The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. Sometimes a degradant presents unexpectedly after GLP toxicology studies are completed or are underway.

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The Pharma Data

APRIL 6, 2021

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. In addition, preclinical data on the synergistic antitumor effect of radium-223 dichloride and enzalutamide will be presented.

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The Pharma Data

NOVEMBER 11, 2020

“These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Viruses work by infecting host cells and hijacking the cell’s replication machinery.

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The Pharma Data

JANUARY 13, 2021

Knopp expects to present results of the trial at a forthcoming medical meeting. Clinical trials for approved eosinophil-depleting drugs have shown that drugs that reduce eosinophil counts provide significant benefit for reduction in asthma exacerbations in patients with moderate-to-severe eosinophilic asthma. study centers.

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Drug Target Review

DECEMBER 13, 2024

1 Lung cancer is primarily classified into two types based on histological examination: Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC). These types differ in their etiology, natural history, and present distinct challenges in disease management. percent of total cancer fatalities.

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LifeSciVC

APRIL 2, 2024

The science presents an opportunity and a challenge for us at Sionna. For years, NBD1 was considered “undruggable”, but Sionna could be on the verge of a breakthrough with four programs in or entering the clinic this year leveraging years of experience and knowledge to crack the code on NBD1.

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The Pharma Data

JANUARY 10, 2021

IDE397 is being developed as a potential best-in-class MAT2A inhibitor for MTAP-deletion, which is prevalent in approximately 15% of all solid tumors. IDE397 program update to be presented at the 39th Annual J.P. IDEAYA’s presentation for the 39 th Annual J.P. SOUTH SAN FRANCISCO, Calif. ,

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Drug Target Review

JULY 11, 2023

Spending a couple of years practicing on the wards around London, and then moving into management consulting at McKinsey & Company which led her to work in pharmaceutical research and development (R&D). She also co-founded and sits on the Board of Directors of Sevenless Therapeutics, a small molecule pain company.

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In

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The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We

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The Pharma Data

OCTOBER 14, 2020

Live Webcast : accessible from the Company’s website at www.eloxxpharma.com under Events and Presentations or with this link: [link]. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. Conference ID : 9467336.

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LifeSciVC

MARCH 1, 2023

Importantly, they also pointed to something that we at HotSpot Therapeutics and a small group of other researchers and companies recognized several years ago – that scientific advances have made this attractive, but once considered ‘undruggable,’ target druggable.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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The Pharma Data

NOVEMBER 10, 2020

11, 2020 (GLOBE NEWSWIRE) — Calithera Biosciences, Inc. , (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced its participation at two upcoming healthcare investor conferences in November.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Presentation at J.P. Pipeline Updates.

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The Pharma Data

JANUARY 7, 2021

ONC201 is currently in a registrational clinical trial for recurrent H3 K27M-mutant glioma and a confirmatory response rate assessment is expected in 2021. FACP and all the employees at Oncoceutics in developing a therapy for patients for which there is no available treatment.”. scientific founder Wafik El-Deiry, M.D.,

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Molecular Design

JUNE 8, 2023

My view is that the data analysis presented in L2021 has minimal relevance to drug discovery so I’ll be saying rather less about the data analysis than I’d have done had J Med Chem asked me to review the study. Let’s take a look now at how the authors of L2021 suggest their study be used.

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The Pharma Data

JANUARY 18, 2021

A live webcast of this presentation will be available for registered participants at: [link]. This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. Riley Securities Oncology Investor Conference being held virtually.

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Alta Sciences

APRIL 17, 2024

They work by binding to specific sequences of nucleotides present within the mRNA structure and can induce mechanisms that either decrease, restore, or modify protein expression. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinical development. Asia, and Europe.

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Advarra

FEBRUARY 24, 2023

In short, FDA is acknowledging this is complex area, so make sure all clinical development and biostatistical experts are well-versed on how to design these types of trials to ensure startup and/or regulatory approval is not delayed.

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The Pharma Data

JANUARY 3, 2021

Calithera will submit the CANTATA results for presentation at a medical meeting. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. SOUTH SAN FRANCISCO, Calif., Exelixis, Inc. Eastern Time / 5:30 a.m.

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The Pharma Data

OCTOBER 14, 2020

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Relative to vaccinia, horsepox has substantially decreased virulence in mice 1. 1 Noyce RS, et al. 2018) PLoS One.

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Agency IQ

JUNE 9, 2023

However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development.

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The Pharma Data

AUGUST 29, 2020

Basel, August 29, 2020 — Novartis today announced new Phase II data for LNP023, an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the virtually held 2020 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting. Blood 2019;134(Suppl 1):3517. 3. Schubart A, et al.

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

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The Pharma Data

NOVEMBER 4, 2020

New CTP-543 Data Presented in Late-Breaking News Session at EADV 2020. Initial data from an ongoing long-term, open label extension study with CTP-543 were presented in the late-breaking news session at the European Academy of Dermatology and Venereology (EADV) Virtual Congress on October 29, 2020. .

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The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. Results will be presented at the virtual CHEST Annual Meeting this weekend.

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The Pharma Data

SEPTEMBER 15, 2020

New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

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The Pharma Data

NOVEMBER 22, 2020

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining.

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The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. The presentation will be available at astrazeneca.com before the call takes place, and replay details after the call.

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The Pharma Data

OCTOBER 26, 2020

Merck presented results from the pivotal Phase 3 KEYNOTE-590 trial for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

DECEMBER 27, 2020

Looking ahead, we believe the field of cell therapy will experience years of rapid growth, especially in conditions for which small molecules or antibodies have failed, such as dry AMD and spinal cord injuries. An additional objective this year will be to build greater awareness for our past achievements and our future plans.

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The Pharma Data

DECEMBER 27, 2020

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.

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Agency IQ

DECEMBER 11, 2023

OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. months, according to the GSK presentation.

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Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Any CMC changes (e.g.,

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The Pharma Data

OCTOBER 28, 2020

This expansion provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas. Press release ). Press release ). Press release , website ). Press release ).

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The Pharma Data

APRIL 7, 2021

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. XELJANZ has been studied in more than 50 clinical trials worldwide and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last eight years. About Abrocitinib. INDICATIONS. Rheumatoid Arthritis.

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