New Drug Approvals

SEPTEMBER 8, 2024

2007.05.007 Drug Discovery, Johnson and Johnson Pharmaceutical Research and Development, LLC, 8 Clarke Drive, Cranbury, NJ 08512, USA Scheme 1. Seladelpar works to block bile acid synthesis. 1] Clinically, Seladelpar reduces pruritus and IL -31 in patients with primary biliary cholangitis. [6] 2007 Jul 15;17(14):3855-9. doi: 10.1016/j.bmcl.2007.05.007.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. This provision would prevent timely IPR challenges of pharmaceutical patents, and would chill the feasibility of such IPR challenges altogether.

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The Pharma Data

JANUARY 5, 2021

Renal Data System to the electronic health records of a large dialysis provider to identify 45,591 adult patients with Medicare Parts A and B who initiated dialysis (2006 to 2011) without previously recognized PAD. Two authors disclosed financial ties to the pharmaceutical industry. © 2021 HealthDay. All rights reserved.

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The Pharma Data

DECEMBER 14, 2020

Patient postoperative 30-day mortality was examined for surgeries performed on surgeons’ birthdays versus other days of the year among patients undergoing one of 17 common emergency surgical procedures in 2011 to 2014. One author disclosed financial ties to the pharmaceutical industry. The researchers found that 0.2

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Hospitals Pharmaceuticals Research 52

The Pharma Data

OCTOBER 29, 2020

Wiggs, from Indiana University in Bloomington, and colleagues used Swedish-registry data to examine the risks for ASD and ADHD in 14,614 children born from 1996 to 2011 to women with epilepsy. One author disclosed financial ties to the pharmaceutical industry. Abstract/Full Text (subscription or payment may be required).

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The Pharma Data

NOVEMBER 2, 2020

The analysis included 3,000 participants with 24-hour ambulatory BP monitoring (ABPM) and 17,969 participants in the 2011-2016 National Health and Nutrition Examination Survey without ABPM. Several authors disclosed financial ties to the pharmaceutical industry. adults was 18.8 percent (44.4 million U.S. percent (53.7 million U.S.

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Pharmaceuticals Treatment Disease Research 52

Drug Target Review

NOVEMBER 1, 2023

2011) D67, 386-394) using PDB ID 4GV1 which was published as part of Addie et al. Capivasertib originated from a collaboration between my former company Astex Pharmaceuticals and the ICR and was further developed by AstraZeneca. Capivasertib (orange) bound to the kinase domain of AKT (blue). Acta Cryst. 2013) 56, 2059-2073.

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Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

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. April 2011). Kaplan FS, Shore EM (April 2011). Clementia Pharmaceuticals. Clementia Pharmaceuticals. 22] Ipsen acquired Clementia in 2019. [23] 23] SYN Desjardins, C.,

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FDA Clinical Trials Treatment Pharmaceuticals 52

The Pharma Data

OCTOBER 14, 2021

Teva Pharmaceuticals Europe BV, a European chapter of Teva Pharmaceutical DiligenceLtd. About Teva Teva Pharmaceutical DiligenceLtd. Around 200 million people around the world take a Teva drug every day and are served by one of the largest and most complex force chains in the pharmaceutical assiduity. Danilo LemboM.D.

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Treatment Pharmaceuticals Hospitals Production 52

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. ” Health Affairs, 2011. Understanding Generic Drugs: The Basics Before diving into educational strategies, let’s refresh our understanding of generic drugs and their importance in healthcare. Shrank, W.H.,

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Drugs FDA Doctors Trials 68

Drug Target Review

JUNE 19, 2024

Also, many companies never reached the point where they received validation from big pharmaceutical companies. MSTX), from 2010, and was also a member of its board of directors from 2011, until Mast’s merger with Savara, Inc. Mr Culley served on the Board of Orphagen Pharmaceuticals, Inc. SVRA) in April 2017.

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Sygnature Discovery

OCTOBER 9, 2024

Since 2011, Sygnature Discovery has delivered over 40 novel pre-clinical and 25 clinical compounds, with its scientists named on over 170 patents. Additional sites are located in Alderley Park, Macclesfield, and Glasgow (UK), as well as Montreal and Quebec City (Canada).

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Science Disease Research Pharmaceuticals 52

Policy Prescription

MARCH 11, 2022

The focus of this post is to simply show that the accused parties did not disregard patient safety in the manner that the pharmaceutical industry sought to portray. . clinics in 2011. Kris Thorkelson never pled guilty to selling counterfeit drugs. Kris Thorkelson never pled guilty to selling counterfeit drugs. I don’t think he did.

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Online Pharmacies Pharmacy FDA International 52

The Pharma Data

NOVEMBER 5, 2020

X4 Pharmaceuticals – Art Taveras was named CSO of Cambridge, Mass.-based Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Venugopal most recently served as executive director at Intercept Pharmaceuticals.

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Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

JANUARY 20, 2021

Franchi served as the Chief Financial Officer for Merrimack Pharmaceuticals where she streamlined financial operations while strengthening the balance sheet. Prior to Merrimack, Ms. Franchi also served as Chief Financial Officer at Good Start Genetics and subsequently at Dimension Therapeutics, Inc. Before these roles, Ms.

