Drug Patent Watch
MAY 2, 2022
DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
MAY 3, 2022
In Drug Channels Institute’s list of the top 15 pharmacies of 2021 , we show that central-fill, mail pharmacies operated by large PBMs and health insurers have displaced retail chains as the largest prescription drug dispensers by revenues. To complement that broader ranking, we present below our exclusive and updated list of the top 15 pharmacies based on specialty drug dispensing revenues in 2021.
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The Pharma Data
MAY 6, 2022
New paper on database and programme in Nigeria shows enormous potential for helping to improve quality of care for women and babies. Quality, standardized data on the health of women and girls who are pregnant or have recently given birth, and their babies, is crucial to inform the design of interventions to help to safeguard their lives and well-being.
The ChEMBL-og
MAY 5, 2022
UniChem new beta interface and web services We are excited to announce that our UniChem beta site will become the default one on the 11th of May. The new system will allow us to better maintain UniChem and to bring new functionality in a more sustainable way. The current interface and web services will still be reachable for a period of time at [link].
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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
MAY 6, 2022
Annual Drug Patent Expirations for EPIDIOLEX Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are twenty-one…. The post New patent expiration for Gw Res drug EPIDIOLEX appeared first on DrugPatentWatch - Make Better Decisions.
Antidote
MAY 4, 2022
Antidote’s podcast, Talk of the Towne , focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an organization with which Antidote is working, and takes an in-depth look at particular therapeutic areas, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Tecan
MAY 3, 2022
By Günter Weisshaar The announcement of the In Vitro Diagnostics Regulation (IVDR) in 2017 was celebrated as an essential upgrade to in vitro diagnostic (IVD) device regulations in Europe. This article discusses the important changes, challenges, and benefits of IVDR, as well as an industry insight into how to work together to ensure IVD devices are, and continue to be, compliant.
Drug Patent Watch
MAY 5, 2022
Annual Drug Patent Expirations for UPNEEQ Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are eight patents protecting this drug. This drug has…. The post New patent for Rvl Pharms drug UPNEEQ appeared first on DrugPatentWatch - Make Better Decisions.
The Connected Lab
MAY 4, 2022
Connected digital technologies and advanced analytics are revolutionizing chromatography and mass spectrometry (CMS) workflows , enabling more efficient and productive ways of working. A cornerstone of digital transformation, these solutions are accelerating the transition to Pharma 4.0 – a future vision of the pharmaceutical industry characterized by smart production workflows, flexible value chains and real-time process optimization.
The Pharma Data
MAY 5, 2022
Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
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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.
PerkinElmer
MAY 6, 2022
The potential to harness an individual’s immune system to treat cancer has revolutionized the oncology field. Coined immunotherapy, this umbrella term describes several types of treatment, including immune checkpoint inhibitors, immune system modulators, and adoptive cell therapies. Each triggers the immune system in a different way to fight cancer.
Drug Patent Watch
MAY 3, 2022
Annual Drug Patent Expirations for NEXTERONE Nexterone is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents…. The post New patent expiration for Baxter Hlthcare drug NEXTERONE appeared first on DrugPatentWatch - Make Better Decisions.
Drug & Device Law
MAY 6, 2022
A California appellate court has ruled that California’s mandatory trial preference statute is not always mandatory, an opinion that gives courts and defendants a slight bit of breathing room in an otherwise unforgiving space. Every practitioner in the product liability space has encountered California’s trial preference statute, Civil Procedure Code Section 36.
The Pharma Data
MAY 5, 2022
Validated Measurable Residual Disease Assays are Critical for the Rapid Development of Future Novel Therapeutics for Patients with Acute Myeloid Leukemia. The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the Measurable residual disease Partnership and Alliance in Acute myeloid leukemia Clinical Treatment (MPAACT), an industry-led research alliance founded in 2018 between Janssen Research & Development, LLC, Genentech (a member of the Roche Group), Novartis, and C
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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
The Pharma Data
MAY 5, 2022
In animal studies that mimic human exposures, an investigational COVID vaccine designed to be taken orally not only protects the host, but also decreases the airborne spread of the virus to other close contacts. The study, led by Duke researcher Stephanie N. Langel, Ph.D., demonstrated the potential of a COVID vaccine that works through the mucosal tissue to neutralize the SARS-CoV-2 virus, limiting infections and the spread of active virus in airborne particles.
