The Pharma Data

JANUARY 6, 2021

With the IND approval, UNION is granted permission to advance oral orismilast into Phase 2b trials in humans with moderate to severe plaque psoriasis to evaluate the safety and efficacy of orismilast. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

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The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. The ASCO GI presentation slides are available on the company’s website.

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Drug Discovery World

OCTOBER 16, 2023

CellProthera selected the UK centres for their excellence in the conduct of clinical research with dedicated staff, equipment, availability of imaging platforms and high interest in cell therapy cardiovascular trials especially University Hospital of Birmingham equipped with a bi-plane Cathlab.

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The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Toronto, Ontario–(Newsfile Corp. – January 25, 2021) – PharmaDrug Inc.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Drug Discovery World

JANUARY 12, 2023

Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials. . Following the launch of Protas, DDW spoke with Protas Chief Executive, Professor Sir Martin Landray, who echoed Cooper’s emphasis on the importance of clinical trial design.

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Drug Discovery World

AUGUST 8, 2022

DDW Editor Reece Armstrong speaks to Stephanie Seremetis, Chief Medical Officer, Rare Blood Disorders at Novo Nordisk to get her response to the company’s latest study results for its Mim8 antibody. We look forward to moving into phase 3 clinical development, which is due to commence in Q4 2022.

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Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. The FDA plans to launch Operation Warp Speed for Rare Diseases in 2023 with a focus on increased communication between the agency and drug and biotech companies. Research sites without access to an IBC may consider relying on a commercial IBC.

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Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. This phase is typically executed by private biotech labs and/or contract research organizations, funded by venture capital and/or pharma balance sheets.

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The Pharma Data

OCTOBER 27, 2020

Molecular Partners, a global leader in the development of DARPin® therapeutics, will be responsible for the conduct of phase 1 & 2 trials that may lead to emergency use approval; Novartis will be responsible for further development, manufacturing, distribution and commercialization.

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The Pharma Data

JUNE 26, 2021

RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. About EXPLORER The EXPLORER clinical research program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition.

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Doctors Hospitals Clinical Trials Treatment 52

The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. AOP anticipates new opportunities in Austria as a hub for research and business. All jobs have been maintained and the workforce has grown from about 220 to 350.

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