Sat.Feb 19, 2022 - Fri.Feb 25, 2022

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Charles River’s expansion to Alderley Park set to bolster UK cell and gene therapy manufacturing capability

Drug Discovery Today

Global cell and gene therapy development and manufacturing business expands into Bruntwood SciTech’s Alderley Park to boost manufacturing capacity.The 17,000 sq ft high-specification lab space is currently under construction, expanding plasmid DNA and viral vector capabilities in Europe.The facility will support therapeutic developers with rapid access to High Quality plasmid, with manufacturing slots available from summer 2022.

Therapies 113
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Which pharmaceutical companies have the most drug patents in Slovakia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Slovakia. 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 Slovakia? appeared first on DrugPatentWatch - Make Better Decisions.

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Solving the Copay and Best Price Challenge

Drug Channels

Today’s guest post comes from Jason Zemcik, Vice President of Patient Affordability at TrialCard. Jason discusses two approaches to address the CMS Final Rule on manufacturer coupons and Best Price: the pharmacy copay offer and direct reimbursement to the patient. He goes on to describe TrialCard’s reimbursement capability solutions. To learn more about TrialCard Pay and how to prepare your copay program for the future, register for Solving the Best Price and Co-Pay Challenge – A Framework for A

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Are We Moving On From Covid?

Eye on FDA

Mask mandates are dropping like flies. Restrictions are being lowered. In my observation, it feels that they are going to the wayside not only because of dropping caseloads, but also because people are just more than ready to move on. There may be some complacence – a feeling that the ubiquitous Omicron has fostered a feeling of inevitability about exposure and eventual infection.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

The Pharma Data

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine” 1,2 Heart failure is a leading cause of hospitalization

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Which pharmaceutical companies have the most drug patents in Australia?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Australia. 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 Australia? appeared first on DrugPatentWatch - Make Better Decisions.

More Trending

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Biomarker Discovery via In Vitro Screening

Crown Bioscience

In this post, we explore why and how to use in vitro screening to identify biomarkers. A case study is also provided to highlight exactly how in vitro screening can be used to develop a biomarker signature of drug response.

Drugs 52
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Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment

The Pharma Data

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, recommending the 75 mg dose of rimegepant (available as an orally dissolving tablet) for marketing authorization for both the acute treatment of migraine with or without aura in adults and th

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Pharmaceutical companies with the most ‘New Combination’ drugs

Drug Patent Watch

This chart shows the companies which have received the most New Combination exclusivities in the past five years. New Combinations are one of the categories for which the FDA grants…. The post Pharmaceutical companies with the most ‘New Combination’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels News Roundup, February 2022: Mark Cuban vs. Generics, Novo Nordisk’s G2N, CVS & 340B, and My Favorite Chart

Drug Channels

Winter—or at least February—is almost over. Celebrate the imminent return of spring with our selection of noteworthy news from around the drug channel. In this issue: Mark Cuban! Novo Nordisk confronts the gross-to-net bubble CVS Health finally acknowledges its profits from the 340B program Plus, an update to my all-time favorite chart. P.S. Please join the nearly 13,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

Drugs 67
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How Machine Learning Drives Clinical Trial Efficiency

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.

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Addressing COVID-19 vaccine hesitancy among people in Australia who regularly inject drugs

National Drug & Alcohol Research Centre Blog

Olivia Price It has been one year since the COVID-19 vaccine rollout commenced in Australia, and while vaccination rates initially lagged behind other countries, over 95% of Australians aged 12 years and older are now fully vaccinated. We tend to consider the remaining unvaccinated people a homogenous ‘anti-vax’ group. However, there are some less vocal, disadvantaged populations with lower rates of vaccine uptake who require targeted efforts to increase uptake.

Vaccine 52
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FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.

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New patent expiration for J And drug PEPCID AC

Drug Patent Watch

Annual Drug Patent Expirations for PEPCID+AC Pepcid Ac is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from two suppliers.…. The post New patent expiration for J And drug PEPCID AC appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Uncertainty quantification for ligand-based drug design

Atomwise Blog

At the American Chemical Society Spring National Meeting & Expo, Atomwise members were selected to present their research and work. Learn what our Atoms have been working on below and visit Atomwise at ACS Spring 2022 National Meeting for other presentation sessions.

Drugs 52
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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Highlights from SLAS 2022 Conference - Event Recap

The Strateos Blog: Drug Discovery

The recent SLAS 2022 conference showcased some great presentations and panel discussions on the transformative potential of laboratory automation and AI-driven machine learning. Strateos’ SVP of Strategy & Operations, Daniel Sipes, echoed this sentiment during his presentation on how automated labs are accelerating medicinal chemistry (MedChem) cycles for drug discovery.

