Drug Discovery World

JULY 22, 2022

A UK centre for synthetic biology has received £5.5 million in funding so it can support start-ups and SMEs in the sector. . The UK’s National Centre for the Industrial Translation of Synthetic Biology, SynbiCITE, will use the funding to support businesses within the sector and to help strengthen the emerging UK bioeconomy. The centre was established in 2013 using funding from the UK Research & Innovation and has since provided synthetic biology start-ups and SMEs from across the UK with ex

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Drug Discovery Today

JULY 18, 2022

Imagen Therapeutics, a global provider of services to the pharmaceutical cancer drug development industry, is celebrating recent success and preparing for rapid growth following the opening of its headquarters at Sci-Tech Daresbury.

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Antidote

JULY 22, 2022

Skin cancer is more common than any other type of cancer, and melanoma causes a large majority of skin cancer-related deaths. While awareness surrounding melanoma and the importance of sun protection has risen in recent years, CDC research shows that melanoma rates have still doubled over the last three decades.

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Drug Channels

JULY 20, 2022

Cut through the steamy summer haze with our refreshing selection of articles and insights. In this issue: CVS disassociates itself from its chain pharmacy association Payers are paying attention to ICER Benefits of the biosimilar boom A fantastic takedown of health insurance deductibles Plus, I join the Advisory Board of Alto Pharmacy. P.S. Join my nearly 30,000 (!

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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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Drug Discovery World

JULY 22, 2022

News round-up by DDW’s Reece Armstrong for 18 – 22 July. Covid-19 vaccines remain effective six months after second dose . Two doses of Covid-19 vaccines were sufficient in providing protection against severe cases of the infectious disease, according to new research.? . New combination therapy shows promise against lung cancers? . Scientists have discovered a new combination of drugs that could act as a promising treatment for people with certain types of lung cancer.?

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Drug Patent Watch

JULY 22, 2022

Annual Drug Patent Expirations for IXEMPRA+KIT Ixempra Kit is a drug marketed by R-pharm Us Llc and is included in one NDA. It is available from one supplier. There are…. The post New patent expiration for R-pharm Us drug IXEMPRA KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels

JULY 22, 2022

Today’s guest post comes from Ian Ocilka, Senior VP of Client Solutions at ConnectiveRx. Ian shares an overview of The Evolving Role of Hubs and Patient Services , his recent presentation at Informa Connect's Hub and Specialty Model East conference in June. Click here to watch Ian’s full presentation. Read on for Ian’s insights. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Drug Discovery World

JULY 22, 2022

By Courtney Ferrebee, PhD, Field Applications Scientist, Taconic Biosciences. Although immunotherapy has revolutionised cancer therapy, the effectiveness of currently available immunotherapies varies significantly across patients and treatment types. As a result, researchers are striving to continually improve immuno-oncology approaches using the patient’s own immune cells to combat tumours.

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Drug Patent Watch

JULY 22, 2022

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

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Advarra

JULY 19, 2022

For research sites whose communities include large populations of non-English speakers, it may be standard operating procedure (SOP) to obtain a translated version(s) of the study’s informed consent document at the beginning of each study. That way, when a non-English speaking potential study participant shows interest in the trial, researchers can help the potential participant learn more about the research without missing a beat.

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Drug Channels

JULY 18, 2022

Informa Connect’s Medicaid Drug Rebate Program (MDRP) Summit. Hybrid Event October 12-14, 2022 | Chicago, IL www.informaconnect.com/MDRP. Don’t miss the Medicaid Drug Rebate Program Summit coming up this fall in Chicago (or virtually). You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs.

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Drug Discovery World

JULY 21, 2022

Two doses of Covid-19 vaccines were sufficient in providing protection against severe cases of the infectious disease, according to new research. . A study 1 led by researchers at the University of Bristol found that two doses of Pfizer-BioNTech and AstraZeneca Covid-19 vaccines provided protection against Covid-19 infections six months after the second dose. .

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Drug Patent Watch

JULY 21, 2022

Annual Drug Patent Expirations for VENCLEXTA Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Abbvie Inc drug VENCLEXTA appeared first on DrugPatentWatch - Make Better Decisions.

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Advarra

JULY 19, 2022

Advarra experts Sharon Ayd and Leslie Paul answer questions from their webinar, The IND Journey Phase I – Navigating Success. Q: If an emergency use authorization (EUA) is granted, once there is an approved treatment, does that mean that the EUA is no longer valid? A: Yes, the EUA is just temporary. If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application.

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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

JULY 18, 2022

Atomwise scientists are using machine learning to help University of Alberta researchers find compounds that have the potential to regrow damaged nerves. Nerve damage is a common problem following injury in neurological disorders, but regrowing damaged nerves is difficult — especially if the underlying condition has been around for a long time. Even if the underlying disease is curable, nerve damage can still persist.

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Drug Discovery World

JULY 20, 2022

Scientists have discovered a new combination of drugs that could act as a promising treatment for people with certain types of lung cancer. . Lung cancer is one of the most common cancers in the world. Every year, it’s thought that around 2.21 million people die due to lung cancer, according to the World Health Organisation (WHO). 1 Whilst some patients can be effectively treated with immunotherapy, this type of treatment doesn’t work for most patients. .

