Drug Discovery Today
APRIL 5, 2022
Researchers delve into the inner workings of the antibody immune response, finding key differences in the metabolism of two closely related immune cell subsets.
Drug Patent Watch
APRIL 5, 2022
This is a guest post by Ray Miller and Megan E. Bowers, Ph.D. at DLA Piper. Ray may be contacted at raymond.miller@dlapiper.com. When it comes to protecting therapeutic assets, I…. The post The value of method of use patent claims in protecting your therapeutic assets appeared first on DrugPatentWatch - Make Better Decisions.
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Drug Channels
APRIL 5, 2022
The highly-consolidated PBM market notched another year of increased concentration. Consider Drug Channels Institute's latest estimates of pharmacy benefit manager (PBM) market share, shown in the chart below. For 2021, we estimate that the three biggest PBMs accounted for 80% of total equivalent prescription claims. Significant business relationships among the largest companies continue to shift market share.
The Pharma Data
APRIL 8, 2022
Pfizer Inc. (NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This analysis reported after a median follow-up of three years, LORBRENA continued to demonstrate meaningful improvement in progression-free survival (PFS) assessed by blinded in
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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
APRIL 5, 2022
Neuro-Bio Ltd, finds its new drug candidate effectively treats neurodegeneration in a mouse model of Alzheimer’s disease.
Drug Patent Watch
APRIL 7, 2022
Annual Drug Patent Expirations for BAXDELA Baxdela is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting…. The post New patent for Melinta drug BAXDELA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
The Pharma Data
APRIL 8, 2022
The average person will take more than 600 million breaths over the course of their life. Every breath stretches the lungs’ tissues with each inhale and relaxes them with each exhale. The mere motions of breathing are known to influence vital functions of the lungs, including their development in babies, the production of air-exchange-enhancing fluid on their inner surfaces, and maintenance of healthy tissue structure.
Antidote
APRIL 7, 2022
Two of the most critical components of any clinical trial recruitment campaign are patient-centricity and trust. Antidote has a robust Contact Center with personable and knowledgeable agents that walk patients through the prescreening process and answer any questions along the way. We spoke with our Contact Center Operations Manager, Andy Schulz, about why he joined the team, what his team’s day-to-day looks like, why it is so important to provide patients with a positive experience during their
Drug Patent Watch
APRIL 8, 2022
Annual Drug Patent Expirations for ZOLADEX Zoladex is a drug marketed by Tersera and is included in two NDAs. It is available from two suppliers. There are two patents protecting…. The post New patent expiration for Tersera drug ZOLADEX appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
APRIL 8, 2022
Today’s guest post comes from Michael Carr, CoAssist Group Vice President at AssistRx. Michael discusses patient support challenges that are unique to specialty-lite pharmaceuticals. He goes on to describe four new categories of patient solutions and pharmacy models specific to this growing market segment. To learn more about CoAssist and AssistRx specialty therapy initiation and patient support services, click here to schedule a meeting with AssistRx at the Asembia Specialty Pharmacy Summit on
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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.
The Pharma Data
APRIL 7, 2022
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.
Drug & Device Law
APRIL 5, 2022
A post-sale duty to warn is almost oxymoronic. If you think about a typical warnings case, the focus is on whether the manufacturer/seller had notice of a potential risk before the product left its control (or prescribed to the plaintiff), and if so, whether that risk was adequately conveyed to the plaintiff. The question we routinely ask in drug and device warnings cases is whether additional or different information would have made a difference to the prescribing physician in choosing a cour
Drug Patent Watch
APRIL 6, 2022
Annual Drug Patent Expirations for LYNPARZA Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eleven patents protecting…. The post New patent for Astrazeneca drug LYNPARZA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
APRIL 7, 2022
Dupixent is the only biologic indicated in the European Union for severe asthma with type 2 inflammation, characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile of Dupixent.
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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
APRIL 7, 2022
A grim milestone has been crossed today in the war in Ukraine – more than 100 attacks on health care verified by WHO since the start of the war on February 24. The attacks so far have claimed 73 lives and injured 51. Of the current total of 103 attacks, 89 have impacted health facilities and 13 have impacted transport, including ambulances. “We are outraged that attacks on health care are continuing.
