Fierce Pharma
AUGUST 30, 2023
After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.
MedCity News
AUGUST 30, 2023
Novo Nordisk is expanding its cardiometabolic drug pipeline with the acquisition of Embark Biotech, a startup developing drugs for a novel target that can suppress appetite and boost calorie burning in cells. Embark’s science comes University of Copenhagen research on a novel fat cell target.
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Fierce Pharma
AUGUST 30, 2023
Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.
MedCity News
AUGUST 30, 2023
While the recent rollbacks of authorization requirements by insurers are a positive step forward, there is still work to be done in streamlining processes and reducing administrative burdens in the healthcare industry.
Fierce Pharma
AUGUST 30, 2023
Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.
Medgadget
AUGUST 30, 2023
Researchers at New York University have developed a new method to target many viruses that cause disease. For viruses with a lipid membrane, which includes many that commonly cause disease, this new technique could prove to be fatal. By targeting the lipid membrane, the approach may circumvent the treatment resistance that arises when viruses mutate to alter their surface proteins, which are the most common targets for conventional anti-viral drugs.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
AUGUST 30, 2023
California passed a law last year aimed at controlling rising healthcare costs that gave the state the ability to scrutinize healthcare deals of a certain size involving California companies. What impact can it have?
Fierce Pharma
AUGUST 30, 2023
After settling a patent case with Vivitrol maker Alkermes, Teva has gained a license to launch its generic version of the opioid dependence and alcohol dependence med years ahead of the drug's pate | Under the patent settlement, Teva will be able to launch its generic two years ahead of the 2029 patent expiration for Vivitrol.
MedCity News
AUGUST 30, 2023
Kidney care company Strive Health announced last week that it is collaborating with primary care company Oak Street Health to serve Medicare members with stage 4 chronic kidney disease and end-stage kidney disease.
PharmaVoice
AUGUST 30, 2023
Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.
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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.
MedCity News
AUGUST 30, 2023
Despite these wins for many patients, the new law is already impacting the discovery and development of new drugs for people living with orphan diseases. Not only are drugs that could treat more than one disease being disincentivized, small molecule medicines, which play an important role in treating neurological disorders, cancers, and other diseases, may also be disadvantaged by the law.
European Pharmaceutical Review
AUGUST 30, 2023
According to a report by Transparency Market Research Inc, the global cell and gene therapy (CGT) manufacturing quality control (QC) market is anticipated to value $2.8 billion in 2031. It is projected to expand at a CAGR of 24.6 percent from 2023 to 2031. Comparatively, the market is expected to value $463.1 million by the end of 2023. With increasing research and development in the cell and gene therapy field, the demand for optimal quality control is needed to ensure the safe and efficient ma
MedCity News
AUGUST 30, 2023
Some states may not be following federal requirements for the Medicaid renewal process, resulting in many individuals being wrongly removed from coverage, CMS said. Children may especially be affected.
PharmaVoice
AUGUST 30, 2023
The list of blockbuster cardiovascular, diabetes and cancer drugs gives the industry a window into how regulators are approaching price negotiations.
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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
AUGUST 30, 2023
Biostax and Immgenuity have entered into an agreement to expedite the development of new immunotherapeutics to treat HIV and other diseases.
Pharmaceutical Commerce
AUGUST 30, 2023
Event’s first session aims to analyze the legislation’s implementation, as FDA enforcement is delayed until November 2024.
Pharmaceutical Technology
AUGUST 30, 2023
The US FDA has granted priority review for Zealand Pharma’s dasiglucagon for hypoglycemia in the infants with congenital hyperinsulinism.
PharmaTimes
AUGUST 30, 2023
The therapy involves treating individuals with atherosclerotic cardiovascular disease - News - PharmaTimes
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Pharmaceutical Technology
AUGUST 30, 2023
The EC has granted approval for Merck’s Keytruda regimen for gastric or gastroesophageal junction (GEJ) adenocarcinoma.
PM360
AUGUST 30, 2023
EVERSANA , a leading provider of commercialization services to the global life sciences industry, today announced the launch of EVERSANA ORCHESTRATE , the life sciences industry’s first end-to-end omnichannel solution focused on amplifying brand impact. It orchestrates “next best experience” commercialization services to simultaneously drive sales and patient outcomes.
Pharmaceutical Technology
AUGUST 30, 2023
Shares in the company tanked 80% following the FDA issued a CRL for its bevacizumab formulation.
PharmaTimes
AUGUST 30, 2023
Funding will progress the manufacture of oligonucleotide therapeutics alongside machine learning - News - PharmaTimes
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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.
Pharmaceutical Technology
AUGUST 30, 2023
The subcutaneous Tecentriq has been approved in the UK for all indications that its intravenous counterpart has received approval.
Optymyze
AUGUST 30, 2023
Drive Sales Performance with Seamless Data Integration In the world of sales, data is the fuel that drives success. To enable sales teams to unlock their true potential, we are.
PharmaTech
AUGUST 30, 2023
In pursuit of increased competitiveness and bottom-line impact, pharmaceutical manufacturers face increasing pressure to fast-track technological innovation while maintaining regulatory compliance. This e-book explores how Artificial Intelligence (AI) can unlock new levels of insights into what is causing variation in processes that can wreak havoc on your drug manufacturing performance.
Legacy MEDSearch
AUGUST 30, 2023
BionicM , an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This registration marks a significant milestone in the company’s commitment to deliver its robotic prosthetic knee to the USA market in 2024 with Japanese-proven technologies. “Having your limbs amputated severely limits your life,” says Xiaojun Sun, CEO of BionicM, a
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
eMediWrite
AUGUST 30, 2023
Background Small and medium-sized businesses (SMEs) are the backbone of India’s economy, creating a large amount of jobs and spurring economic expansion. Delay in payments is one of the main issues MSMEs in India deal with, though. Delayed payments put SMEs at a disadvantage compared to large size counterparts, inhibiting their ability to compete effectively in the market, and addressing the issue requires a multi-faceted approach involving various stakeholders.
Pharmacy Times
AUGUST 30, 2023
Sodium chloride injection contains sodium chloride in water and is administered intravenously, which is intended for a single-dose injection to replenish fluids and electrolytes.
PharmaTech
AUGUST 30, 2023
This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.
Pharmaceutical Technology
AUGUST 30, 2023
Alvotech and Bioventure received the Egyptian Drug Authority's approval to produce and supply AVT02 (adalimumab), a biosimilar for Humira.
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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.
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