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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DrugBaron

FEBRUARY 7, 2022

Finding small molecule drugs is much harder than finding a needle in a haystack – discovering the right arrangement of atoms to bind precisely to a protein target to elicit a particular response is a problem of vast dimensionality. We are most familiar with the numbers involved when dealing with antibodies: a typical antibody library might contain 10 13 different clones – but even that hardly scratches the surface of the 10 80 or so possible CDR sequences.

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Drug Channels

FEBRUARY 11, 2022

Today’s guest post comes from John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds. John discusses some of the findings in CoverMyMeds’ recently published report on medication access. He describes patient-centric, data-driven solutions to help patients access, afford, and adhere to their therapies. To learn more, download CoverMyMeds’ 2022 Medication Access Report.

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ProRelix Research

FEBRUARY 8, 2022

A lot has changed over the past few decades in the way clinical trials are conducted. Advances in data management systems, risk-based monitoring, pharmacovigilance, electronic databases, and application of complex […]. The post Clinical Trial Outsourcing and Management in USA appeared first on ProRelix Research.

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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.

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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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Drug Patent Watch

FEBRUARY 28, 2022

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-seven patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

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PerkinElmer

FEBRUARY 28, 2022

In early 2019, no one could have predicted that a novel coronavirus would sweep around the globe and cause one of the most significant health crises of recent times. Fast-forward to today, and thousands of scientists have turned their attention to studying SARS-CoV-2, the virus responsible for the current COVID-19 pandemic. This research pivot led to a torrent of scientific papers describing the structure and biology of the virus being published.

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Drug Channels

FEBRUARY 18, 2022

Today’s guest post comes from Garry Marshall, Senior Director of Business Strategy at Wolters Kluwer, Health. Garry discusses healthcare business vertical integration and its effect on care quality for patients and on providers' work experiences. To learn more, download the Wolters Kluwer Expert Insight article Vertical Integration Strategies: Using Data to Align Partners and Reduce Variation in Care.

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ProRelix Research

FEBRUARY 27, 2022

The World Health Organization (WHO) defines clinical trials as a type of research that studies new tests and treatments and evaluates their effects on human health outcomes (1). Clinical trials […]. The post Clinical Trial Approval Process in Australia appeared first on ProRelix Research.

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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 28, 2022

Annual Drug Patent Expirations for PRISTIQ Pristiq is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from four suppliers. There are two…. The post New patent expiration for Pf Prism drug PRISTIQ appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Discovery Today

FEBRUARY 2, 2022

Data shows SARS-CoV-2 human challenge studies are safe in healthy young adults

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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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Drug Channels

FEBRUARY 15, 2022

Time to update Drug Channels' exclusive look at independent pharmacy owners’ business economics. Our analysis again reveals that despite what you may have heard, many independent pharmacies continue to hang on in a highly challenging retail environment. Prescription profits remained stable, while the average pharmacy owner’s salary jumped for the second year.

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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

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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 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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Drug Discovery Today

FEBRUARY 10, 2022

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

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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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Drug Channels

FEBRUARY 4, 2022

Today’s guest post comes from Jeff Berkowitz, CEO of advisory firm Real Endpoints. Jeff describes problems with Medicare copays that reduce adherence and persistence among seniors. He then describes RE Assist , Real Endpoints’ tech-enabled solution with key information on foundations for more than 30 diseases. To learn more about Medicare copayments and how the RE Assist solution helps patients, register to view Real Endpoints’ free webcast: Solving the Medicare Co-pay Dilemma.

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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 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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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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Olympian Clinical Research

FEBRUARY 17, 2022

Prurigo nodularis (PN) is a rare skin disorder that causes hard, itchy, or painful bumps to appear on the skin. Symptoms of PN usually begin to appear in middle-aged adults, but it can affect people of all ages. What Does Prurigo Nodularis Look Like? The primary symptom of prurigo nodularis is the appearance of firm, itchy or painful lumps called nodules on the skin.

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The Strateos Blog: Drug Discovery

FEBRUARY 16, 2022

Strateos is pleased to be taking part alongside other thought leaders in the field of lab automation at PharmaIQ Live: SmartLab Digital 2022 on March 8-9, 2022.  John Harman, Strateos’ Senior Director of Product Management will be presenting a talk focused on accelerating drug discovery workflows through automation, robotics, and lab digitalization.

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Drug Channels

FEBRUARY 1, 2022

The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare. (See links below.) These data provide our first official look at how the pandemic has affected U.S. healthcare spending. Today, I examine the key insights from these latest figures.

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National Drug & Alcohol Research Centre Blog

FEBRUARY 13, 2022

Tom Santo Jr. To reduce the likelihood of opioid use disorder (OUD) among people prescribed opioids for chronic non-cancer pain (CNCP), it is important to identify individual risk factors for OUD among this population. However, until now, little has been known about the relationship between a childhood trauma and OUD risk among people prescribed opioids for CNCP.

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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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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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Sygnature Discovery

FEBRUARY 11, 2022

We’re thrilled to be working with cutting-edge new Dutch biotech company River BioMedics to identify new drugs that directly treat heart failure and cardiovascular disease – the number one cause of death in the world. This exciting partnership combines our novel assay development and hit identification expertise with River BioMedics unique, state-of-the-art technology: advanced human-predictive in vitro 3D heart models, plus their deep knowledge of cardiac biology.

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Policy Prescription

FEBRUARY 9, 2022

Mark Cuban’s new online pharmacy venture – the Mark Cuban Cost Plus Drug Company (“Cost Plus Drug”) – will not help overcome the biggest obstacle to drug affordability in America, which is drug company monopolies on patented brand name prescription drugs. When only one company makes a drug and can charge as much as the market will bear, which is the case in the United States, the prices are often outrageous, with several treatments exceeding half a million dollars.

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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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Pharmaceutical Development Group

FEBRUARY 1, 2022

Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines.

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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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