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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Pharma 356

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.

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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.

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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.

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Prescription Medicine Pharma Patients 122

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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?

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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.

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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.

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MedCity News

JULY 23, 2024

The National Community Pharmacists Association and providers argued that Change Healthcare didn’t take the needed precautions against the cyberattack that happened earlier this year. The post NCPA, Providers File Lawsuit Against UHG Over Change Healthcare Cyberattack appeared first on MedCity News.

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Healthcare Healthcare 115

pharmaphorum

JULY 23, 2024

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

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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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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.

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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.

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Medicine Medical Leads Training 105

Fierce Pharma

JULY 22, 2024

As lawmakers and industry groups seek to get a handle on U.S. | As lawmakers and industry groups seek to get a handle on U.S. drug shortages, a new white paper from German market analytics firm QYOBO supports the thesis that disproportionately low prices for generic medicines can make it difficult for drugmakers to keep supplies afloat.

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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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Marketing Government 119

MedCity News

JULY 21, 2024

The dynamics of care delivery have already begun to shift, whether healthcare likes it or not. And it’s an opportunity to collaborate alongside healthcare consumers to shape what will be. The post Healthcare’s Failure of AI Imagination appeared first on MedCity News.

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Healthcare Healthcare Patients 118

Advertiser: ZoomInfo

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

Competition

pharmaphorum

JULY 25, 2024

Ipsen has signed yet another portfolio-expanding deal – its fifth of the year so far – claiming rights outside the US to a drug for common brain cancer glioma from Day One Biopharmaceuticals.

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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.

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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

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 105

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.

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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.

FDA

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.

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Healthcare Healthcare Marketing 109

MedCity News

JULY 22, 2024

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. The post Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test appeared first on MedCity News.

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Competition Pharmaceutical Medicine FDA 111

pharmaphorum

JULY 12, 2024

A new payment policy proposal released by the Centers for Medicare and Medicaid Services (CMS) this week covers digital tools used for behavioural health, which could be a boost for the digital health sector.The Medicare Physician Fee Schedule (PFS) sets out the method of payment, rates, and codes for healthcare providers participating in Medicare, and is often used by the administration as an instrument to encourage some forms of healthcare intervention.

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Healthcare Provider Physicians Healthcare Healthcare 110

Copyright Clearance Center

JULY 25, 2024

As AI continues to revolutionize corporate operations, a new collective licensing solution from CCC ensures that both content creators and users can thrive.

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European Pharmaceutical Review

JULY 17, 2024

European Pharmacopoeia has confirmed it will remove the rabbit pyrogen test (RPT) from its monographs. This milestone decision was made during the Ph. Eur.’s 179th session in June 2024. The RPT has been the traditional detection method for pyrogens, the European Directorate for the Quality Of Medicines (EDQM) explained. In June 2021, the European Pharmacopoeia Commission (EPC) committed to completely replace the RPT in the 59 Ph.

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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.

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FDA 347

PharmaVoice

JULY 16, 2024

An industry reeling from a precarious market is showing signs of stabilizing as the future becomes a little less cloudy, an Evaluate report suggests.

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Pharma Marketing 105

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.

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Insurance Healthcare Healthcare 121

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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

Distribution

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.

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Pharmaceutical Technology

JULY 2, 2024

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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Patients 116

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.

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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.

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Pharma Competition 309

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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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