Fri.Jan 13, 2023

article thumbnail

AmerisourceBergen Expands Global Footprint and Commercialization Solutions with Acquisition of PharmaLex

Fierce Pharma

AmerisourceBergen Expands Global Footprint and Commercialization Solutions with Acquisition of PharmaLex. jpiatt. Fri, 01/13/2023 - 10:18.

233
233
article thumbnail

Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales

Fierce Pharma

AstraZeneca pulls leukemia drug Lumoxiti off market after disappointing sales. kdunleavy. Fri, 01/13/2023 - 09:29.

Sales 254
article thumbnail

Novo Nordisk’s Diabetes Pill Rybelsus Gets FDA O.K. as First-Line Therapy

MedCity News

The FDA approved a change in Rybelsus’s label, allowing the drug to be used as an initial therapy for type 2 diabetes patients. The once-daily pill has already become a blockbuster product for Novo Nordisk.

FDA 124
article thumbnail

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.

article thumbnail

Roche searches pharma chief Anderson's successor from within: chairman

Fierce Pharma

Roche searches pharma chief Anderson's successor from within: chairman. aliu. Fri, 01/13/2023 - 09:36.

Pharma 245
article thumbnail

Oula Rakes in $19.1M for Hybrid Maternity Clinic

MedCity News

The funding round was led by 8VC and included participation from Chelsea Clinton’s fund, Metrodora; the Female Founders Fund; Collaborative Fund; and Alumni Ventures. In total, Oula has raised $22.3 million. The company plans to use the funds to grow in its New York market and add more services.

Marketing 123

More Trending

article thumbnail

Sometimes Striking Is the Only Way Nurses Can Protect Patient Safety, Expert Says

MedCity News

There’s been a recent wave of nurse strikes, but Theresa Brown — a nurse and New York Times bestselling author — said she’s never met a nurse that happily embraces striking. Nurses only strike when it’s the only option left to protect patients and deliver quality care, she declared.

Safety 111
article thumbnail

Moderna's proposed Spikevax price hikes 'hard to justify,' White House says

Fierce Pharma

Moderna's proposed Spikevax price hikes 'hard to justify,' White House says. zbecker. Fri, 01/13/2023 - 11:07.

201
201
article thumbnail

Simple Steps Providers Can Take to Improve Vaccine Uptake

MedCity News

Healthcare providers are the key to closing the vaccination gap: both as persuasive messengers and as the practical providers of vaccination.

article thumbnail

Chasing Roche, Merck talks up subcutaneous Keytruda ahead of phase 3 data drop

Fierce Pharma

Chasing Roche, Merck talks up subcutaneous Keytruda ahead of phase 3 data drop. ntaylor. Fri, 01/13/2023 - 09:28.

130
130
article thumbnail

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.

article thumbnail

Here are some interesting companies I met at JPM this week

MedCity News

Reporters are pitched endlessly about companies they need to meet at this annual healthcare conference and the ecosystem it has sprung. These companies stood out to me and they play in the biopharma, devices, diagnostics and health tech worlds.

Biopharma 108
article thumbnail

California sues insulin producers and PBMs over pricing

pharmaphorum

The ‘big three’ insulin producers Novo Nordisk, Eli Lilly, and Sanofi are being sued by the state of California for allegedly working together to set artificially inflated prices for their products. The lawsuit also takes aim at the three largest pharmacy benefit managers (PBMs) in the US – CVS Caremark, Express Scripts, and OptumRx – which are accused of adopting a system of rebates that incentivise manufacturers to raise list prices for insulin and promote higher-priced products.

article thumbnail

Our predictions for Pharma in 2023

Impetus Digital

It is the time of year when everyone predicts what the next 12 months will hold. At Impetus Digital, we get a first-hand look into evolving industry trends daily from our clients and their advisors, putting us in a unique position to make these predictions. For the sake of this article, we have narrowed the list down and now focus on 8 key themes: Hybrid meetings and events becoming the new normal.

Pharma 99
article thumbnail

Why you should include your residents in your senior living marketing

Clear Pivot

Your website is one of the most important tools you have to communicate what your senior living community is all about. And what better way to showcase that than involving your residents? Letting residents tell their stories through your company blog, email, and social media channels enriches a sense of community and helps those thinking about moving in decide if it’s right for them.

article thumbnail

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.

article thumbnail

Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

Hip Innovation Technology , LLC (HIT), a medical device company developing innovative orthopaedic device solutions to advance the quality of life and quality of care for patients, is pleased to announce the first U.S. implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA).

FDA 98
article thumbnail

JPM2023: Breakthroughs await, but so do roadblocks

pharmaphorum

Editor-in-chief Jonah Comstock lays out a few of the most potent threads he heard in the conference centres, hotel rooms, and rain-soaked Lyfts of San Francisco. After my customary cross-country redeye, I’ve officially traded the relentless rain of San Francisco for the gentle snowfall of my native Boston. And as I look out the window at that snow, my travel-addled brain can’t help but see it as a metaphor for pharma in 2023: a crisp white, wide canvas laden with possibilities, but also one that

FDA 98
article thumbnail

Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines

European Pharmaceutical Review

The European Pharmacopoeia (Ph. Eur.) Commission (EPC) adopted the revised general monographs 2034 and 2619 , at its 174th session in November 2022 , which now includes a paragraph explaining the Ph. Eur. approach to the control of N -nitrosamine impurities. A paragraph on N -nitrosamines has been added to Substances for pharmaceutical use (2034) under ‘Production’: “ N -Nitrosamines.

article thumbnail

Indoco Remedies Ltd.-Walk-In Interviews for Production/ Microbiology On 14th Jan’ 2023

Pharma Pathway

Indoco Remedies Ltd.-Walk-In Interviews for Production/ Microbiology On 14th Jan’ 2023. Job Description. Walk-In Interviews for Production/ Microbiology On 14th Jan’ 2023 @ Indoco Remedies Ltd. Company Name: Indoco Remedies Ltd. Department: Production/ Microbiology. Qualification: B.Pharma/ M.Pharm/ B.Sc/ M.Sc/ Diploma. Experience : 02 to 10 years.

