Fri.Dec 09, 2022

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AZ writes the 'next chapter' in Enhertu's saga with head-to-head win versus Roche's Kadcyla

Fierce Pharma

AZ writes the 'next chapter' in Enhertu's saga with head-to-head win versus Roche's Kadcyla. fkansteiner. Fri, 12/09/2022 - 09:22.

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Women’s Health is Suffering Due to Lack of Research and Funding, Experts Say

MedCity News

Women’s health has been historically underfunded — in terms of both research dollars and venture capital investment. Lawmakers can’t craft effective policy nor can startups innovate in the women’s health space without good data and research, said panelists at a recent healthcare conference in Washington, D.C.

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ASH: Bristol Myers bolsters Breyanzi's case in earlier lymphoma amid clash with Gilead

Fierce Pharma

ASH: Bristol Myers bolsters Breyanzi's case in earlier lymphoma amid clash with Gilead. aliu. Fri, 12/09/2022 - 09:15.

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How One Company Is Making Psychedelic Therapy a Workplace Benefit

MedCity News

Enthea, a benefit plan administrator, works with self-insured employers to provide insurance coverage for psychedelic-assisted therapy. The company has gained $2 million in seed funding, led by Tabula Rasa Ventures. With the money, it is planning a nationwide rollout.

Insurance 117
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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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Combo of Roche's Tecentriq and Exelixis' Cabometyx fails another trial, this time in lung cancer

Fierce Pharma

Combo of Roche's Tecentriq and Exelixis' Cabometyx fails another trial, this time in lung cancer. fkansteiner. Fri, 12/09/2022 - 11:22.

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Enhancing Care and Access with Virtualist Partners

MedCity News

Instead of trying to fix access issues by adding more office-based doctors, health systems should consider how to best implement a program that utilizes Virtualists for workforce expansion.

Doctors 117

More Trending

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Gilead Sciences Gets a Shot at Next-Gen Cell Therapy With $325M Arcellx Alliance

MedCity News

In partnering with clinical-stage Arcellx, Gilead Sciences gains the opportunity to develop a cell therapy for multiple myeloma that could offer advantages over currently available therapies for the blood cancer. The deal announced Friday came as Arcellx reported additional data during the annual meeting of the American Society of Hematology that showed continued durability of the cell therapy. .

Biopharma 117
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ASH: Despite partial clinical hold, bluebird's sickle cell gene therapy remains on track

Fierce Pharma

ASH: Despite partial clinical hold, bluebird's sickle cell gene therapy remains on track. kdunleavy. Fri, 12/09/2022 - 19:15.

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4 “Must-have” Healthcare Benefits Tips During Open Enrollment

MedCity News

The annual open enrollment period is the right time to proactively address common benefits knowledge roadblocks with more in-depth education and communications.

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UCB's bimekizumab, after FDA rejection in psoriasis, proves its worth in hidradenitis suppurativa

Fierce Pharma

UCB's bimekizumab, after FDA rejection in psoriasis, proves its worth in hidradenitis suppurativa. zbecker. Fri, 12/09/2022 - 16:28.

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How Machine Learning Drives Clinical Trial Efficiency

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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Oligonucleotide synthesis market to reach $16.7 billion by 2027

European Pharmaceutical Review

According to a new market report by ResearchAndMarkets, the global oligonucleotide synthesis market is projected to reach $16.7 billion by 2027 during the forecast period, due to the rise in ongoing clinical trials for oligonucleotide-based therapies in key therapeutic sectors such as oncology. The research projected a compound annual growth rate (CAGR) of 16.8 percent from $7.7 billion in 2022.

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Fierce Pharma Asia—MEI and Kyowa Kirin’s PI3K woes; Takeda’s dengue nod, Daiichii Sankyo’s Enhertu positivity

Fierce Pharma

Fierce Pharma Asia—MEI and Kyowa Kirin’s PI3K woes; Takeda’s dengue nod, Daiichii Sankyo’s Enhertu positivity. esagonowsky. Fri, 12/09/2022 - 10:43.

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AMR surveillance must improve, says WHO report

European Pharmaceutical Review

The Global Antimicrobial Resistance and Use Surveillance System (GLASS) report 2022 by the World Health Organization (WHO), which contains AMR trends for the first time since 2017, showed that common bacterial infections are becoming increasingly resistant to treatments. Data from the 2022 GLASS report. The document includes data on antimicrobial consumption (AMC) in humans in 27 countries and analyses for antimicrobial resistance (AMR) rates in relation to national testing coverage.

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Autolus announces primary endpoint met in FELIX trial, prices public offering

pharmaphorum

Autolus Therapeutic Plc. (Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., has announced that the pivotal phase 2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukaemia (ALL) patients has met its primary endpoint of overall remission rate (ORR) at interim analysis.

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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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Dr. Sy Pretorius, Eversana’s new COO, is flipping the script on his career

PharmaVoice

With a long history in the clinical space, Pretorius is now applying those deep insights to the commercial side of the business.

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Catalent opens one of largest cell therapy manufacturing facilities in the world

European Pharmaceutical Review

Catalent, a contract manufacturing organisation (CMO), has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world, at its European Center of Excellence for Cell Therapies in Gosselies, Belgium. The 60,000 square foot (5,600 square metre) new state-of-the-art facility houses multi-product, segregated suites facilitates autologous and allogeneic cell therapy manufacturing through to late-stage clinical and commercial-scale supply.

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Lupin Limited- Walk-In Interview for M.Sc/ B.Sc/ Diploma Chemical in Production On 10th Dec’ 2022

Pharma Pathway

Lupin Limited- Walk-In Interview for M.Sc/ B.Sc/ Diploma Chemical in Production On 10th Dec’ 2022. Job Description. Walk-In Interview for M.Sc/ B.Sc/ Diploma Chemical in Production On 10th Dec’ 2022 @ Ankleshwar, Gujarat. Lupin Limited is an Indian Multinational pharmaceutical Company based in Mumbai, Maharashtra, India. It is one of the largest generic pharmaceutical Companies by revenue globally.