The Pharma Data
MAY 5, 2022
Cognitive impairment as a result of severe COVID-19 is similar to that sustained between 50 and 70 years of age and is the equivalent to losing 10 IQ points, say a team of scientists from the University of Cambridge and Imperial College London. The findings, published in the journal eClinicalMedicine, emerge from the NIHR COVID-19 BioResource. The results of the study suggest the effects are still detectable more than six months after the acute illness, and that any recovery is at best gradual.
The Pharma Data
MAY 5, 2022
Jakavi is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GvHD) 1,2 In clinical trials, Jakavi demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GvHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively 2,3 GvHD is a common and potentially life-threatening complication that arises in appro
The Pharma Data
MAY 5, 2022
Sanofi today launches Foundation S – The Sanofi Collective, its philanthropic endowment fund aiming to create healthier futures for generations. Using donations, partnerships and collective action, Foundation S will focus on three critical areas: childhood cancer, the health of communities most vulnerable to the effects of climate change and pollution, and access to lifesaving medicines and vaccines.
The Pharma Data
MAY 2, 2022
The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD).
The Pharma Data
MAY 2, 2022
Teva Branded Pharmaceutical Products R&D, Inc. and Auspex Pharmaceuticals, Inc., U.S. affiliates of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have reached an agreement with Lupin to resolve the dispute over Lupin’s Abbreviated New Drug Application (“ANDA”) for a generic deutetrabenazine product. Teva and Lupin have been involved in a patent infringement litigation in which Teva asserted a number of patents against Lupin that cover Teva’s AUSTEDO (deutetrabenazine) prod
The Pharma Data
MAY 2, 2022
– Gilead to License Exclusive Worldwide Rights to the Investigational Candidate DF7001, a 5T4-Targeting NK Cell Engager for Solid Tumors –. – Gilead to Have Options to License Several Additional NK Cell Engager Programs –. Gilead Sciences, Inc. (Nasdaq: GILD) and Dragonfly Therapeutics today announced a collaboration designed to advance a number of Dragonfly’s novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications.
Drug Patent Watch
MAY 3, 2022
EPIDIOLEX (cannabidiol) Gw res ltd Patent: 10,195,159 Expiration: May 7, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of May 1, 2022 appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MAY 2, 2022
Amgen (NASDAQ:AMGN) today released its 2021 Environmental, Social & Governance (ESG ) report, providing a comprehensive overview of the many ways the Company is doing its part to build a better, healthier world. . “Our core business of improving human health, in and of itself, contributes meaningfully to the greater good,” said Judy Brown, senior vice president, Corporate Affairs at Amgen, “and through our ESG programs, we are building on that foundation to address other c
Drug Patent Watch
MAY 6, 2022
This chart shows the pharmaceutical companies with the most patents in Ireland. 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 Ireland? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
MAY 5, 2022
This chart shows the pharmaceutical companies with the most aerosol dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most aerosol dosed drugs…. The post Which pharmaceutical companies have the most aerosol dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
MAY 4, 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
MAY 3, 2022
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Norway. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Norway? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
MAY 2, 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.
Drug Patent Watch
MAY 1, 2022
This chart shows the drugs with the most patents in Luxembourg. 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 Luxembourg? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 30, 2022
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Romania? appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MAY 5, 2022
The investigational prescription digital therapeutic uses a combination of sensors, software, and music based on Rhythmic Auditory Stimulation (RAS) MedRhythms to receive a $3 million upfront payment as part of the agreement and is eligible to receive potential development and commercial milestone payments. Biogen Inc. (Nasdaq: BIIB) and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential trea
The Pharma Data
MAY 5, 2022
New estimates from the World Health Organization (WHO) show that the full death toll associated directly or indirectly with the COVID-19 pandemic (described as “excess mortality”) between 1 January 2020 and 31 December 2021 was approximately 14.9 million (range 13.3 million to 16.6 million). “These sobering data not only point to the impact of the pandemic but also to the need for all countries to invest in more resilient health systems that can sustain essential health services during crises, i
The Pharma Data
MAY 6, 2022
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age.
Drug & Device Law
MAY 3, 2022
Today’s case is a straight warnings case. So, there should be little surprise that if it involves a generic drug preemption shuts it down. But that does not mean that plaintiffs did not try several avenues of attack to try to find a warning claim that would stick. None did. The case is Roncal v. Aurobindo Pharma USA, Inc. , 2022 WL 1237888 (D.N.J.
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