Pharma 88
article thumbnail

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.

article thumbnail

Moderna becomes latest company to join the ABPI

PharmaTimes

Company becomes the latest member of the ABPI and galvanises the company’s UK connections

109
109
article thumbnail

Novick Biosciences- Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023

Pharma Pathway

Novick Biosciences- Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023. Job Description. Walk-In Interview for FRD/ Analytical On 14th to 30th Jan’ 2023 @ Novick Biosciences. Department: FRD/ Analytical. Designation: Research Associate/ HOD/ Team Lead. Experience: 03 to 10 years. Qualification: M.Sc, M.Pharm. Job Location: Hyderabad.

article thumbnail

LA Public Library Tops in World for Digital Lending

Copyright Clearance Center

The post LA Public Library Tops in World for Digital Lending appeared first on Copyright Clearance Center.

98
article thumbnail

AstraZeneca's Tezspire receives approval for asthma treatment

PharmaTimes

Green light for new asthma pen which offers self-administration option across the EU

107
107
article thumbnail

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.

article thumbnail

How biotechs can weather the market storm

PharmaVoice

Execs at JPM sound off on moves companies can make to survive the challenging market conditions.

article thumbnail

Vital Pharma- Multiple Openings for Maintenance/ QC/ Production/ Receptionist / AR&D/ FR&D @ Hyderabad

Pharma Pathway

Vital Pharma- Multiple Openings for Maintenance/ QC/ Production/ Receptionist / AR&D/ FR&D @ Hyderabad. Job Description. Multiple Openings for Maintenance/ QC/ Production/ Receptionist / AR&D/ FR&D @ Hyderabad. Department: Maintenance – Asst. Manager. Qualification: Diploma/B-tech. Experience: 5-10 years. Skills: Manufacturing (Formulation), maintenance management, Production, Utility Management, HVAC, Water system, EHS knowledge, Air compressor, Documentation, vacuum pumps’.

Pharma 85
article thumbnail

Repurposing Off-Patent Drugs Through Crowd Funding

Impetus Digital

In our first Fireside Chat of 2023, Savva Kerdemelidis , Founder & CEO of Crowd Funded Cures , joined Natalie Yeadon , Co-founder & CEO of Impetus Digital , and explored the concepts of interventional pharmacoeconomics and pay-for-success contracts to fund new uses for off-patent drugs and other unmonopolizable therapies. Here is a sneak peek of our conversation: Q: You started the company as a charity.

article thumbnail

Centaur Pharmaceuticals-Walk-In Interviews for Multiple Positions in QA/ QC 15th Jan’ 2023

Pharma Pathway

Centaur Pharmaceuticals-Walk-In Interviews for Multiple Positions in QA/ QC 15th Jan’ 2023. Job Description. Walk-In Interviews for Multiple Positions in QA/ QC 15th Jan’ 2023 @ Centaur Pharmaceuticals. Department: QA/ QC. Designation: Officer/ Executive/ Sr. Executive/ Asst. Manager/ Dy. Manager. Experience: 02 to 12 years. Qualification: M.Sc Chemistry, B.Pharm.

article thumbnail

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

article thumbnail

Evergreen Sanofi Ventures increases to $750M with further Sanofi commitment

pharmaphorum

Sanofi Ventures – focused on early-to-mid stage investing, company co-creation, leading financing rounds, and prioritising those companies advancing innovation – has announced an additional multi-year commitment from French drugmaker Sanofi, with an increase in capital to more than $750 million to the evergreen venture fund. Confirmed by the executive committee, the additional capital will fuel the expansion and investment capacity of the Sanofi Ventures investment team on a global scale.

article thumbnail

BioMatrix Healthcare Pvt. Ltd- Walk-In Interview for F&D/ ADL On 17th Jan’ 2023

Pharma Pathway

BioMatrix Healthcare Pvt. Ltd- Walk-In Interview for F&D/ ADL On 17th Jan’ 2023. Job Description. Walk-In Interview for F&D/ ADL On 17th Jan’ 2023 Department @ BioMatrix Healthcare Pvt. Ltd. Department: F&D/ ADL. Experience: Min. 2 years. Qualification: B.Pharm/ M.Pharm/ M.Sc/ B.Sc. Location: Ahmedabad. Date : 17th Jan’ 2023.

article thumbnail

2nd Next Generation RNA Therapeutics Summit

pharmaphorum

Bringing Next Generation RNA Therapies to Patients Faster. The 2nd Next Generation RNA Therapeutics Summit returns as the first and only industry-dedicated forum solely focused on next generation RNA therapeutics and vaccines that are more targeted, and efficacious, with reduced off targets than first generation RNA therapies to accelerate their therapeutic and commercial potential.

article thumbnail

Orchestrating Exceptional Member Journeys

Penrod

The post Orchestrating <span class="underline">Exceptional</span> Member Journeys appeared first on Penrod.

52
article thumbnail

Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.