Drug Discovery Today

MARCH 28, 2022

Science Minister George Freeman says life sciences have an essential part to play in creating the economy and ecosystem of tomorrow.

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Drug Channels

APRIL 1, 2022

Today’s guest post comes from Fauzea Hussain, Vice President of Public Policy at McKesson. Fauzea succinctly describes the complicated and contradictory aspects of the Centers for Medicare & Medicaid Services' Final Rule on Best Price, a.k.a. the Medicaid copay accumulator rule. She then outlines how the rule, if implemented, is likely to hurt patients.

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Eye on FDA

MARCH 30, 2022

Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in motion as well. It is a fundamental re-shifting of the landscape. And there are consequences. First, government funding supporting access to vaccination and treatment for COVID has run out and so far, is not replenished.

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Drug Patent Watch

APRIL 1, 2022

Annual Drug Patent Expirations for AMONDYS+45 Amondys 45 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sarepta Theraps drug AMONDYS 45 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.

Clinical Trials

Drug Discovery Today

MARCH 28, 2022

Phase 2 study is the first approved by the FDA and DEA to test psychedelic therapies in the area of binge eating disorders

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Drug Channels

MARCH 29, 2022

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: PBM Industry Update: Trends, Controversies, and Outlook. Broadcast live on April 22, 2022 , from 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration to participate in the event.

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Drug Patent Watch

APRIL 1, 2022

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

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Drug Discovery Today

MARCH 30, 2022

The topic of this month’s newsletter from Drug Discovery Today is “Epigenetics”.

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Drug Channels

MARCH 31, 2022

Ah, it’s finally spring in downtown Philadelphia, our home base. (Photographic evidence on your right.) Along with sunshine and fine weather, this vernal equinox has ushered in a crop of new and noteworthy stories: Health inequities in utilization management Insurers compute big white bagging savings The biosimilar boom accelerates The patient upside of manufacturers’ copay support Whoa.

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The Pharma Data

MARCH 31, 2022

French AMF approved EUROAPI’s listing prospectus EUROAPI first day of trading expected to occur on May 6, 2022 subject to the approval of the Distribution by the Ordinary and Extraordinary Shareholders’ Meeting to be held on May 3, 2022 Sanofi will host today a dedicated Capital Markets Day at 1:30 pm CET to present EUROAPI’s business in greater detail The Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi shares After the Distribution, Sanofi has confirmed its intenti

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Clinical Trials

Drug Patent Watch

APRIL 1, 2022

Annual Drug Patent Expirations for CONTRAVE Contrave is a drug marketed by Nalpropion and is included in one NDA. It is available from three suppliers. There are eighteen patents protecting…. The post New patent for Nalpropion drug CONTRAVE appeared first on DrugPatentWatch - Make Better Decisions.

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Crown Bioscience

MARCH 31, 2022

This post explores the benefits of combining high-content imaging (HCI) and high-content analysis (HCA) with 3D in vitro tumor organoids for drug discovery and validation studies. An increasing number of large in vitro screening studies are showing that novel clinically relevant biomarkers of drug response and important drug effects can be discovered by probing a wider array of cellular parameters combined with dose–response assessments.

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Drug Channels

MARCH 28, 2022

Informa Connect’s Medicaid & Government Pricing Congress. Hybrid Event In-Person: May 23-25, 2022, Philadelphia, PA | Virtual: June 1-2, 2022 www.informaconnect.com/medicaid-government-pricing. Don’t miss the Medicaid & Government Pricing Congress , coming up May 23-25, 2022 (in-person in Philadelphia) and June 1-2, 2022 (virtually)! You'll be part of the important discussions surrounding the critical policy updates and approaches to effectively contract, report and comply with state and

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The Pharma Data

MARCH 31, 2022

Through Save Legs. Change Lives. ™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. Change Lives.™ Spot Peripheral Artery Disease Now, a multi-year initiative aimed at creating urgency and action to address the hidden threat of peripheral artery disease (PAD)-related amputation, with an initial fo

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Clinical Trials

Drug Patent Watch

MARCH 31, 2022

Annual Drug Patent Expirations for NOXAFIL Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co and, and is included in four NDAs. It is available…. The post New patent expiration for Schering drug NOXAFIL appeared first on DrugPatentWatch - Make Better Decisions.

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Olympian Clinical Research

MARCH 31, 2022

Anxiety is the most common mental illness in the United States, affecting over 40 million adults every year. With anxiety at an all-time high as we live through a pandemic and an increasingly globalized and technologically advanced world, it can be challenging to understand what type of anxiety you may be experiencing. The most common types of anxiety are social and general anxiety, but how can you tell the difference?

