Fierce Pharma

MAY 8, 2024

Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U. | Following the lead of French pharmaceutical giant Sanofi, Pfizer has agreed to settle more than 10,000 personal-injury claims from users of heartburn drug Zantac, resolving litigation in several U.S. state courts, according to Bloomberg.

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Leads Pharmaceutical 352

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.

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Healthcare Healthcare 120

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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FDA 103

European Pharmaceutical Review

MAY 8, 2024

New data from a Phase IIa trial in moderate-to-severe atopic dermatitis has demonstrated that a novel monoclonal antibody (mAb) could facilitate dosing every 12 weeks for induction therapy. This is due to a 31-day half-life at anticipated therapeutic dose levels, Inmagene Biopharmaceuticals confirmed. Humanised anti-OX40 IgG1 mAb IMG-007 works via a silenced antibody -dependent cellular cytotoxicity (ADCC) function, Inmagene explained.

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Safety Patients Medicine Medical 117

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PharmaTech

MAY 8, 2024

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

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Fierce Pharma

MAY 8, 2024

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European | Once hailed as a landmark accomplishment and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

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Marketing Medicine 327

pharmaphorum

MAY 14, 2024

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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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.

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Sales Training 89

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.

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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.

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FDA Pharma 258

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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.

Safety

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.

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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).

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Pharmaceutical Technology

MAY 15, 2024

Nabla Bio has secured $26m in a Series A financing round led by Radical Ventures, for generative protein designing.

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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.

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Distribution Manufacturing Medicine Pharmaceutical 90

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

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.

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Patients 258

MedCity News

MAY 12, 2024

No matter what form they take, one thing is clear — there is an urgent demand for digital primary care providers to guide patient navigation in the digital health era. The post Healthcare’s Next Void to Fill: Digital Primary Care appeared first on MedCity News.

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Patients 109

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.

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Marketing 91

Pharmaceutical Technology

MAY 8, 2024

AstraZeneca has begun the global withdrawal of its Covid-19 vaccine Vaxzevria, citing a surplus of updated vaccines.

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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

PharmaVoice

MAY 8, 2024

Partnerships have been key to building the company’s AI capabilities and patient-focused R&D, said AstraZeneca’s head of U.S. oncology.

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Patients 98

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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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.

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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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Marketing 95

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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

Pharmaceutical Technology

MAY 14, 2024

The two companies will develop neuroplastogens for psychiatric disorders as psychedelic market activity ramps up.

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Marketing 94

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.

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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.

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Biopharma 278

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.

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Safety Healthcare Healthcare 99

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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.

Specialization

pharmaphorum

MAY 10, 2024

Sanofi has licensed joint commercial rights to Novavax’s COVID-19 vaccine and will work with the biotech on the development of combined flu/COVID shots in a deal worth up to $1.2 billion.

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Pharmaceutical Technology

MAY 10, 2024

The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.

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FDA 105

Clarivate

MAY 8, 2024

Discover how the Web of Science Research Intelligence platform will revolutionize research evaluation by driving responsible innovation and demonstrating societal impact. At Clarivate , we recognize the pivotal role that research plays in shaping the future. That’s why we’re excited to announce the development of Web of Science Research Intelligence , a next-generation software solution powered by AI that will empower researchers to accelerate breakthroughs and research institutions to better me

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Competition Management Prospecting Networking 83

Fierce Pharma

MAY 8, 2024

Amid a U.S. | In a letter to FDA Commissioner Robert Califf, M.D., the House Committee on Oversight and Accountability chairman argued that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare against the United States.

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FDA Pharmaceutical 290

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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.

Management