MedCity News

JUNE 12, 2023

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities.

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MedCity News

OCTOBER 27, 2022

Earlier this year, the FDA approved the biotech’s first rare disease drug, a treatment for a type of anemia. Agios Pharmaceuticals sold royalties to an approved cancer drug to get immediate cash to support its new focus on rare diseases.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals. Biosimilars are key to making healthcare more affordable and accessible.

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Clarivate

MARCH 8, 2023

Biopharma companies are investing in the use of real world data (RWD) to accelerate innovation. The Professional Society for Health Economics and Outcomes Research (ISPOR) has cited real world evidence (RWE) as the number one trend in healthcare decision making for the second year running [1].

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pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel.

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pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50

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European Pharmaceutical Review

DECEMBER 21, 2022

This US pathway offers early-phase benefits, including greater FDA collaboration. This US pathway is usually leveraged at later stages in drug development and permits sponsors to use surrogate endpoints to get faster FDA approval. Medicines and Healthcare products Regulatory Agency. Breakthrough therapy designation.

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Clarivate

AUGUST 2, 2022

Four major trends came to light from CIRS’ most recent analysis of new active substance (NAS) approvals for the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada, Swissmedic and the Australian Therapeutic Goods Administration (TGA).

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pharmaphorum

JANUARY 6, 2023

Emerging and mid-sized companies launching products in Europe are also navigating a healthcare ecosystem that is complex and fragile due to regulatory and cost pressures. This will enable biopharmas to create a more streamlined drug development process rooted in lean process execution and higher-quality data.”.

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Pharma Marketing Network

MARCH 25, 2022

With an estimated 65 million people serving as caregivers, 1 the role is now a factor in an ever-increasing list of healthcare priorities. If caregiving is positioned as an essential service and caregivers are counted among healthcare’s front-line service providers, 4 does it follow caregivers are a viable healthcare vertical?

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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Medico Reach

AUGUST 1, 2022

Whether you are a start-up looking for investment or are interested in working in venture capital (VC), the worldwide biopharma and MedTech industries are growing. In 2022, over $14 billion was funded in biopharma setup globally, and 37 major IPOs of VC-backed biotech company businesses raised a combined $4.2 New Enterprise Associates.

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Pharmaceutical Technology

JULY 7, 2022

There is a lot of excitement that we could be at the start of a new era for the biopharmaceutical industry, with the hope of delivering revolutionary healthcare for previously unaddressed diseases finally becoming a reality.

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European Pharmaceutical Review

APRIL 30, 2024

What are the top three trends that you are seeing in the biopharma manufacturing space? Let’s talk about continuous biopharma manufacturing. Speaking of your biopharma clients, what are you hearing about their main priorities? I believe this is going to be an emerging trend in the market.

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PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We We are thrilled to welcome Timmy to the Ardelis leadership team.

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Pharmaceutical Representative Training

JANUARY 29, 2025

Biosimilars: The Future of Affordable Biologic Therapies Biologics are some of the most expensive forms of therapy in modern healthcare. Biosimilars are biologic formulations that are very similar to a reference biologic product already approved by the FDA. The Cost-Saving Alternative: What are Biosimilars?

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Clarify Health

MAY 19, 2020

After FDA-approval comes the last critical mile of this journey: bringing the product to market. There is also a looming, time-sensitive reality that biopharma companies face once their products hit the market: they need to recoup the costs of development as quickly as possible before drug patents expire and generics threaten sales.

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PM360

SEPTEMBER 15, 2022

But battling information asymmetry is one of the best ways to address the ongoing inequities in our healthcare system. But to shift the industry’s approach to healthcare, all stakeholders must move the efforts, attention, and education necessary to find a common ground and ensure that the patients’ interests are always driving development.

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PM360

JUNE 24, 2024

This fuels an enormous need for effective patient communication and education as new therapies move through the biopharma pipeline. Those of us in the biopharma industry know how fraught drug development can be. Food & Drug Administration (FDA). It’s better to pay a good one than to receive a letter from the FDA.

