Pharmaceutical Technology

AUGUST 18, 2023

Nuvectis Pharma has received US Food and Drug Administration (FDA) orphan drug designation for NXP800 to treat cholangiocarcinoma.

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Pharmaceutical Technology

OCTOBER 13, 2023

South Rampart Pharma has received the US Food and Drug Administration (FDA) fast track designation for SRP-001 to treat acute pain.

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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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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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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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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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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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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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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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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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World of DTC Marketing

FEBRUARY 4, 2021

Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label.

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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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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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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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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

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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Pharmaceutical Technology

JANUARY 19, 2023

Sun Pharma stated that it will follow Concert’s plan to seek approval from the US Food and Drug Administration (FDA) for its new drug application in the first half of the year. The post Sun Pharma to buy Concert Pharmaceuticals for $576m appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. At the core of the debate was a new provision allowing the US Centers for Medicare & Medicaid Services (CMS) to negotiate prices with pharmaceutical companies for a select number of drugs.

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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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World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. We can’t continue to develop drugs the same way as we have done before.

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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

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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World of DTC Marketing

OCTOBER 6, 2021

to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London. Remdesivir was the first drug approved by the Food and Drug Administration to treat COVID-19. And while it costs $17.74 Merck charges the U.S.

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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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Pharmaceutical Technology

MARCH 3, 2023

French biopharmaceutical firm Ipsen has concluded the purchase of US-based Albireo Pharma , expanding its rare disease portfolio. Last month, the US Food and Drug Administration (FDA) accepted Bylvay for Priority Review to treat Alagille syndrome (ALGS) in paediatric and adult patients.

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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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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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Pharmaceutical Technology

SEPTEMBER 29, 2022

Among these facilities, four are approved by the US Food and Drug Administration (FDA). The post Torrent Pharma to acquire Curatio for $245.16m appeared first on Pharmaceutical Technology. Having a presence in 40 countries, the company has seven manufacturing plants.

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MedCity News

JUNE 16, 2023

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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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

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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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease.

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Pharma Marketing Network

MARCH 25, 2023

Pharmaceutical advertising is a crucial aspect of promoting and marketing drugs to the public. This type of advertising is crucial in promoting new drugs and informing healthcare professionals about their benefits and potential side effects. “Direct-to-Consumer Advertising of Prescription Drugs.” ” U.S.

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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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Pharmaceutical Technology

AUGUST 16, 2022

Even giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market demand for huge numbers of injectables, including high-value biologics and Covid-19 vaccines, according to a GlobalData analysis.

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World of DTC Marketing

APRIL 7, 2021

QUICK READ: The compensation for pharma CEOs is starting to be reported and it’s off the charts. Pharma, PBM, and health insurance CEOs earn hundreds of millions of dollars to do one thing; make their companies a lot of money. drug spending by 9 percent” What about taxpayers? Bob Bradway of Amgen bagged a $20.1

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