Wed.Jun 26, 2024

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes

MedCity News

The American Hospital Association sent letters to the Senate and House urging them to support legislation that would prevent the CMS from enforcing its final rule on minimum staffing requirements for long-term care facilities. The organization argued that the mandate could lead nursing homes to reduce capacity or close altogether. The post AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes appeared first on MedCity News.

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With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market

Fierce Pharma

Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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CDC immunization advisers vote to shrink recommendations for RSV vaccination

Fierce Pharma

The respiratory syncytial virus (RSV) vaccine showdown already saw a shakeup last month with a new competitor in Moderna’s mRESVIA. | The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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A Tipping Point: Organ Shortages and the Future of Transplantation

MedCity News

Increasingly, more patients qualify for transplants, making organ shortages today’s most pressing issue. The post A Tipping Point: Organ Shortages and the Future of Transplantation appeared first on MedCity News.

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Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval

Fierce Pharma

The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. | Even after the FDA has converted J&J’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod, the door to an accelerated approval in the same indication remains open, according to AstraZeneca spinout Dizal Pharma.

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Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms

MedCity News

The 2024 Benefit Consultant Sentiment Index published by MedCity News and sponsored by Quantum Health, now in its second year, is based on a survey of more than 100 seasoned healthcare benefits consultants who represent a cross-section of employer size. A few shared their impressions of some of the report findings. The post Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms appeared first on MedCity News.

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Sanofi asks for private equity bids for its consumer health unit: Bloomberg

Fierce Pharma

It finally appears to be go-time in Sanofi’s continuing effort to separate from its consumer health unit. | Sanofi has told prospective buyers of its consumer health unit to provide bids for its consumer division by the middle of July, Bloomberg reports. Private equity firms Advent International and PAI Partners are believed to be the most serious potential suitors.

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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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Streamlining the Patient Consent Process

MedCity News

Velatura, a leading multi-jurisdictional health information exchange and health data utility, along with Docusign, the leading intelligent agreement management solution that accelerates the process of doing business, have joined forces to streamline the process of obtaining and managing informed patient consent. The post Streamlining the Patient Consent Process appeared first on MedCity News.

Patients 101
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Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's

Fierce Pharma

With U.K. consumer health giant Haleon slimming down and India’s Dr. Reddy’s Laboratories beefing up its over-the-counter offerings, the two have arrived at a deal that makes sense for both. | Haleon has continued its push to divest, selling its nicotine replacement therapy (NRT) business outside of the United States to Dr. Reddy’s for 500 million pounds ($633 million).

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Mavida Health Expands Offerings for LGBTQIA+ Families

MedCity News

Mavida Health’s new offerings for LGBTQIA+ patients include virtual spaces for queer parents to connect, gender-affirming care for queer and trans birthing people, specialized perinatal mental health providers in the LGBTQIA+ community and educational content inclusive of all identities. The post Mavida Health Expands Offerings for LGBTQIA+ Families appeared first on MedCity News.

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Sumitomo Pharma's new CEO weighs layoffs in Japan after sharp sales drop, US job cuts: report

Fierce Pharma

A recent layoff round affecting 400 U.S. staffers was just the latest in Sumitomo Pharma’s waves of workforce reductions. | Sumitomo Pharma's new CEO is looking to restructure and cut jobs in the company's home country after a sharp revenue dip, according to an interview he gave with Nikkei Asia.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The Financial Potential of Convertible Notes in the Pharmaceutical Sector

MedCity News

These notes serve not only as a means to raise capital but also as a bridge to future financing rounds or significant liquidity events. The post The Financial Potential of Convertible Notes in the Pharmaceutical Sector appeared first on MedCity News.

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EuroAPI telegraphs 2 site sales, hundreds of layoffs as it rolls ahead with restructuring scheme

Fierce Pharma

The toll of Sanofi spinoff EuroAPI’s newly unveiled restructuring scheme is coming into focus as the manufacturer moves forward with its sweeping four-year efficiency plan. | The toll of Sanofi spinoff EuroAPI’s newly unveiled restructuring scheme is coming into focus as the manufacturer moves forward with its sweeping 4-year efficiency plan.

