Drug Patent Watch

DECEMBER 17, 2024

Flexibility has become more than just a buzzword it’s a necessity. Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. But what exactly makes flexibility so important for CDMOs, and how can they cultivate this essential trait? Let’s dive into the world of pharmaceutical outsourcing and explore why adaptability is the key to success.

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Bio Pharma Dive

DECEMBER 17, 2024

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

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Medicine Drugs 232

Pharmaceutical Technology

DECEMBER 17, 2024

Construction has already begun on the Ozempic-producers new Denmark production facility and 40,000m2 warehouse.

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Production 165

Bio Pharma Dive

DECEMBER 17, 2024

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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FDA Approval Antibody Drugs 182

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

DECEMBER 17, 2024

The two-day event included talks on subjects ranging from how to best utilise AI to how to build a stable CRO.

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Trials 162

Bio Pharma Dive

DECEMBER 17, 2024

Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s chief scientist.

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Scientist 147

Bio Pharma Dive

DECEMBER 17, 2024

The company forecast revenue next year will grow slightly versus this year, when excluding certain factors. “The uncertainty caused by COVID [is] mostly resolved,” its CFO said.

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Pharmaceutical Technology

DECEMBER 17, 2024

However, caution persists:166 of 785 US venture-backed companies with an innovator drug in development have not raised capital since 2021.

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Development Drugs 147

Bio Pharma Dive

DECEMBER 17, 2024

Rising maternal mortality, particularly among vulnerable groups, has roots in insufficient research involving pregnant women.

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Research 130

Pharmaceutical Technology

DECEMBER 17, 2024

GSKs GSK227 has gained Priority Medicines (PRIME) designation from the EMA for the treatment of relapsed ES-SCLC.

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Medicine 147

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Clinical Supply

Rethinking Clinical Trials

DECEMBER 17, 2024

December 8, 2024 : The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

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Pharmaceutical Technology

DECEMBER 17, 2024

Bavarian Nordic has signed a licence and manufacturing agreement with the Serum Institute of India (SII) for its mpox vaccine, MVA-BN.

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Fierce Pharma

DECEMBER 17, 2024

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and AZ's bid for a full approval of Andexxa.

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Manufacturing Drugs 121

Pharma Times

DECEMBER 17, 2024

New CT-guided radiotherapy system offers personalised cancer treatment

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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

Fierce Pharma

DECEMBER 17, 2024

Its not a new question, but it is one that is gaining increased traction: Is there a link between Novo Nordisks diabetes superstar Ozempic and blindness? | After the recent release of two independent studies from the University of Southern Denmark suggested the use of Ozempic increases patients' chances of developing a rare eye disorder, the Danish Medicines Agency has asked European officials to investigate.

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Medicine Development 96

Pharma Times

DECEMBER 17, 2024

First patient dosed in landmark trial for GAD treatment

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Trials 72

Fierce Pharma

DECEMBER 17, 2024

After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.< | After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.

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Advarra

DECEMBER 17, 2024

2024 has been a year of growth and evolution in clinical research. The coming year is expected to be no different. As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, an

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Clinical Supply

pharmaphorum

DECEMBER 17, 2024

Phase 2b results with Sanofi and Teva's duvakitug are exciting and warrant a swift move to phase 3 in inflammatory bowel disease, say the companies.

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Drugs 59

Outsourcing Pharma

DECEMBER 17, 2024

AbbVie acquires Nimble Therapeutics in $200M deal to advance oral peptide therapies for autoimmune diseases.

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Drugs Marketing 56

Fierce Pharma

DECEMBER 17, 2024

With Eylea biosimilar competition creeping in and Roches Vabsymo jockeying for market share in key indications, Regeneron is racing to carve out a new market for the high-dose version of its block | High-dose Eylea demonstrated non-inferiority to the original version of the drug in patients with macular edema following retinal vein occlusion, an indication Eylea has held for a decade.

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Marketing Drugs 56

pharmaphorum

DECEMBER 17, 2024

Closed Loop Medicine's smartphone app for blood pressure monitoring has shown proof-of-concept in the Cure-19 study.

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Medicine Drugs 53

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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

Pharmaceutical Commerce

DECEMBER 17, 2024

Cheryl Allen, BS Pharm, MBA, founding partner, Curatio Scientia Advisors, discusses "Enhancing Patient Access and Support Through Technology: A Comprehensive Assessment," and upcoming industry challenges.

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Fierce Pharma

DECEMBER 17, 2024

Its the end of an era at Jazz Pharmaceuticals as the drugmakers co-founder and CEO, Bruce Cozadd, eyes his exit after nearly 22 years with the companysome 15 of which were spent at the helm. | Current helmsman Bruce Cozadd plans to retire from his role at Jazz Pharmaceuticals in the next 12 months, the company said Monday. Jazz aims to complete its search for a CEO successor by the end of 2025, after which Cozadd will stay on board as the drugmaker's board chair.

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Pharmaceutical Commerce

DECEMBER 17, 2024

The latest news for pharma industry insiders.

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Protein Marketing Research 52

Outsourcing Pharma

DECEMBER 17, 2024

Nintx advances plant-based therapies for complex diseases with new Series A funding.

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Development 40

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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

Pharmaceutical Commerce

DECEMBER 17, 2024

The 430,000 square-foot finished production facility will house multiple product types within the rare disease sector, including hemophilia.

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Production 52

Fierce Pharma

DECEMBER 17, 2024

Sandoz has agreed to pay another group of plaintiffs in the long-running price-fixing litigation it inherited from former parent company Novartis, marking a further step by the company to leave the | Sandoz has agreed to pay another group of plaintiffs in the long-running price-fixing litigation it inherited from former parent company Novartis, marking a further step by the company to leave the "legacy" allegations behind.

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Drug Channels

DECEMBER 17, 2024

Happy New Year, everyone! Its been a huge year for Drug Channels Institute (DCI). In January, HMP Global acquired DCI. Thanks to our new friends at HMP, we will hold the Drug Channels Leadership Forum. This landmark event will take place in March 2025 in Miami. (If you havent done so yet, click here to request an invitation.) Once again, I thank you, dear readers, for welcoming Drug Channels into your inboxes, browsers, and apps.

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Pharmacy Drugs 40

Fierce Pharma

DECEMBER 17, 2024

As one of the largest vaccine makers, Pfizer has a big part of its business hinging on potential immunization policy changes under the incoming Trump administration. | Pfizer CEO Albert Bourla said he has developed "a good relation" with Trump's pick for HHS secretary, Robert F. Kennedy Jr., as the New York pharma assumes no material vaccine policy changes in the U.S. in 2025.

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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