Pharmaceutical Technology

JULY 1, 2022

The latest issue of Pharma Technology Focus is out now. Read it for free on all devices. Some months after the first Covid-19 vaccines became available, the World Health Organization (WHO) set a target of vaccinating 70% of each country’s population by the end of June 2022. Global trends indicate that initially, a slow supply did not allow African countries, in particular, to stay on pace to meet this target, and now vaccination rates have even begun to slow down.

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MedCity News

JULY 1, 2022

Novartis is acquiring an FDA priority review voucher from Mallinckrodt Pharmaceuticals. The $100 million price tag is in the neighborhood of the going rate for these vouchers, which grant a company a shorter regulatory review timeline for a drug that addresses a rare or neglected disease.

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Pharmaceutical Technology

JULY 1, 2022

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness.

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Food and Drug Administration FDA Safety Food 105

European Pharmaceutical Review

JULY 1, 2022

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. The article, published in the Journal of Validation Technology ( JVT ), presents the case study of a company undergoing an investigation and developing a strategy for identifying worst-case sampling locations on equipment, after a regulatory auditor asked for such a rationale and no written documentation could be provided.

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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

Distribution

MedCity News

JULY 1, 2022

Rising deal premiums and shrinking profit margins are threatening the sustainability of the traditional approach to mergers and acqusitions, according to a report by Accenture. The firm expects growth-minded companies will turn to other pathways.

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pharmaphorum

JULY 1, 2022

One of the main assets of Sanofi’s $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. The regulator is requiring Sanofi to stop dosing some patients in phase 3 trials of the BTK inhibitor tolebrutinib (SAR442168) in multiple sclerosis and myasthenia gravis, following reports of drug-induced liver damage in some subjects.

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Copyright Clearance Center

JULY 1, 2022

The post ALA Conference Draws 14K Attendance appeared first on Copyright Clearance Center.

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PharmaTimes

JULY 1, 2022

Xenpozyme is a treatment for ASMD and the condition’s only current enzyme replacement therapy

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Pharmaceutical Technology

JULY 1, 2022

Blueprint Medicines has entered strategic financing partnerships for up to $1.25bn with life sciences-focused investors Sixth Street and Royalty Pharma. The company noted that the deal will bring substantial non-dilutive, low-cost capital to boost innovation and growth. The funding will offer capital to extend Blueprint’s varied pipeline toward marketing as well as to continue seeking strategic and synergistic business development prospects.

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Medicine Food and Drug Administration FDA Prospecting 59

PharmaTimes

JULY 1, 2022

Chronic myeloid leukaemia therapy Scemblix receives NICE final draft recommendation in Britain

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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.

Safety

MedCity News

JULY 1, 2022

Check out new developments from Equiva, SonALAsense, Sensible Care, and more.

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Healthcare Healthcare 87

Map My Customers

JULY 1, 2022

Mapping out your sales pipeline is an essential part of maximizing the success of your team’s efforts. It helps guide management decisions that can reduce any bottlenecks within the sales process and give reps a clear roadmap, allowing them to pinpoint where their efforts are and will be most effective. Some use sales CRM tools that can categorize sales data and create visualizations to display the sales pipeline, show the separate stages, and show how many customers/prospects are in each

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Sales pipeline Sales CRM Sales process 52

eMediWrite

JULY 1, 2022

In the healthcare sector, sales agents are required to run their “territories” like their own businesses. Top-performing medical sales representatives have an entrepreneurial mind-set for this precise reason. Knowing which clients generate the most business and what their “purchasing” style is will help you match your selling approach to it.

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pharmaphorum

JULY 1, 2022

SAE Media Group’s Inaugural Conference…. Medical Devices and IVD 2022. 14 – 15 November 2022. London, UK. [link]. Navigating The MDR and IVDR and Best Strategies for Compliance. SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in London, UK. The MDR implementation last May has highlighted issues within the industry that need to be addressed and the upcoming IVDR updates will have a profound impact on the medical devi

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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.

Specialization

Pharmaceutical Commerce

JULY 1, 2022

Logistics experts provide an outlook on what the industry must do to overcome potential bottlenecks.

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pharmaphorum

JULY 1, 2022

Blueprint Medicines has taken an unusual route to raising cash for its R&D pipeline – selling off some of the royalties from its already-approved medicines in return for a cash injection of up to $1.25 billion. The targeted cancer drug specialist has sold its interest in tyrosine kinase inhibitor Ayvakit/Ayvakyt (avapritinib) and Roche-partnered RET inhibitor Gavreto (pralsetinib) in two separate transactions with Sixth Street and Royalty Pharma.

