Drug Discovery Today
MAY 26, 2022
‘GMC Life Sciences Fund by Praetura’ aims to bolster Greater Manchester and Cheshire and Warrington’s flourishing life sciences sector. The fund, raised by partners including Bruntwood SciTech, Greater Manchester Combined Authority (GMCA) and Cheshire and Warrington Local Enterprise Partnership (LEP), will be deployed by Manchester-based Praetura Ventures.
Drug Channels
MAY 24, 2022
A few weeks ago, GoodRx surprised investors with the unpleasant news that a major grocery chain had stopped accepting its discount card for an unspecified number of prescriptions. As I explain below, the unnamed chain appears to be Kroger— the sixth-largest U.S. pharmacy. What’s more, GoodRx disclosed that Kroger accounts for an unexpected one-quarter of its prescription business.
Drug Patent Watch
MAY 27, 2022
This chart shows the patent expirations for capsule dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Capsule dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.
Translation
MAY 27, 2022
Thanks to a spotlight from the Covid-19 pandemic, the biotechnology industry attracted record investment in 2020 and 2021. But maintaining that edge will require building more talent and improving commercial development and execution, according to McKinsey. One competitive differentiator: deepening relationships between academia and industry. This June’s BIO International Convention in San Diego is crammed with 100+ sessions in just four days.
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
Drug Discovery Today
MAY 26, 2022
The EIT Health Catapult 2022 competition winners, selected from 9 finalists, are digital health start-up, Ebenbuild; medtech start-up, Leuko and biotech start-up, SolasCure. The winners were chosen during this year’s EIT Health Summit at the Karolinska Institutet in Stockholm, which took place 24th-25th May. Previous winners have enjoyed major acquisitions and impressive levels of funding – with two participants from the 2020 competition recently attracting the interest of prominent biotech and
The Pharma Data
MAY 27, 2022
68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile 1 Sustained clinical benefit from Kymriah treatment demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months 1 Kymriah can be administered in the outpatient setting, offering increased flexibility and potentially reducing the burden of therapy for patients and their care teams 1,2 Kymriah is now F
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Creative Biolabs
MAY 25, 2022
Cancer has become the second largest health threat in the world, with about 10 million people dying of cancer in 2020. For decades, cytotoxic-based chemotherapy has been the main treatment for all kinds of cancers. These cytotoxic drugs include DNA base analogs, antimetabolic drugs, tubulin inhibitors, etc. However, most of these chemotherapeutic drugs show a low therapeutic index, and serious side effects are usually attributed to the exposure of non-specific drugs to off-target tissues.
Drug Discovery Today
MAY 27, 2022
Medicines Discovery Catapult (MDC) is hosting UK SPINE, ‘Healthspan vs. lifespan: New medicines to close the gap’ - a conference on ageing, which aims to tackle one of the UK’s most pressing healthcare challenges.
The Pharma Data
MAY 27, 2022
Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months. “We continue to work around the clock with our government partners and industry to ensure there’s adequate infant formula available wherever and whenever parents and caregivers need it,” said FDA Commissioner Robert M.
Drug Patent Watch
MAY 27, 2022
Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are ten patents protecting…. The post New patent for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.
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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.
ProRelix Research
MAY 26, 2022
The United States has always been and remains to be the leading place for the conduct of clinical trials. According to Clinicaltrials.gov, the largest clinical trials registry, 32% of registered […]. The post Planning Clinical Trial in USA? Here is what you should know appeared first on ProRelix Research.
Advarra
MAY 25, 2022
Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error. That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical tri
The Pharma Data
MAY 27, 2022
Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma¹ Glofitamab has the potential to offer a readily available, fixed-duration CD20xCD3 bispecific antibody treatment approach for people with aggressive lymphoma Glofitamab is part of Roche’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and prefer
Drug Patent Watch
MAY 27, 2022
Annual Drug Patent Expirations for TLANDO Tlando is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. The generic ingredient…. The post New patent for Antares Pharma drug TLANDO appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Olympian Clinical Research
MAY 24, 2022
May is Mental Health Awareness Month , so there’s no better time to focus on our mental health and well-being. Good mental health is essential to our overall well-being and happiness, so it’s essential to do what we can to maintain it. To honor Mental Health Awareness Month, we have come up with a list of tips to help our patients and community members like you keep their mental health in optimal shape. 1.