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Drug Patent Watch

JULY 21, 2022

Palbociclib is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Drug patent litigation for PALBOCICLIB.…. The post New tentative approval for Eugia Pharma drug palbociclib appeared first on DrugPatentWatch - Make Better Decisions.

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Antidote

JULY 19, 2022

Updated July 2022:

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Pharma Manufacturing

JULY 20, 2022

Four factors to keep in mind for mAb facility design and operations

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Drug Discovery World

JULY 20, 2022

Precision medicine start-up Vesynta has become the first medtech company to move into a laboratory at south London’s latest incubator space. . The company, which was spun out from the?Adaptive and Responsive Nanomaterials group at University College London, has moved into the Innovation Gateway at The London Cancer Hub in Sutton. The start-up is developing a technology platform to support personalised dosing. .

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Drug Patent Watch

JULY 21, 2022

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

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DrugBaron

JULY 19, 2022

Despite the current hype around so called “advanced therapies”, which range from gene editing to cell therapies, and the inexorable advance of biologic therapeutics such as monoclonal antibodies, even in 2022 the majority of drugs in development and reaching patients are still small organic molecules. From enzyme inhibitors to receptor antagonists, allosteric modulators to suicide substrates, small molecules can modulate protein function in uniquely diverse ways.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exch

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Drug Discovery World

JULY 19, 2022

Automation has long been a buzzword associated with cutting-edge science, yet even in the most advanced labs it is usually only applied to specific assays and methods. However, by building automation across your full laboratory workflows and integrating it into existing protocols, Biotech R&D can be transformed. In this FREE TO REGISTER webinar, Russ Green, Product Lead at Automata Technologies, discusses the key pillars of automation across laboratory environments to increase throughput, en

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Drug Patent Watch

JULY 21, 2022

Annual Drug Patent Expirations for ONIVYDE Onivyde is a drug marketed by Ipsen Inc and is included in one NDA. It is available from one supplier. There are sixteen patents…. The post New patent for Ipsen Inc drug ONIVYDE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug & Device Law

JULY 18, 2022

At the end of the term, the Supreme Court, in Ruan v. United States , 2022 WL 2295024, 142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. §841’s “knowingly or intentionally” scienter (that’s legal Latin for the degree of intent required for a crime or tort) requirement for illegal drug distribution.

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Advarra

JULY 21, 2022

For decades, many research sites have primarily relied on institutional review board (IRB) oversight provided by committees administered by the local institution conducting the research. Additionally, IRBs administered by independent organizations have always been an option for research sites who do not administer their own local IRB. Recently, federal requirements have shifted to require most multisite clinical trials rely on a single IRB (sIRB) for oversight at all participating sites.

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Drug Discovery World

JULY 19, 2022

A major milestone has been met in the construction of a new multi-million-pound health centre in Liverpool. . The new Pembroke House centre will be operated jointly by Liverpool School of Tropical Medicine and iiCON: Infection Innovation Consortium. It aims to expand Liverpool’s leading capabilities in infectious disease research and innovation through partnerships between industry, research, and the NHS. .

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Drug Patent Watch

JULY 21, 2022

Annual Drug Patent Expirations for SPIRIVA Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from two suppliers. There are sixteen patents…. The post New patent expiration for Boehringer Ingelheim drug SPIRIVA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug & Device Law

JULY 19, 2022

They say everything is bigger in Texas and when it comes to cowboy boots – they are actually correct. Built by Bob “Daddy-O” Wade in 1979, the largest cowboy boots in the world measure 35 feet tall and 33 feet long and purportedly can hold 300,000 gallons of beer. They stand in front of a Saks Fifth Avenue at the North Star Mall in San Antonio, Texas – only about an hour away from where Spano v.

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Drug Discovery World

JULY 19, 2022

Organ-on-a-chip Company (OOC) CN Bio has expanded its contract research services with the opening of new laboratory facilities at Cambridge Science Park. The company has double its laboratory space in response to the increasing demand for OOC services as seen throughout drug discovery and development programmes. . CN Bio states that a rising demand into OOC services demonstrates an acceptance of the technology by pharma and biotech companies within their therapeutic programmes.

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Drug Discovery World

JULY 19, 2022

An early-stage clinical trial has been launched in the US investigating a vaccine against Nipah virus infection. . The clinical trial has been launched by the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate an investigational vaccine to prevent infection with Nipah virus. The virus is being manufactured by pharmaceutical company Moderna and was developed in collaboration with NIAID’s Vaccine Research Center.

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Drug Discovery World

JULY 19, 2022

Non-coding or ‘junk’ DNA could contribute to the development of certain cancers due to how it disrupts the replication of the genome, scientists have discovered. . A team from The Institute of Cancer Research (ICR), London reconstituted the entire process of DNA replication in a test tube in order to understand it more completely. . The team found that non-coding DNA or repetitive patterns of DNA could disrupt the replication of the genome. .

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Drug Discovery World

JULY 18, 2022

Big data and AI are all the rage. But, beyond these buzzwords and the quantity of data, what’s next for these powerful tools? Troy Groetken of intellectual property and technology law firm McAndrews, Held & Malloy tells Lu Rahman how pharma companies can take this data from where it currently stands (drug design and development) to a more clinical level.

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