Fierce Pharma

JUNE 30, 2023

A former statistician at Pfizer and his associate have been charged (PDF) with insider trading, using advance inform | A former statistician at Pfizer and his associate have been charged with insider trading, using advance information to make more than $350,000 from stock purchases that they executed one day before the company made trial results public for COVID-19 blockbuster Paxlovid.

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European Pharmaceutical Review

JUNE 30, 2023

A collaborative approach to advancing adoption of RMMs EPR ’s Caroline Peachey explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry. The power of rapid methods for fungal ID By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety.

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Safety Pharmaceutical Patients 105

Fierce Pharma

JUNE 30, 2023

The Securities and Exchange Commission (SEC) has revealed insider trading charges against five—including former Alexion Vice President | The SEC has revealed insider trading charges against five—including former Alexion vice president Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals.

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Pharmaceutical 223

Pharmaceutical Technology

JUNE 30, 2023

Health Canada has approved Endo International’s Xcopri as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.

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Management 116

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Fierce Pharma

JUNE 30, 2023

Shareholders in Alkermes have quelled Sarissa Capital, reelecting seven board members and rejecting three nominees from the activist investor.

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MedCity News

JUNE 30, 2023

With few workers entering a field dominated by older Gen X-ers and Baby Boomers, there’s a growing gap in skilled medical coders — people who read notes from doctors and apply appropriate codes for billing and reimbursement purposes. So many are turning to AI.

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European Pharmaceutical Review

JUNE 30, 2023

Demand for process analytical technology ( PAT ) is being driven by the growing adoption of automation and digitalisation in sectors such as pharmaceutical industry, a report by Market.us has found. With PAT being widely used in pharma, rising R&D expenses are anticipated to boost demand for these technologies. Growth and limitations in the global PAT market The PAT market is expected to grow $10.6 billion in 2032, the report suggested.

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Marketing Manufacturing Pharmaceutical Pharmaceutical products 92

Fierce Pharma

JUNE 30, 2023

Boehringer Ingelheim's Cyltezo stands out from the crowd because it's the only Humira biosimilar to carry an interchangeability designation.

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MedCity News

JUNE 30, 2023

Author Health helps seniors with serious mental illness and substance use disorders by working with Medicare Advantage plans. The company launched Wednesday with $115 million in financing, and announced that Humana is its first payer partner.

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Fierce Pharma

JUNE 30, 2023

Shionogi will pay $100 million upfront to purchase an infectious disease company. Takeda unveiled more data to back its enzyme replacement therapy for a rare heart disease. | Shionogi will pay $100 million upfront to purchase an infectious disease company. Takeda unveiled more data to back its enzyme replacement therapy for a rare heart disease. AbbVie's BTK patent infringement lawsuit against BeiGene may have merit, according to a patent expert.

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Pharma 187

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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.

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European Pharmaceutical Review

JUNE 30, 2023

The limulus amebocyte lysate (LAL) assay for bacterial endotoxin testing (BET) is currently facing some of its greatest challenges as a reagent in the pharmaceutical industry, according a paper published in the Journal of Applied Bioanalysis. The author highlighted key obstacles and offered potential opportunities for the future. Challenges The first current challenge the author discussed was the supply of materials and conservation of resources for endotoxin testing.

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Fierce Pharma

JUNE 30, 2023

Fujifilm has tapped a new leader on its quest to deliver 200 billion yen ($1.4 billion) from its Bio CDMO business by March 2025. | Effective immediately, company veteran Lars Petersen has ascended to the throne as president and chief executive officer of Fujifilm Diosynth Biotechnologies. Petersen, who most recently worked as chief operating officer of the CDMO’s site in Hillerød, Denmark and head of the company’s large-scale strategic business unit, is succeeding Martin Meeson, who has captain

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Pharmaceutical Technology

JUNE 30, 2023

BioMed X has announced that it has begun a joint research project with Sanofi on artificial intelligence (AI) driven drug development.

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MedCity News

JUNE 30, 2023

During a recent virtual panel discussion, health system executives discussed what it should ideally look like when health system leaders come together to launch a digital project. They stressed it is vital to assemble a diversified decision-making team and that leaders should prioritize addressing the organization’s challenges and opportunities rather than being captivated by flashy new products.