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Pharmacy Times

JULY 1, 2022

Nearly 63% of newly diagnosed patients have advanced colorectal cancer, which requires more aggressive treatment and reduces the associated 5-year survival rate.

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Patients 48

pharmaphorum

JULY 1, 2022

Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to encroach on its territory. Top-line results from the AEGEAN trial of AZ’s PD-L1 inhibitor Imfinzi (durvalumab) plus chemotherapy given pre-surgery for resectable NSCLC tumours have revealed a significant improvement in the pathologic complete response (pCR) rate compared to chemo alone.

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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.

Safety

Progressive Medical

JULY 1, 2022

You must be a registered user to view this information. The post Monthly Employee Portal Updates | June 2022 appeared first on Progressive Medical, Inc.

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Medical 40

pharmaphorum

JULY 1, 2022

Novartis is still waiting for FDA approval of its PD-1/PD-L1 inhibitor latecomer tislelizumab in relapsed oesophageal cancer, but is already planning a move the drug into the first-line setting. New phase 3 data from the RATIONALE 306 study have shown that previously-untreated patients with advanced oesophageal squamous cell carcinoma (ESCC) treated with tislelizumab plus chemotherapy had improved overall survival (OS) compared to those given chemo plus placebo.

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Pharmaceutical Commerce

JULY 1, 2022

Cheshire facility will offer plasmid DNA production, CGT development.

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Manufacturing 52

pharmaphorum

JULY 1, 2022

On the heels of approvals in the US, Europe and Japan, Bayer’s Kerendia for chronic kidney disease (CKD) associated with type 2 diabetes has been cleared for use in China, unlocking another big market for the drug. Kerendia (finerenone) – a non-steroidal, selective mineralocorticoid receptor (MR) antagonist – has been shown to reduce the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy in the FIDELIO-DKD study.

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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.

Management

Pharmacy Times

JULY 1, 2022

Ashwagandha KSM-66 (Anxiety & Stress Relief) from Nature’s Bounty is indicated to help manage occasional stress and anxiety.

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Management 49

pharmaphorum

JULY 1, 2022

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. This post, which includes references to Marshall B. Rosenberg’s psychological concept of Nonviolent Communication, shares a simple three-step method to solving conflicts without spoiling foundational human relationships – and sometimes even improving them.

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Pharmacy Times

JULY 1, 2022

Findings from a study highlight the efficacy and safety of bulevirtide for the treatment of chronic hepatitis delta virus.

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Safety 49

European Pharmaceutical Review

JULY 1, 2022

The last several years have presented employers in the pharmaceutical industry with a challenging, rapidly changing landscape. With the advent of social movements such as #MeToo and Black Lives Matter, and the impact of the COVID-19 pandemic, the priorities and concerns of employers are shifting significantly. This evolving focus is clearly visible in the growing emphasis now placed by many global businesses on environmental, social and governance (ESG) issues – and especially the ‘social’ eleme

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Government Pharmaceutical Safety Consulting 89

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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

Leads

Pharmacy Times

JULY 1, 2022

Many patients with heart failure are hesitant to receive the COVID-19 vaccine due to the fear of myocarditis.

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Patients 49

PharmaKinnex

JULY 1, 2022

Inside Sales Vs. Outside Sales: How They Can Work Together For Pharma July 1, 2022. PharmaK. When you add inside sales to your existing outside sales team, you can really boost the amount of success your pharma sales team has. This can result in exponential growth for your product. The inside sales team generally focuses on making appointments, generating leads, and building relationships with prescribers.

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Pharmacy Times

JULY 1, 2022

The first step to reducing recurrent C. difficile infections is prevention.

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Pharmaceutical Technology

JULY 1, 2022

Ildong Pharmaceutical will licence a suite of Twist Bioscience's VHH antibody libraries after the two companies entered a partnership agreement. Twist's VHH libraries, used for discovering and developing antibodies for use in immuno-oncology, will be licensed by Ildong for three years for research and development works. . Twist will be entitled to receive an upfront payment, annual maintenance fees, further payments on successfully meeting clinical and regulatory milestones and royalty payments

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Pharmaceutical Pharma Sales 59

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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.

Patients