Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Target Review

JUNE 5, 2024

We have several international trials ongoing or being initiated in a range of indications. About the author James Graham, CEO of Recce Pharmaceuticals Recce Pharmaceuticals. James Graham is the CEO of Recce Pharmaceuticals. Could you tell us how the development of the R435 and R529 candidates is progressing?

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Drug Patent Watch

FEBRUARY 27, 2025

Navigating the Complex World of Global Drug Patents: Strategies and Challenges Ahead As a pharmaceutical professional, you know how crucial it is to protect your innovative drug patents in the global market. This is a nightmare scenario for any pharmaceutical company, and it's a reality that many face every day.

Marketing 52

Marketing Drugs Regulations Pharmaceutical Companies 52

Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. examines how the Inflation Reduction Act could ultimately impact pharmaceutical wholesalers’ customers and business outlook.

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Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities.

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Pharmaceuticals Biosimilars Licensing Licensing 75

Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s pharmaceutical law ceased to apply to the U.K. from the E.U. on February 1, 2020 started a year-long transition period; The E.U. excluding Northern Ireland) as of January 1, 2021.

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International Regulations Pharmaceuticals Production 52

Drug Patent Watch

JULY 13, 2020

Mudawi in the Journal of Pharmaceutical Research International under the terms of the Creative Commons Attribution License.…. This article was originally published by Mohammed M. Alshehri and Mahmoud M. The post Common Drugs with Effective Off-Label Uses appeared first on DrugPatentWatch - Make Better Decisions.

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Licensing Licensing Drugs International 94

Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

International 52

International Laboratories Drugs Pharmacokinetics 52

Drug Target Review

OCTOBER 30, 2024

About the author Anirban Datta, Head of Discovery Biology at Verseon International Corporation Anirban Datta PhD is the head of discovery biology at Verseon International Corporation. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery. Cell Stem Cell. 2013;13(6):734-44.

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Treatment Disease Clinical Trials Molecular Biology 105

SCIENMAG: Medicine & Health

JANUARY 24, 2024

LA JOLLA (January 22, 2024)—Salk Professor Ronald Evans has been named the 2024 recipient of the Japan Prize in the field of Medical Science and Pharmaceutical Science. The Japan Prize Foundation awards this prestigious international award annually to “express Japan’s gratitude to international society.”

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International Science Pharmaceuticals 79

The Pharma Data

AUGUST 30, 2021

.–(BUSINESS WIRE)– Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY ® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache Federation Joint Congress 2021. Teva Pharmaceuticals USA, Inc.,

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International Clinical Trials Treatment Trials 52

National Drug & Alcohol Research Centre Blog

DECEMBER 4, 2023

In Australia, both methadone and buprenorphine have been subsidised by the Pharmaceutical Benefit Scheme (PBS) for the treatment of opioid dependence (termed ‘opioid agonist treatment’ or OAT) for several decades. Our recent article, published in The International Journal of Drugs , presents the Australia-wide results. Chidwick, K.,

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Treatment Community Pharmacies Pharmacy International 133

Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

The Pharma Data

SEPTEMBER 9, 2021

Teva Pharmaceuticals USA, Inc., affiliate of Teva Pharmaceutical Industries Ltd. This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. 8-12, 2021. 8-12, 2021.

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International Treatment Clinical Trials Trials 52

FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

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Pharmaceuticals Licensing Licensing Compliance 59

The Premier Consulting Blog

APRIL 3, 2024

This is done by using the tools such as the established conditions and the pharmaceutical quality system and others as described in the ICH Q12 4 Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Pharmaceutical Development Q8(R2). ICH Harmonised Guideline. Available at: [link]

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Pharmaceuticals Cell Based Assays Production International 52

The Pharma Data

MAY 19, 2023

HIGH SCHOOL SCIENTISTS AND ENGINEERS WIN NEARLY $9 MILLION AT THE REGENERON INTERNATIONAL SCIENCE AND ENGINEERING FAIR 2023 Regeneron Pharmaceuticals, Inc. In field tests, their incubation system was an effective alternative to insecticides and lowered the mealybug population density nearly four-fold.

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Engineering International Science Virus 52

Drug Target Review

FEBRUARY 10, 2025

We believed the missing piece was essentially an internal biotech at MD Anderson – one that could collaborate with researchers to industrialise their processes for cell therapies. Dr. Bock has previously held leadership roles at MD Anderson, Teva Pharmaceuticals, CoGenesys, and Human Genome Sciences.

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Therapies Treatment Engineering Clinical Trials 64

Advarra

MARCH 6, 2025

Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Without clinical research, these medical breakthroughs would remain out of reach for patients.

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Clinical Research Research Clinical Trials Bioethics 52

The Pharma Data

JUNE 2, 2022

(Nasdaq: GILD) announced today that Stacey Ma, PhD will join the company as Executive Vice President, Pharmaceutical Development and Manufacturing, and will become a member of the company’s senior leadership team, reporting to Chairman and Chief Executive Officer Daniel O’Day. Dr. Ma holds a PhD in chemical engineering from Yale University.

