Fierce Pharma
JANUARY 27, 2023
J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma aliu Fri, 01/27/2023 - 11:02
pharmaphorum
JANUARY 27, 2023
AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe
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Fierce Pharma
JANUARY 27, 2023
Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira zbecker Fri, 01/27/2023 - 11:50
MedCity News
JANUARY 27, 2023
Medtech companies should be particularly mindful of the following legal and regulatory compliance issues. This is especially true for companies transitioning to data-based services.
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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
Fierce Pharma
JANUARY 27, 2023
With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug aliu Fri, 01/27/2023 - 15:29
MedCity News
JANUARY 27, 2023
Read about news from Carrum Health, New Enterprise Associates, American Medical Women’s Association, and Iaso Therapeutics.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
JANUARY 27, 2023
About 47% of American adults have hypertension and 14% have diabetes. Yet, 12% of people have set a goal to manage their blood pressure and 6% have a goal to manage their diabetes, a new HealthJoy survey found. Comparatively, about half of Americans have a musculoskeletal condition, and 35% of respondents are interested in managing back or joint pain.
Fierce Pharma
JANUARY 27, 2023
FDA advisors vote to standardize COVID vaccines as bivalent, stump for more data kdunleavy Fri, 01/27/2023 - 10:01
MedCity News
JANUARY 27, 2023
Intermountain Healthcare recently partnered with Story Health to help manage patients’ heart failure by increasing access to specialty care. Under the partnership, Intermountain clinicians are working with Story’s health coaches to help patients keep up with their treatment plans while they’re outside the walls of the doctor’s office.
Fierce Pharma
JANUARY 27, 2023
Chiesi fills CEO post with Baxter veteran Accogli after acquiring Amryt in $1.
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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.
pharmaphorum
JANUARY 27, 2023
Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.” The complaint – originally filed in May 2022 in a New Jersey federal court – alleges that SaveOnSP took advantage of J&J’s Janssen CarePath programme, which covers eligible patients’ out-of-pocket expenses for 44 of its more expensive prescription drug
Impetus Digital
JANUARY 27, 2023
O ur client wanted to better understand the needs, preferences, and treatment gaps among adult patients with a rare genetic disease in the USA. They had first conducted a virtual advisory board with physicians treating this condition but wanted to supplement that initiative by gathering patient insights to get a more comprehensive and accurate picture.
pharmaphorum
JANUARY 27, 2023
The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows. In fact, 76% of healthcare professionals have recently cited feelings of burnout, leading to a turnover rate twice as high as before the pandemic and increased levels of vacant positions across clinical research sites.
Pharmaceutical Technology
JANUARY 27, 2023
The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.
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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.
pharmaphorum
JANUARY 27, 2023
Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds. Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceutical company – our recent interview provided some interesting insights into the changing landscape of the indus
European Pharmaceutical Review
JANUARY 27, 2023
The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Once implemented the manufacturing regulatory framework will apply to all point of care (POC) products manufactured in the UK, such as: Advanced therapy medicinal products (ATMPs), such as cell therapy , gene therapy and tissue engineered products 3D prin
pharmaphorum
JANUARY 27, 2023
Ipsen has suffered rather a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against approval. The EMA’s human medicines committee delivered a negative opinion on palovarotene , making it very unlikely that the drug will be approved by the European Commission, although Ipsen says it will be requesting a re-examination of the marketing application.
European Pharmaceutical Review
JANUARY 27, 2023
To help expand access to medicines in low- and middle-income countries (LICs) Eli Lilly and Company has announced it will provide $1.15m to a new cold chain capacity initiative. The investment will enable an estimated 150 medical-grade refrigeration units to be installed at 25 Life for a Child partner facilities in Africa, Latin America, the Caribbean and Southeast Asia.
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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.
pharmaphorum
JANUARY 27, 2023
As the legendary investor Warren Buffett once said, forecasts about the future usually tell you more about the forecaster than they do about the future. It’s wise advice from the “Sage of Omaha”; indeed, one highly respected financial newspaper began its 2023 predictions by conceding that it had been wrong on five major counts for 2022. Still, pretty much every business decision is based on some kind of forecast, or scenario; the alternative would be to do nothing, ever.
