The Pharma Data

NOVEMBER 11, 2020

He accepted a faculty position at the University of Mississippi in 1978, rising to become the director of the school’s Research Institute of Pharmaceutical Sciences in 1986. departing in 2003 to become the chief scientific officer for Tapestry Pharmaceuticals and ChromaDex Inc. In 2009, he established Ironstone Separations Inc.,

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New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 22 October 2009. Hind M, Stinchcombe S (November 2009). Clementia Pharmaceuticals. Clementia Pharmaceuticals. 22] Ipsen acquired Clementia in 2019. [23] 20 June 2022.

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Molecular Design

OCTOBER 20, 2024

One way of doing this is to build models for predicting biological activity and other pharmaceutically relevant properties such as aqueous solubility, permeability and metabolic stability. Generally you should also validate your models and this is especially important for models with large numbers of adjustable parameters.

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New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 16] [17] The compound was first patented in 2009. [18] 21] In August 2017, it was announced that Cerecor had sold its rights to aticaprant to Janssen Pharmaceuticals. [22]

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The Pharma Data

NOVEMBER 25, 2020

Vifor Pharma Group is a global pharmaceuticals company. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. The company develops, manufactures and markets pharmaceutical products for precision patient care. 2009 Oct 7; 15(37): 4638-4643. Qual Life Res. 2000;9:491-497.

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Drug Target Review

SEPTEMBER 26, 2023

2009 Sep;14(17–18):876–84. Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies. Neurotoxicology. 2010 Aug;31(4):331–50. Easter A, Bell ME, Damewood JR, Redfern WS, Valentin JP, Winter MJ, et al. Drug Discov Today. Toxicol In Vitro.

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Drug Target Review

APRIL 8, 2024

In 2009, he became the Joseph R. Dr Cote later founded Clarient, which brought high tech diagnostic capabilities to practicing pathologists and oncologists and was acquired by GE in 2009. Coulter Jr. Chair of the Department of Pathology and Professor of Biochemistry and Molecular Biology. He is founding Director of the Dr John T.

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Hospitals Therapies Clinical Trials Molecular Biology 52

Eye on FDA

JULY 7, 2020

For some years CDER published its Guidance Agenda to include a guidance on the use of links to third party websites by pharmaceutical companies. OPDP has indicated in the past that the use of sponsored links without risk information is a no-no. This item disappeared from the agenda, however, and no draft guidance was issued.

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The Pharma Data

OCTOBER 21, 2020

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. About ViiV Healthcare.

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Molecular Design

MAY 11, 2019

While the Ro5 article highlighted molecular size and lipophilicity as pharmaceutical risk factors, the rule itself is actually of limited utility as a drug design tool. The orchids in Blanchisseuse have been particularly good this year and I’ll include some photos of them to break the text up a bit.

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Practical Cheminformatics

APRIL 3, 2023

Inspired by the MolSkill paper, David's tool displays molecules and asks the user to guess whether a molecule came from a pharmaceutical patent or a generative model. An elegant approach to this question is the synthetic accessibility (SA) score published in 2009 by Peter Ertl and Ansgar Schuffenhauer.

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New Drug Approvals

SEPTEMBER 7, 2024

Refer to WO 2004101742 A2, US 2005/0143320 Al, US 2006/0014821 Al, US 2009/0137818 Al, WO 2013049382 A2, WO 2013166319 A1, WO2018042343, WO2018023054, WO 2022013684, WO 2021252644, WO2022020711, WO 2022020242, US 11,174,231 B1, US 11,124,497 B1, WO 2005113580, and WO2006061714). Patent CN114524821A. WO2023177854 [link] Example 15.

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Metabolite Tales Blog

MARCH 1, 2023

2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 2009, 41, 157-167 [link] 19 Molecules. 2017, 30, 1, 13–37 [link] 2a Drug Metab. 2006 , 34, 145-51 [link] 3 Drug Metab. 1980, 8, 34-38 [link] 4 J. Food Drug Anal. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites. 2023, 13, 1, 92- [link] 8 J.

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New Drug Approvals

JANUARY 9, 2024

Nature Cell Biology, 11, 1275 – 1276, 2009), whilst different tumors appear to require some, but they are independent of other interphase CDKs (CDK2, CDK4 , CDK6). 27, 6012-6018, 2009; Christian et al., 3, S179-S185, 2009). Mar 23;25(6):839-50. 2007; Ganuza et al., May 30; 31(11): 2498-510, 2012).

