MedCity News
JULY 26, 2024
GenAI will help healthcare reach its destination of efficiency and superior outcomes, but we can’t lose sight of the need for human touch, quality interactions and data to navigate us forward. The post GenAI is a Goal but Not the Destination in Healthcare appeared first on MedCity News.
Fierce Pharma
JULY 15, 2024
While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.
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Copyright Clearance Center
JULY 16, 2024
July 16, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced the availability of artificial intelligence (AI) re-use rights within its Annual Copyright License s (ACL), an enterprise-wide content licensing solution offering rights from millions of works to businesses that subscribe.
Pharmaceutical Technology
JULY 22, 2024
As the use of AI soared across healthcare, NVIDIA fit the bill in providing the necessary technology – and its stock tells the same story.
Clarivate
JULY 11, 2024
“AI Everywhere All at Once.” This year’s theme from Outsell, Inc. perfectly captures the expansion of artificial intelligence across all facets of our lives. In academia, this rapid advancement raises more questions than answers. How do we ensure ethical AI use? How can we advance research and drive research integrity? How do we use AI to advance student learning skills?
European Pharmaceutical Review
JULY 30, 2024
Japanese researchers have developed a new method for photoisomerisation of E -cinnamamides to Z -cinnamamides. The approach uses a recycling photoreactor coupled with a high-performance liquid chromatography (HPLC) system. As organic compounds, many Z -alkenes “cannot be prepared through conventional methods involving thermodynamic methods”. On the other hand, “photoisomerisation can offer good yields”, they noted.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Fierce Pharma
JULY 2, 2024
After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.
PharmaTech
JULY 17, 2024
The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.
pharmaphorum
JULY 11, 2024
The US Senate has come together to pass a bill that aims to prevent pharma companies from filing multiple patents around biologic drugs as a way to delay biosimilar competitors.Lawmakers unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150), which is part of a lengthening list of measures being taken by Congress to curb the prices of medicines in the US.
Pharmaceutical Technology
JULY 1, 2024
On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.
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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.
European Pharmaceutical Review
JULY 4, 2024
Altering the conditions that T cells are grown in can improve CAR T-cell therapy, US researchers have found. Discovered by chance, their new method has potential to treat solid cancer tumours more efficiently, according to the findings. Putting T cells on a keto diet [putting our T cells on a three-day ‘keto’ diet] showed reduced maturity at the end of the manufacturing process.
MedCity News
JULY 18, 2024
The Federal Trade Commission recently released an interim report that details how the practices of pharmacy benefit managers negatively impact patients and pharmacies. Some experts hope for legislative action based on the report. The post The FTC Released a Scathing Interim Report on PBMs. What’s Next? appeared first on MedCity News.
Fierce Pharma
JULY 15, 2024
It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.
Pharmaceutical Commerce
JULY 19, 2024
FDA to review one-year results for Susvimo showing non-inferior visual acuity gains in diabetic macular edema and in the Diabetic Retinopathy Severity Scale for Diabetic Retinopathy.
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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
pharmaphorum
JULY 1, 2024
AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.
Eversana Intouch
JULY 9, 2024
MM+M recently named Agios Pharmaceuticals’ “Do You See It?” campaign as their Campaign of the Week! The campaign focuses on the hidden dangers of thalassemia, a rare genetic condition affecting an estimated 8,000 Americans. The disease can result in anemia-like symptoms, with severe cases requiring regular blood transfusions, while milder cases often go untreated.
European Pharmaceutical Review
JULY 11, 2024
Dr Roopal Thakkar has been appointed as Executive Vice President, Research & Development and Chief Scientific Officer of AbbVie. He is the company ’s current Senior Vice President, Chief Medical Officer, Global Therapeutics. “As AbbVie’s Chief Scientific Officer, Dr Thakkar will continue to build momentum across discovery and all stages of development to fully realise the potential of our diverse pipeline.