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Healthcare Healthcare 76

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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

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Pharmaceutical Technology

JUNE 30, 2023

BioMarin’s Roctavian, a one-time therapy for severe haemophilia A, has secured FDA approval following previous rejections and delays.

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FDA 97

PharmaTimes

JUNE 30, 2023

ELATIVE, a randomised PBC trial involving 161 patients, has successfully met its primary endpoint - News - PharmaTimes

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Patients 94

PharmaVoice

JUNE 30, 2023

Vacation is calling, but so are patients. Here's how the industry adjusts in the summer.

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Pharma Patients 102

PharmaTimes

JUNE 30, 2023

Partnership will establish drug candidates using both laboratory tests and machine-learning - News - PharmaTimes

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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.

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MedCity News

JUNE 30, 2023

Dry eye disease drug Xiidra is the centerpiece of the Bausch + Lomb acquisition. The deal with Novartis also includes two experimental products, one for eye pain and the other a medical device for delivering medicines to the eye.

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Medicine Medical Biopharma Pharma 56

Pharmaceutical Technology

JUNE 30, 2023

At DDW 2023, a comment was made following a presentation discussing the preliminary induction findings from the Phase IIb/III QUASAR (NCT04033445) trial in ulcerative colitis (UC).

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Clarify Health

JUNE 30, 2023

In the U.S., one in every ten adults owes medical debt. To help remedy this problem, the U.S. enacted the No Surprises Act in 2020. The rule aims to protect patients by establishing rules for out-of-network care and promoting transparency in healthcare pricing. Its provisions are designed to prevent patients from being caught off guard by exorbitant bills and provide avenues for resolving billing disputes.

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Networking Insurance Patients Healthcare 52

Cesare Ferrari

JUNE 30, 2023

In the MedTech community, there are 2 common positions regarding business plans and business cases. Some people consider business plan and business case the “compass” of the business, the new venture, or the new project. They rely on it, and they use it to evaluate business opportunities, new projects, and new ventures. Others are more skeptical regarding business plans considering them less useful and some extremists consider them totally useless.

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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.

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Penrod

JUNE 30, 2023

Last month, we shared some insight on our Core Value of Flexibility 🤸‍♂️ Our five Core Values are: Accountability Flexibility Growth Grit Teamwork This month, let’s chat about our Core Value of Grit! 👊 We define Grit “an unwavering commitment to long-term goals. Even when you fall down. Even when you screw up. Even when progress towards that goal is halting or slow.

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MedTechVets

JUNE 30, 2023

JUNE 30 – We were proud to interview MedTechVet Academy Mentor, Jack Saladow. Jack is currently the President of his own consulting business, Jack Saladow & Associates. He specifically provides sales, marketing, and strategic planning services to manufacturers of a wide range of medical devices and technology. After returning from a stint in the Peace Corps, he accepted an offer from McGaw Laboratories and has enjoyed a 49-year career in the healthcare industry. “ My mentorship activi

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Consulting Medical Healthcare Healthcare 52

Legacy MEDSearch

JUNE 30, 2023

Cresilon, Inc. (“Cresilon”), a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care.

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FDA Food and Drug Administration Recruitment Medical 52

Star OUTiCO

JUNE 30, 2023

Today is Social Media Day , so we’re sharing top tips from our recruiters on how to secure your dream job using social media – more precisely, using LinkedIn. 40 million people use LinkedIn to search for jobs every week; three people are hired each second on the platform; 75% of people who change jobs use LinkedIn to help them decide to, and people hired through LinkedIn are 40% less likely to leave their new role within six months.* 1.

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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

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Pharmaceutical Technology

JUNE 30, 2023

Cold agglutinin diseaseis under clinical development by NovelMed Therapeutics and currently in Phase I for Acquired (Autoimmune) Hemolytic Anemia.

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PharmaTech

JUNE 30, 2023

Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.

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Pharmaceutical Technology

JUNE 30, 2023

Sangamo Therapeutics has signed a licence agreement with Voyager Therapeutics for a therapy to treat prion disease.

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PharmaTech

JUNE 30, 2023

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

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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.

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