115

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.

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Vaccination Vaccine Containment Pharmacy 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

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. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. receptors.

Medicine 52

Medicine Containment In-Vitro Development 52

The Pharma Data

JANUARY 18, 2021

OKYO has previously announced that it anticipates making an investigational new drug submission with the US Food and Drug Administration for the use of chemerin in the treatment of DED. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Gary S.

Life Science 40

Life Science Development Sales Drugs 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

XTalks

JANUARY 5, 2021

Both drug discovery and drug repurposing to manage and treat the disease will also continue as experts learn more about the virology and epidemiology of the novel SARS-CoV-2 coronavirus that wreaked havoc in 2020. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity.

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Life Science Clinical Trials Clinical Trials Trials 98

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’. About mRNA-1273. W911QY-20-C-0100.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

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