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Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Agency IQ

JANUARY 19, 2024

These four are the Persistent Organic Pollutants Regulation (2019/1021/EU), the Medical Devices Regulation (2017/745/EU) , the Regulation establishing the EEA (401/2009/EC), and the General Food Law Regulation establishing EFSA (178/2002/EC). Chemical information stemming from Union legislation will be included.

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products. Any CMC changes (e.g.,

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Drug Target Review

JUNE 21, 2023

An example is Vertex Pharmaceuticals’ approved treatment for cystic fibrosis (Kalydeco) 6 , which counteracts the outcome of a specific mutation thereby stabilising the defective CTFR protein, and restoring proper pulmonary function. 2009 Nov 27;326(5957):1231-5. doi: 10.1126/science.1178955. PMID: 19965467. Elliott, M.

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New Drug Approvals

SEPTEMBER 29, 2024

In January 2023, Quince put out word that it had sold Cortexyme’s legacy small molecule protease inhibitor portfolio to Lighthouse Pharmaceuticals, a company co-founded by a former Cortexyme CEO ( press release ). 2009 Mar;77(3):1246-61. Periodontitis has been linked epidemiologically to cognitive impairment, and P. Infect Immun.

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

2009 ; Perneger, Giner, del Rio, & Mino, 1998 ; Strang et al., intervention expense (costs of pharmaceutical product, staff and facilities for supervised consumption); 3. Despite a robust international evidence base for the social and health benefits of HAT ( Haasen et al., 2010 ; van den Brink et al., patient safety (i.e.

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The Pharma Data

FEBRUARY 22, 2022

Antoine Yver took over in 2021 as Chief Medical Officer of Centessa Pharmaceuticals, Inc. From 2009 to 2016, he led global oncology development at AstraZeneca, delivering TAGRISSO and LYNPARZA, including Senior Vice President, GMD Head of Oncology and Lead, China GMD (2013-2016).

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The Pharma Data

AUGUST 19, 2021

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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The Pharma Data

DECEMBER 18, 2020

This commitment is evidence that the world learned an important lesson from the 2009 H1N1 pandemic. Our research and development efforts have begun to pay off. Equitable global access, inclusive of lower income countries, is critical to helping end the COVID-19 pandemic.”.

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Agency IQ

JULY 5, 2023

The AWIA, section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS. The Agency is now reconsidering that action.

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LifeSciVC

APRIL 27, 2023

Chapter 1 – An Unreasonable Idea The year was 2009. Our small team was able to support multiple major pharmaceutical companies plowing through diligence, not just withstanding the onslaught but in fact delivering a data package of Phase 3-ready quality. Barack Obama had just been sworn in as the 44 th president.

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Broad Institute

MAY 14, 2024

His T7 expression technology can be used to make large quantities of nearly any RNA or protein and has been for decades, and continues to be, a mainstay of biomedical research and pharmaceutical production. There’s not a single molecular biology or biochemistry lab I know that doesn’t use T7.” and around the world.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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The Pharma Data

DECEMBER 3, 2020

About Takeda Pharmaceutical Company Limited. Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Minerva Med.

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Drug Patent Watch

JANUARY 14, 2025

In the fast-paced world of pharmaceuticals, negotiations play a pivotal role in shaping the industry’s landscape. Let’s dive into the intricacies of pharmaceutical negotiations, exploring valuable lessons, current trends, and strategies for success.

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The Pharma Data

MAY 4, 2021

In December 2009 , Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. See the full Prescribing Information here.

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Agency IQ

JUNE 16, 2023

The AWIA, section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic.

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The Pharma Data

OCTOBER 29, 2020

In December 2009 , Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

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Agency IQ

SEPTEMBER 29, 2023

2009-AA05 Revisions to Standards for the Open Burning/Open Detonation of Waste Explosives Proposed Rule Stage This rulemaking will consider revisions to the regulations that allow for the open burning and detonation (OB/OD) of waste explosives. Comite Progreso de Lamont v. Cal, 21-cv-08733).

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Other stimulants excluding synthetic piperazines and cathinones were found in one-quarter (25 %) of drug items overall but peaked from 2006–2009 when they were detected in the majority (52–78 %) of samples. Pharmaceuticals (5 %) and supplements (4 %) appeared consistently as adulterants, but their prevalence has generally declined over time.

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