The Pharma Data

JANUARY 26, 2021

As CMO, Dr. Short will be responsible for overseeing the clinical development of VarmX’s pipeline, including progression of its lead product, VMX-C001, into clinical proof of concept and registrational studies. Gerard Short, MBBS, as Chief Medical Officer (CMO). Notes to Editors. About VarmX.

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The Pharma Data

MARCH 2, 2021

This new collaboration builds on the positive experience from previous partnerships with Gubra and combines Gubra’s proprietary streaMLine platform and expertise in obesity and peptide chemistry with Boehringer Ingelheim’s expertise in lead optimization and clinical development. population will have obesity. About Boehringer Ingelheim.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

2016 Jun 1;8(341):341ra76. [3] 2016 March 4. [5] 5] Clinical development success rates for investigational drugs. December 2008. [2] 2] A genomic approach to therapeutic target validation identifies a glucose-lowering GLP1R variant protective for coronary heart disease. Sci Transl Med. 2012 Jul 6;337(6090):100-104. [4]

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The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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The Pharma Data

JUNE 19, 2023

The findings bolster the idea, which is currently under investigation in at least three clinical trials, that when it comes to treating resistant breast cancer, two drugs may be better than one. Spencer’s lab took pictures of living ovarian and breast cancer cells every 15 minutes over the course of two days.

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The Pharma Data

MAY 31, 2022

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

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The Pharma Data

JANUARY 13, 2021

This press release contains “forward-looking statements,” including statements relating to planned regulatory filings and clinical development programs. These investigational drug products are still undergoing pre-clinical or clinical study to verify their safety and effectiveness. 2016 Sep;150(3):485-7.

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The Pharma Data

NOVEMBER 18, 2021

Senior Vice President, Early Clinical Development, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ The winners are RADD Pharmaceuticals and Rubik Rectifiers (LabCentral, Cambridge, MA), Waypoint Bio (BioLabs@NYULangone, New York, NY) and Altay Rectifiers and VastBiome (MBC BioLabs, San Francisco Bay Area, CA).

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Drug Target Review

JULY 1, 2024

He is spearheading the scientific and clinical development and fundraising of South Rampart Pharma and technology development efforts. was founded in 2016 to develop safer, non-opioid therapies for acute and chronic pain. Dr Bazan is the CEO and Co-founder of South Rampart Pharma, Inc. South Rampart Pharma, Inc.

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The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. “We are excited by this opportunity and look forward to disclosing our strategy for the further development and re-partnering of this program at around the time of our full year results in February 2021.”

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The Pharma Data

MARCH 23, 2021

STEP ( S emaglutide T reatment E ffect in P eople with obesity) is a phase 3 clinical development programme with once-weekly subcutaneous semaglutide 2.4 The global clinical phase 3a programme consists of four trials and has enrolled approximately 4,500 adults with overweight or obesity. mg in obesity. Source link:[link].

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The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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The Premier Consulting Blog

OCTOBER 21, 2024

The 2022 FDORA Omnibus Act, enacted on December 29, 2022, further solidified this shift by making confirmatory trials a key component of the clinical development plan, contrasting with earlier practices where they were often a post-approval requirement.

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The Pharma Data

NOVEMBER 19, 2020

2016), 59, 6595-6628. We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR ® technology and structure-based drug design platform capabilities. References. Hilgenfeld, Febs J. 2014), 281, 4085-4096. Pillaiyar, et al, J.

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Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Drug metabolism and drug transport of the 100 most prescribed oral drugs. Basic Clin Pharmacol Toxicol. 131(5): 311- 324. link] [3] FDA prescribing information for daprodustat. link] [4] Licea Perez et al.,

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The Pharma Data

DECEMBER 15, 2020

The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA ® and BioLineRx was the study sponsor and owns all rights to motixafortide. Kenilworth, N.J. ,

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The Pharma Data

DECEMBER 13, 2020

1 Prevalence of type 2 diabetes in patients with NASH estimated to be 47%; approximately 26% of T2DM patients have NASH; clinical and economic burden of NASH in T2DM greater than with either disease alone (Younossi ZM et al, Hepatology 2016, 64, 73–84; Cusi K, Diabetes Care 2020, 43:275-79; Younossi ZM et al, Diabetes Care 2020, 43:283–89.

