DrugBank

DECEMBER 18, 2024

This may enable the development of highly targeted therapies and individualized treatment plans, maximizing therapeutic efficacy while minimizing the risk of adverse side effects. For instance, consider Foundation Medicine's FoundationOne CDx , an FDA-approved comprehensive genomic profiling test for solid tumors.

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The Pharma Data

MARCH 26, 2021

The positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research which ultimately showed the treatment offers RMS patients superior efficacy on the primary endpoint of reduced annualised relapse rate compared to an established therapy, as well as a proven safety profile.”. About Ponesimod.

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The Pharma Data

DECEMBER 8, 2020

With offices in the Netherlands, Germany and Singapore, the plan is to invest about 80% into European companies and the rest in North American startups. . Offering 23 million shares between $14-$17 apiece for a hopeful total of $391 million , the company is lining up the biggest debut on record for a Canadian biotech. Nuance Pharma

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The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. by Janssen Pharmaceuticals, Inc. Study The randomized, open-label phase III EINSTEIN-Jr.

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

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The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. There are currently no approved therapies to treat this disorder’s hyperphagia, anxiety, or metabolic aspects.

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The Pharma Data

DECEMBER 1, 2020

Genesis is progressing both an internal drug pipeline, as well as select external partnerships, to create transformative therapies for patients. Dr. Stock worked closely with Dr. Prasit at three previous companies, and has co-invented thirty-six patents and led the discovery of multiple clinical molecules.

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The Pharma Data

JANUARY 17, 2021

“Our vision is that all cancer patients globally have access to state-of-the-art diagnostics to enable improved outcomes through earlier, faster, and more accurate diagnosis, therapy selection, and monitoring, and this partnership is an important step toward realizing that vision.”.

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Drug Target Review

AUGUST 3, 2023

How does your team navigate these challenges to help ensure the successful implementation and advancement of personalised treatments and therapies? Reassuring participants that they will retain full control over their genetic data is also crucial, making it much more likely they will agree to be recontacted in the future for further research.

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The Pharma Data

NOVEMBER 30, 2020

We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.” ” Abbreviations used: CGRP – calcitonin gene-related peptide. GPCR – G protein-coupled receptors. About Sosei Heptares.

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The Pharma Data

DECEMBER 29, 2020

Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy.

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

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The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. and around the globe.”. About EGFR Exon20 Insertion+ mNSCLC.

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

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The Pharma Data

JANUARY 19, 2021

So far, one patient in the trial experienced a complete remission at a 100 mg dosage, and another patient at the 200 mg dosage, even after failing seven previous therapies. As with any innovative therapy, “It takes multiple iterations and time to get things right,” he pointed out. “We So, people are starting to take a fresh look.”.

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The Pharma Data

OCTOBER 20, 2020

.–( BUSINESS WIRE )– Mycovia Pharmaceuticals, Inc. Oteseconazole received FDA Qualified Infectious Disease Product Status and Fast-Track designation with NDA submission planned for 1H 2021. The majority of these infections can be effectively managed with approved therapies.

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Dark Matter Blog

AUGUST 27, 2020

In addition to the early work of Matt Disney at the Scripps Research Institute and others in the academic community showing that this was even possible, a number of pharmaceutical companies have made important advances towards drugging RNA structures to discover new therapeutics. We will replace it.”

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The Pharma Data

DECEMBER 16, 2020

About Voclosporin Voclosporin is a novel therapy in development for patients with LN, an inflammation of the kidney which is one of the most serious complications of the autoimmune disease SLE. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN.

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The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. Forward-looking Statements.

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The Pharma Data

JUNE 26, 2021

Application seeks two pediatric indications, including an age-appropriate new weight-based oral suspension formulation to help minimize dosing errors If approved, XARELTO ® will be the first and only oral Factor Xa inhibitor indicated in the U.S. Food and Drug Administration (FDA) for the use of XARELTO ® (rivaroxaban) in pediatric patients.

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The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. TREMFYA is approved in the U.S., The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®. Editor’s Note: a.

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The Pharma Data

DECEMBER 8, 2020

OSAKA, Japan–( BUSINESS WIRE )– As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade.

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Codon

JUNE 18, 2024

Credit: Mikhail Shapiro Just consider a pharmaceutical company that wants to test whether an engineered immune cell, such as those used for CAR-T therapy , can detect and destroy cancer cells. At least six types of CAR-T cells have already passed through clinical trials and garnered FDA approval.

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced financial results for the first half of fiscal year 2020 (period ended September 30, 2020). 29, 2020 06:19 UTC. Press release ). Press release ). Press release ).

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The Pharma Data

AUGUST 31, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple company-sponsored presentations in prostate and bladder cancers will be highlighted at the virtual 2021 American Urological Association Annual Meeting (AUA 2021), September 10-13. “We 2] ERLEADA ® received U.S. DRUG INTERACTIONS.

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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The Pharma Data

NOVEMBER 4, 2020

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. About Amarin.

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Codon

MARCH 24, 2024

To make matters worse, many companies struggled with engineering problems on the path to scale. Between the technical uncertainty and the horrendous PR, pharmaceutical companies had little interest in adopting molecular farming technologies. Cirsium Bio is using plants to produce viral vectors for gene therapy.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Approximately 4,500 people in the U.S.

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The Pharma Data

FEBRUARY 8, 2021

In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained with ERLEADA ®. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. ERLEADA ® received U.S.

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The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. percent of patients in the combination arm versus 56.2 10 months. [iv]

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announces new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world.

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The Pharma Data

NOVEMBER 23, 2021

Livtencity received Breakthrough Therapy and Priority Review designations for this indication. The FDA granted the approval of Livtencity to Takeda Pharmaceuticals Company Limited. Cleveland Clinic Cytomegalovirus (CMV) CMV is short for cytomegalovirus. It’s a type of herpes contagion.

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Drug Patent Watch

DECEMBER 19, 2024

As companies invest billions in research and development, protecting their innovations through strategic patent management has become more important than ever. This comprehensive guide will explore how pharmaceutical companies can leverage their drug patent portfolios to maximize value, maintain market dominance, and drive innovation.

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