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.

Drugs

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.

FDA

The Pharma Data

JULY 29, 2021

Kumquat brings together an accomplished team and distinguished scientific founder with a proven track record of innovative oncology drug discovery and development. The company was launched in 2019 and has raised over $100 million from OrbiMed, Sequoia Capital China, EcoR1, Lilly Asia Ventures, and Roche Venture Fund.

Small Molecule

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.

Treatment

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.

Drugs

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.

Clinical Trials

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.

Pharma Companies

The Pharma Data

DECEMBER 21, 2020

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

Therapies

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.

FDA

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.”

FDA Approval

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.

FDA

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. . .

Compliance

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.

Clinical Development

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.

Production

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.

Pharma Companies

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.

Clinical Trials

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

Clinical Trials

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.

Treatment

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.

Disease

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.

Therapies

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.,

Drugs

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.

Clinical Development

The Pharma Data

NOVEMBER 4, 2020

million as of December 31, 2019. Research and development expenses were $16.3 million for the same period in 2019. The increase in research and development expenses relates primarily to the ongoing Phase 2 clinical trial of CTP-692. million for the same period in 2019. 2019.

Pharmaceuticals

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.

Vaccine

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.

Clinical Trials

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.

Pharmaceuticals

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.,

Therapies

The Pharma Data

MARCH 23, 2021

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer now possesses the exclusive rights to develop and commercialize larotrectinib worldwide, and also has exclusive rights to the investigational TRK inhibitor selitrectinib (BAY 2731954) which is currently in clinical development.

Treatment

The Pharma Data

OCTOBER 18, 2020

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. References: 1. European Medicines Agency. emc/medicine/34321.

Treatment

The Pharma Data

MARCH 16, 2021

We are excited to embark on this partnership with Boehringer Ingelheim to identify potential therapeutic candidates and advance them to clinical development in order to help improve the lives of those affected by this serious mental health condition.”. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros.

Licensing

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.

Clinical Trials

The Pharma Data

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. AR-301 (VAP). aureus) alpha-toxin in VAP patients. AR-101 (HAP).

Pharmaceuticals

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.”.

Trials

The Pharma Data

MAY 16, 2022

Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible. “We Today’s news brings us one step closer to our goal of offering therapeutic options for the diverse communities affected by HIV as we work to end the epidemic for everyone, everywhere.”.

Treatment

The Pharma Data

AUGUST 7, 2020

Results included global public and private financing from regenerative medicine and advanced therapy developers, and highlighted a 120 per cent increase over the first half of 2019. The ARM report also showcased robust pipelines of therapies targeting indications in cancers, infectious diseases and inherited disorders.

Clinical Trials

The Pharma Data

OCTOBER 28, 2020

Examples of forward-looking statements in this press release include, among others, statements about the expected timing and results of our ongoing and future clinical trials and our expectations regarding the potential benefits, activity and effectiveness of our product candidates. Source link.

Clinical Trials

The Pharma Data

NOVEMBER 18, 2021

Senior Vice President, Early Clinical Development, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ in 2019, is a preclinical- stage medicine discovery company that’s working to develop curatives by targeting complaint-causing recap factors (TFs). About This Time’s Winning Companies.

Molecular Biology