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The Pharma Data

DECEMBER 15, 2020

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration.

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Agency IQ

SEPTEMBER 15, 2023

In August 2016, the CHPA provided a lengthy comment asserting, essentially, that the petitioners had already sought relief in its earlier petition and that the Nonprescription Drugs Advisory Committee (NDAC) had addressed the concerns raised again in this latest petition.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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LifeSciVC

APRIL 27, 2023

By the time Chapter 1 was nearing its end, Project Troubled Water, then Nimbus Discovery, became Nimbus Therapeutics as we took a further step to forward integrate into clinical development. We kept 5% of the Gilead deal proceeds in 2016 in the hopes we could span our way to a next BD deal in our pipeline – and we did!

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The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. 7,8,9,10,11. Saphnelo is under regulatory review for SLE in the EU and Japan.

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The Pharma Data

FEBRUARY 22, 2022

Then, she served on the Board of Directors of Capgemini for two years (2016-2018) before being appointed to her current position as Group CFO. He began his oncology development career at Rhône Poulenc Rorer Inc. In 1999, he joined the Aventis Group as Senior Director, Oncology Global Clinical Development.

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The Pharma Data

OCTOBER 19, 2020

The appointments of Maarten and Teun come at an essential time for AM-Pharma as we finalize all preparations to move into the last stage of clinical development for our lead program,” said Erik van den Berg , Chief Executive Officer at AM-Pharma. USA) from the period of 2006 to 2016. Kenilworth, N.J.,

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The Premier Consulting Blog

JUNE 18, 2023

This reflects the FDA’s long history of reviewing submissions that implement CM&S across a broad range of areas, including quantitative clinical pharmacology, dose-response modeling, benefit-risk assessment, complex innovative designs and disease modeling/trial simulation.

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The Pharma Data

JUNE 26, 2021

From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO ® and its potential role in addressing critical unmet medical needs.

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The Pharma Data

NOVEMBER 22, 2020

With Cytokinetics’ consent, Amgen granted a sublicense to Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) to commercialize omecamtiv mecarbil in Europe and the Commonwealth of Independent States, including Russia.

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Drug Target Review

DECEMBER 28, 2023

His research unveiled the critical role of Fc receptors and the tumour microenvironment in the mechanism of action of anti CTLA-4 antibodies, and he is an inventor of several key patents supporting the clinical development of antibodies targeting immune checkpoints.

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The Pharma Data

JANUARY 24, 2021

” About Elasmogen: Spun-out from the University of Aberdeen, Scotland in 2016, Elasmogen is developing soloMERs ; fully humanized (or de-immunised) VNAR, as next generation, single chain therapeutics for auto-inflammatory diseases, oncology and intracellular delivery.

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Agency IQ

DECEMBER 11, 2023

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

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Codon

MARCH 24, 2024

The real cost is clinical development. In 2016, a company called Synageva BioPharma (formerly AviGenics) was acquired by Alexion for $8.4B. Between the technical uncertainty and the horrendous PR, pharmaceutical companies had little interest in adopting molecular farming technologies. Why rock the boat?

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Agency IQ

JUNE 28, 2024

That said, FDA has not done nothing in 2024 related to clinical trial diversity. In January 2024, the FDA updated a 2016 guidance on the Collection of Race and Ethnicity Data. The new DAP guidance goes into more detail about research programs with “several clinical studies” that are subject to DAP requirements.

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The Pharma Data

JULY 6, 2021

GSK has built an industry-leading and high-performing Vaccines business, which has increased revenues from £4.6billion in 2016 to £7.0billion in 2020, and is expected to deliver high single digit % sales CAGR in 2021-26.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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Drug Target Review

NOVEMBER 30, 2023

Our investigational active immunisation therapies could potentially delay or perhaps even prevent the onset of clinical dementia symptoms. We – as a team – are very proud to be advancing these products, three of which are in mid- to late-stage clinical development. billion plus additional royalties.

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Agency IQ

AUGUST 2, 2024

The Office of the National Coordinator for Health Information Technology, which has been historically known as ONC, is the federal entity that oversees many of the health information technology (IT) products that are carved out of FDA’s authority under the provisions of the 2016 21 st Century Cures Act.

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