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 18, 2024
A much diminished 23andMe exists today, a far cry from the phenomenon that it was in the world consumer DNA testing. Could things have unfolded differently under a different leader with a different vision? The post 23andMe: What If … appeared first on MedCity News.
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MedCity News
APRIL 15, 2024
Two CVS stores in Rhode Island have filed petitions to join the Pharmacy Guild, which is building a national pharmacy union. The locations are close to CVS Health’s headquarters in Woonsocket, Rhode Island. The post Two CVS Locations Make Moves To Join National Pharmacy Union Movement appeared first on MedCity News.
pharmaphorum
APRIL 16, 2024
A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.
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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
PharmaTech
APRIL 12, 2024
The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.
Copyright Clearance Center
APRIL 16, 2024
In a publishing environment buffeted by digital disruption and calls for open access, university presses in 2024 must manage to remain relevant and sustainable even as their audiences grow.
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
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?
pharmaphorum
APRIL 16, 2024
Boehringer Ingelheim says the strongest R&D pipeline in its history is set to deliver 25 new product launches between now and 2030
PharmaTech
APRIL 11, 2024
The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.
Pharmaceutical Technology
APRIL 17, 2024
Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).
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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.
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 14, 2024
Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care. The post A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health appeared first on MedCity News.
pharmaphorum
APRIL 15, 2024
Shah Capital has fired a broadside at the management team of Novavax, seeking a change in leadership at the vaccine company and the appointment of two handpicked directors to the board. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs.
European Pharmaceutical Review
APRIL 11, 2024
Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, [which has] resulted in increased competition and price pressure, driving the growth of the biosimilar market” A report published by Towards Healthcare has estimated that the global biosimilar market will value $1,26,019.67 million by 2032, at 17.6 percent CAGR between 2023 and 2032.
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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
Pharmaceutical Technology
APRIL 16, 2024
The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.
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
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.
pharmaphorum
APRIL 15, 2024
Life sciences service provider (and pharmaphorum parent company) Eversana has completed the integration of Healthware Group, the Italy-based global agency and consultancy it acquired in October. The group will now be known as Eversana Intouch Healthware and will operate as Eversana’s sixth full-service affiliate.
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.
European Pharmaceutical Review
APRIL 11, 2024
The pharmaceutical industry is becoming increasingly conscious of emissions and the importance of sustainable manufacturing. Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. 1 That’s more than the automotive sector, which released 46.4 megatonnes in the same year, and the increased demand and complexity of medicines since then will only have swollen this figure. 1 Every major pharmaceutical manufact
Pharmaceutical Technology
APRIL 18, 2024
Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.
Fierce Pharma
APRIL 16, 2024
Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. | Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug.
MedCity News
APRIL 16, 2024
In vulnerable moments when employees need it most, virtual specialty care delivers a human connection that offers empathy, support, and guidance. The post Guidance and Education For Employees Facing a Cancer Journey 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.
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.
European Pharmaceutical Review
APRIL 15, 2024
FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.
Pharmaceutical Commerce
APRIL 15, 2024
Results of the trial suggest that early intervention for intracerebral hemorrhage using parafascicular surgery were safe.
Fierce Pharma
APRIL 11, 2024
After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s | FDA Commissioner Robert Califf, M.D., told lawmakers that the agency, as the "referee," needs to be given more authority in order to preemptively halt drug shortages.
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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.
MedCity News
APRIL 16, 2024
Intra-Cellular Therapies reported its drug Caplyta met the main and secondary goals in the first of three pivotal studies in major depressive disorder. Success in two of them could support expanding the label of the drug, which is currently approved in schizophrenia and bipolar depression. The post Depression Trial Win Moves Intra-Cellular Drug Closer to Label Expansion & Blockbuster Status appeared first on MedCity News.
pharmaphorum
APRIL 15, 2024
Roche’s CD20xCD3 bispecific antibody Columvi has improved survival when used as a second-line therapy for diffuse large B-cell lymphoma (DLBCL) in a phase 3 trial, setting up regulatory filings for earlier use of the drug in the treatment pathway.
European Pharmaceutical Review
APRIL 16, 2024
A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space.
Pharmaceutical Technology
APRIL 18, 2024
Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.
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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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