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With FDA filing on the horizon, Karuna appoints new CEO

PharmaVoice

Allergan alum Bill Meury will take the helm as current CEO Steve Paul transitions to lead R&D.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Glenmark Pharmaceuticals-Walk-In Interviews for Production/Packing/ Semi Solid On 11th Dec’ 2022

Pharma Pathway

Glenmark Pharmaceuticals-Walk-In Interviews for Production/Packing/ Semi Solid On 11th Dec’ 2022. Job Description. Walk-In Interviews for Production/Packing/ Semi Solid On 11th Dec’ 2022 @ Glenmark Pharmaceuticals. Department: Production/Packing/ Semi Solid. Designation: Officer/ Jr. Officer/ Sr. Officer. Qualification: B.Pharm/ M.Pharm/ M.Sc/ B.Sc/ Diploma/ B.A/ B.Com/ ITI Regular.

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Health Innovators – Dr.?Jack Hoppin?and Dr.?John Babich

pharmaphorum

A few weeks ago, pharmaphorum Editor-in-Chief Jonah Comstock popped in on Ratio Therapeutics co-founders Dr. Jack Hoppin and Dr. John Babich at their WeWork coworking space in downtown Boston for a Health Innovators interview. Jack and John tell Jonah about the emerging area of targeted radiotherapeutics and how their company is combining that technology with mathematical modelling to optimise this exciting new area of oncology care. .

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EC grants marketing authorisation for Takeda’s dengue vaccine

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. This development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided a positive recommendation in October this year.

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Sanofi backs out of $500m cancer alliance with Revolution

pharmaphorum

Sanofi has walked away from a four-year-old partnership with Revolution Medicines focused on an SHP2 inhibitor, intended as a combination with KRAS inhibitors, including Sanofi’s Mirati-partnered adagrasib. The deal – which included a $50 million upfront payment and up to $450 million in follow-up payments – had advanced the RMC-4630 drug candidate from preclinical testing to a phase 2 trial in combination with Amgen’s first-to-market KRAS inhibitor Lumakras (sotorasib) as a treatment for KRASG1

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Catalent completes cell therapy manufacturing facilities in Belgium

PharmaTimes

Facility represents one of the largest commercial-scale operations in the world

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Your Unitary Patent Checklist: Five steps to take to prepare

Clarivate

Earlier this year, we provided an overview of the Unitary Patent (UP) and how it will affect patent owners and practitioners. Now, with the announcement that the Unified Patent Court (UPC) sunrise period is adjusted to begin March 1, 2023, IP professionals are likely wondering what they can do to prepare. To help you get ready, we created a simple checklist of five steps you can take to prepare.

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Novadip reveals results from severe bone non-union trial

PharmaTimes

Study involves candidate NVD-003 and the treatment of lower limb trauma

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Health Canada approves VBI Vaccines’ PreHevbrio for Hepatitis B

Pharma Leaders

PreHevbrio has been approved for active immunisation against infection which is caused by all known subtypes of HBV in people aged 18 years and above. It is said. The post Health Canada approves VBI Vaccines’ PreHevbrio for Hepatitis B appeared first on Pharmaceutical Business review.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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SABCS: AZ’s oral SERD data may “relaunch enthusiasm” for class

pharmaphorum

The results of the SERENA-2 trial of AstraZeneca’s oral selective estrogen receptor degrader (SERD) camizestrant, reported at the SABCS congress this week, could restore confidence in the much-beleaguered class, which has been hit by a series of clinical setbacks in recent months. That’s the view of study investigator Mafalda Oliveira of Vall d’Hebron University Hospital in Spain, who said the data is “noteworthy and may relaunch the enthusiasm for the development of oral SERDs in breast cancer.

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Selmar Lab Pvt. Ltd-Walk-In Interview for Production/ Electrical/ Safety On 10th & 12th Dec’ 2022

Pharma Pathway

Selmar Lab Pvt. Ltd-Walk-In Interview for Production/ Electrical/ Safety On 10th & 12th Dec’ 2022. Job Description. Selmar Lab Pvt. Ltd is located at Sy. No. 180/1 to 180/15 and 10/1, IDA, Kazipally, Jinnaram Mandal, Sangareddy District, Telangana. Selmar Lab Pvt. Ltd, We are Conducting Walk-In Interviews for Following.!!! Walk-In Interview for Freshers & Experienced in Production/ Electrical/ Safety On 10th & 12th Dec’ 2022 @ Selmar Lab Pvt.

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IN FOCUS: Solvias

Pharmaceutical Technology

Rankings 2022. M&A – Commended PRODUCT LAUNCHES – Commended RESEARCH AND DEVELOPMENT – Commende d. Pharmaceutical Technology Excellence Rankings – The Verdict. Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. The company is ranked in the M&A, PRODUCT LAUNCHES and RESEARCH AND DEVELOPMENT categories in the 2022 Pharmaceutical Technology Excellence Rankings.

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Novick Biosciences- Walk-In Interview for FRD/ Analytical FRD On 10th to 24th Dec’ 2022

Pharma Pathway

Novick Biosciences- Walk-In Interview for FRD/ Analytical FRD On 10th to 24th Dec’ 2022. Job Description. Novick Biosciences- Walk-In Interview for FRD/ Analytical FRD On 10th to 24th Dec’ 2022. Job Description. Walk-In Interview for FRD/ Analytical FRD On 10th to 24th Dec’ 2022 @ Novick Biosciences. Department: FRD/ Analytical FRD.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.