Sat.Jun 10, 2023 - Fri.Jun 16, 2023

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The ingredients of a successful biopharma collaboration

PharmaVoice

Collaboration is important along the entire spectrum and lifecycle of biopharma, and finding an effective partner is harder than it sounds.

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Discover If Your Medical Sales Reps Feel Safe Opening Up to You

MedReps

Communication is important, especially between medical sales reps and sales team leaders. In order for everyone to be on the same page, as well as deal with successes and setbacks accurately, there needs to be open communication. If your medical sales reps are too afraid to talk to you about their issues with the job, such as problems making a certain sale or the inability to find a certain client’s pain point, then they will more than likely not meet their quotas and start looking to find anoth

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How steep is pharma’s patent cliff?

PharmaVoice

The big pharma patent cliff is almost here — and could change the face of the industry. Here’s a look at the key stats behind the coming wave of blockbuster losses.

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BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Fierce Pharma

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against alle | The drugmaker will defend itself against claims from a German healthcare worker who sued the company for at least 150,000 euros ($161,500). The plaintiff alleges she suffered bodily harm resulting from Pfizer and BioNTech's Comirnaty vaccine.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Which Digital Health Tools Will Be the Greatest Victim to Turnover from Hospitals?

MedCity News

Hospitals’ digital health adoption exploded during the pandemic, leading to many vendor contracts spanning three to five years. As these contracts reach their expiration dates over this year and next, a new report predicts that telemedicine platforms and remote patient monitoring tools face the highest risk of being turned over by hospitals.

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Boost Local Visibility: Top Local SEO Tips for Multilocation Healthcare Businesses

Healthcare Success

Consumers across the globe have come to rely on search engines for reliable, trustworthy, accurate, and timely healthcare information. This has significantly increased competition among providers, making SEO—particularly local SEO—a crucial part of any digital marketing strategy. Local SEO is beneficial for any size business but critical for multilocation companies.

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Bayer needs 'midsize acquisition' to reach $10B oncology sales goal, exec says

Fierce Pharma

Bayer recently laid out its ambition | Bayer recently laid out its ambition to achieve $10 billion in sales from its oncology business by 2030 and become a top 10 cancer drug player. To get there, the company is looking outside for a “midsize acquisition,” Bayer’s oncology chief Christine Roth said.

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To Get Better Staffing Levels, Hospitals Must Prioritize Nurses’ Hiring Demands

MedCity News

Many health systems aren’t employing the right tactics for hiring and retaining nurses, according to a new report. It argued that hospitals would have an easier time hiring and retaining nurses if they focused more on the things workers want most from their employers — such as flexible scheduling and professional development opportunities.

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Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial

Pharmaceutical Technology

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. Following underwhelming topline results from the Phase II trial (NCT04135495) announced in late 2022, Eloxx recalculated the results using the change in ppFEV1 (a secondary outcome) from day 1 instead of from baseline.

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Working with Rare Disease Communities and Advocacy Groups

PM360

While all patient communities and advocacy groups offer patients, their families, and their caregivers support, advice, and information, rare disease patient groups can be especially tight-knit. With such limited information out there for some rare diseases, these groups are often the only resource for people looking for answers. Furthermore, these patients are typically the ones raising money for research into potential treatments and cures, as well as banding together to try to change governme

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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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Eli Lilly's Mounjaro is primed to surpass Novo Nordisk's popular diabetes and obesity duo: report

Fierce Pharma

In the battle for superiority in the field of next-gen diabetes and obesity treatments, Novo Nordisk holds the lead as the developer of the metabolism-regulating treatment semaglutide. | In the battle for diabetes and obesity superiority, Novo Nordisk holds a head start as the original developer of the metabolism-regulating treatment semaglutide. But Eli Lilly is quickly gaining ground and is primed to become the market leader with its GLP-1 treatment Mounjaro, according to GlobalData.

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Ipsen Itching Drug Scratches Off a Second FDA Approval in Rare Liver Indication

MedCity News

Ipsen drug Bylvay is now FDA approved for treating pruritus, or severe itching, which is a complication of the rare liver disease Alagille syndrome. The oral drug was previously approved for treating pruritus in another rare inherited liver disease called PFIC.

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Embracing the 60-Plus Economy

Pharmaceutical Commerce

In this latest Harvard Business School Healthcare Alumni Association Q&A, Susan Wilner Golden, DSC, lecturer at the Stanford Graduate School of Business, reveals an untapped $22 trillion global opportunity for all companies and others supporting healthy aging and longer life spans.

