Fierce Pharma
APRIL 17, 2024
One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.
MedCity News
APRIL 17, 2024
This week, the FTC ordered Cerebral to pay a $7 million fine, accusing the company of mishandling users’ sensitive health data and misleading consumers about cancellation policies. Experts agree that other virtual healthcare providers need to work on their legal and compliance strategies in order to avoid a similar fate. The post What Does the FTC’s $7M Fine Against Cerebral Mean for the Industry?
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Fierce Pharma
APRIL 17, 2024
In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).
MedCity News
APRIL 17, 2024
Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. The post Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too appeared first on MedCity News.
Fierce Pharma
APRIL 17, 2024
After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. | Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday. Under the deal, Medincell is line to receive an upfront payment of $35 million plus much more in potential development and commercial milestones.
MedCity News
APRIL 17, 2024
The challenge? Maintaining high Star Ratings or improving upon existing ratings gets increasingly difficult over time. The post Star Ratings and Member Experience: Two Sides of the Same Coin appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
APRIL 17, 2024
In addition to panel discussions around some of the hottest topics in healthcare transformation, there is also a startup pitch contest, a presentation on government funding for startups and networking opportunities. The post Want to Connect with Innovative Healthcare Startups and Investors? Register for MedCity INVEST Today! appeared first on MedCity News.
pharmaphorum
APRIL 17, 2024
Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.
MedCity News
APRIL 17, 2024
The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. The post FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries appeared first on MedCity News.
pharmaphorum
APRIL 17, 2024
Drug shortages fuelled by Brexit are now the 'new normal' in the UK and worsened in 2023, says Nuffield Trust report.
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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
APRIL 17, 2024
A report by Market Research Future has predicted that the rapid sterility testing market will increase in value from $2.3 billion in 2023 to $4.3 billion by 2032. It is expected hold a compound annual growth rate (CAGR) of 8.20 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to t
pharmaphorum
APRIL 17, 2024
The FTC is seeking a $7 million fine on telehealth company Cerebral for violating patients' data privacy and making cancellation difficult.
Pharmaceutical Technology
APRIL 17, 2024
Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).
pharmaphorum
APRIL 17, 2024
MaaT Pharma's microbiota therapy MaaT013 shows survival benefit in acute GvHD in an early access programme, boding well for an ongoing phase 3 trial.
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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
Pharmaceutical Technology
APRIL 17, 2024
LX2006 consists of adeno-associated virus (AAV) vector carrying the frataxin gene, responsible for causing Friedreich’s ataxia.
pharmaphorum
APRIL 17, 2024
GSK reveals data from EAGLE-1 trial of novel antibiotic gepotidacin for gonorrhoea, amid growing resistance to existing antibiotics.
European Pharmaceutical Review
APRIL 17, 2024
Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). One-year data from the Phase III OCARINA II trial demonstrated a near-complete suppression of relapse activity (97.2 percent had no relapse) in patients through 48 weeks of the treatment.
PharmaTech
APRIL 17, 2024
Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.
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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.
PharmaTimes
APRIL 17, 2024
The findings suggest why children tend to experience milder symptoms compared to older adults
PharmaTech
APRIL 17, 2024
At INTERPHEX 2024, Pharmaceutical Technology sat down with Christa Myers of CRB Group and Nadiyra Walker Speight of Fujifilm Diosynth Biotechnologies to discuss implementation of Annex 1.
Pharmaceutical Commerce
APRIL 17, 2024
A panel uncovers the value in meeting carbon-neutral goals by 2030.
PharmaTech
APRIL 17, 2024
Wenyu Zhang, PhD, addressed new trends in the aseptic industry and the chief concerns companies should keep in mind while weighing their options, at INTERPHEX 2024.
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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.
PharmaTimes
APRIL 17, 2024
Both companies will facilitate career progression while advancing the life sciences industry
PharmaTech
APRIL 17, 2024
Former FDA drug investigator, Daniel Roberts, discusses the importance of updating process validation and maintaining proper data integrity at a keynote session during INTERPHEX.
pharmaphorum
APRIL 17, 2024
Eli Lilly’s diabetes and obesity therapy tirzepatide could find a use as a treatment for obstructive sleep apnoea (OSA) after hitting the mark in a pair of phase 3 trials.
Pharmaceutical Commerce
APRIL 17, 2024
The latest news for pharma industry insiders.
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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
Pharmacy Times
APRIL 17, 2024
If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.
Pharmaceutical Commerce
APRIL 17, 2024
Masterclass session addresses looking beyond a dashboard by added capabilities with added value.
PharmExec
APRIL 17, 2024
With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis.
Evolve Your Success
APRIL 17, 2024
Unlock the secrets to thriving in the intricate dance of medical sales with insights from Dr. Abhineet Chowdhary a distinguished neurosurgeon with a wealth of knowledge on the clinician-sales rep dynamic. Prepare to have your perspective transformed as we dissect the crucial elements of trust, preparedness, and communication that define successful collaborations.
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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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