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Repurposing FDA-approved drugs may help combat COVID-19

The Pharma Data

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Specifically, the team found that these drugs inhibit certain viral enzymes, called proteases, that are essential for SARS-CoV-2 replication in infected human cells. “The SARS-CoV-2 vaccines target the spike protein, but this protein is under s

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New patent for Rigel Pharms drug TAVALISSE

Drug Patent Watch

Annual Drug Patent Expirations for TAVALISSE Tavalisse is a drug marketed by Rigel Pharms Inc and is included in one NDA. There are fourteen patents protecting this drug. This drug…. The post New patent for Rigel Pharms drug TAVALISSE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Self-supervised learning of atomic and molecular representations with 3D equivariant graph neural networks

Atomwise Blog

At the American Chemical Society Spring National Meeting & Expo, Atomwise members were selected to present their research and work. Learn what our Atoms have been working on below and visit Atomwise at ACS Spring 2022 National Meeting for other presentation sessions.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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We Said It Before; We’ll Say It Again – Drug/Device Companies Should Join PLAC

Drug & Device Law

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). We continue to believe that PLAC membership helps pharmaceutical and medical device defendants litigate stronger (through inter-industry cooperation on shared issues of concern), smarter (through cutting edge CLE and webinars), and more efficiently (

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US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

The Pharma Data

– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction. – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”[i],[ii]. – Heart fai

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New patent for Msd Merck drug PIFELTRO

Drug Patent Watch

Annual Drug Patent Expirations for PIFELTRO Pifeltro is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Msd Merck drug PIFELTRO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for J And drug PEPCID COMPLETE

Drug Patent Watch

Annual Drug Patent Expirations for PEPCID+COMPLETE Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA. It is available from four suppliers.…. The post New patent expiration for J And drug PEPCID COMPLETE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Viiv Hlthcare drug DOVATO

Drug Patent Watch

Annual Drug Patent Expirations for DOVATO Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Viiv Hlthcare drug DOVATO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Amgen Inc drug LUMAKRAS

Drug Patent Watch

Annual Drug Patent Expirations for LUMAKRAS Lumakras is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. The generic ingredient in…. The post New patent for Amgen Inc drug LUMAKRAS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Msd Merck drug DELSTRIGO

Drug Patent Watch

Annual Drug Patent Expirations for DELSTRIGO Delstrigo is a drug marketed by Msd Merck Co and is included in one NDA. It is available from one supplier. There are three…. The post New patent for Msd Merck drug DELSTRIGO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Allergan, an AbbVie Company, to Present Data from its Leading Portfolio of Eye Care Treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting

The Pharma Data

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. Presentations will include updated analyses that help further scientific understanding of DURYSTA ® (bimatoprost intracameral implant), as well as new data on the XEN ® Gel Stent.

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FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis

The Pharma Data

Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022 Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases. Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to its novel investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF).

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Bayer extends clinical development program for finerenone with Phase II study investigating the initial combination therapy with empagliflozin in patients with chronic kidney disease and type 2 diabetes

The Pharma Data

There is a high unmet need for new treatments to preserve kidney function and delay kidney disease progression in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) / The Phase II CONFIDENCE study will investigate the effect of the simultaneous initiation of combination therapy with finerenone and the SGLT2 inhibitor empagliflozin in patients with CKD and T2D.

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Medicago and GSK announce the approval by Health Canada of COVIFENZ®, an adjuvanted plant-based COVID-19 vaccine

The Pharma Data

A vaccine manufactured in plants and developed in Canada. Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announced that Health Canada has granted approval for COVIFENZ®, COVID-19 vaccine, (plant-based virus-like particles [VLP], recombinant, adjuvanted). This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID?

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Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

The Pharma Data

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 years of age.

Vaccine 52
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FDA Approves Treatment for Wider Range of Patients with Heart Failure

The Pharma Data

Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and ho

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Scientists uncover a new approach for treating aggressive cancer

The Pharma Data

Researchers at the University of North Carolina at Chapel Hill and the UNC Lineberger Comprehensive Cancer Center have uncovered a new role of a chromatin-modulatory enzyme, termed EZH2, during cancer development. They then developed a new therapeutic approach with a potent small-molecule inhibitor of this enzyme. Certain subtypes of blood cancers such as acute leukemias rely on multiple mechanisms for sustaining growth of aggressive cancer cells.

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More than half of parents and pregnant women exposed to aggressive formula milk marketing – WHO, UNICEF

The Pharma Data

New report details exploitative practices employed by $55 billion formula industry, compromising child nutrition, violating international commitments. More than half of parents and pregnant women (51 per cent) surveyed for a new WHO/UNICEF report say they have been targeted with marketing from formula milk companies, much of which is in breach of international standards on infant feeding practices.