The Pharma Data
APRIL 6, 2022
VUITY is the first and only eye drop to treat presbyopia, or age-related blurry near vision, in adults and is FDA-approved for once-daily administration In the VIRGO trial evaluating twice-daily administration of VUITY, the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met Data from the VIRGO trial will be presented at upcoming medical congresses and serve as the basis for a supplemental U.S.
The Pharma Data
APRIL 6, 2022
Novartis announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade. “The simpler organizational model we are unveiling today is central to our growth strategy as it will make us more agile and competitive, enhance patient and customer orientation, unlock significant potential in our R&D pipeline and drive value-creation through oper
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There are two…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for ZTLIDO Ztlido is a drug marketed by Scilex Pharms Inc and is included in one NDA. It is available from one supplier. There are five…. The post New patent for Scilex Pharms drug ZTLIDO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 5, 2022
Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 5, 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 nine…. The post New patent for Gilead Sciences drug VEKLURY appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 4, 2022
Annual Drug Patent Expirations for ORACEA Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. There are eleven…. The post New patent expiration for Galderma Labs drug ORACEA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
APRIL 3, 2022
Treatment with mavacamten showed sustained improvement in left ventricular outflow tract (LVOT) gradients, New York Heart Association (NYHA) Class and N-terminal pro brain natriuretic peptide (NT-proBNP) levels. At 48 and 84 Weeks, Mavacamten safety was consistent with that seen in the EXPLORER-HCM study. Interim results were presented as a late-breaking clinical trial at the American College of Cardiology’s 71 st Annual Scientific Session.
The Pharma Data
APRIL 4, 2022
If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalised patients Since the beginning of the pandemic, more than one million people hospitalised with COVID-19 have been treated with Actemra/RoActemra worldwide 1 Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European Union Roche has established a comprehensive access approach to improve availability of Actemra/RoActemra around
The Pharma Data
APRIL 4, 2022
If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) 300 mg weekly to treat adult and pediatric pati
The Pharma Data
APRIL 4, 2022
Thrive for Change winning projects include work to eliminate food waste in Bolivia, put vegetable production tools into the hands of African farmers and use microalgae to eliminate nutrient pollution in the world’s water / Winners are delegates from Bayer’s Youth Ag Summit and YAS University / Awardees will receive a €5,000 bursary to execute their impact projects ein Stipendium in Höhe von 5.000 Euro für die Durchführung ihrer Projekte.
Drug Patent Watch
APRIL 6, 2022
ORACEA (doxycycline) Galderma labs lp Patent: 9,241,946 Expiration: Apr 5, 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 April 3, 2022 appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
APRIL 5, 2022
Sanofi launches today its Diversity, Equity & Inclusion (DE & I) Board , the first -of-its-kind in the pharmaceutical industry to feature outside advisors. Sanofi’s DE&I Board will include three of the most influential voices in the DE&I space as Board members appointed for 3 years : organizational psychologist & best-selling author John Amaechi , award-winning social entrepreneur Caroline Casey , and DE&I pioneer and renowned thought-leader Dr.
Drug Patent Watch
APRIL 3, 2022
This chart shows the pharmaceutical companies with the most patents in Brazil. 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 Brazil? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 8, 2022
This chart shows the pharmaceutical companies with the most patents in Luxembourg. 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 Luxembourg? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 7, 2022
This chart shows the drugs with the most patents in Singapore. 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 Singapore? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 6, 2022
This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Netherlands. 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 Netherlands? appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 5, 2022
This chart shows which pharmaceutical companies received the most new drug approvals last year. The drug companies with the most new drugs last year are Abbvie Inc Am Regent Janssen…. The post Pharmaceutical companies with the most drug approvals last year appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 4, 2022
This chart shows the pharmaceutical companies with the most patents in Argentina. 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 Argentina? appeared first on DrugPatentWatch - Make Better Decisions.
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