Pharma Pathway
JANUARY 27, 2023
Natco Pharma Limited -Walk-In Interview for Multiple Positions On 28th Jan’ 2023 Job Description Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulation (“FDF”) and active pharmaceutical ingredients (“APIs”). Our focus is primarily on niche therapeutic areas and complex products.
PharmaTimes
JANUARY 27, 2023
Therapy involves patients with paediatric-onset hypophosphatasia – a rare bone disease
Pharma Pathway
JANUARY 27, 2023
Aurobindo Pharma-Walk-In Interviews for Quality Assurance/ Quality Control On 28th Jan’ 2023 Job Description Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.
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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.
Pharmaceutical Technology
JANUARY 27, 2023
The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Kite’s axicabtagene ciloleucel (yescarta) to treat aggressive forms of lymphoma. The chimeric antigen receptor T-cell (CAR-T) therapy axicabtagene ciloleucel has been recommended for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients who have previously received two or more lines of systemic thera
Pharma Pathway
JANUARY 27, 2023
Sun Pharma- Walk-In Drive for Production/R&D/ Process Development On 28th Jan’ 2023 Job Description Walk-In Interview for Production/R&D/ Process Development Department: Production/R&D/ Process Development Division: API Education: M.Sc/ B.E Chemical Experience: 02 to 10 years Position: Officer/ Sr. Officer/ Manager Date: 28th Jan 2023 Time: 10:00 AM to 03:00 PM Venue: Sun Pharmaceutical Industries Ltd, Panoli Plot No. 24/2 & 25 Phase IV, GIDC Industrial Estate , Panoli -394
pharmaphorum
JANUARY 27, 2023
pharmaphorum editor-in-chief Jonah Comstock joins Adi Hoess, CEO of Affimed Therapeutics, at their JPM2023 headquarters at the Zeppelin Hotel, to learn about Affimed’s work and their plans for the year to come. Affimed is using bispecific antibodies to activate the innate immune system of cancer patients to create longer-lasting and more effective results.
Pharma Pathway
JANUARY 27, 2023
MSN Laboratories Pvt. Ltd-Walk-In Drive for Freshers & Experienced On 29th Jan’ 2023 Job Description MSN Laboratories Pvt. Ltd-Walk-In Drive for Quality Control in Formulation Division @ Corporate Office Department: Quality Control- Formulation Qualification: B.Pharmacy/ M.Pharmacy Pharmaceutical Analysis/ M.Sc Chemistry Division: Formulation Experience : 0 to 08 years Work Location: MSNF-II, Kothur Openings : 50 Date of Interview: 29th Jan’ 2023 Interview Time: 9:00 AM to 02:00 PM V
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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
PharmaTimes
JANUARY 27, 2023
Clinical study is researching patients with diabetes and advanced chronic kidney disease
Pharma Pathway
JANUARY 27, 2023
Neuland Laboratories Pvt. Ltd-Walk-In Interview for Freshers & Experienced On 28th Jan’ 2023 Job Description Walk-In Interviews for Production & Production Documentation @ Neuland Laboratories Pvt. Ltd Department: Production & Production Documentation Designation: Chemist Experience: 2 to 6 years Qualification: M.Sc / B.Sc Job Location: Unit-I Bonthapally & Unit -III , Hyderabad Walk-In Date: 28th Jan’ 2023 Time: 09:30 AM 04:00 PM Venue: Neuland Laboratories Ltd, Survey
Pharmatutor
JANUARY 27, 2023
GENETIC LEVEL THERAPY FOR NEONATAL PROBLEMS admin Fri, 01/27/2023 - 14:22 About Author KONDEPATI MALLESH BABU Priyadarshini Institute of Pharmaceutical Education and Research kondepatimallesh@gmail.
Pharma Pathway
JANUARY 27, 2023
Aspiro Pharma -Walk-In Interviews for Engineering Department On 29th Jan’ 2023 Job Description Greetings from Aspiro Pharma !!! Walk-In Interviews for Engineering Department @ Aspiro Pharma Department: Engineering Position: Officer – Sr. Executive Experience: 02 to 07 years Qualification: Diploma/ B.Tech Date: 29th Jan’ 2023 Time: 09:00 AM to 01:00 PM Venue: Hetero Corporate Office, Sanath Nagar, Hyderabad Candidates those who are unable to attend this drive can share their resume to v
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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.
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