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The US Food and DrugAdministration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. As a draft framework, the FDA is seeking public comment on this new guidance.
For the COVID-19 vaccine, the Food and DrugAdministration (FDA) set up rigorous standards for vaccine developers to meet. Let’s also remember that pharma is going to make a LOT of money on these vaccines. The post How did pharma develop a vaccine so quickly? That’s a hell of an incentive.
Food and DrugAdministration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. As with Novo Nordisk’s popular offering for obesity, Wegovy, demand for Eli Lilly’s dual GIP/GLP-1 agonist Mounjaro appears to be outpacing supply once again. |
In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. They relied so much on a new drug that they tried to market a product with bad science behind it. ” The U.S.
billion on Thursday for allegedly delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought in 2019. Food and DrugAdministration approval for the non-Hodgkin lymphoma drug by a Dec. The post BMS: Delayed new drug to avoid paying billions?
Pharma companies are flush with cash and looking to make deals, but there are still a lot of small biotech companies that don’t have enough money to launch their products entirely. A study in 2020 estimated that the median cost of getting a new drug into the market was $985 million, and the average price was $1.3 million $1228.9
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 DrugAdministration on Biogen Inc.’s
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.
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. Where to start?
Pharmaceutical Technology outlines some of the biggest US Food and DrugAdministration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.
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.
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.
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.
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.
PBMs, insurers, pharma companies, and hospitals don’t want to give up their profits even if it’s better for the general population. To help it along, it has enlisted Bakul Patel; a former official tasked with creating the regulatory classification of “software as a medical device” at the FDA.
The US Food and DrugAdministration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.
The US Food and DrugAdministration (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.
In the wake of the Food and DrugAdministration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever.
A study of the causes of warning letters issued by the US Food and DrugAdministration (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.
The US Food and DrugAdministration (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.
The US Food and DrugAdministration (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.
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.
The Luye Pharmadrug 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
The US FoodDrugAdministration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A).
a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and DrugAdministration (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.
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).
The US Food and DrugAdministration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.
The US Food and DrugAdministration (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.
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?
The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and DrugAdministration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.
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.
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.
AGEPHA Pharma has received approval from the US Food and DrugAdministration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease.
Novartis Pharma AG has agreed to a radiotherapeutic radioligand therapy-focused license and collaboration with Ratio Therapeutics. The US Food and DrugAdministration (FDA) approved Novartis’ Pluvicto (lutetiumlutetium Lu 177 vipivotide tetraxetan) in 2022.
This disease is progressively fatal and results in heart failure, BridgeBio Pharma, Inc. The US Food and DrugAdministration (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.
The Food and DrugAdministration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.
Ascendis Pharma has submitted a supplemental biologics licence application (sBLA) to the US Food and DrugAdministration (FDA) for TransCon hGH to treat adults with growth hormone deficiency (GHD).
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 DrugAdministration (FDA) or European Medicines Agency (EMA).
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.
Food and DrugAdministration (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.
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 perspective.
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