Tue.Oct 04, 2022

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Google Cloud unveils medical imaging suite with Hologic, Hackensack Meridian as 1st customers

MedCity News

Google Cloud unveiled a new product suite to make medical imaging data more interoperable and useful via artificial intelligence. Hackensack Meridian Health has begun using it to detect metastasis in prostate cancer patients earlier, and Hologic is using it to strengthen its diagnostic platform that screens women for cervical cancer.

Medical 125
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Pfizer acquires biopharma firm Biohaven for $11.6bn

Pharmaceutical Technology

Pfizer has acquired commercial-stage biopharmaceutical firm Biohaven Pharmaceutical for $148.50 for each share or a total consideration of nearly $11.6bn in cash. In May, Pfizer entered a definitive agreement to acquire all outstanding shares of Biohaven which were not previously held by the former. . With the takeover, Biohaven became a wholly-owned Pfizer subsidiary.

Biopharma 106
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Mental health startup for seniors rakes in $32M from General Catalyst, Mass General, others

MedCity News

There is a dearth of professionals with licenses and training to provide care for seniors’ mental and behavioral health challenges — such as Alzheimer’s and other dementias, anxiety and depression. Seattle-based Rippl Care is seeking to change this. The startup just closed a $32 million seed funding round led by ARCH Venture Partners and General Catalyst.

Training 120
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European Commission’s approval of Mounjaro provides hope within obesity space

Pharmaceutical Technology

The type 2 diabetes (T2D) space recently witnessed a new approval: on 15 September, the European Commission (EC) authorised Eli Lilly’s Mounjaro (tirzepatide) for T2D patients. Mounjaro is a dual gastric inhibitory polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist. This event is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity.

Safety 105
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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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A preview of INVEST 2023: Themes and networking opportunities revealed

MedCity News

Save the date for INVEST 2023, which will take place on May 22-24 at the Ritz Carlton hotel in Chicago. The conference unites novel startups with active investors, highlights payer and provider perspectives, identifies challenges and opportunities in the life sciences, and describes healthcare’s overall transformation.

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Solid Biosciences acquires AavantiBio, conducts $75 million private placement

pharmaphorum

The life sciences company Solid Biosciences is merging with the privately-held gene therapy company AavantiBio in a deal which is expected to result in a combined sum of $215 million in cash and investments – projected to be enough for funding into 2025. AavantiBio, a precision genetic medicine company that was bankrolled by Solid’s rival Sarepta back in 2020, focuses on neuromuscular and cardiac rare diseases.

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Roche gets FDA approval for HER2 breast cancer diagnostic

pharmaphorum

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 million new cases each year, and each year over 620,000 breast cancer patients will die.

FDA 97
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Kaiser Permanente commits $50M to battle food insecurity

MedCity News

Research has proven there is a strong link between food security and health outcomes. Kaiser Permanente’s $50 million commitment will build on things the organization is already doing, including connecting people with SNAP and sending medically tailored meals to those in need.

Food 110
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Drug Solutions Podcast: Drug Delivery Systems: Optimer’s Therapeutic Targeting and Scaling Capabilities vs. ADCs

PharmaTech

An expert from Aptamer Group reveals the potential of Optimers (a type of aptamer) in the realm of drug delivery, including its targeting capabilities, scalability, and key differences between Optimers and antibody-drug conjugates.

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Chronic loneliness is killing people: The solution is personal

MedCity News

In order to make an impact and improve physical and mental health, we need to recognize the need to approach loneliness as a condition. Building connections through social intervention is the most direct way to affect change.

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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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Validating FTIR for rapid cleaning verification

European Pharmaceutical Review

Currently, validation of cleaning processes for pharmaceutical manufacturing equipment is done using analytical methods such as swab or rinse and subsequence laboratory testing. Fourier-transform infrared (FTIR) technology has the potential to produce the results in real-time, as well as improve the analytical accuracy significantly. However, although FTIR has proven to be effective, it must be robust to be used in a Good Manufacturing Practice (GMP) manufacturing facility.

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Cala Health’s real-world study validates its wearable’s long-term efficacy

MedCity News

Cala Health recently published a post-market study showing that its wrist-based wearable to treat essential tremor effectively reduced patients’ tremor power with no loss of effect over time. Most patients involved in the study reported improvement in daily activities, such as eating, drinking, texting and writing.

Marketing 103
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Pilot to support ATMP research and development

European Pharmaceutical Review

The European Medicines Agency (EMA) is set to launch a pilot aimed at helping advanced therapy medicinal product (ATMP) scientists navigate the regulatory challenges throughout the research process: from initial investigation to the development of medicines, to support non-profit’s solve unmet clinical needs and progress ground-breaking research for EU patients.

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Medical groups ask AG to investigate violence against hospitals that support transgender youth

MedCity News

Following a series of violent threats directed at medical centers that care for transgender youth, […].

