The Pharma Data

SEPTEMBER 6, 2020

Genentech and Blueprint Medicines will co-commercialise Gavreto in the United States. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Gavreto is now the sixth FDA-approved medicine in Roche’s portfolio of treatments for lung cancer.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S.

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FDA Approval In-Vitro Antibody Medicine 52

The Pharma Data

JANUARY 6, 2021

SK Chemicals has shared their expertise in these diseases and validated the predicted targets and compounds through in vitro and in vivo studies. SK Chemicals successfully developed the first new drug in Korea, Sunpla®, in 1999, thereby opening up a new chapter in the field of synthetic new medicines. About Standigm.

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FDA Approval Life Science Drugs In-Vivo 52

The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S.

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FDA Approval In-Vitro DNA Medicine 52

The Pharma Data

MAY 31, 2022

The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Jude Children’s Research Hospital.

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FDA Approval Protein In-Vitro Medicine 52

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. And all are predominantly prevented or treated with medicines that are decades old.

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Gene Therapy In-Vitro Gene Medicine 98

The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on 22 April 2021.

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The Pharma Data

JANUARY 6, 2021

(“CytoDel” or “the Company”), a privately-held corporation, today announces the publication of preclinical data on the Company’s lead product, Cyto-111, in the peer-reviewed journal, Science Translational Medicine. Cyto-111 was conceived, expressed and purified in the laboratory of Konstantin Ichtchenko, Ph.D.,

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Medicine Antibody Protein In-Vitro 52

XTalks

JULY 10, 2024

The US Food and Drug Administration (FDA) has granted marketing authorization to Cepheid for its groundbreaking Xpert HCV test and GeneXpert Xpress System, marking a significant advancement in the diagnosis and treatment of hepatitis C virus (HCV). About 80 percent of acute cases are asymptomatic.

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RNA In-Vitro Genotype Marketing 97

XTalks

DECEMBER 19, 2023

billion Company: Pfizer Disease it is FDA-approved to treat: Comirnaty is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. billion in sales in 2022.

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XTalks

NOVEMBER 7, 2022

Liquid biopsy tests in oncology involve isolating entities such as circulating tumor cells (CTC), circulating tumor DNA (ctDNA) and tumor-derived exosomes. These tumor-derived entities are used to derive genomic and proteomic data. The same webinar held a Q&A session with Dr. Bahassi and two other experts from Medpace, Dr. Lyon L.

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XTalks

AUGUST 8, 2024

The US Food and Drug Administration (FDA) has approved Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma who have specific HLA types and have undergone prior chemotherapy. It is also the first new treatment for adults with synovial sarcoma in over a decade.

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Engineer Clinical Trials Clinical Trials FDA Approval 52

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”.

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The Pharma Data

DECEMBER 20, 2020

Elizabeth’s Medical Center and associate professor of Urology at Tufts University School of Medicine, said at the time, “The results of the EMPOUR study over the 52-week period demonstrated the sustained benefits of fibegron. Approval demonstrates our ability to execute upon the entirety of the drug development and registration process.

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The Pharma Data

FEBRUARY 12, 2022

On January 21, 2022, the FDA approved a supplemental new medicine operation (sNDA) for Veklury to expand the suggestion to the treatment ofnon-hospitalized grown-up and adolescent cases who are at high threat of progression to severe COVID-19, including hospitalization or death. About the CARAVAN Study (GS-US-540-5823).

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XTalks

DECEMBER 11, 2023

Their groundbreaking Tablo Hemodialysis System, cleared by the US Food and Drug Administration (FDA) for use from hospital to home, signifies a monumental leap in technology, revolutionizing the dialysis experience for patients while streamlining operational aspects for providers. In 2021, Axonics achieved an impressive revenue of $180.3

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The Pharma Data

OCTOBER 14, 2021

“For more than a decade, we’ve been committed to advancing the science of Alzheimer’s as well as our investigational medicine gantenerumab, and we look forward to delivering a comprehensive and robust data set that furthers our collective understanding of this devastating disease,” said Levi Garraway, M.D.,

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Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., Pfizer Responds to Research Claims carterda Fri, 01/27/2023 - 19:48 Pfizer Responds to Research Claims Friday, January 27, 2023 - 08:00pm Share New York, N.Y., It is important to note that these studies are required by U.S.

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

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Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

SEPTEMBER 10, 2020

OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S. and more than 2.3

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The Pharma Data

APRIL 26, 2022

— Approval is Supported by Phase 2/3 Data Demonstrating the Safety and Tolerability Profile and Clinical Improvement Outcome in Hospitalized Pediatric Patients Treated with Veklury — Gilead Sciences, Inc. Nasdaq: GILD) today announced that the U.S. Overall, 75% and 85% showed clinical improvement (?2

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In-Vitro Licensing Licensing FDA Approval 52

The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG was recently approved by the U.S. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. ENSPRYNG, the first approved treatment for NMOSD that can be taken at home, offers favourable efficacy and safety, which are important for improved long-term outcomes.’’.

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The Pharma Data

MAY 17, 2023

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS).

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In-Vitro FDA Approval Trials Clinical Trials 40

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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Clinical Trials Clinical Trials Antibody Medicine 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. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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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. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.

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Roots Analysis

JANUARY 14, 2024

Given the ongoing scientific advancements and the rise of FDA-approved biologics, the pharmaceutical industry seems to be approaching the era of biologics. In fact, biologics are anticipated to play a significant role in shaping the pharmaceutical industry and will eventually serve as an integral part of traditional medicines.

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XTalks

AUGUST 12, 2020

Related: FDA Approves Rukobia for HIV Patients with Limited Treatment Options. This may help explain why HIV is adequately controlled, but not eradicated, with current treatments. The research study was published in Cell Reports.

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RNA Protein DNA In-Vivo 52

The Pharma Data

MAY 4, 2021

Internal Medicine. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts).

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Vaccination Vaccine Production Sales 40

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

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Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Food and Drug Administration (FDA): Oversees the safety and effectiveness of medical devices in the United States.

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The Pharma Data

FEBRUARY 25, 2021

Roche announces results from Evrysdi (risdiplam) study in infants with Type 1 spinal muscular atrophy (SMA) published in New England Journal of Medicine. The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older.

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Protein Medicine FDA Approval In-Vitro 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. 59% of infants were able to sit without support for at least 5 seconds. No new safety signals were identified.

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Protein In-Vitro Medicine FDA Approval 52

XTalks

JANUARY 6, 2025

Whether its the integration of nanotechnology in medicine, the evolution of point-of-care (POC) diagnostics or the transformative impact of CRISPR and regenerative medicine, these biotech trends are pushing scientific boundaries and creating new opportunities for businesses and researchers alike.

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XTalks

DECEMBER 6, 2024

The US Food and Drug Administration (FDA) has granted accelerated approval to Merus Bizengri (zenocutuzumab-zbco) for the treatment of metastatic non-small cell lung cancer (NSCLC) and advanced pancreatic adenocarcinoma with NRG1 gene fusions in patients who have had disease progression during or after prior systemic therapy.

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