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Science Pharmaceuticals Engineering Production 52

The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. About Spectrum Pharmaceuticals, Inc.

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Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 6, 2021

INDIANAPOLIS , May 6, 2021 /PRNewswire/ — With a goal of integrating data and technology to help streamline diabetes management, Eli Lilly and Company (NYSE: LLY) signed strategic international agreements with four companies – DexCom, Inc., 1 International Diabetes Federation. Glooko Inc. IDF Diabetes Atlas, 9 th edn.

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International Therapies Disease Production 52

PPD

DECEMBER 16, 2024

Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years. Lacking internal expertise or capacity often slows progress, making outsourcing a strategic necessity.

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Drug Development Clinical Trials Compliance Trials 52

thought leadership

MAY 7, 2024

Pharmaceutical companies need to be prepared for the new European Health Technology Assessment Regulation (HTAR), which will take effect in January 2025. It is crucial for companies to establish new internal timelines and processes to bring drugs, and eventually also medical devices, to the European market.

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Pharmaceutical Companies International Regulations Pharmaceuticals 59

Drug Target Review

DECEMBER 22, 2023

The regulatory science project I pursued for my first master’s degree titled, “21st Century Pharmaceutical Excipients: Consequences of a Global Supply Chain and Lack of Excipient Regulations” aimed to draw attention to the risks created by the lack of sufficient oversight of the pharmaceutical excipient supply chain.

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Drug Target Review

OCTOBER 31, 2023

Ashley Hall, CDO of Reneo Pharmaceuticals Throughout my education I was discouraged by many around me. How did that transfer into the pharmaceutical industry? This sector of the pharmaceutical industry combined both my science and law background. Witnessing that growth, from intern to say, senior director level, is so rewarding.

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Cell Biology Pharmaceuticals Science Disease 107

The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). About CASI Pharmaceuticals. CASI Pharmaceuticals, Inc. The Company’s operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals ( China ) Co., and BEIJING , Jan.

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Pharmaceuticals Clinical Trials Licensing Licensing 52

PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

DrugBank

NOVEMBER 4, 2024

The pharmaceutical industry is the primary source of antibiotic innovation; therefore, it must lead the way in combating resistance.      Urgency of Antibiotic Resistance    The escalating threat of antibiotic resistance is an incoming global crisis projected to affect international health and the economy.

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Pharmaceutical Companies Pharmaceuticals Government DNA 71

biobide

MAY 18, 2023

Good laboratory practice (GLP) ensures the safety, quality, and organization of pharmaceutical research. The practice is followed to maintain consistently high standards and comply with any regulations set by government agencies, internal company procedures, and international regulations, like the 3Rs.

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Laboratories International Regulations Government 53

Drug Target Review

APRIL 19, 2024

Sibylla’s scientific founders come from very different scientific fields that do not usually speak to each other, such as theoretical physics, molecular biology and pharmaceutical chemistry. We also have collaborations with pharmaceutical companies where we leverage the best of our unique platform and pharma expertise on the target.

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Molecular Biology Research Pharmaceuticals Small Molecule 111

thought leadership

AUGUST 10, 2023

Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices.

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Compliance International Pharmaceuticals Production 52

DrugBaron

NOVEMBER 9, 2020

The global scientific community and pharmaceutical industry is delivering technically challenging innovation at a pace that arguably has never been witnessed before. Worse still, the extra costs from meeting all these objectives simultaneously are largely hidden, subsumed in the general productivity decline in pharmaceutical R&D.

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Vaccine Pharmaceutical Companies Government Pharmaceuticals 100

Drug Target Review

NOVEMBER 15, 2023

In addition to internal working practices, free-flowing collaboration with an external contract research organisation (CRO) is instrumental in driving drug development success. Nick is a highly experienced commercial leader with more than 20 years in the pharmaceutical and biotechnology industries.

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Pharmacokinetics International Laboratories Drugs 105

The Pharma Data

JULY 28, 2021

Additionally, Viviane Monges will join EUROAPI, a future leading European company dedicated to the development, production, and marketing of active pharmaceutical ingredients (API), as an independent non-executive Chair of the Supervisory Board. At Wyeth Pharmaceuticals/Pfizer she served as CFO of the Global Pharma Business unit.

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Pharmaceutical Companies International Pharmaceuticals Compliance 52

The Pharma Data

APRIL 6, 2021

Teva Pharmaceutical Industries Ltd. In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-966-1396; Israel 1-809-203-624 or International +44 (0) 2071 928000; passcode: 8347148. Teva Pharmaceutical Industries Ltd. About Teva.

International 52

International Pharmaceuticals Production Research 52

Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. we analyze the IRA’s likely consequences for wholesalers and the overall pharmaceutical business. In Subsection 6.5.1.,

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Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40