Drug Discovery World

NOVEMBER 24, 2022

A new report by Charles River Associates for the European Federation of Pharmaceutical Industries and Associations (EFPIA has revealed that Europe is falling behind the US and Asia in its pharmaceutical R&D investment, particularly when it comes to Advanced Therapies Medicinal Products (ATMPs) like tissue, gene and cell therapies. .

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Drug Discovery World

JULY 25, 2024

Why: The US has been a leader in biotech since the 1970s, thanks to significant government support for biomedical research, a strong venture capital industry and a lack of regulation over pricing. Why: Government backing has played an important role in the development of India’s biotech industry.

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Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. MONTRÉAL, QC – August 31, 2020 – Janssen Inc.,

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. government may also purchase an additional 200 million doses of Ad26.COV2.S

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Drug Discovery World

MAY 6, 2024

Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany. Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) spent €41.5 billion ($7.9

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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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DrugBank

APRIL 25, 2024

As the pharmaceutical industry is pushing to deliver new and better drugs while racing against time and budget constraints, it is becoming crucial to not just use artificial intelligence (AI) but truly maximize its potential. Invest in Your Tech Infrastructure A solid tech foundation is essential for AI to work in the pharmaceutical sector.

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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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The Pharma Data

DECEMBER 10, 2020

Pharmaceutical Care Management Association , the Court recognized that state legislatures have important powers to regulate abuses of corporate healthcare middlemen, called Pharmacy Benefit Managers (PBMs). In Rutledge v. Attorneys general from 45 states filed briefs opposing the PBM industry.

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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. These risks face fewer regulations but must meet certain standards to ensure ethical use.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. NEW BRUNSWICK, N.J., Follow us at @JNJNews.

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FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. Jazz Pharmaceuticals has supplied the cannabidiol for the trials at no cost. It’s time to stop borrowing cannabis regulations from other industries.”

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The Pharma Data

OCTOBER 28, 2020

OSAKA, Japan–( BUSINESS WIRE )– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), announced today that it will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. About Takeda Pharmaceutical Company Limited.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. More notably, Ms.

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Drug Discovery World

MARCH 7, 2023

The Middle East represents one of the world’s most lucrative markets for pharmaceuticals. Along with Africa, the Middle East stands as fifth largest pharmaceutical market in the world 1. By 2025, it’s estimated that Qatar’s drug market will reach a compound annual growth rate (CAGR) of 3.9%

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Drug Channels

JULY 18, 2022

You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs. Don’t miss the Medicaid Drug Rebate Program Summit coming up this fall in Chicago (or virtually). And so much more !

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation. Code Ann. § McClain , No.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

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Drug Channels

SEPTEMBER 3, 2024

Register Today. Download the brochure.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert , Gail H.

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H1 Blog

SEPTEMBER 26, 2023

Another challenge faced by international clinical trials is the lack of reliable data about local health systems and regulations. Many countries have laws that govern how a trial must be conducted, making it difficult for pharma and biotech companies to navigate without local knowledge.

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Drug Discovery World

OCTOBER 31, 2023

The UK’s regulator, the MHRA, has indicated support in its early-stage advice, but suggests more clinical data is also needed. These factors have made regulators reluctant to rely on NfL in benefit-risk assessments of new therapies. Barriers to widespread adoption However, not everybody is as enthusiastic as we are.

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The Pharma Data

JANUARY 24, 2021

About Citius Pharmaceuticals, Inc. Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. SOURCE Citius Pharmaceuticals, Inc. CRANFORD, N.J. ,

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Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. Government Accountability Office highlight disparities in patient representation in many clinical trials, prompting the FDA to issue draft guidance on Race and Ethnicity Diversity Plans 5,7.

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The Pharma Data

SEPTEMBER 28, 2020

UK and EU pharmaceutical industry bodies ABPI and EFPIA have joined forces to ask the UK government and the European Commission to prioritise medicines in upcoming trade talks. Pharma industry bodies call for medicine supply to be safeguarded in upcoming talks.

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The Pharma Data

APRIL 28, 2021

NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., Opportunity to advance Pfizer’s expertise and deep heritage in infectious disease. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. For more than 170 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

APRIL 28, 2021

Initial agreement covers reservation of the large-scale state-of-the-art biologics facility in Singapore site for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®. Follows recent initial agreements for providing manufacturing capacity for CureVac and BioNtech .

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. ” About Hepion Pharmaceuticals. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases. Source link.

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