LifeSciVC

DECEMBER 5, 2024

When I joined in 2005, the “patient” (Atlas) was undergoing surgery and we came out of the decade in 2010 with a small partnership, around one table, in one office in Cambridge. I limit it to R&D-stage since it takes longer than a fund cycle to bring a new drug from discovery to commercial).

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Marketing RNA Science Drugs 76

Common Sense for Drug Policy Blog

FEBRUARY 22, 2024

Brain Disease Model of Addiction "In 1997, Alan Leshner, the Director of the US National Institute on Drug Abuse (NIDA), proclaimed that addiction was a chronic, relapsing, brain disease ( Leshner, 1997 ). Drug Alcohol Depend. dwf_admin Thu, 02/22/2024 - 11:04 Source Hall W, Gartner C, Morphett K. 2023;253:111033. 2023.111033

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Disease Treatment Drugs 52

Metabolite Tales Blog

JULY 4, 2024

First-ever identification of an aldehyde oxidase-mediated DDI Inhibition of aldehyde oxidase mediated metabolism of OS1-930 by erlotinib Where metabolic pathways have not been interrogated for drugs in development, unwelcome surprises may arise. 2005; 338(1):450-455. Drug Metabol Drug Interact. Biochem Biophys Res Commun.

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Drugs 52

The Pharma Data

OCTOBER 23, 2020

Johnson has served as the president and the chief executive officer of the Parenteral Drug Association since 2009. Mr. Johnson specializes in United States and international drug regulatory requirements, quality practices and technical operations.

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Pharmaceuticals International Engineering Science 52

FDA Law Blog: Biosimilars

AUGUST 21, 2023

During a routine inspection in June 2022, Drug Enforcement Administration (“DEA”) diversion investigators determined that People’s Rx pharmacy violated recordkeeping requirements, improperly dispensed controlled substances to practitioners for office stock and issued prescriptions without authorization. 16, 2023 ( DOJ Press Release ).

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

In On Speed Rasmussen ( 2008 ) traces the history of this category of drugs, showing how early twentieth-century pharmacies in the United States sold invigorating tonics containing cocaine and nasal decongestants containing amphetamines. dwf_admin Fri, 01/05/2024 - 12:43 Source Hardon A. Chemical 24/7. Chemical Youth. 2020;183-213.

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PLOS: DNA Science

JUNE 22, 2023

“If you’re an adult with newly diagnosed non-small cell lung cancer that’s spread and tests positive for PDL1 without an abnormal EGFR your first option could be …” announces a TV ad for a pair of targeted cancer drugs, flying by so fast that I doubt many patients can grasp anything.

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Drugs Small Molecule DNA Bioethics 52

PLOS: DNA Science

APRIL 13, 2023

Drug addiction is prevalent and deadly. received treatment, according to the National Institute on Drug Abuse (NIDA). A complex mix of gene variants and environmental factors lies behind the compulsion to repeatedly take a drug and increase the dose, despite knowing the dangers. That’s the goal of the new report.

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DNA Drugs Treatment Science 52

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). 2021 ; Harvey et al.

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Marketing Drugs Production Pharmaceuticals 40

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. “PPAR-beta/delta agonists for Type 2 diabetes and dyslipidemia: an adopted orphan still looking for a home” Expert Opinion on Investigational Drugs. 2007 Jul 15;17(14):3855-9.

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FDA Law Blog: Drug Discovery

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

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Drug Target Review

APRIL 9, 2024

In 2005, he joined CNIO to lead the Genomic Instability Group where he has been ever since. Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects.

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RNA Cell Biology Clinical Development Disease 64

The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care. STOCKHOLM , Nov. [link].

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Broad Institute

JANUARY 30, 2024

In his lab at the Broad Institute of MIT and Harvard , he uses genomic technology to explore how bacteria become drug-resistant, to study how the immune system goes awry in sepsis, and to develop new molecular diagnostic approaches for bacterial infections. million deaths attributed directly to resistant infections.

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Hospitals Virus Medical Schools Science 137

Sygnature Discovery

MARCH 24, 2022

The attraction of integration Originally from Kenya but a proud Yorkshirewoman – Leeds became her hometown at the age of 12 – Lynette gained her BSc in Pharmacology from the University of Sheffield in 2005. The main thing that drew me here was the opportunity to work on integrated drug discovery projects,” Lynette said. “In

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Computational Chemistry International Science Pharmaceuticals 52

Common Sense for Drug Policy Blog

SEPTEMBER 15, 2023

Goofball’ was originally a term for barbiturate-type drugs with the earliest mention in the literature as heroin-methamphetamine injection in 2005 [ 17 ]. Qualitative research has found many people who use drugs (PWUD) believe methamphetamine can prevent or reverse opioid-related overdoses [ 20 ] and reduce withdrawal severity [ 22 ].

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Production Drugs Research 40

Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. West Virginia, sadly, is the poster child of the opioid drug crisis in the United States. Last year, the state ranked 5th in the rate of drug overdose deaths.