Medical 129
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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.

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‘Junk’ DNA may hold the key to neurological disorders

PharmaTimes

University of Lincoln and the University of Sheffield are researching how DNA could be repaired

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Report: 43% of working-age adults are inadequately insured

MedCity News

Of people who were found inadequately insured, 9% were uninsured, 11% had a period without coverage over the past year and 23% had coverage all year but were underinsured, the Commonwealth Fund report showed.

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Large bacterial culture volumes can be filtered without centrifuge

European Pharmaceutical Review

A paper, published in the Journal of Applied Microbiology , suggested that filtering large volumes of bacterial cultures using modified vacuum filtration kits removes the need for pre-treatment with a centrifuge – a time-consuming process that often produces poor filtration results for high bacterial volumes, according to researchers. The altered equipment allowed hands-free filtration of multiple samples simultaneously and offered higher flow rates.

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AstraZeneca throws lifeline to gene-editing biotech LogicBio with $68M buyout

MedCity News

AstraZeneca’s LogicBio acquisition comes at a critical time for the biotech. Though LogicBio has encouraging early clinical data for its lead gene-editing therapeutic candidate, the company’s cash woes include a flagging stock price that is set to lose its listing on the Nasdaq.

Leads 99
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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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Eli Lilly receives marketing authorisation for baricitinib

PharmaTimes

Treatment involves adult patients with severe alopecia areata

Marketing 136
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Fear creates urgency: Big tech’s move into healthcare can lead to a better system for all

MedCity News

To position the healthcare system for long-term success, traditional healthcare providers must tap into new disruptive forces to create navigable, discoverable, accessible, and personalized experiences for patients who now expect a new consumer-centered model of care.

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How to Talk to Medical Sales Recruiters

MedReps

Working with a medical sales recruiter is sometimes the easiest way to find a job in the field. However, before you can accept one of the jobs they’ve found for you, you first need to discuss your schooling, training, goals and more with the recruiter, which can be a bit intimidating. How should you talk to a medical sales recruiter? Is it okay to ask them questions?

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FDA approves Taiho drug for rare bile duct cancer with certain genetic signature

MedCity News

Taiho Oncology’s cancer drug Lytgobi is the third FDA-approved therapy for bile duct cancer driven by FGFR2 genetic alterations. The accelerated approval for Taiho’s drug follows regulatory nods for products from Incyte and QED Therapeutics that address the same genetic signature.

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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.

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To stay on the leading edge of oncology, AbbVie knows it has to take risks

PharmaVoice

In a field that has seen rapid progress but ongoing areas of unmet need, AbbVie is betting on emerging tech.

Leads 105
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Sanofi’s RNA therapies strategy adds new piece with alliance in muscular dystrophy

MedCity News

Sanofi is collaborating with startup miRecule to develop an RNA therapy for facioscapulohumeral muscular dystrophy. The pharmaceutical giant gets global rights to miRecule’s therapy for this type of muscular dystrophy, which has no FDA-approved treatments.

FDA 96
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Mankind Pharma Limited- Openings for Production -Ophthalmic, Sterile Injectable- Apply Now

Pharma Pathway

Mankind Pharma Limited- Openings for Production -Ophthalmic, Sterile Injectable- Apply Now. Job Description. Openings for Production -Ophthalmic, Sterile Injectable @ Mankind Pharma Limited. Department: Production -Ophthalmic, Sterile Injectable. Designation: Officer/ Operator. Qualification : B.Pharma / ITI/ Diploma/ B.Sc. Experience: : 01 to 12 years.

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Sanofi exec jumps to Owkin to ramp up the AI biotech’s pharma partnership plans

MedCity News

Alban de La Sablière, global head of partnering at Sanofi for the past six years, has joined artificial intelligence biotech Owkin as its first chief business officer. In addition to finding more business partnerships, de La Sablière will also oversee expansion of Owkin’s internal drug and diagnostics pipeline.

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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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Missing Revenue in the Global Flip: Getting the Open Access Math Right

Copyright Clearance Center

The post Missing Revenue in the Global Flip: Getting the Open Access Math Right appeared first on Copyright Clearance Center.

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Headspace Health calls for third-party researchers to study company’s impact on mental health

MedCity News

One area in particular Headspace Health is looking for researchers to study is the impact of the company on underserved populations. It is looking for peer-reviewed research proposals from academic institutions, nonprofit organizations, government agencies, healthcare institutions and other researchers. .

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Online? Beware the ‘New Google’ (And Much More)

Copyright Clearance Center

The post Online? Beware the ‘New Google’ (And Much More) appeared first on Copyright Clearance Center.

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Building on the groundwork laid by the No Surprises Act

MedCity News

When Congress passed the No Surprises Act (NSA) in December, 2021, its goal was to […].

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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.