Antidote
AUGUST 2, 2022
Mitral valve regurgitation is a common kind of heart disease in the United States. Not only does it impact many people today, but its prevalence is expected to double by 2030.
Eye on FDA
AUGUST 2, 2022
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year.
Drug Channels
AUGUST 5, 2022
Today’s guest post comes from Karina Castagna, SVP of Access and Adherence at OptimizeRx. Karina discusses the challenges health care providers and patients face in their quest to secure prior authorizations from payers. She argues that manufacturers adopt an electronic health record-based solution to facilitate access to therapies, from the point of prescription through the point of dispensing at the pharmacy.
Drug Patent Watch
AUGUST 5, 2022
This chart shows the drugs with the most patents in Colombia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Colombia? appeared first on DrugPatentWatch - Make Better Decisions.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Antidote
AUGUST 1, 2022
Complement 3 glomerulopathy (C3G) is a rare type of kidney disease, estimated to impact just 1 to 2 million people worldwide. C3G is a genetically inherited disorder that impacts all races and genders equally, and the average patient is diagnosed between the ages of 21 and 26.
Broad Institute
AUGUST 4, 2022
Molecular map reveals insights into the genetic drivers of chronic lymphocytic leukemia By Karen Zusi-Tran August 4, 2022 Breadcrumb Home News Molecular map reveals insights into the genetic drivers of chronic lymphocytic leukemia New map of chronic lymphocytic leukemia could potentially help identify new diagnostic markers, offer more accurate prognoses, and develop novel treatments.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Drug Patent Watch
AUGUST 5, 2022
Annual Drug Patent Expirations for HYSINGLA+ER Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are…. The post New patent expiration for Purdue Pharma drug HYSINGLA ER appeared first on DrugPatentWatch - Make Better Decisions.
Advarra
AUGUST 4, 2022
Perhaps one of the most important aspects of a clinical trial is the informed consent process. Stemming from the ethical principle of Respects for Persons in 1976, the Belmont Report established informed consent parameters, a process designed to provide information to allow potential participants to make the best decision for themselves. This must occur prior to participating in the research.
sptlabtech
AUGUST 3, 2022
Hot off the press, The State of Automated Pipetting 2022 shines a light on what's driving laboratories to automate their day-to-day liquid handling tasks. Across many application areas, researchers and lab staff are transitioning away from handheld pipettors to automated pipetting solutions. Drawing on insights gathered from professionals in biotech, pharma, CROs, and research institutions, our survey report explores the current automation adoption trends for liquid handling.
Broad Institute
AUGUST 2, 2022
Gallery Program By Maria Nemchuk August 2, 2022 Breadcrumb Home Gallery Program RE:presentation (Chapter 2) by Emilio Vavarella November 22, 2023-March 20, 2024 An exhibit in the Second Floor Connector Gallery and Stanley Building Lobby. Stemming from his previous work in which his mother wove a textile out of his genetic code , now in the permanent collection of the Museum of Modern Art in Bologna, Italy, at Broad, Emilio has been working on a custom software that translates an individual’s
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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 Patent Watch
AUGUST 4, 2022
This chart shows the pharmaceutical companies with the most patents in Finland. 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 most drug patents in Finland? appeared first on DrugPatentWatch - Make Better Decisions.
Advarra
AUGUST 2, 2022
The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. In an effort to keep up with current technological trends, along with both site and participant interest, many sponsors are considering switching to a DCT model by building their own, purchasing, or licensing DCT technology.
Pharma Manufacturing
AUGUST 3, 2022
Modern radiopharmaceutical companies are stacked with experienced experts who are laser-focused on correcting the missteps and misfortunes of earlier pioneers
Drug & Device Law
AUGUST 3, 2022
Even a meritless lawsuit can impose an enormous burden on a company. There is the ridiculous expense, of course. Legal fees and other costs of defending a lawsuit can easily add up to more money than most juries award to plaintiffs. Some of those costs can be indirect but profound. Employees who would prefer to be busy working on product improvements end up being distracted by deposition preparation, document collection, etc. .
