Tue.Feb 27, 2024

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Organon's prolific asthma med Singulair needs new safety labeling, NY attorney general argues

Fierce Pharma

Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side ef | Organon’s inherited asthma med Singulair is back in the spotlight for the wrong reasons after New York Attorney General Letitia James raised fresh concerns about the drug’s neuropsychiatric side effects—especially in kids.

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Viking Therapeutics Obesity Drug’s Data Raise Best-in-Class Expectations

MedCity News

The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

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Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

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FDA says yes to Allecra, no to Venatorx UTI drugs

pharmaphorum

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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Beyond Faith: Can Hospitals Collect When Patients Rely on Sharing Ministries?

MedCity News

There is a ubiquitous lack of understanding and regulation surrounding the HCSM coverage which leaves hospitals stuck with the bill and negatively impacts the bottom line.

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Study rings warning bell over cancer therapy access in UK

pharmaphorum

UK cancer survival is lagging 10-15 years behind other countries due to lower rates of chemotherapy and radiotherapy, says UCL study backed by CRUK.

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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

Amgen has opened a new biomanufacturing plant in Central Ohio, US. It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. “As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us

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UK biotech Curve swings £40.5m in Pfizer-backed round

pharmaphorum

UK biotech Curve Therapeutics raises $51 million in a Pfizer-led Series A that will support its platform for screening drugs within cells.

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MHRA Chief Executive to step down

European Pharmaceutical Review

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. Dame June will remain in the position until then to support the new Chief Executive’s transition into the role. Leading the MHRA – a five year journey Professor Graham Cooke, interim chair of the MHRA board, remarked that Dame June’s “leadership of the MHRA over the last five years, particularly during the COVID-19 pand

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How Machine Learning Drives Clinical Trial Efficiency

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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FDA Grants Priority Review to Epkinly for Relapsed/Refractory Follicular Lymphoma

Pharmaceutical Commerce

Epkinly (epcoritamab-bysp), a subcutaneously administered, T-cell engaging, bispecific antibody, was previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory follicular lymphoma following two or more prior lines of therapy.

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How Clarivate works towards SDG 4: Ensuring inclusive and equitable quality education

Clarivate

At Clarivate we put sustainability at the heart of our business goals. Environment, social and governance issues are at the core of our global culture, serving as guiding principles for every decision we make. Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward.

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EMA Recommends New ALS Treatment

PharmaTech

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

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Trademarks on the rise: applications recover in 2023 after a dip in 2022

Clarivate

When global trademark filing activity fell in 2022 , questions rose around what this signified. Would 2023 data show a second year of decline, indicating uncertain economic outlooks? Or would filing activity recover? To answer this question, we dove into curated trademark data from CompuMark to analyze application and filing history. With access to over 147 million trademark records, including application and filing history gathered directly from Patent and Trademark Offices (PTOs) such as the E

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Accelerating Clinical Supply Through Integrated Drug Development

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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Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections

PharmExec

The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.

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Novo Nordisk joins molecular glue club with Neomorph deal

pharmaphorum

Novo Nordisk has signed a wide-ranging deal with US molecular glue biotech Neomorph that could be worth up to $1.46 billion.

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Genmab and AbbVie's sBLA for Epkinly Granted FDA Priority Review for Relapsed/Refractory Follicular Lymphoma

PharmExec

Epkinly (epcoritamab-bysp) is a subcutaneously administered, T-cell engaging, immunoglobulin G1-bispecific antibody under evaluation for aggressive B-cell lymphomas.

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Behind a big-name rare disease biotech, an exec draws from personal experience

PharmaVoice

The personal impact of rare disease has shaped Gianluca Pirozzi, a senior vice president at AstraZeneca’s Alexion, as a parent and drug developer.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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IQVIA Executive Director Discusses Global Use of Medicines 2024 Report - Part 2

PharmExec

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses how climate events and COVID-19 have impacted medicine use and spending.

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Seven Trends to Watch in Healthtech AI

MedCity News

As the role of AI in healthcare settings continues to evolve and generate debate, here are seven things to keep an eye on.

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IQVIA Study Highlights the Importance of Adult Vaccination in the US

PharmExec

Results of the study determined that adult flu vaccination rates among Medicaid populations were significantly low, highlighting other health inequities.

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Gilead’s Biktarvy gains FDA expanded indication approval for HIV

Pharmaceutical Technology

Gilead Sciences has received FDA approval for an expanded indication for Biktarvy to treat HIV patients with M184V/I resistance mutations.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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With Generative AI, Layoffs Increasing Complexity for C-Suites in 2024, What Playbook Should Executives Deploy for the Next Three Quarters?

PharmExec

A Harvard Business School Healthcare Alumni Association (HBSHAA) Q&A with Professor Deborah Ancona, founder of the MIT Leadership Center.

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Sponge-on-a-string test to benefit NHS patients with oesophageal cancer

PharmaTimes

Eight out of ten patients who took the test were discharged without needing further testing

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EMA CHMP recommends AstraZeneca’s Voydeya for PNH treatment

Pharmaceutical Technology

The EMA CHMP has recommended AstraZeneca's Voydeya for marketing authorisation to treat paroxysmal nocturnal haemoglobinuria (PNH).

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UK and Netherlands researchers call for funding to investigate cancer treatments

PharmaTimes

The white paper outlines three strategic recommendations to support further research

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Novo Nordisk signs $1.46bn deal to develop molecular glue therapies

Pharmaceutical Technology

Novo Nordisk has partnered with US startup Neomorph to develop multiple molecular glue degraders for cardiometabolic and rare diseases.

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FDA to Evaluate BeiGene’s Tevimbra Combination for Gastric/Gastroesophageal Junction Adenocarcinoma

PharmExec

Trial data support Tevimbra combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction cancer.

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Bristol Myers Squibb acquires RayzeBio for $4.1bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a radiopharmaceutical company, for $4.1bn.

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AstraZeneca VP, Head of US Lung Cancer Franchise Discusses the Recent FDA Approval of TAGRISSO

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Arun Krishna, VP, Head of US Lung Cancer Franchise, AstraZeneca, talks about the FDA's approval of TAGRISSO with the addition of chemotherapy in adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.