Sun.Nov 20, 2022

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NICE questions value and efficacy of five Covid-19 drugs with rejection

Pharmaceutical Technology

The UK's National Institute for Health and Care Excellence (NICE) has published a draft guidance that does not recommend the use of five major Covid-19 therapies. This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK.

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How monoclonal antibodies lost the fight with new COVID variants

NPR Health - Shots

The treatments were highly popular earlier in the pandemic. One by one, they got knocked out by more convenient, less expensive treatment options, and new COVID variants.

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Health Canada grants expanded authorisation for Novavax’s Covid-19 vaccine

Pharmaceutical Technology

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease. The latest development was based on findings from a Phase II clinical trial of the vaccine in South Africa as well as from the Phase III Prevent-19 trial in the US and Mexico.

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China announces 1st COVID-19 death in almost 6 months

Medical Xpress

China on Sunday announced its first new death from COVID-19 in nearly half a year as strict new measures are imposed in Beijing and across the country to ward against new outbreaks.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Ex-Theranos CEO Elizabeth Holmes sentenced to 11 years

pharmaphorum

Elizabeth Holmes, the founder and former chief executive of blood testing biotech Theranos, has been sentenced after being convicted of defrauding investors in the company earlier this year, receiving a prison sentence of more than 11 years in a California court. That’s shorter than the 15 years sought by prosecutors, but considerably longer than the 18 months’ house arrest that Holmes’ defense attorneys had pushed for, and there is likely to be an appeal against the sentence,

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Tumor matrix profiling gives clues to progression of some lung cancers

Medical Xpress

Scientists at the Garvan Institute of Medical Research have identified molecular profiles of the surrounding matrix of a common type of lung cancer that might indicate which patients are likely to develop aggressive tumors.

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Overcoming the challenges of developing vaccines in an accelerated timeframe

pharmaphorum

The COVID-19 pandemic stopped the world in its tracks. It provided a range of new challenges for industry stakeholders, including governments, public health bodies, and regulatory agencies – to name a few. In addition, it offered the opportunity for new solutions and approaches to many of today’s healthcare challenges. The world responded to the crisis at unprecedented speed, as leaders and experts focused on different ways to operate and succeed within the constraints of a new dynamic.

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Big Pharma Embraces Sustainability and Carbon Net Zero Goals

BioSpace

Large pharmaceutical companies are making plans to comply with sustainability and carbon net zero targets. Hear from AstraZeneca and Merck KGaA's MilliporeSigma about their strategies.

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GSK’s pullback from cell therapy continues as Immatics alliance ends

pharmaphorum

Immatics has become the latest partner for GSK in the area of cell therapy for cancer to see its alliance shelved, just two and a half years after being set up. In its third-quarter results update , the Tuebingen, Germany-based biotech said it had been informed by GSK in early October that it would be terminating their partnership announced in February 2020, adding that the decision was made “unrelated to the programmes and the progress achieved in the collaboration to date.” The de

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Merck Acquires Imago and its LSD1 Inhibitors in $1.3B Deal

BioSpace

With a $1.36 billion buyout, Merck bolstered its oncology program with the acquisition of Biotech Bay-based Imago Biosciences, a company focused on chronic bone marrow cancers.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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New patent expiration for Endo Ventures drug SUMAVEL DOSEPRO

Drug Patent Watch

Annual Drug Patent Expirations for SUMAVEL+DOSEPRO Sumavel Dosepro is a drug marketed by Endo Ventures Ltd and is included in one NDA. There are nine patents protecting this drug. SUMAVEL…. The post New patent expiration for Endo Ventures drug SUMAVEL DOSEPRO appeared first on DrugPatentWatch - Make Better Decisions.

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What You Need to Know Before Applying to a Small Pharma Company

BioSpace

BioSpace spoke with Annick Deschoolmeester, Head of Human Resources at Pharvaris, about some of the ways she's noticed small companies differ from large ones.

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New tentative approval for Teva Pharms drug eltrombopag

Drug Patent Watch

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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Lysogene Becomes Latest Company to Fail with AAVs in CNS Disorders

BioSpace

Lysogene’s investigational gene therapy LYS-SAF302 failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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New tentative approval for Amneal Pharms drug saxagliptin

Drug Patent Watch

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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FDA Action Alert: Spectrum, ImmunoGen, Scynexis and Y-mAbs

BioSpace

The FDA has a number of PDUFA dates for the remainder of November for Spectrum, ImmunoGen, Scynexis and Y-mAbs.

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Which pharmaceutical drugs have the most drug patents in Chile?

Drug Patent Watch

This chart shows the drugs with the most patents in Chile. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Chile? appeared first on DrugPatentWatch - Make Better Decisions.

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RVAC Medicines and A*STAR to Build Capabilities for mRNA Production in Singapore RVAC Medicines Pte. Ltd., a messenger RNA technology platform company incubated by CBC Group, a healthcare-dedicated asset management firm headquartered in Singapore, and the Agency for Science, Technology and Research announced the signing of a master research collaboration agreement to jointly study and develop solutions to build mRNA manufacturing and analytics capabilities in Singapore. Elpiscience Announces Studies Presented at SITC 2022 Annual Meeting Elpiscience Biopharmaceuticals, Inc. presented positive studies for its innovative immunotherapeutic molecules at the SITC 2022 Annual Meeting, including anti-SIRP? monoclonal antibody ES004, PD-L1/SIRP? bispecific antibody ES019, anti-LILRB2 monoclonal antibody ES009, anti-SIGLEC15 antibody ES012, and anti-LAG3 monoclonal antibody ES005. Eisai to Present Full Findings From Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) and Other Alzheimer's Disease Research at the

BioSpace

Former Theranos CEO Elizabeth Holmes will serve 11 years in prison on four counts of fraud, according to her sentencing by a federal judge in a California courtroom on Friday afternoon.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.