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Treatment Pharmaceuticals Drug Development Science 40

NIH Director's Blog: Drug Development

FEBRUARY 4, 2014

After some additional studies to validate that PCSK9 is a solid target, a half-dozen pharmaceutical firms are now racing to develop drugs that lower cholesterol by blocking this protein [2]. References: [1] Trial watch: phase II and phase III attrition rates 2011-2012. Arrowsmith J, Miller P. Nat Rev Drug Discov. 2013 August. [2]

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The Pharma Data

JULY 22, 2021

Teva Pharmaceutical Industries Ltd. In 2011, he transitioned to the role of Chief Operating Officer in a joint venture formed by Teva and P&G focusing on both companies’ global OTC businesses. NYSE and TASE: TEVA) today announced changes to its leadership team.

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International Marketing Pharmaceuticals Engineering 52

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] 2] It first appeared in the scientific literature in 2010 or 2011. [16] 2] It first appeared in the scientific literature in 2010 or 2011. [16] December 2011).

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Karydas is chief financial officer at Syndax Pharmaceuticals. Sucampo Pharmaceuticals and Histogenics Corporation.

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The Pharma Data

NOVEMBER 4, 2020

Thoresen is an experienced leader with an impressive track record in a wide range of executive management roles in the pharmaceutical industry. Mr. Thoresen holds a law degree from the top-ranked University of Oslo and core competencies in strategy and organizational development, operational execution, and industry and government relations.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. Stages of process validation Process validation involves three distinct stages as described in the 2011 FDA guidance, “Process Validation: General, Principles and Practices.”

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Small Molecule Drugs FDA Production 52

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

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Sygnature Discovery

JULY 31, 2023

Founded in 2011, NuChem Sciences delivers expert integrated and standalone discovery solutions across medicinal, synthetic, scale-up, process and computational chemistry, as well as DMPK, in vitro biology and in vivo pharmacology.

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Computational Chemistry Science Pharmaceutical Companies Clinical Trials 52

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. June 2011). June 1992).

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FDA Clinical Trials Treatment Trials 62

New Drug Approvals

JANUARY 31, 2024

71(20), 6503-6513, 2011). Opevesostat ODM208 2231294-96-3 Chemical Formula: C21H26N2O5S Molecular Weight: 418.508 2-[(1,3-dihydro-2H-isoindol-2-yl)methyl]-5-{[1-(methanesulfonyl)piperidin-4-yl]methoxy}-4H-pyran-4-one Opevesostat tosylate 2832831-08-8 Molecular Formula C 21 H 26 N 2 O 5 S.C 7 H 8 O 3 S Molecular Weight 590.71

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Therapies Disease Treatment Production 52

New Drug Approvals

SEPTEMBER 9, 2024

2011), (253 mg, 558 μmol) dissolved in dry THF (1 mL) was added dropwise over 10 min. Arbemnifosbuvir, AT-752, 1998705-63-7, PD160572 E9V7VHK36U INN 12706 C 24 H 33 FN 7 O 7 P 581.5 CN113784721 US20160257706 WO2022076903 US10874687 PATENT US20160257706 [link] Example 1. The reaction mixture was cooled down to 0° C. Rachakonda, S.,

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Production Pharmaceuticals 62

Common Sense for Drug Policy Blog

JUNE 6, 2024

Underground labs can be defined as illicit operations where IPEDs, most commonly anabolics androgenic steroids, are produced from these imported powders outside of registered pharmaceutical manufacture. 2011 ; Nettleton 2013 ; Morrison 2015 )." 2014 ), and can broadly be characterised as social supply (Coomber et al.

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Marketing Drugs Production Pharmaceuticals 40

The Pharma Data

AUGUST 9, 2020

About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). Br J Pharmacol.

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Clinical Trials Disease Treatment Trials 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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FDA Regulations Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 10, 2020

Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions. Yong-Jun Liu , the newly appointed President of Innovent also made his first public appearance on the virtual R&D day.

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Sygnature Discovery

DECEMBER 17, 2021

Our South San Francisco office at Oyster Point To bolster our stateside presence, we appointed Dr David Lustig as Vice President of Business Development for the US, bringing his extensive experience of the pharmaceutical industry and commercialisation into the Sygnature fold. We were also hard at work expanding our scientific portfolio.

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Small Molecule Laboratories Drugs Drug Development 52

Elrig

APRIL 29, 2025

Following his post-doctoral fellowship, Matt joined Neuroscience Discovery at MSD in New Jersey in 2011 but relocated to Boston in 2014. As registration for the forum is free, it offers a fantastic opportunity for the local academic, biotech, and pharmaceutical communities to network and discuss cutting edge science.

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Drugs Science Clinical Trials Doctors 52

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. Before that, Ms. Before joining Acorda, Ms.

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Clinical Trials Trials Production Therapies 40

Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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Packaging Licensing Licensing Regulations 40

Agency IQ

JULY 22, 2024

EPA’s regulatory agenda for Spring 2024 Agenda Stage of Rulemaking Title Estimated Publication Former Estimated Date First on Agenda Proposed Rule Stage Removal of Affirmative Defense Provisions from Specified CAA Section 111 and 112 Regulations July 2024 Spring 2024 Final Rule Stage Standards of Performance for New, Reconstructed, and Modified Sources (..)

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Regulations Production Engineering International 40

Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions.

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Science Regulations International FDA 40

Agency IQ

JANUARY 19, 2024

The newly proposed directive focuses solely on amending a fellow directive – the RoHS Directive (2011/65/EU) restricting the use of hazardous substances in electrical and electronic equipment. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

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