An obesity drug biotech gets buy-in from Eli Lilly, venture firms
Bio Pharma Dive
NOVEMBER 7, 2023
Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.
Bio Pharma Dive
NOVEMBER 7, 2023
Startup OrsoBio raised $60 million in a Series A round co-led by Longitude Capital and Enavate Sciences, and joined by the pharma’s venture arm.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.
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Bio Pharma Dive
NOVEMBER 7, 2023
The price is below what some analysts had predicted and significantly less than $34,000 Sage initially set for its earlier postpartum infusion, Zulresso.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 7, 2023
The Tamil Nadu Drug Control Administration (TN DCA) has initiated action against the use of analgesic and anti-inflammatory drugs, diclofenac and aceclofenac, in veterinary treatments on account of sharp decline in vulture population in the forest areas of the state.
Bio Pharma Dive
NOVEMBER 7, 2023
The biotech company creator hopes its new office will help its portfolio companies grow and strike partnerships in the region.
Pharma Mirror
NOVEMBER 7, 2023
Navigating regulatory compliance in the pharmaceutical industry is crucial to ensure the safety, efficacy, and quality of pharmaceutical products. The pharmaceutical industry is heavily regulated in most countries to protect public health and to maintain the integrity of the products. Here are some key aspects to consider when navigating regulatory compliance in the pharmaceutical industry: Understanding Regulatory Authorities: Identify the regulatory authorities that govern pharmaceuticals in y
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 7, 2023
At AAO 2023, results were presented from the Phase IIa trial of Allgenesis’ AG-73305, evaluating its application for the treatment of DME.
Bio Pharma Dive
NOVEMBER 7, 2023
The biotech will terminate studies of its drug in psoriasis and psoriatic arthritis after the “magnitude of efficacy” reported in one was less than Ventyx’s target.
Pharmaceutical Technology
NOVEMBER 7, 2023
At BIO-Europe 2023, experts said competition from the US and China and proposed European legislation are hurdles for this sector.
Fierce Pharma
NOVEMBER 7, 2023
Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.
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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
Pharmaceutical Technology
NOVEMBER 7, 2023
The new incentives to improve access to medication across Europe are seen as innovation-stifling measures by the industry.
Fierce Pharma
NOVEMBER 7, 2023
Pfizer’s $3.5 billion cost-savings drive has made its way overseas. | The layoffs at Pfizer's Newbridge, Kildare, manufacturing site are the latest in the company's effort to save $3.5 billion by 2024 amid declining demand for its COVID-19 products.
Pharmaceutical Technology
NOVEMBER 7, 2023
These studies evaluated the effectiveness of HD Eylea (aflibercept 8mg) in patients with AMD and patients with DME.
BioSpace
NOVEMBER 7, 2023
The third-quarter growth of Gilead’s HIV, oncology and cell therapy businesses was completely offset by declining COVID-19 and liver disease sales, with revenue flat compared to the same period last year.
Pharmaceutical Technology
NOVEMBER 7, 2023
At the BIO-Europe conference, experts said smaller oncology biotechs need to explore alternate financing strategies for pipeline development.
pharmaphorum
NOVEMBER 7, 2023
Frontiers Health 23 - Day 1 from the marvellous Auditorium della Tecnica in Rome, where we are set to bring you the biggest news stories, trends, and industry insights
Pharmaceutical Technology
NOVEMBER 7, 2023
The UK National Institute for Health and Care Excellence (NICE) unveils refreshed support service, NICE Advice, for the life sciences sector.
BioSpace
NOVEMBER 7, 2023
The company on Wednesday reported nearly 50 billion euros, or $53.3 billion, in revenue with zero cash flow. Several layers of management will be eliminated as structural split-off strategies are considered.
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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.
Pharmaceutical Technology
NOVEMBER 7, 2023
The UK MHRA has granted authorisation for Anastrozole, previously a breast cancer treatment for post-menopausal women, to prevent the cancer.
BioSpace
NOVEMBER 7, 2023
Activist hedge fund investor Elliott Investment Management has bought over a $1 billion stake in BioMarin as the biotech grapples with a leadership change and disappointing sales of its hemophilia A gene therapy.
Pharmaceutical Technology
NOVEMBER 7, 2023
Patients who have used the products should consult their healthcare provider and properly discard the product.
BioSpace
NOVEMBER 7, 2023
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.
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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
Pharmaceutical Technology
NOVEMBER 7, 2023
The US Food and Drug Administration (FDA) has granted approval for Zydus Lifesciences’ NDA for Zituvimet for type 2 diabetes mellitus.
pharmaphorum
NOVEMBER 7, 2023
In this week’s episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Raquel Izumi, chief operating officer and co-founder of Vincerx Pharma, who is on a mission to improve antibody drug conjugate (or ADC) drug development, aiming to conquer cancer with safe, well-tolerated, and paradigm-shifting therapeutics.
Pharmaceutical Technology
NOVEMBER 7, 2023
GlobalData uncovers the leading innovators in transdermal drug delivery for the pharmaceutical industry.
Fierce Pharma
NOVEMBER 7, 2023
There might just be a silver lining for Johnson & Johnson in the FDA's recent approval of Amgen’s Stelara biosimilar. | There might just be a silver lining for Johnson & Jonhson in the FDA's recent approval of Amgen’s Stelara biosimilar. That’s because the coming entry of a cheaper copycat presents J&J with an opportunity to elude Medicare price negotiations outlined in the Inflation Reduction Act.
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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.
Pharmaceutical Technology
NOVEMBER 7, 2023
GlobalData uncovers the leading innovators in cancer immunotherapy for the pharmaceutical industry.
BioSpace
NOVEMBER 7, 2023
With headwinds in the wider biotech sphere, the third quarter showed continuing vulnerabilities in the COVID space while the weight-loss drugs drove blockbuster sales.
Pharmaceutical Technology
NOVEMBER 7, 2023
Landmark Bio and Galapagos have signed an agreement for the manufacture of the latter’s oncology CAR T-cell therapy
Fierce Pharma
NOVEMBER 7, 2023
Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. Vertex and CRISPR Therapeutics are up first with a Dec. | Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. One potential advantage for bluebird, giving the timing, could be a chance to view its rival's pricing before deciding itself.
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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.
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