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Improving Rare Disease Clinical Trial Design

PM360

According to the National Organization for Rare Disorders (NORD) , there are over 7,000 known rare diseases, with 90% having no effective treatment method or cure. 1 When an individual is diagnosed with a rare disease, they often experience fear, uncertainty, and anxiety. Obtaining a diagnosis is only the first step, leaving many without the direction or resources to find the additional medical care they need.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Merck's Keytruda aims for updated stomach cancer label with positive data

Fierce Pharma

Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study. | After scoring accelerated approval to treat HER2-positive stomach cancer in 2021, the drug has now shown it can stave off tumor progression in patients with PD-L1 positive tumors.

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Digital Health’s ROI Reckoning: How To Uncover New Value From Old Investments

MedCity News

To increase your return on technology investment, start with an audit of existing technology. Where is it falling short? Do problems stem from lack of functionality or troubles with adoption? What do all users think?

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Beacon Therapeutics enters gene therapy arena with $120m launch

Pharmaceutical Technology

Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.

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Cala® Launches The Cala kIQ™ System, Offering Meaningful Tremor Relief for Patients With Essential Tremor and Now Parkinson’s Disease

Legacy MEDSearch

Cala , the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease. The Cala kIQ System delivers Cala TAPS (Transcutaneous Afferent Patterned Stimulation) therapy, which is validated by large clinical studies and real-w

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Sanofi goes 'all in' on AI with new app to support company's manufacturing, R&D and more

Fierce Pharma

Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making. The platform is one step in the company's digital transformation and goal to become the "first pharma powered by AI at scale.

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Pharma Injecting Life into Digital Health Amidst Funding Downturn

MedCity News

The consensus is 2022 was a challenging year for digital health companies. Venture capital and other startup investment in the U.S. digital health sector plummeted to $15 billion from more than $29 billion in 2021, according to Rock Health. Market analysts CB Insights similarly tracked private investment last year in U.S. digital health at $17.7 billion in 2022 — down 56% from $40.2 billion in 2021.

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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World’s largest lutetium-177 production site opens

European Pharmaceutical Review

A new therapeutic radionuclide facility, the world’s largest production site of lutetium-177, has opened in Germany. ITM Isotope Technologies Munich SE ( ITM )’s manufacturing plant in Neufahrn near Munich will produce the innovative medical isotope for targeted cancer therapies. “Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients.

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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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Game on, AbbVie. Roche's Columvi nabs FDA nod as 2nd bispecific for large B-cell lymphoma

Fierce Pharma

Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma. | Less than a month after AbbVie and Genmab won FDA approval for Epkinly, Roche has crossed the finish line with its bispecific answer to large B-cell lymphoma, though with a narrower label.

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FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med

MedCity News

The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.

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US FDA grants fast track status for CellCentric’s inobrodib

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. Inobrodib is an oral first-in-class cancer drug, indicated for patients who have previously received four or more lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent and a proteasome inhibitor.

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FDA approves new cell therapy manufacturing plant

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The 244,000 square foot facility in Devens is BMS’ third commercial cell therapy facility in the US. It is located on the company’s existing Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade.

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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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With FTC eyeing biopharma M&A deals, Pfizer refiles paperwork for $43B buyout of Seagen

Fierce Pharma

An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout o | An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout of Horizon Therapeutics has raised concerns that the United States’ antitrust watchdog is tightening the screws on major M&A moves in the biopharma industry. A month later, according to an SEC filing, Pfizer has withdrawn its notification for its proposed $43 billion acquisition of cancer drug specialist Seagen and will submit another later in the day.

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CMS Tests New Primary Care Model in 8 States

MedCity News

The Making Care Primary Model will be tested by the Center for Medicare and Medicaid Innovation from July 1, 2024, to December 31, 2034, in Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington.

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Lotus Pharmaceuticals and Teraju Pharma link for marketing in Malaysia

Pharmaceutical Technology

Lotus Pharmaceuticals and Teraju Pharma have entered a strategic partnership to market Lotus’s products in a range of therapeutic areas in Malaysia. Teraju Pharma will be responsible for marketing and promoting the products using its relationships and infrastructure. The company is a specialised pharmaceutical wholesaler and holds a licence, issued by the country’s ministry of health, to import non-registered pharmaceutical products, orphan drugs and other life-saving medicines.

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How To Get Results With Sales Activity Management In 2023

Spotio

At the end of every month, sales managers may be asking themselves a single question: Why is my sales team falling short of their selling quota? Sales metrics might answer that question, but too often, sales managers look at metrics that are outside of their control. A Harvard Business Review study found that of 306 metrics sales managers track, only 17% are sales activities.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.