Bio Pharma Dive

JULY 26, 2023

The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.

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Vaccination Vaccine Trials 246

Pharmaceutical Technology

JULY 26, 2023

Eli Lilly has extended the tender offer expiration date for the acquisition of all Dice Therapeutics in a deal valued at $2.4bn.

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Rethinking Clinical Trials

JULY 26, 2023

Professor Carl Bergstrom In this Friday’s PCT Grand Rounds, Professor Carl Bergstrom of the University of Washington will present “How Can Researchers Fight Misinformation About Medicine?” The Grand Rounds session will be held on Friday, July 28, 2023, at 1:00 pm eastern. Bergstrom is a professor of biology at the University of Washington.

Medicine 130

Medicine Clinical Trials Clinical Trials Trials 130

Bio Pharma Dive

JULY 26, 2023

In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

Marketing 130

Marketing Drugs 130

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Pharmaceutical Technology

JULY 26, 2023

In the global pharmaceutical industry, there were 92 private equity deals announced in Q2 2023, worth a total value of $17.3bn, according to GlobalData's Deals Database.

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Bio Pharma Dive

JULY 26, 2023

The cost cuts at the nearly 30-year-old biotech are part of plans to seek a “strategic transaction” for the company’s only remaining drug prospect.

Drugs 130

Drugs 130

Bio Pharma Dive

JULY 26, 2023

Led by Vivek Ramaswamy's brother, Kriya has now raised over $600 million to fund gene therapy research spanning ophthalmology, neurology and metabolic disease.

Gene Therapy 130

Gene Therapy Gene Research 130

Pharmaceutical Technology

JULY 26, 2023

The US Food and Drug Administration (FDA) has approved Tarsus Pharmaceuticals’ Xdemvy for the treatment of Demodex blepharitis.

FDA Approval 130

FDA Approval Drugs 130

Bio Pharma Dive

JULY 26, 2023

The startup is the latest young company to emerge with plans to make production of cell-based medicines easier for researchers and biotechs.

Manufacturing 130

Manufacturing Medicine Production Research 130

Pharmaceutical Technology

JULY 26, 2023

Bioengineering company Ossium Health has secured $52m in Series C funding for expanding its bone marrow stem cell bank.

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Bio Pharma Dive

JULY 26, 2023

The startup, which initially aims to make cancer medicines, claims to have a new twist on covalent drug research.

Drugs 130

Drugs Medicine Research 130

Pharmaceutical Technology

JULY 26, 2023

Roche’s anti-VEGF monoclonal antibody Avastin (bevacizumab) is one of the most successful oncology drugs of all time.

Antibody 130

Antibody Drugs 130

ACRP blog

JULY 26, 2023

As leaders in the clinical research enterprise seek to expand the public’s understanding of clinical trials and their potential benefits for healthcare at the personal, community, and national levels, communications tactics cannot remain stuck at the one-on-one rate of physician referrals or patient recruiters reaching out to individual potential volunteers for real progress to be seen.

Clinical Research 98

Clinical Research Clinical Research Coordinator Packaging Packaging 98

Pharmaceutical Technology

JULY 26, 2023

Intrommune Therapeutics has completed the last patient last visit for its desensitisation candidate INT301.

Allergies 130

Allergies Trials 130

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

ProRelix Research

JULY 26, 2023

Ensuring the safety and efficacy of new drugs, medical devices, and biological products does not end once the treatment is approved or is on the market but extends to the […] The post Pharmacovigilance (PV) Services at a Glance appeared first on ProRelix Research.

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Production Marketing Drugs Research 98

XTalks

JULY 26, 2023

The US Food and Drug Administration (FDA) has granted approval to Daiichi Sankyo’s Vanflyta (quizartinib) for newly diagnosed patients with FMS-like tyrosine kinase 3 receptor-internal tandem duplication ( FLT3 -ITD) positive acute myeloid leukemia (AML). FLT3 -ITD mutations occur in about a quarter of all AML cases. Vanflyta is the first and only FLT3 inhibitor approved in the US for FLT3 -ITD positive AML and across all three treatment phases: induction, consolidation and maintenance.

FDA Approval 98

FDA Approval Immune Response Drugs Trials 98

Fierce Pharma

JULY 26, 2023

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. | The U.S. Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. The agency also expects supply issues with three other doses to persist longer than previously thought.

FDA Approval 98

FDA Approval Drugs 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (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. One of the FDA’s enforcement mechanisms is the issuance of marketing violation letters to pharmaceutical companies found in violation of advertising and promotion regulations.

Marketing 97

Marketing Compliance Regulation Drugs 97

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

BioPharma Reporter

JULY 26, 2023

Leslie Orne joined Trinity Life Sciences in 2001 and was recently appointed CEO and president of the fast-growing healthcare consultancy. She previously held the title of chief commercial officer (CCO) and president.

Life Science 97

Life Science 97

Fierce Pharma

JULY 26, 2023

With a European approval for chronic kidney disease nod in hand, Boeringer Ingelheim and Eli Lilly's Jardiance is looking to catch up to AstraZeneca's Farxiga in this use and continue growing its r | After recent label expansions in the U.S. and Europe paid off with a sizable sales increase for Jardiance, the drug has added a third use to its European label.

FDA Approval 88

FDA Approval Sales Drugs 88

Pharma Times

JULY 26, 2023

The new company’s core mission is to boost patient access to disease-modifying treatments - News - PharmaTimes

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Fierce Pharma

JULY 26, 2023

Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter. | Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter.

FDA Approval 87

FDA Approval Drugs 87

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Pharma Times

JULY 26, 2023

The advice includes a national rollout of the HCV GP champion programme and further testing - News - PharmaTimes

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BioSpace

JULY 26, 2023

In a recent study of the U.S. states with the best and worst job markets, nine came out on top. Read on for details about the life sciences industry and jobs available in each state.

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Marketing Life Science 82

Fierce Pharma

JULY 26, 2023

Alkermes brought in $617 million during the second quarter, including $248 million of back royalties on Johnson & Johnson's Invega franchise. The company recently won an arbitration case against the pharma giant.

Sales 75

Sales 75

BioSpace

JULY 26, 2023

Amid the impending drug pricing pressures from the Inflation Reduction Act, Roche is discontinuing a mid-stage hemophilia A gene therapy candidate and four early-stage hopefuls.

Gene Therapy 79

Gene Therapy Gene Drugs 79

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Fierce Pharma

JULY 26, 2023

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. | The FDA signed off on Octapharma's blood coagulant Balfaxar as a treatment to counter the effects of commonly used blood thinner warfarin.

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BioSpace

JULY 26, 2023

With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.

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Pharmaceutical Commerce

JULY 26, 2023

Updated deal will cover exclusive US commercialization for several of Alvotech’s biosimilars.

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Fierce Pharma

JULY 26, 2023

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. | In a quarter fueled by sales of Shingrix and its HIV medicines, GSK topped revenue expectations and bumped up its sales projection for the year. While the company anxiously awaits the launch this fall of RSV vaccine Arexvy, it is tamping down expectations of an immediate boom in sales for the potential blockbuster.

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Sales Vaccination Vaccine Medicine 67

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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply