World of DTC Marketing
MARCH 28, 2022
Oxford researchers say they have confirmed that alcohol is a direct cause of cancer, emphasizing how their findings reinforce the need to lower levels of alcohol consumption in the population for cancer prevention. The question is will the healthcare community do anything about these findings? Worldwide, alcohol is responsible for an estimated 3 million deaths each year, with over 400,000 from cancer.
Bio Pharma Dive
MARCH 28, 2022
The drug, found to be ineffective against a coronavirus strain known as BA.2, is no longer authorized for use in 10 states and U.S. territories, a limitation that could be widened further.
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BioPharma Reporter
MARCH 28, 2022
CytoImmune Therapeutics, a clinical-stage immunotherapy company developing a novel class of engineered natural killer (NK) cell-based cancer therapies, has announced the opening of its clinical cell manufacturing facility in Toa Baja, Puerto Rico.
Bio Pharma Dive
MARCH 28, 2022
The study setback raises questions over how well a type of genetic medicine can work in adults with central nervous system disorders like ALS.
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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
Pharma Times
MARCH 28, 2022
Digital health boost as new website focuses on dry eye disease, which currently affects one in four people across the UK
Bio Pharma Dive
MARCH 28, 2022
Accelerate your path to novel, reliable answers with expert-curated biomedical and clinical data.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MARCH 28, 2022
A panel of experts will debate the merits of Amylyx Pharmaceuticals' experimental medicine Wednesday. New documents from the FDA show agency scientists hold significant reservations.
Pharma Times
MARCH 28, 2022
Collaboration between Babylon Health and tech giant seeks to speed up historically slow patient access to data
BioPharma Reporter
MARCH 28, 2022
Janssenâs Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
NY Times
MARCH 28, 2022
Jada Pinkett Smith’s hair loss condition played a major role in an incident at the Oscars. Here’s what we know about it.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Channels
MARCH 28, 2022
Informa Connect’s Medicaid & Government Pricing Congress. Hybrid Event In-Person: May 23-25, 2022, Philadelphia, PA | Virtual: June 1-2, 2022 www.informaconnect.com/medicaid-government-pricing. Don’t miss the Medicaid & Government Pricing Congress , coming up May 23-25, 2022 (in-person in Philadelphia) and June 1-2, 2022 (virtually)! You'll be part of the important discussions surrounding the critical policy updates and approaches to effectively contract, report and comply with state and
The Pharma Data
MARCH 28, 2022
BIIB078, an investigational antisense oligonucleotide for C9orf72-associated amyotrophic lateral sclerosis (ALS), did not show clinical benefit; clinical program will be discontinued Biogen and Ionis remain committed to their decade-long pursuit of advancing ALS research and developing therapies for all forms of this progressive and fatal neurodegenerative disease.
Drug Patent Watch
MARCH 28, 2022
Annual Drug Patent Expirations for ARESTIN Arestin is a drug marketed by Orapharma and is included in one NDA. It is available from one supplier. There are two patents protecting…. The post New patent expiration for Orapharma drug ARESTIN appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MARCH 28, 2022
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic ® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic ® is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults.
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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.
Drug Patent Watch
MARCH 28, 2022
Annual Drug Patent Expirations for TYMLOS Tymlos is a drug marketed by Radius Health Inc and is included in one NDA. It is available from one supplier. There are four…. The post New patent for Radius Health drug TYMLOS appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MARCH 28, 2022
– Funding Will Reach Under-Resourced Communities Most Impacted by the HIV Epidemic and COVID-19 Pandemic –. Gilead Sciences, Inc., (Nasdaq: GILD) today announced $24 million in grants to help reduce health disparities, improve access to quality healthcare, advance medical education and support local communities most impacted by the HIV epidemic and COVID-19 pandemic.
pharmaphorum
MARCH 28, 2022
Dubai-based Altibbi already claims to be the largest operator in the Middle East region for Arabic language telehealth, and is poised to expand its services with the help of $44 million in new funding. Indian drugmaker Hikma Pharmaceuticals and Dubai’s Foundation Holdings led the round, which was also joined by Dubai-based Global Ventures and Amman-based DASH Ventures and will be used to expand Altibbi’s business into online pharmacy and diagnostics collection services.
The Pharma Data
MARCH 28, 2022
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure or premature death / Kerendia™ (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD and T2D / The approval is based on the results of the Phase III studies FIDELIO-DKD and FIGARO-DKD, investigating the efficacy and safety of fine
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
XTalks
MARCH 28, 2022
Beyond Meat and PepsiCo are coming together to launch a plant-based jerky in the US. In 2021, the two food giants teamed up for their Planet Partnership , a joint venture seeking “to develop, produce and market innovative snack and beverage products made from plant-based protein.” The first products of that deal are three varieties of Beyond Meat Jerky.
The Pharma Data
MARCH 28, 2022
Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024. Tomorrow, Sanofi will host an Immunology Investor Event with key members of the leadership team providing updates on how the company is advancing its Immunology strategy, includ
pharmaphorum
MARCH 28, 2022
Roche has moved a step closer to extending the use of its B-cell lymphoma therapy Polivy into the first-line setting, after getting a recommendation for approval in the EU from EMA advisors. The CHMP backed Polivy (polatuzumab vedotin) for previously-untreated diffuse large B-cell lymphoma (DLBCL) in combination with R-CHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) late last week.
Outsourcing Pharma
MARCH 28, 2022
The companies plan to work on developing personalized care solutions via digital pathology to come up with treatment options for patients with solid tumors.
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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.
pharmaphorum
MARCH 28, 2022
GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity against new variants of the virus. The US regulator has trimmed back the emergency-use authorisation for Xevudy (sotrovimab), saying that new data suggests the current 500mg dose of the antibody is unlikely to be effective against the BA.2 subvariant of Omicron.
Outsourcing Pharma
MARCH 28, 2022
The drug has received the agencyâs seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
BioPharma Reporter
MARCH 28, 2022
A new study will seek to understand the bodyâs response to the Nipah virus in order to support development of vaccines.
FDA Law Blog
MARCH 28, 2022
By Sara W. Koblitz — It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice. Almost a year after the D.C. Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied
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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.
Drug Discovery Today
MARCH 28, 2022
Science Minister George Freeman says life sciences have an essential part to play in creating the economy and ecosystem of tomorrow.
Drug Patent Watch
MARCH 28, 2022
This chart shows the pharmaceutical companies with patents in the most countries. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the greatest global patent coverage? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery Today
MARCH 28, 2022
Phase 2 study is the first approved by the FDA and DEA to test psychedelic therapies in the area of binge eating disorders
pharmaphorum
MARCH 28, 2022
Israel-based AION Labs and German independent research institute BioMed X announced its third global call for applications to form a new start-up company focused on using AI to design and optimise antibodies for targeted therapies. . Noga Yerushalmi, investment director at M Ventures (the venture arm of Merck), tells us how AION Labs was formed and aspires to help ease the pharma industry’s shared challenges by offering its vast resources a new start-up.
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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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