Pharma Manufacturing
MAY 26, 2022
With utility costs on the rise, many pharma manufacturers are taking a closer look at their facilities and finding that better facility design, resource management and maintenance strategies can offer sources of overlooked savings, as well as opportunities for sustainability.
The Pharma Data
MAY 27, 2022
In the pivotal clinical study CARTITUDE-1, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 80 percent of patients who responded experienced a stringent complete response . The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) granted conditional marketing authorisation of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults wit
Drug Patent Watch
MAY 27, 2022
Annual Drug Patent Expirations for OLUMIANT Olumiant is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are…. The post New patent for Eli Lilly drug OLUMIANT 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
Translation
MAY 21, 2022
Inspired by the successes of the Defense Advanced Research Projects Agency (DARPA), the Biden Administration has introduced ARPA-H, or the Advanced Research Projects Agency for Health. The Administration designed ARPA-H to stimulate the groundbreaking innovation for which DARPA is renowned. Since 1958, DARPA has helped bolster national security while laying the groundwork for many of today’s dominant technologies, such as satellite navigation, drones, and even the internet.
Pharma Manufacturing
MAY 26, 2022
New, complex therapies coming through the pharma pipelines are putting immense pressure on supply chains and manufacturing capacity, challenging traditional scale-up and manufacturing processes at the same time — and CDMOs have stepped up into the thick of it all.
The Pharma Data
MAY 27, 2022
ViiV Healthcare and MPP are actively negotiating voluntary licensing terms to help widen access to innovative HIV prevention measure . ViiV Healthcare has today announced that it is committing to license its patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) and is entering into negotiation on voluntary licensing terms with the UN-backed Medicines Patent Pool (MPP).
Drug Patent Watch
MAY 27, 2022
Annual Drug Patent Expirations for TOSYMRA Tosymra is a drug marketed by Upsher Smith Labs and is included in one NDA. It is available from two suppliers. There are seven…. The post New patent for Upsher Smith drug TOSYMRA appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
MAY 21, 2022
Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims. For the third time , we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members. Still not convinced?
Pharma Manufacturing
MAY 26, 2022
While change does not always happen quickly in the pharma industry, the ongoing global pandemic has quickened the pace of emerging trends.
The Pharma Data
MAY 27, 2022
The U.S. federal government spent an estimated $1.8 billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness.
Drug Patent Watch
MAY 26, 2022
Annual Drug Patent Expirations for REZUROCK Rezurock is a drug marketed by Kadmon Pharms Llc and is included in one NDA. There are four patents protecting this drug. This drug…. The post New patent for Kadmon Pharms drug REZUROCK appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
MAY 24, 2022
New Jersey ain’t Florida and vice versa. Obviously, it’s warmer in Florida for more of the year and it never gets cold enough to snow. That could be a pro or a con. Florida has the second longest coastline among U.S. States which gives it a greater opportunity to have more highly rated beaches. But a true New Jerseyan will put Cape May and Long Beach Island toe-to-toe with Miami and Destin.
Pharma Manufacturing
MAY 23, 2022
For pharma, picking the right partner can have an enormous impact on project outcomes
The Pharma Data
MAY 27, 2022
Today, the U.S. Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. This type of specialized medical infant formula is currently in short supply in the U.S.
Drug Patent Watch
MAY 26, 2022
Annual Drug Patent Expirations for KISQALI Kisqali is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight patents protecting…. The post New patent for Novartis drug KISQALI appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
MAY 26, 2022
Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions. In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support fraudulent misrepresentation claims and other claims based on alleged fraud or mistake.
Pharma Manufacturing
MAY 23, 2022
Andrea Corona is joined by Zach Gilulah, pharma machine health lead at Augury.
The Pharma Data
MAY 27, 2022
AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults. Healthcare professionals can now use Vaxzevria as a third dose booster in patients previously given a primary vaccine schedule of either Vaxzevria or an EU-approved mRNA COVID-19 vaccine.
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