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EvolutionaryScale emerges with $142m for AI drug discovery

pharmaphorum

AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.

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Bridging Authenticity: The Transformative Power of Allyship

ALULA

Since our Pride Month series is all about prompting more open conversations about LGBTQIA+ allyship, I took the opportunity to interview my colleague Brian Cole about his allyship journey. Not only is Brian my colleague , but he is also my dad, so it was powerful to address how features of allyship show up across our shared work, home, and social spaces.

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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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Akili lifted by FDA nod for adult ADHD digital therapeutic

pharmaphorum

Digital health company Akili will go into its merger with Virtual Therapeutics with FDA approval for its adult ADHD app

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After 33 years, Geron’s first approval marks a turn in Nobel-winning science

PharmaVoice

The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.

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Wales and NI follow England in backing Vertex CF therapies

pharmaphorum

Three of the four UK nations have agreed a long-term deal with Vertex Pharma for reimbursement of its cystic fibrosis therapies, ensuring permanent access to the drugs for eligible patients.The new agreement with England, Wales, and Northern Ireland marks the end of a long-standing and sometimes bitter dispute over the high cost of Vertex's CFTR modulator drugs.

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Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease

MedCity News

The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. The post Novo Nordisk Drug Fails Pivotal Test in Hypertension and Chronic Kidney Disease appeared first on MedCity News.

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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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Smith+Nephew takes sports injury message to Wimbledon

pharmaphorum

Smith+Nephew takes sports injury message to Wimbledon Phil.

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Quality Considerations in Changing Excipient Providers

PharmaTech

In the premiere episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

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Imfinzi fails lung cancer trial, but scores in bladder cancer

pharmaphorum

AstraZeneca’s hopes of positioning its PD-L1 inhibitor Imfinzi as a post-surgery therapy for people with earlier-stage lung cancer have taken a knock, although it performed well in a bladder cancer study.Top-line results from the phase 3 ADJUVANT BR.31 study showed that giving Imfinzi (durvalumab) as adjuvant therapy for stage IB-IIIA non-small cell lung cancer (NSCLC) was no better than placebo at extending disease-free survival (DFS).

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Lilly joins fellow pharma giants in OpenAI partnership

Pharmaceutical Technology

The collaboration is intended to leverage OpenAI's generative AI-based platform to invent novel antimicrobials to treat drug-resistant pathogens.

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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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Best Location Analytics Tools for Sales Teams

Spotio

Location analytics has the potential to completely revolutionize your sales process. Once you have access to this kind of technology, territory management, route optimization, and activity tracking tasks will become easier and more accurate for your sales team. Keep reading to learn what location analytics is, how to use this technology in a sales context, the benefits of location analytics for sales teams, and nine tools you can use for this purpose.

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China NMPA approves Simcere Zaiming’s Enlituo for mCRC treatment

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted marketing approval for Simcere Zaiming’s Enlituo for the treatment of metastatic colorectal cancer (mCRC).

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Stand Out In Med Sales: The Power Of A Personal Story With Emma Sturtevant

Evolve Your Success

Medical sales expert Emma Sturtevant! Joins us to unpack the transformative potential of personal stories in the competitive field of medical sales. With her rich background in public health, psychology, and communication, Emma offers invaluable insights into how crafting a compelling personal narrative can differentiate you in job interviews and provide ongoing motivation in your career.

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India’s telecom transformation: Innovation, investment and intellectual property

Clarivate

As technology continues to drive progress, Intellectual Property (IP) plays a vital role in fostering innovation and nurturing economic and technological growth. This is particularly true in the telecom sector, where new ideas and advancements are contributing to the creation and maintenance of digitally empowered, knowledge-based economies. In our latest report, co-authored by Jio Platforms Ltd (JPL), “The Role of Intellectual Property in India’s Telecom Growth Story,” we take an in-depth look

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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.