World of DTC Marketing

FEBRUARY 2, 2022

Biogen will partner with Roche on the development, and potential sale of a promising cancer drug the Swiss pharma is advancing for several types of lymphoma, announcing Tuesday it’s exercised an option to share rights to the treatment. Food and Drug Administration on Biogen Inc.’s

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Fierce Pharma

JULY 18, 2023

In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. In tandem with Taiwan’s Food and Drug Administration, GSK this week initiated a recall of two batches of its severe asthma injection Nucala after glass fragments were found in a vial of the drug. . |

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World of DTC Marketing

MAY 16, 2022

Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials. Will patients, who are obese and don’t have Type 2 diabetes, ask for the drug for weight loss, and will patients understand the risks?

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Pharmaceutical Technology

DECEMBER 19, 2023

Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.

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Pharma Marketing Network

MARCH 11, 2025

Introduction Pharma marketing is constantly evolving, with new digital tools, regulatory updates, and data-driven strategies shaping the industry. How do pharma marketing executives ensure they are using the best tools and strategies? However, with so much information available, finding the right resources can feel overwhelming.

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World of DTC Marketing

JUNE 22, 2022

PBMs, insurers, pharma companies, and hospitals don’t want to give up their profits even if it’s better for the general population. Dr de Salvo has been vocal about the need for greater interoperability since her days in the Obama administration, where she was in charge of coordinating American health information technology.

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European Pharmaceutical Review

JANUARY 23, 2025

1 all revenue in big pharma now come from dealmaking, confirming a need for robust inorganic growth and value creation strategies The year began with this forecast holding true, as the pharmaceutical industry declared major M&A deals including Johnson & Johnsons acquisition of Intra-Cellular Therapies, Inc. trillion Firepower.

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PharmaTech

NOVEMBER 5, 2024

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.

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Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 GlobalData’s report showed LY03010 is expected to launch in the US in 2024. million in 2031, representing 0.6

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World of DTC Marketing

JULY 15, 2021

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.

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European Pharmaceutical Review

NOVEMBER 16, 2022

The drug will support patients in the worsening opioid crisis in the US, driven by the increased prevalence of synthetic opioids, such as fentanyl. Other drugs in Opiant’s development pipeline include OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose (ACO).

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

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European Pharmaceutical Review

NOVEMBER 22, 2022

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Pharmaceutical Technology

MAY 1, 2023

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share.

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European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Attending CPHI Barcelona 2023?

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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World of DTC Marketing

JUNE 22, 2021

Milton Friedman A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare patients could end up being higher than the budgets for the Environmental Protection Agency or NASA. There are no measurements on patent centricity.

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Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

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Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A).

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European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising. billion, and rising.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

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European Pharmaceutical Review

NOVEMBER 19, 2024

Novartis Pharma AG has agreed to a radiotherapeutic radioligand therapy-focused license and collaboration with Ratio Therapeutics. The US Food and Drug Administration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022.

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Pharmaceutical Technology

OCTOBER 1, 2024

Ascendis Pharma has submitted a supplemental biologics licence application (sBLA) to the US Food and Drug Administration (FDA) for TransCon hGH to treat adults with growth hormone deficiency (GHD).

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European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

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European Pharmaceutical Review

FEBRUARY 12, 2025

This disease is progressively fatal and results in heart failure, BridgeBio Pharma, Inc. The US Food and Drug Administration (FDA) granted approval of acoramidis as Attruby as a near complete TTR stabiliser in November 2024. BEYONTTRA (acoramidis) is indicated for adults with wild-type or variant ATTR-CM.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Pharma companies around the world have also faced similar threats , some of which have impacted national security and public health.

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European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. 1 The last four are produced at separate plants and thus less discussed for pharma since they are unlikely to be producing them in house. Water quality from an Annex 1 and Pharma 4.0 US Food and Drug Administration.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. Teikoku Pharma says that it believes TPU-006 might help reduce opioid-based dependency for post-surgical pain. Opioid-based medication remains the go-to option for pain management.

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PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. Promising AI Use Cases in Pharma.

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PM360

AUGUST 29, 2022

Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute. There are no shortcuts in drug development, and nor should there be.

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World of DTC Marketing

JUNE 8, 2021

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. standards for approving new drugs”.

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PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today?

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pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

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Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. We also explore how AI is being used to design digital twins for clinical trials.

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