Fierce Pharma
NOVEMBER 22, 2022
'Monopoly' allowed Bristol Myers and generics makers to 'steal' from Revlimid purchasers, lawsuit says. kdunleavy. Tue, 11/22/2022 - 11:13.
MedCity News
NOVEMBER 22, 2022
Based on some independent research that my company commissioned with more than 200 companies, we came to several conclusions that are highlighted in the article. Broadly, however, it signals the false sense of (cyber)security that many companies are currently harboring.
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Fierce Pharma
NOVEMBER 22, 2022
Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck. fkansteiner. Tue, 11/22/2022 - 10:07.
Pharmaceutical Technology
NOVEMBER 22, 2022
Umoja Biopharma has signed a research agreement with IASO Biotherapeutics (IASO Bio) to develop off-the-shelf therapies for haematological malignancies. Under the alliance, the companies will assess the induced cytotoxic innate lymphocytes (iCIL) platform of Umoja with chimeric antigen receptors (CARs) of IASO to develop the next generation of widely accessible, easily available cell therapies.
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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
Fierce Pharma
NOVEMBER 22, 2022
Merck's Keytruda tees up BMS stomach cancer fight with new trial win. zbecker. Tue, 11/22/2022 - 11:04.
MedCity News
NOVEMBER 22, 2022
Home care is no longer only for elderly patients who require a visiting nurse to come into their home and check on them post-discharge. Pippa Shulman, Medically Home’s chief medical officer, said that her company’s health systems partners need to be on board with the fact that hospital-level care is moving away from brick-and-mortar facilities.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 22, 2022
GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. Some patients will be able to continue to receive the drug via a compassionate use programme.
Fierce Pharma
NOVEMBER 22, 2022
2023 preview: Despite Biden's drug pricing win, the biopharma industry is not 'anywhere near done with this conversation'. esagonowsky. Tue, 11/22/2022 - 14:22.
PharmExec
NOVEMBER 22, 2022
The Digital Medicine Society (DiMe) CEO Jennifer Goldsack and Takeda’s Head of Digital Health Sciences, Data Sciences Institute Shoibal Datta describe the current landscape of digitized clinical trials and the decisions needed to fully utilize their potential.
Fierce Pharma
NOVEMBER 22, 2022
Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule. ntaylor. Tue, 11/22/2022 - 10:22.
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MedCity News
NOVEMBER 22, 2022
NovaWell, the behavioral health affiliate of Horizon Healthcare Services, is offering four solutions for health plans and health systems. The program was created from Horizon’s own success in New Jersey.
Fierce Pharma
NOVEMBER 22, 2022
ScPharmaceuticals prices $50M offering to fund commercialization of on-body infusor. ntaylor. Tue, 11/22/2022 - 10:28.
European Pharmaceutical Review
NOVEMBER 22, 2022
Triastek, Inc. a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs. T21 is Triastek’s third FDA IND clearance for a 3D-printed medicine.
MedCity News
NOVEMBER 22, 2022
Machine learning algorithms have reached a familiar milestone in the healthcare industry –in order for them to be more widely embraced by providers, different approaches to roadtesting and validating them are underway.
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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.
European Pharmaceutical Review
NOVEMBER 22, 2022
A paper, published in Molecules , has developed validated the use of ultra-performance liquid chromatography with triple quadrupole mass spectrometry, or UHPLC-MS/MS, for identification and detection of the ?-lactams cephapirin and ceftiofur in cleaning solutions of the production reactors. Trace detection of ?-lactam antibiotics in cleaning rinse solutions and manufacturing aids in pharmaceutical facilities is crucial and regulated.
PharmaVoice
NOVEMBER 22, 2022
How Boston became the biotech capital of the U.S., and is now preparing for the next era of life sciences growth.
Pharmaceutical Technology
NOVEMBER 22, 2022
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted emergency regulatory approval for Shionogi ’s new anti-SARS-CoV-2 drug, Xocova (ensitrelvir fumaric acid, S-217622), for Covid-19. This approval under the emergency regulatory approval system is granted under the Article 14-2-2 of the Pharmaceuticals and Medical Devices Act, the company noted.
Legacy MEDSearch
NOVEMBER 22, 2022
New View Surgical, Inc., an emerging medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced the closure of a $12.1M Series B-1 equity financing round to fund the commercialization of its VisionPort System. The company expects to launch the VisionPort System in the US before the end of 2022.
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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.
MedCity News
NOVEMBER 22, 2022
At the 5th annual HLTH conference in Las Vegas, 14 healthcare executives from companies such as Babson Diagnostics to Wheel responded to questions such as what’s the difference between a positive and negative user experience in telehealth? They also previewed their plans for 2023.
Pharmaceutical Technology
NOVEMBER 22, 2022
It's the last issue of Pharmaceutical Technology Focus in 2022, and a lot of changes have occurred over the year, not just in the pharma space, but also from a geopolitical, financial and energy perspective. Most recently, after a tumultuous 45 days, Liz Truss resigned as the UK’s prime minister paving the way for Rishi Sunak to take on the mantle. In this issue, we talk to different stakeholders in the pharmaceutical space to gauge what the sector is hoping Sunak achieves in his tenure when it
MedCity News
NOVEMBER 22, 2022
A new venture capital firm named HC9 Ventures recently launched and announced the close of a $83 million fund. It is led by three healthcare industry veterans, and its more than 125 investors are “intentionally and only healthcare executives,” according to HC9 Co-Founder Richard Lungen.
PharmaVoice
NOVEMBER 22, 2022
Evelina Vågesjö, co-founder and CEO of the immunotherapy company Ilya Pharma, is working on a new modality to speed wound healing.
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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
NOVEMBER 22, 2022
A series of recently released studies on Papa, a companion care company, found that the startup reduced emergency department visits, decreased healthcare spending and improved loneliness.
Pharma IQ
NOVEMBER 22, 2022
Speakers from AstraZeneca, Merck, Moderna and Johnson & Johnson on building the lab of the future.
European Pharmaceutical Review
NOVEMBER 22, 2022
Merck has announced it will acquire biopharma Imago BioSciences, Inc for around $1.35 billion in total equity value, to facilitate development of Imago’s lead candidate bomedemstat (IMG-7289), an investigational oral lysine-specific demethylase 1 (LSD1) inhibitor for myeloproliferative neoplasms (MPNs). ”Robert M. Davis, President and Chief Executive Officer at Merck declared, “This acquisition of Imago strengthens our presence in the growing field of haematology.”.
MedCity News
NOVEMBER 22, 2022
Cancer is a serious public health issue, accounting for nearly 10 million deaths and over […].
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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
European Pharmaceutical Review
NOVEMBER 22, 2022
The US Food and Drug Administration ( FDA ) has accepted priority review of AbbVie’s Biologics License Application of epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody (BsAb), for adults with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcori
MedCity News
NOVEMBER 22, 2022
We’re now accepting applications for INVEST Pitch Perfect, scheduled for May 22-24 at the Ritz Carlton in Chicago. The contest will spotlight novel healthcare startups across five categories: biopharma, diagnostics, medical devices, health tech: consumers/employers, health tech: payers/providers. Register and submit your application today.
Copyright Clearance Center
NOVEMBER 22, 2022
The post Literature Monitoring: A Critical Tool for Pharmacovigilance in Life Sciences appeared first on Copyright Clearance Center.
Integrity Solutions
NOVEMBER 22, 2022
With employee turnover one of the most serious internal threats credit unions and banks face today, many forward-thinking financial institutions are taking a hard look at their organizations culture and opportunities to change. Leaders increasingly understand that company culture strongly influences employee engagement — and employee engagement levels are excellent predictors of future turnover.
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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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