Drug Discovery Today

FEBRUARY 24, 2022

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.

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Drug Patent Watch

FEBRUARY 25, 2022

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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Drug Channels

FEBRUARY 25, 2022

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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Eye on FDA

FEBRUARY 22, 2022

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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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

Treatment

The Pharma Data

FEBRUARY 25, 2022

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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Drug Patent Watch

FEBRUARY 22, 2022

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.

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National Drug & Alcohol Research Centre Blog

FEBRUARY 24, 2022

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.

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The Pharma Data

FEBRUARY 25, 2022

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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Drug Patent Watch

FEBRUARY 24, 2022

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

FEBRUARY 24, 2022

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.

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Clinical Trials

Atomwise Blog

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 25, 2022

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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Drug Patent Watch

FEBRUARY 25, 2022

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.

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Crown Bioscience

FEBRUARY 24, 2022

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.

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Clinical Trials

Atomwise Blog

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 25, 2022

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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Drug Patent Watch

FEBRUARY 25, 2022

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.

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The Strateos Blog: Drug Discovery

FEBRUARY 22, 2022

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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Clinical Trials

Drug & Device Law

FEBRUARY 21, 2022

It more or less came out of nowhere, but we’re now watching what’s going on in the Martinez v. Coloplast Corp. , No. 2:18-CV-220-JTM-JEM (N.D. Ind.), pelvic mesh case. Recently, we’ve come across a number of interesting, and generally favorable, Fed. R. Civ. P. 702 expert gatekeeping decisions bearing that caption, as Martinez approaches trial (scheduled for March 21, although the plaintiff has sought a continuance).

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The Pharma Data

FEBRUARY 24, 2022

– 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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Drug Patent Watch

FEBRUARY 25, 2022

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.

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Drug Patent Watch

FEBRUARY 25, 2022

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.

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Drug Patent Watch

FEBRUARY 25, 2022

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.

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Drug Patent Watch

FEBRUARY 25, 2022

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.

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Drug Patent Watch

FEBRUARY 25, 2022

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.

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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 24, 2022

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.

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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 24, 2022

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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The Pharma Data

FEBRUARY 23, 2022

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.

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