MedCity News
JULY 9, 2024
A uniQure gene therapy for Huntington’s disease has interim clinical data showing an 80% slowing of disease progression. An accelerated approval pathway is one of the topics the company wants to discuss with the FDA. The post With New Huntington’s Gene Therapy Data, uniQure Hopes for Faster Path With FDA appeared first on MedCity News.
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.
Fierce Pharma
JULY 11, 2024
Even as pharma companies have yet to feel the full effects of the Inflation Reduction Act, Senate lawmakers have turned their attention to another facet of drug pricing with a bill meant to cr | The bill looks to limit the number of patents that companies can assert in litigation on individual products. It's intended to crack down on "patent thickets," which can delay and thwart generic competition.
Referral MD
JULY 23, 2024
ReferralMD, a leader in healthcare technology solutions, is excited to announce that Baptist Memorial Health Care, one of the nation’s largest not-for-profit health care systems and the largest Medicaid provider in the region, has significantly improved their referral management process with ReferralMD. The centralized Referral Center at Baptist Memorial sought a comprehensive referral management platform to replace their previous system.
pharmaphorum
JULY 31, 2024
Vertex has filed for FDA approval of its non-opioid pain drug suzetrigine, starting the clock ticking on a review that should be completed early next year
Quantified
JULY 30, 2024
The Power of Storytelling in Sales When was the last time you got lost in a story? Whether in a book, podcast, or movie, a well-told story has a powerful impact on its audience. When messages delivered as stories can be up to 22 times more memorable than mere facts. Stories engage multiple parts of our brains, enhancing focus and retention. Your Brain on Stories Neurological Engagement: Stories activate multiple brain areas, including motor cortexes, emotion, and visual processing centers, makin
European Pharmaceutical Review
JULY 9, 2024
Researchers have developed an ultrasensitive analytical method for quantifying nitrite quantity in process water for pharmaceutical products. The team tested various samples two ion chromatography analytical methods. This included a range of water types eg, purified and potable water, according to the paper. Kumar et al. explained that “accurate determination of nitrite content in process water will support an understanding of the potential for nitrosamine formation from nitrite in process water
MedCity News
JULY 9, 2024
Illinois, Kentucky, Oregon, Utah and Vermont have been authorized by HHS to provide Medicaid/Children’s Health Insurance Program coverage to those transitioning out of incarceration up to 90 days before they’re released. Several healthcare leaders called the action a necessary step. The post Health Leaders Applaud HHS’ Action Giving Some Incarcerated Individuals Medicaid Coverage Before Release appeared first on MedCity News.
Fierce Pharma
JULY 18, 2024
Pfizer’s blockbuster drug tafamidis for the treatment of the rare heart disease transthyretin amyloid cardiomyopathy (ATTR-CM) needs at least a 96% discount off its list price to be considered cost | Pfizer’s blockbuster tafamidis for the treatment of the rare heart disease ATTR-CM needs at least a 96% discount off its list price to be considered cost-effective under common benchmarks, a draft report by ICER has found.
Pharmaceutical Technology
JULY 31, 2024
Gene therapy research is expensive. Biotechs invest millions of dollars in early research to develop therapies for conditions that might be rare. But when funds are limited and the market potential is dim, such programs are often abandoned by companies, leaving patients and investigators in a bind.
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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
pharmaphorum
JULY 19, 2024
FDA will create a rare disease hub to speed the development of new treatments and build connections between developers and the rare disease community
Spotio
JULY 22, 2024
In both inside and outside sales environments, a lot of emphasis is placed on nurturing leads and closing deals. And while those steps are crucial when it comes to locking down new clients, improving your team’s activity-to-appointment ratio should also be a priority. The first step toward closing a deal is getting a prospect to commit to that first appointment, after all.
European Pharmaceutical Review
JULY 1, 2024
At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.
MedCity News
JULY 29, 2024
As the FDA stakes its claim as the primary regulator of AI in healthcare, it must navigate the delicate balance between fostering innovation and ensuring safety and responsibility. The post Enabling Clinical Trial Innovation Through AI Regulation at FDA appeared first on MedCity News.
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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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