Fierce Pharma

DECEMBER 4, 2023

Last year, roughly 250 products that contain the decongestant phenylephrine—including popular brands such as Sudafed, NyQuil, Benadryl and Tylenol—rang up sales of nearly $1.8 billion. | House Republicans want to know why it has taken so long for the FDA to act on the decongestant phenylephrine. Rep. Lisa McClain (Mich.), who chairs the House oversight subcommittee on health care and financial services, has sent a letter to FDA commissioner Robert Califf, requesting a briefing on the effectivene

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Containment Branding Sales Production 122

Bio Pharma Dive

DECEMBER 4, 2023

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Pharmaceutical Technology

DECEMBER 4, 2023

The US Food and Drug Administration (FDA) has granted approval for Ambio’s generic version of Forteo for the treatment of osteoporosis.

FDA Approval 246

FDA Approval Drugs 246

Bio Pharma Dive

DECEMBER 4, 2023

The acquisition of Carmot, which had been planning an IPO, will hand Roche three weight loss medicines in early clinical testing.

Medicine 306

Medicine Drugs 306

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 4, 2023

Roche has signed an agreement for the acquisition of US-based company Carmot Therapeutics in a deal valued at $2.7bn, to be paid in cash.

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Bio Pharma Dive

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

Drug Trials 273

Drug Trials Trials Medicine Drugs 273

Bio Pharma Dive

DECEMBER 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

Clinical Trials 270

Clinical Trials Clinical Trials Trials 270

Pharmaceutical Technology

DECEMBER 4, 2023

Eli Lilly has received approval from the US FDA for Jaypirca to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL)

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Bio Pharma Dive

DECEMBER 4, 2023

Jaypirca, which has been on the market for less than a year, can now be used for more types of blood cancer but not as early as rival drugs from AbbVie and AstraZeneca.

Drugs 162

Drugs Marketing 162

Pharmaceutical Technology

DECEMBER 4, 2023

The $247m deal will focus on the use of generative artificial intelligence to develop an antibody therapy for an unnamed cancer.

Antibody 162

Antibody Drugs Development 162

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Clinical Supply

Pharma Times

DECEMBER 4, 2023

In England, an estimated 4,500 people are living with undiagnosed HIV - News - PharmaTimes

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FDA Law Blog

DECEMBER 4, 2023

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

Pharmacy 139

Pharmacy Containment Drugs Compliance 139

Pharmaceutical Technology

DECEMBER 4, 2023

R-209 is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Inflammatory Bowel Disease.

Clinical Development 130

Clinical Development Development 130

Pharma Times

DECEMBER 4, 2023

The neurological condition affects around 50 million people worldwide - News - PharmaTimes

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126

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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

Pharmaceutical Technology

DECEMBER 4, 2023

Everest’s clinical trial in China will contribute to Kezar’s global PALIZADE study of zetomipzomib for lupus nephritis.

Clinical Trials 130

Clinical Trials Clinical Trials Drugs Trials 130

pharmaphorum

DECEMBER 4, 2023

Uveal melanoma: A new generation of therapies offers hope for patients Mike.

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124

Pharmaceutical Technology

DECEMBER 4, 2023

A statement issued by leading industry bodies emphasises climate change as an urgent health challenge at COP28, as the president defends fossil fuel use.

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130

Fierce Pharma

DECEMBER 4, 2023

Fujifilm Corporation is spreading the wealth across two production units as the contract development and manufacturing organization (CDMO) juggernaut works through a cell therapy expansion. | Fujifilm is dividing $200 million between a pair of subsidiaries. Those are: Fujifilm Cellular Dynamics, which specializes in development and manufacturing of human induced pluripotent stem cells (iPSC), and the organization’s CDMO for biologics and advanced therapies, Fujifilm Diosynth Biotechnologies.

Manufacturing 122

Manufacturing Production Development 122

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Clinical Supply

Pharmaceutical Technology

DECEMBER 4, 2023

Palvella will receive $5m as an upfront payment, with Ligand getting 8%-9.8% in tiered royalties on worldwide sales of Qtorin rapamycin.

Sales 130

Sales Trials 130

Fierce Pharma

DECEMBER 4, 2023

A challenging year for the biotech industry has taken a heavy toll on Chinese manufacturer WuXi Biologics, sending the company’s stock plummeting nearly 24% Monday. | WuXi Biologics expects to miss its original sales target for the year by around $400 million, thanks to reductions across its development and manufacturing services. WuXi blamed the projected miss largely on a COVID-related revenue slowdown and a decline in projects.

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Contract Manufacturing Manufacturing Sales Development 119

Pharmaceutical Technology

DECEMBER 4, 2023

Dan Herron, of digital offerings at RWS Life Sciences, details how AI and algorithms can be used to optimise these administrative processes.

Clinical Trials 130

Clinical Trials Clinical Trials Life Science Trials 130

pharmaphorum

DECEMBER 4, 2023

UK primary care group adopts digital heart failure pathway Phil.

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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 Technology

DECEMBER 4, 2023

GC Biopharma has concluded the construction activities at an mRNA manufacturing plant at its vaccine production site in South Korea.

Manufacturing 130

Manufacturing Vaccination Vaccine Production 130

pharmaphorum

DECEMBER 4, 2023

Undiagnosed dementia in UK needs drastic action, says review Phil.

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XTalks

DECEMBER 4, 2023

Most oncology products approved in the past few decades are known for being highly toxic, non-specific and fraught with severe side effects for cancer patients. This was because higher doses often correlated with a better reduction in tumor size, so trial designs were predicated on obtaining the maximum tolerated dose (MTD). But today, with a rise in molecularly targeted therapies, oncology development has shifted to identifying an optimal biologic dose that balances toxicity with efficacy.

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Development Drugs Clinical Trials Clinical Trials 111

pharmaphorum

DECEMBER 4, 2023

Roche has agreed a deal to acquire US biotech Carmot Therapeutics that if consummated will thrust it into the increasingly competitive market for incretin-based therapies for diabetes and obesity. The Swiss pharma group has agreed to pay $2.7 billion upfront in cash when the deal closes, with shareholders in the US company also in line for up to $400 million if the drug programmes covered by the agreement meet various milestones.

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Marketing Drugs 116

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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

BioSpace

DECEMBER 4, 2023

The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.

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Regulation Development 108

pharmaphorum

DECEMBER 4, 2023

AstraZeneca links with Absci on AI for biologics discovery Phil.

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XTalks

DECEMBER 4, 2023

Ripple pea milk, a leading US plant-based milk brand, recently raised a substantial $49.2 million in its latest funding round, elevating the company’s total investments to a staggering $274 million. This financial boost coincides with a growing interest in the pea milk category, which has recently overshadowed the broader alt-dairy sector in year-on-year growth.

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Protein Branding Production Marketing 105

pharmaphorum

DECEMBER 4, 2023

Building vs buying: How to best implement data analysis systems in pharma sales Mike.

Sales 114

Sales 114

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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