Fierce Pharma
MAY 14, 2024
With new four-year data in hand, Novo Nordisk can make a case for its popular obesity med Wegovy to be used as a long-term treatment. | An analysis unveiled at the European Congress on Obesity showed that Wegovy patients lost 10% of their weight, on average, over a 4-year span.
pharmaphorum
MAY 15, 2024
The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer
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MedCity News
MAY 13, 2024
The U.S. Department of Justice recently launched a task force on healthcare monopolies. Experts have varying opinions on how it will impact the healthcare industry. The post DOJ Launches Task Force on Healthcare Monopolies: Will It Make A Difference? appeared first on MedCity News.
Integrity Solutions
MAY 14, 2024
For many in sales, negotiation is one of the most challenging aspects of the job. More often than not, these salespeople approach negotiation as a win-or-lose endurance game, a contentious battle that pits two opposing sides against each other. “Winning” means convincing the customer to accept your point of view—even if the outcome isn’t necessarily in the customer’s best interest.
Pharmaceutical Technology
MAY 15, 2024
Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.
Fierce Pharma
MAY 14, 2024
It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). | It’s been a long wait for Ascendis Pharma to score FDA approval for its hormone replacement therapy TransCon PTH (palopegteriparatide). And now, it’ll take another three months for the United States regulator to decide on the treatment for the endocrine disease hypoparathyroidism.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
MAY 13, 2024
As more hospitals across the country shut down their maternity wards, a Sutter Health-owned hospital in Berkeley has taken proactive steps to ensure it can continue providing care for the pregnant people in its community. The hospital partnered with Millie, a Berkeley-based startup offering hybrid maternal care from midwives and doulas. The post Sutter Health Partners with Millie to Incorporate Midwifery into Its Maternal Care Model appeared first on MedCity News.
ALULA
MAY 9, 2024
In the US alone, 6.2 percent of the total population identify as AANHPI (Asian American, Native Hawaiian, Pacific Islander). May is dedicated to honoring people in the US with AANHPI heritage , so it’s a great time to celebrate their voices and experiences – and to reflect on how we can integrate their stories into our lives all year long , especially with our colleagues and teams.
Pharmaceutical Technology
MAY 15, 2024
Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.
Fierce Pharma
MAY 13, 2024
While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global sta | While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage.
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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.
pharmaphorum
MAY 14, 2024
The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).
MedCity News
MAY 13, 2024
In part 2 of our Q&A, Okamura addresses the need for biopharma companies to leverage digital technologies in disease management. The post Astellas Pharma CEO Q&a (Part 2): We Have To Have Alternatives for Prescription Medicine Business appeared first on MedCity News.
European Pharmaceutical Review
MAY 9, 2024
Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca. “Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.
Pharmaceutical Technology
MAY 15, 2024
The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.
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Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Fierce Pharma
MAY 10, 2024
Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. | Right after an industry survey suggested that switching away from Chinese CDMOs could take biopharma companies up to eight years, lawmakers have adjusted the BIOSECURE Act. The new draft lays out a 2032 deadline for the separation mandate.
pharmaphorum
MAY 15, 2024
Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.
MedCity News
MAY 14, 2024
Healthcare devices must be exempted from general right to repair legislation. The post Right-to-Repair Laws Could Threaten Healthcare Safety appeared first on MedCity News.
European Pharmaceutical Review
MAY 15, 2024
Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”. Their study compared the stability, sterility, and binding affinity to VEGF and Ang-2 of faricimab.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Pharmaceutical Technology
MAY 14, 2024
The two companies will develop neuroplastogens for psychiatric disorders as psychedelic market activity ramps up.
Fierce Pharma
MAY 10, 2024
After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID ef | After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID efforts.
pharmaphorum
MAY 14, 2024
Cytokinetics has revealed the results from a phase 3 trial of its hypertrophic cardiomyopathy (HCM) drug aficamten that it hopes will allow it to compete with Bristol-Myers Squibb’s first-to-market Camzyos.
MedCity News
MAY 15, 2024
Blackstone Life Sciences startup Uniquity Bio emerged from stealth with an in-licensed drug candidate that could treat a wide range of immunology and inflammation indications. The antibody’s target puts it in competition with drugs from AstraZeneca, Pfizer, and Sanofi. The post Blackstone Unveils Immunology Startup With $300M and a Phase 2-Ready Drug From Merck appeared first on MedCity News.
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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
European Pharmaceutical Review
MAY 10, 2024
the success of CGT depends on a robust and reliable supply chain” Cell and gene therapies (CGT) offer a revolutionary approach to the treatment, prevention and potential cure of diseases. These advanced medical treatments provide hope for patients suffering from conditions that have historically been poorly understood and widely considered incurable, including genetic diseases and cancers.
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
Fierce Pharma
MAY 13, 2024
Of all the allegations thrown at WuXi AppTec during an ongoing U.S. | Facing potential sanctions from the Department of Defense and a recent allegation that it had transferred a U.S. client's data to Beijing without consent, WuXi AppTec is again rebutting claims of its ties with Chinese authorities.
pharmaphorum
MAY 13, 2024
Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.
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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.
MedCity News
MAY 13, 2024
Investing in youth brain capital is not just a moral imperative. It is an economic necessity. The post America Is Losing One of Its Most Precious Assets: Our Brain Power appeared first on MedCity News.
European Pharmaceutical Review
MAY 13, 2024
Eighty four percent of pharmaceutical and healthcare companies consider that the new EU Corporate Sustainability Due Diligence Directive (CSDDD) directive is an opportunity to “align human rights and environmental protection with their business objectives”, findings from a survey by supply chain specialist INVERTO has found. EU operations must comply with the new directive.
Pharmaceutical Technology
MAY 10, 2024
Shionogi has concluded an exclusive global licence agreement for Maze Therapeutics’ MZE001 aimed at treating Pompe disease.
Fierce Pharma
MAY 14, 2024
When Bayer unveiled a restructuring in January, the company didn’t provide specifics on the number of planned job cuts. | When Bayer unveiled a restructuring in January, the company didn't provide specifics on the number of planned job cuts. Now, the size of the initial round of cuts shows that CEO Bill Anderson means business.
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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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