Clinical Development, FDA Approval, Pharmaceutical Companies and Therapies

Clinical Development

FDA Approval

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Therapies

Janssen submits EMA filing for bladder cancer treatment

Drug Discovery World

SEPTEMBER 14, 2023

Patients with mUC, including FGFR-driven tumours, face a particularly poor prognosis and the need for innovative therapies remains high. 8 On August 29, Janssen submitted a supplemental New Drug Application (sNDA) to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase III THOR study.

Treatment

Treatment Clinical Pharmacology FDA Approval Therapies

Drug discovery quarterly review: Second quarter 2023

Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. billion, a decrease of $15.0 Chris Boshoff, M.D.,

Vaccine

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Trending Sources

ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine

The Pharma Data

OCTOBER 21, 2020

21 October 2020 — ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

Clinical Development

Clinical Development Therapies Clinical Trials FDA Approval

The science of ageing and restoring healthspan

Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a commercial stage pharmaceutical company. acquired by Teva Pharmaceuticals in 2014.

Science

Science Disease FDA Approval Pharmaceutical Companies

Drug discovery hotspots: What is the secret to Switzerland’s success? (p1)

Drug Discovery World

JULY 2, 2024

They developed the molecule, which went on to become Tracleer, a blockbuster drug for pulmonary arterial hypertension (PAH), and Actelion was subsequently acquired by Johnson & Johnson for $30 million. In 2005, Glycart was acquired by the Roche Group and integrated in Roche Pharma Research and Early Development (pRED).

Science

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UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

FDA Approval

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Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

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. and CHICAGO , Oct.

FDA Approval

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. is a leading global pharmaceutical company headquartered in Japan. About Biogen. About Eisai Co.,

Clinical Trials

Clinical Trials FDA Approval Trials FDA

Cell and gene therapy – where is the innovation?

Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

Therapies

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Biopharma Money on the Move: December 2 – 8

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.

RNA

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RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

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.

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

The Pharma Data

NOVEMBER 30, 2020

It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. ” Abbreviations used: CGRP – calcitonin gene-related peptide. About Sosei Heptares.

Small Molecule

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United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

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.

FDA

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Beyond Steel Tanks

Codon

MARCH 24, 2024

Between the technical uncertainty and the horrendous PR, pharmaceutical companies had little interest in adopting molecular farming technologies. Once approved, patent-protected drugs are the highest-margin physical products on the planet—even with the high price of bioreactors. The real cost is clinical development.

Engineering

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XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

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.

Doctors

Doctors Hospitals Clinical Trials Treatment

Takeda FY2020 H1 Results Demonstrate Portfolio Resilience; Confirms Full-Year Management Guidance & Raises Forecasts for Free Cash Flow, Reported OP & Reported EPS

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 ).

Engineering

Engineering Pharmaceutical Companies Therapies Clinical Trials

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

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. Protalix’s Senior Vice President and Chief Development Officer.

Clinical Trials

Clinical Trials Disease Treatment Trials

Drug Discovery Digest

Janssen submits EMA filing for bladder cancer treatment

Drug discovery quarterly review: Second quarter 2023

Trending Sources

ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine

The science of ageing and restoring healthspan

Drug discovery hotspots: What is the secret to Switzerland’s success? (p1)

UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

Cell and gene therapy – where is the innovation?

Biopharma Money on the Move: December 2 – 8

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

United Therapeutics Receives FDA Orphan Drug Designation For Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis

Beyond Steel Tanks

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

Takeda FY2020 H1 Results Demonstrate Portfolio Resilience; Confirms Full-Year Management Guidance & Raises Forecasts for Free Cash Flow, Reported OP & Reported EPS

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

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