The Pharma Data

MAY 31, 2022

We look forward to continuing our collaboration with Biogen and the Parkinson’s community in our unified goal to develop BIIB122 as a potential treatment option for people and families living with Parkinson’s disease.”. BIIB122 is an investigational small molecule inhibitor of LRRK2 that was discovered and developed by Denali.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. link] [4] Licea Perez et al.,

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Drug Target Review

MAY 1, 2024

The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development. Notably, novel linker-payload technologies applied to the same target have provided significant improvements over previous generation ADCs.

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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.”. For additional information, please visit www.lexpharma.com. About LX9211.

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The Pharma Data

JANUARY 13, 2021

Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for immunological and neurological diseases of high unmet need. Knopp’s clinical-stage oral small molecule, dexpramipexole, is in Phase 2 clinical trials in moderate-to-severe eosinophilic asthma.

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The Pharma Data

DECEMBER 21, 2020

Program focused on identifying small molecules that target a GPCR for degradation as potential therapeutic agents for gastrointestinal disorders. The principle of TPD is to use small molecules to commit the target protein into the E3 ligase-mediated degradation pathway thereby eliminating or reducing its activity.

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The Pharma Data

OCTOBER 18, 2020

Dr. Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinical development for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.

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Precision for Medicine

JUNE 26, 2023

“Our partnerships are with the most innovative organizations, utilizing the most advanced, cutting-edge technologies and providing us with unparalleled experience in manufacturing small molecule, biologics and next-generation medicines,” said John Khoury, Executive Vice President at Project Farma.

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The Pharma Data

OCTOBER 27, 2020

Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC). View original content to download multimedia: [link]. SOURCE Mirati Therapeutics, Inc.

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The Pharma Data

NOVEMBER 18, 2021

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. Nasdaq GILD) and Arcus Biosciences,Inc.

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The Pharma Data

MARCH 1, 2022

” The lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. About Syndesi Therapeutics.

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The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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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 For further information, please see www.ultimovacs.com. View source version on businesswire.com: [link]. Source link.

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The Pharma Data

FEBRUARY 21, 2022

Bayer’s research and development pipeline continues to grow as the company is building on its existing competencies, such as the expertise around small molecules, while expanding into new modalities, including cell and gene therapies.

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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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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. We hope it was a useful two-parter! We’re looking forward to the next crop!

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The Pharma Data

JANUARY 13, 2021

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. This press release and further information about Tonix can be found at www.tonixpharma.com.

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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. Such work requires medical judgment and a lot of associated information to make the determination.

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The Pharma Data

JANUARY 3, 2021

The information relating to cash, cash equivalents and investments is preliminary, has not been audited and is subject to change upon completion of the audit of Calithera’s financial statements as of and for the year ended December 31, 2020. Webcast and Conference Call Information. SOUTH SAN FRANCISCO, Calif., million – $1.5

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The Pharma Data

OCTOBER 21, 2020

We look forward to advancing clinical development of KB-0742 to establish the dose, safety and efficacy of this investigational therapy as a potential treatment for MYC-amplified tumors.”. We designed KB-0742 to be an orally bioavailable CDK9 inhibitor with a differentiated selectivity profile,” said Norbert Bischofberger, Ph.D.,

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The Pharma Data

OCTOBER 26, 2020

The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S.

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The Pharma Data

JANUARY 18, 2021

For more information visit www.sorrentotherapeutics.com. for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.

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The Pharma Data

APRIL 11, 2023

These results, along with a mathematical model-informed approach have supported the currently ongoing dose expansion for BAY 2416964. In the New Drugs on the Horizon session at AACR, Bayer will present preclinical data on its novel selective diacylglycerol kinase (DGK) zeta inhibitor BAY 2965501, which is under Phase 1 clinical evaluation.

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The Pharma Data

JANUARY 11, 2021

is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. For more information on MediciNova, Inc., About MediciNova. MediciNova, Inc. please visit www.medicinova.com.

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The Pharma Data

APRIL 27, 2021

IMPORTANT SAFETY INFORMATION: Events of anaphylaxis have been reported. For complete information on the safety of COMIRNATY® always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website. Pfizer Disclosure Notice.

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The Pharma Data

NOVEMBER 22, 2020

The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. Conference Call and Webcast Information. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter , LinkedIn , Facebook and YouTube.

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The Pharma Data

MAY 7, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S. The information contained in this release is as of May 7, 2021. AUTHORIZED USE IN THE U.S.:

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The Pharma Data

SEPTEMBER 9, 2020

We routinely post information that may be important to investors on our website at www.Pfizer.com. The information contained in this release is as of September 7, 2020. The information contained in this release is as of September 7, 2020. For more information, please visit www.BioNTech.de. Pfizer Disclosure Notice.

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The Pharma Data

JULY 21, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com. IMPORTANT SAFETY INFORMATION FROM U.S. The information contained in this release is as of July 21, 2021.

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The Pharma Data

MAY 6, 2021

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com. IMPORTANT SAFETY INFORMATION FROM U.S. The information contained in this release is as of May 6, 2021.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy. Blood 2019;134(Suppl 1):3517.

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The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. The information contained in this release is as of August 20, 2020.

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The Pharma Data

DECEMBER 10, 2020

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead. The information contained in this release is as of December 10, 2020.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

NOVEMBER 20, 2020

We routinely post information that may be important to investors on our website at www.Pfizer.com. The information contained in this release is as of November 20, 2020. The information contained in this release is as of November 20, 2020. For more information, please visit www.BioNTech.de. Pfizer Disclosure Notice.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

DECEMBER 11, 2020

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine.com. With the vaccine being authorized for emergency use in the U.S., the companies will begin delivering the first doses in the U.S.

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