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Pharmacy Regulations Doctors Drugs 52

DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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Disease Treatment Drugs Clinical Trials 98

The Pharma Data

JANUARY 17, 2021

The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. . BARCELONA, Spain , Jan. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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Clinical Trials Treatment Trials Virus 52

The Pharma Data

JUNE 2, 2022

Food and Drug Administration, European Medicines Agency and China’s National Medical Products Administration. “I Dr. Yang joined Gilead in 1993 and became Senior Vice President of Pharmaceutical Development and Manufacturing in 2005.

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Science Pharmaceuticals Engineering Production 52

The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration last year and appears to be on track for a potential regulatory review as a treatment for multiple myeloma next year. a biotech company focused on yeast-based antibody discovery, and served as president and CEO from 2000 to 2005. Cilta-cel snagged Breakthrough Therapy Designation from the U.S.

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Government Molecular Biology Regulations Laboratories 52

Alta Sciences

OCTOBER 9, 2024

Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinical drug development, with a focus on abuse potential studies. Since 2005, the PharmaVoice 100 has become one of the publication’s most anticipated features. Beatrice Setnik, PhD, has been honored as a PharmaVoice 100 winner.

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Clinical Pharmacology Drug Development Science Clinical Trials 40

The Open Targets Blog

FEBRUARY 22, 2023

New Probes & Drugs data Probes & Drugs is a central hub for chemical biology research, integrating the most relevant probe sources. In their Ver 04.2022 release , Probes & Drugs have included two new compound datasets: DrugMAP and VGSC-DB.

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Disease Production Regulations Drugs 52

The Pharma Data

NOVEMBER 22, 2021

It’ll support AstraZeneca’s focus on specialised and perfection drugs and foster the discovery and development of coming generation rectifiers, including nucleotide- grounded, gene-editing and cell curatives. Over the once century, roughly 50 Nobel Prize winners in chemistry and physiology or drug have been associated with Cambridge.

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Molecular Biology Laboratories Engineering Hospitals 52

Common Sense for Drug Policy Blog

SEPTEMBER 12, 2020

Zeese, 1955-2020 We are sad to report that the co-founder and President of Common Sense for Drug Policy, Kevin B. Kevin was one of the nation's foremost authorities on drug policy issues. He worked on a wide array of drug related issues since he graduated from George Washington University Law School in 1980. He is sorely missed.

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Doctors Government Drugs International 40

The Premier Consulting Blog

NOVEMBER 16, 2022

One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Therefore, when excipients are selected for formulating a new drug product, it is essential that they either meet current FDA standards or are qualified for use in the drug product.

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Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Chem Immunol Allergy 86:151-183 (2005).

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Therapies Engineering Molecular Biology Science 105

The Pharma Data

MARCH 9, 2021

Edgardo Hernandez, who currently serves as senior vice president, global parenteral drug product and device manufacturing, will succeed O’Neill as senior vice president and president of Lilly manufacturing operations. Prior to joining Lilly in 2005, Hernandez worked for Pfizer.

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Compliance Engineering Doctors Production 52

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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New Drug Approvals

DECEMBER 3, 2022

852808-04-9 ABT-737 is a small molecule drug that inhibits Bcl-2 and Bcl-xL , two members of the Bcl-2 family of evolutionarily-conserved proteins that share B cl-2 H omology (BH) domains. ABT-737 Molecular Weight 813.43 Formula C 42 H 45 ClN 6 O 5 S 2 CAS No. Reed, John C.; Shen, Wang; Tahir, Stephen K.; Thompson, Craig B.;

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Small Molecule Clinical Trials Laboratories Regulations 52

Molecular Design

JANUARY 21, 2019

partial least squares) that have been used for decades for modeling multivariate data in drug discovery. I seem to remember sending an email to the vice chair of the 2005 or 2007 CADD GRC suggesting a session on model validation although there was little interest at the time. Should CoMFA be regarded as ML? If not, why not?]

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The Pharma Data

DECEMBER 15, 2020

The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drug development tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.

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The Pharma Data

MARCH 11, 2021

Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs). Ltd and has been approved in Japan since April 2005. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co.,

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Trials Hospitals Treatment Science 52

The Pharma Data

MARCH 17, 2022

The challenge, launched at EXPO 2020 Dubai, invites final year MD and/or PhD students and postdoctoral researchers from across the world to propose their innovative ideas to help accelerate drug discovery and development across AstraZeneca’s core disease areas.

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Science Clinical Trials Disease Research 40

Metabolite Tales Blog

MARCH 1, 2023

2 Figure 1 Not only does the carboxylic acid moiety of the infamous drug zomepirac undergo conjugation to an unstable acyl glucuronide, the pyrrole undergoes oxidative metabolism to an epoxide intermediate that can be trapped by glutathione (Figure 2). 2a Figure 2 Also reported are more complex “per-oxidative” oxidations.

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Metabolic Stability Drugs Pharmacokinetics Science 52

Agency IQ

NOVEMBER 10, 2023

Finally, a third regulation, Regulation (EC) No 2049/2005 , provides for reduced fees for small and medium-sized businesses (SMEs). Amendments in 1999 and 2005 aimed to ensure that EMA’s costs for the services it provides were adequately covered. literature monitoring), since national regulators charge their own fees.

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