FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan.

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The Pharma Data

JANUARY 4, 2021

Rothenberg took over as Pfizer CMO in January 2019, but spent more than 12 years in total working for the pharmaceutical giant. From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products.

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The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

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Drug Target Review

NOVEMBER 15, 2024

As Novo Nordisk UK’s head of clinical development during the COVID pandemic, I led our efforts in the UK to ensure research continuity in metabolic diseases amidst a global focus on COVID-19. The disruptions caused by the pandemic transformed how research was conducted.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Back in 2019, he was working in full-service ophthalmology when he learned he was going blind due to a rare and orphan disease called Wolfram syndrome. Canary Advisors recommends including patient advisory boards, which a sponsor, CRO, or patient advocacy organization can create in the early stages of clinical development.

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The Pharma Data

OCTOBER 31, 2020

With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD in 2019 and is estimated to reach 5.03 Currently the market is comprised primarily of the neuraminidase inhibitor oseltamivir and the newly developed endonuclease inhibitor baloxavir. in the near future.”

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

NOVEMBER 23, 2020

The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. . .

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The Pharma Data

JANUARY 21, 2021

Securities and Exchange Commission (“SEC”) on November 27, 2019, amended on December 18, 2019 and declared effective on December 20, 2019 and an additional registration statement on Form S-3 (File No. The gross proceeds of the offering are expected to be approximately $100.0 333-235297) that was filed with the U.S.

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Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. 2019 May 22;10:1078. She has established a track record as a successful leader and entrepreneur in the biotech industry. Frontiers in Immunology.

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The Pharma Data

JANUARY 25, 2021

. “This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. ” About Photocure ASA.

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The Pharma Data

JUNE 2, 2022

Per 2019 agreement, Bristol Myers Squibb to also add one additional autologous TCR-T target where Immatics will receive an upfront payment of $20 million and be eligible for milestone payments and royalties.

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The Pharma Data

JANUARY 20, 2021

The securities are being offered pursuant to a registration statement that was filed with the Securities and Exchange Commission (“SEC”) on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019.

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The Pharma Data

JANUARY 3, 2021

InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs, such as TLC19 for the treatment of Coronavirus disease 2019 (COVID-19) as well as other programs for severe acute and chronic pulmonary diseases.

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The Pharma Data

JUNE 2, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 About MAPSTM technology platform.

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The Pharma Data

MAY 31, 2022

A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. billion to be paid upon the achievement of certain paediatric clinical development milestones. The consideration for the acquisition comprises an upfront payment of $2.1 MAPS TM technology platform.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. Sci Rep 9, 18911 (2019). References Hingorani, A.D.,

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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. Financial terms of the new agreement are not disclosed.

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The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. (Alume) announced today that it has been awarded a $2.5M

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The Connected Lab

APRIL 8, 2020

“A Tough Road: Cost To Develop One New Drug Is $2.6 Billion; Approval Rate for Drugs Entering Clinical Development Is Less Than 12%.” 2019, Freedman, David H. 7787, 2019, doi:10.1038/d41586-019-03846-0. 2019, blog.benchsci.com/pharma-companies-using-artificial-intelligence-in-drug-discovery. Nature , vol.

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Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. 2019 Mar 1;55:93–100. Toxicol Sci.

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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Science Translational Medicine, 2019 Researchers continue to produce impressive miniature human tissues that resemble the structure of a range of human organs, including the livers, kidneys, hearts, and even the brain. 2019 Jun 19;11(497). [2] 2] Clinical development success rates for investigational drugs.

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The Pharma Data

JANUARY 27, 2021

As a clinician, healthcare administrator, biotech entrepreneur and venture capital investor, Steve’s leadership and breadth of experience in the clinical development of cell and gene therapies will be invaluable to PlateletBio as we progress our cell therapy platform into the clinic later this year,” said Sam Rasty, Ph.D.,

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The Pharma Data

OCTOBER 15, 2020

ASLAN believes ASLAN003 has the potential to bethe most potent oral inhibitor of DHODH currently in development for autoimmune disease, more than 30 times more potent at inhibiting the DHODH enzyme than teriflunomide. In 2019, ASLAN completed a Phase 2 study testing ASLAN003 in AML. SINGAPORE, Oct.

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The Pharma Data

JANUARY 26, 2021

27, 2021 /PRNewswire/ — BenevolentAI today announced that the biopharmaceutical company AstraZeneca has selected a novel chronic kidney disease (CKD) target to advance to its drug development portfolio, making it the first AI-generated target from the collaboration to enter the Company’s portfolio. . LONDON , Jan.

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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. billion during 2019-2023 (Technavio 2019). References: Bailly, C.,

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Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. According to an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinical development in the U.S.A., Asia, and Europe.

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The Pharma Data

MARCH 5, 2021

Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

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The Pharma Data

DECEMBER 14, 2020

The shares of common stock described above are being offered by the Company pursuant to its automatically effective shelf registration statement previously filed with the SEC on September 5, 2019.

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The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. ” About Ascentage Pharma. Ascentage Pharma (6855.HK)

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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 Ton Berkien joins Ultimovacs with over 15 years of experience in strategic business development and corporate finance in the biopharmaceutical industry.

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The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We The NDA was resubmitted on May 2020. We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.

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The Pharma Data

OCTOBER 19, 2020

She is executive medical director of immunology clinical development for the pharmaceutical company AbbVie in North Chicago, Ill. “Upadacitinib has shown superiority to one of the current standard-of-care treatment options in the clinic for these difficult-to-treat patients,” Pangan said. ” Rinvoq received U.S.

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The Pharma Data

AUGUST 6, 2020

China has several home-grown COVID-19 vaccines in clinical development. Clover Biopharmaceuticals has an S-Trimer subunit vaccine candidate, SCB-2019 , which is being evaluated with two adjuvant systems by GlaxoSmithKline and Dynavax in phase 1 study, with results expected this month.

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Metabolite Tales Blog

JANUARY 26, 2023

Likely linked to this are the scaffolds taken through to clinical developed, since a feature common to the vast majority of CYP2D6 substrates is a basic nitrogen atom and a planar aromatic ring that need to fit in a rather buried active site, compared to the larger and more flexible active site of CYP3A4. link] Maréchal et al.,

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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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