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Practical Cheminformatics

MARCH 28, 2022

Clustering Fragment Screening Hits With a Self-Organizing Map (SOM) In a paper, " Fragment binding to the Nsp3 macrodomain of SARS-CoV-2 identified through crystallographic screening and computational docking ", published last year by scientists from UCSF and the Diamond Light Source, the authors reported more than 200 structures of fragments bound to the Nsp3 macrodomain of SARS-CoV-2.

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The Pharma Data

MARCH 31, 2022

A Phase 2 clinical trial evaluating various additional COVID-19 booster shots has begun enrolling adult participants in the United States. The trial aims to understand if different vaccine regimens – prototype and variant vaccines alone and in combinations – can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot.

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Drug Patent Watch

MARCH 30, 2022

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

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Molecular Design

MARCH 31, 2022

Enthalpy-driven binding has been presented as a rationale for screening fragments although some have argued that thermodynamic signature is actually a 'red herring' in the context of drug discovery. Binding of a ligand grown from a fragment hit incurs a translational entropy penalty that is similar to that of the original fragment hit and it is therefore it is hardly surprising that synthetic elaboration results in binding that is more driven by entropy.

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The Anticancer Fund

APRIL 1, 2022

1 April 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Our intention is to help bring these findings to the attention of the broader cancer research community.

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The Pharma Data

MARCH 31, 2022

Sanofi successfully priced yesterday, March 30, 2022, its offering of a dual-tranche EUR 1.5 billion of notes (the “Notes”). It comprises an inaugural issue of sustainability-linked bond for a nominal amount of EUR 650 million of notes, tied to Sanofi’s commitment to improve access to essential medicines in low- and lower-middle-income countries via its global health nonprofit unit.

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Drug Patent Watch

MARCH 29, 2022

Annual Drug Patent Expirations for XTORO Xtoro is a drug marketed by Merlion Pharms Gmbh and is included in one NDA. There are three patents protecting this drug. This drug…. The post New patent for Merlion Pharms drug XTORO appeared first on DrugPatentWatch - Make Better Decisions.

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Sygnature Discovery

MARCH 31, 2022

Take a look at this new paper on drug discovery equipment

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Policy Prescription

APRIL 1, 2022

The U.S. Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. that may have amounted to a quarter-billion dollars. The investigation comes about two months after The Wall Street Journal reported on a lawsuit filed by Gilead Sciences alleging a massive breach in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patien

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The Pharma Data

MARCH 29, 2022

Ondexxya (andexanet alfa)has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.

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Drug Patent Watch

MARCH 29, 2022

Annual Drug Patent Expirations for CYCLOPHOSPHAMIDE Cyclophosphamide is a drug marketed by Ani Pharms, Cipla, Hikma, Sti Pharma Llc, Amneal, Baxter Hlthcare, Jiangsu Pharms, Eugia Pharma Speclts, Ingenus Pharms Llc,…. The post New patent for Ingenus Pharms drug CYCLOPHOSPHAMIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. In that instance, the FDA had limited its cleared “intended use” to disc spaces in the lowest part of the spine, while essentially identical, equally safe placement in adjacent disc spaces was off-label (and also the medical standard of care).

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The Pharma Data

MARCH 29, 2022

ELEVATE UC 52 met the co-primary endpoints of clinical remission at both weeks 12 and 52 and all key secondary endpoints. – Etrasimod demonstrated a safety profile consistent with previous studies. Pfizer Inc. (NYSE: PFE) today announced positive top-line results from a second Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).

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Drug Patent Watch

MARCH 29, 2022

Annual Drug Patent Expirations for ACZONE Aczone is a drug marketed by Allergan and Almirall and is included in two NDAs. It is available from four suppliers. There are two…. The post New patent for Almirall drug ACZONE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MARCH 29, 2022

Annual Drug Patent Expirations for LONHALA+MAGNAIR+KIT Lonhala Magnair Kit is a drug marketed by Sunovion Resp and is included in one NDA. It is available from one supplier. There are…. The post New patent for Sunovion Resp drug LONHALA MAGNAIR KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MARCH 29, 2022

Annual Drug Patent Expirations for TRUDHESA Trudhesa is a drug marketed by Impel Neuropharma and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent for Impel Neuropharma drug TRUDHESA appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

MARCH 28, 2022

BIIB078, an investigational antisense oligonucleotide for C9orf72-associated amyotrophic lateral sclerosis (ALS), did not show clinical benefit; clinical program will be discontinued Biogen and Ionis remain committed to their decade-long pursuit of advancing ALS research and developing therapies for all forms of this progressive and fatal neurodegenerative disease.

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The Pharma Data

MARCH 28, 2022

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a 2.0 mg dose of Ozempic ® (once-weekly semaglutide subcutaneous injection), a glucagon-like peptide-1 (GLP-1) analogue for the treatment of adults with type 2 diabetes. Ozempic ® is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults.

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