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European Pharmaceutical Review

OCTOBER 19, 2023

billion deal, in which Eli Lilly agreed to acquire two of POINT Biopharma Global’s late-stage radioligand therapies for oncological indications. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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pharmaphorum

JANUARY 13, 2023

AZ’s head of biopharma R&D Mene Pangalos said the new device would help support the use of Tezspire to treat “a broad population of severe asthma patients.” AZ said it expects a regulatory decision by the FDA on the pre-filled pen in the first half of 2023. ” It is estimated that there are 2.5

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Clarivate

MAY 24, 2023

A narrow FDA AdComm vote in favor of accelerated approval for Sarepta’s first-in-class gene transfer therapy illustrates challenges faced by regulators, payers and developers as a wave of innovative genetic treatments for rare diseases comes to market.

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Pharmaceutical Technology

DECEMBER 12, 2022

Regulatory decisions by the US FDA and EMA and clinical trial announcements for select therapies from late October to late November, and the CMOs contracted to manufacture them. Allegropharma GmbH & Co KG, AGC Biologics, and Rentschler Biopharma SE are tasked with producing the biological API for the vaccine.

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Legacy MEDSearch

MAY 19, 2023

PaceMate ® announced today its collaboration with AliveCor ® , the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world.

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Clarivate

JULY 5, 2023

The month of July could see seven FDA-approved adalimumab biosimilars launch in the United States, an unprecedented situation for a market that has been relatively slow to embrace biosimilars. By end of year, as many as ten adalimumab biosimilars could be on the U.S. biologics market and reduce prescription drug costs.

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Medgadget

MARCH 2, 2023

The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. This will hopefully lead to an FDA approval for its first indication, after which Alpha TAU plans on expanding to other types of cancer and geographic regions such as Europe and Japan. The rest of the patients had partial responses.

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PM360

OCTOBER 22, 2024

DANNY SIGURDSON CEO and Founder Courier Health To effectively engage patients and prescribers to improve overall adherence to prescribed medication regimens, biopharma companies first need the visibility and full context of where a patient stands in their treatment journey. Support healthcare providers in a real and personal way.

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Clarivate

MARCH 17, 2022

Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Ahead of the meeting, the FDA highlighted nonclinical findings (i.e., We look at the outcome of a recent Food and Drug Administration meeting and their draft guidance for more information.

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Clarivate

NOVEMBER 13, 2023

More recently, the FDA has developed the Patient Focused Drug Development (PFDD) Guidance Series, which provides sponsors with guidance on how to collect and submit patient experience data in medical product development for regulatory decision making. All data were collated in FDA COA Evidence Dossiers. Mainland China and Japan.

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Clarivate

NOVEMBER 8, 2022

RNA therapeutics actually burst onto the scene prior to the COVID-19 pandemic, with the FDA approval of Ionis/Biogen’s SPINRAZA®, for the treatment of spinal muscular atrophy, in 2016. In addition to that drug, Alnylam ® Pharmaceuticals has had four FDA approvals of RNA therapies for rare diseases. Cargene Biopharma Inc.,

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Medgadget

FEBRUARY 17, 2023

Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. This year it is scheduled for May 16-18, 2023 in Tel Aviv, and topics range from medical robotics, to bio-convergence, to the impact of AI on biopharma.

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PM360

JANUARY 24, 2025

In the pharmaceutical sector, this evolved further with privacycompliant data enrichment, enabling hyper-personalized messaging for healthcare providers (HCPs). Compliant: Validated to comply with FDA regulations. By tracking preferences and behaviors, companies tailored interactions to make them more meaningful and effective.

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PM360

DECEMBER 14, 2023

We’re now leveraging our expertise in communicating with healthcare professionals to deliver essential information and practical tools to physicians and other healthcare providers to help them address the challenges faced by patients with chronic illness.”

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Clarivate

JANUARY 8, 2024

FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. The year 2024 is shaping up to be the best of times and the worst of times for the pharma industry,” said Henry Levy, President, Life Sciences & Healthcare at Clarivate. Granted U.S.

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Clarivate

NOVEMBER 10, 2022

The evidence standards that a COA must meet to support key clinical trial endpoints have become increasingly stringent in recent decades, following the introduction of the United States Food and Drug Administration (FDA) Patient Reported Outcomes (PRO) draft guidance in 2006, followed by the full guidance in 2009.

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Clarivate

OCTOBER 30, 2022

The FDA allowed DTx products for psychiatric disorders to be marketed as class II medical devices without FDA clearance during the public health emergency declared for the COVID-19 pandemic, which was recently extended to run through the remainder of 2022. As a result, few products have FDA clearance. What’s next?

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PM360

JULY 13, 2023

The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023. Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC).

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