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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.
Drug Patent Watch
AUGUST 4, 2022
Annual Drug Patent Expirations for NUCYNTA Nucynta is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. There are eight…. The post New patent expiration for Collegium Pharm drug NUCYNTA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 4, 2022
Annual Drug Patent Expirations for NUCYNTA+ER Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are…. The post New patent expiration for Collegium Pharm drug NUCYNTA ER appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 4, 2022
Annual Drug Patent Expirations for XERMELO Xermelo is a drug marketed by Tersera and is included in one NDA. It is available from two suppliers. There are five patents protecting…. The post New patent for Tersera drug XERMELO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 3, 2022
This chart shows the drugs with the most patents in Japan. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Japan? appeared first on DrugPatentWatch - Make Better Decisions.
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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
Drug Patent Watch
AUGUST 3, 2022
Annual Drug Patent Expirations for CAROSPIR Carospir is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from two suppliers. There are five…. The post New patent for Cmp Dev drug CAROSPIR appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 3, 2022
Annual Drug Patent Expirations for VEKLURY Veklury is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are ten…. The post New patent for Gilead Sciences drug VEKLURY appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 1, 2022
This chart shows the drugs with the most patents in Slovenia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Slovenia? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 31, 2022
Expiring drug patents are continuously driving innovation, as branded firms seek out new high-margin opportunities. Examining the patent expirations by year can indicate which pharmaceutical companies face the most peril…. The post Drugs facing the most patent expirations this year appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 31, 2022
Annual Drug Patent Expirations for ADDYI Addyi is a drug marketed by Sprout Pharms and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for Sprout Pharms drug ADDYI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 31, 2022
Annual Drug Patent Expirations for MACRILEN Macrilen is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are two patents protecting…. The post New patent expiration for NOVO drug MACRILEN appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 30, 2022
This chart shows the drugs with the most patents in Cyprus. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Cyprus? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 30, 2022
Annual Drug Patent Expirations for EVAMIST Evamist is a drug marketed by Padagis Us and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent expiration for Padagis Us drug EVAMIST appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
AUGUST 2, 2022
This chart shows the companies which have received the most New Patient Population exclusivities in the past five years. New Patient Populations are one of the categories for which the…. The post Pharmaceutical companies with the most ‘New Patient Population’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 31, 2022
MACRILEN (macimorelin acetate) Novo Patent: 6,861,409 Expiration: Aug 1, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of July 31, 2022 appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
JULY 30, 2022
MACRILEN (macimorelin acetate) Novo Patent: 6,861,409 Expiration: Aug 1, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of July 31, 2022 appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
AUGUST 5, 2022
Today’s post is for procedure geeks, especially those who litigate MDLs. Offensive non-mutual collateral estoppel prevents a defendant from relitigating an issue that it lost in earlier litigation against a different plaintiff. The issue is when offensive non-mutual collateral estoppel applies to a case that was part of an MDL. More specifically, the issue is which state’s law determines whether offensive non-mutual collateral estoppel applies in a particular case.
Drug & Device Law
AUGUST 1, 2022
We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption. See Maglioli v. Alliance HC Holdings LLC , 16 F. 4th 393 (3d Cir. 2021). The other shoe dropped the other day when a district court ruled that the PREP Act allowed a state-law negligence claim arising from administration of a COVID vaccine, even though the Act clearly
Drug & Device Law
AUGUST 2, 2022
Since the Supreme Court decided Bruesewitz v. Wyeth LLC , 562 U.S. 223 (2011), product liability litigation over childhood vaccines is rare but not extinct. As demonstrated by today’s case — Garcia v. Sanofi Pasteur Inc. , 2022 U.S. Dist. LEXIS 134330 (E.D. Cal. Jul. 28, 2022). And while the decision does discuss preemption, this case was largely sunk by a complete failure to meet federal pleadings standards.
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