Pharmaceutical Technology

DECEMBER 6, 2022

HPAPIs may now represent more than 30% of the drug development pipeline. Within that figure, GlobalData estimates that around 60% of pipeline HPAPIs are developed to target oncology. In the early stages of drug development, protecting operators from unknown risks is absolutely crucial.

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pharmaphorum

JUNE 30, 2022

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. Patient journey.

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European Pharmaceutical Review

SEPTEMBER 14, 2023

There was a significant slowdown in drug development, clinical trials, and new drugs coming to market. EMA prepares for winter antibiotic shortages That slowdown resulted in 211 drug shortages in 2010—the highest number recorded in a single year at the time. 1 We can only learn from the past and try not to repeat history.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. compared to 38.5% on placebo. Please check your email to download the Report.

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Pharmaceutical Technology

FEBRUARY 8, 2023

The recent town hall, titled “Clinical Development of Gene Therapy Products for Rare Diseases”, was meant to further that dialogue with those in pharmaceutical industry developing new gene therapies for underserved patient groups. GlobalData is the parent company of Pharmaceutical Technology.

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Pharmaceutical Technology

APRIL 26, 2023

In a 2022 Cochrane review , researchers concluded patients who used digital interventions such as mobile phones and smart inhalers had better medication adherence and asthma control, and improved quality of life. Digital inhaler platforms have the potential to allow remote care delivery and informed treatment decision-making.

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Syner-G

MAY 4, 2022

May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager. In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions.

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Pharmaceutical Technology

DECEMBER 9, 2022

Brazilian public spending on healthcare, drug pricing reforms and remote medicine. of the total value of pharmaceutical market sales, with the value of generics sales forecast to grow to $5.7bn in 2022. These treatments may still be in development or already have approval somewhere in the world. </p>

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Pharmaceutical Technology

MAY 3, 2023

In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.” In 2017, FDA announced the Drug Competition Action Plan (DCAP) to allow consumers to get access to medicines.

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Pharmaceutical Technology

APRIL 26, 2023

This investment will be used to further the development of the Singapore-based pharmaceutical company’s solid tumour-focused monoclonal antibodies. The funding and a prize-win from Amgen will support the company’s drug development plans as Singapore continues developing its pharmaceutical market.

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Pharmaceutical Technology

DECEMBER 13, 2022

In 2022, Andrew McVeigh joined Suvoda as Chief Architect after holding technical leadership positions at Hulu, LiveRamp, Amazon, and RiotGames. Prominent SaaS systems were a huge inspiration, McVeigh says, but the technical challenge presented by the drug development world came with different demands.

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PharmaKinnex

APRIL 28, 2022

3 Reasons Why Rare Disease Marketing Strategies Need To Start With Inside Sales April 28, 2022. Over the past few years, rare disease drugs have seen an increase in research and development from the big pharmaceutical companies. The power of inside sales begins here.

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Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. billion in 2022 alone to expand capacity.

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Pharmaceutical Technology

MARCH 15, 2023

According to GlobalData’s Pharma Intelligence Center Deals Database, figure 1 shows the parent holding company SVB Financial Group and its subsidiaries were involved in more than $1.4bn in total venture financing raised from 2010 to 2022 for drug development. Free Report How is the Biopharmaceutical industry evolving?

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Pharmaceutical Technology

NOVEMBER 30, 2022

Over the past few years, there has been a boom in anti-obesity drug development, with major companies achieving substantial sales in the field. According to GlobalData, as of November 28, there were 316 generic and novel drugs marketed to treat obesity. billion in 2022 alone to expand capacity.

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pharmaphorum

APRIL 19, 2022

In 2022, pharma is truly a global industry, and innovation can come from anywhere. RudaCure is a four-year-old biotech company based in the South Korea, focusing on ocular disease and chronic pain with a pair of potentially first-in-class drugs. Now, the company is trying to make contacts beyond South Korea’s borders. Conclusion.

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Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. 1 Tufts Center for the Study of Drug Development (CSDD); Jan/Feb 2022 Impact Report.

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Putting Patients First Blog

JULY 10, 2023

MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. MACC Commissioner United States Food and Drug Administration 5 630 Fishers Lane, Rm. The NHC was a strong supporter of the inclusion of these guidances in the Prescription Drug User Fee Act (PDUFA) VI agreement. Califf M.D., Califf M.D.,

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Putting Patients First Blog

APRIL 7, 2025

14 In addition, sponsors should ensure that the datasets used to develop AI models reflect the intended patient population and disease variations. 15 ,16 Failure to do so risks overlooking meaningful variability and could reinforce historical limitations in drug development. Khair ElZarrad, Aaron Y.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

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Pharmaceutical Technology

MAY 23, 2023

For example, in November 2022, the FDA approved CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec) as the first gene therapy for haemophilia B. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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Putting Patients First Blog

MAY 29, 2024

We believe in the power of high-quality patient engagement that is characterized by sustained, reciprocal communication between patients and decision- makers. The NHC urges CMS to engage collaboratively with MA plans to track the clarity, accuracy, and transparency of marketing materials and communications.

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Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). However, additional initiatives that de-risk the development process are still needed, says Ruiz.

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Pharmaceutical Technology

APRIL 24, 2023

Langer’s engineering lab was instrumental in the development of these lipid nanoparticles, playing into his role in co-founding Moderna. billion in Spikevax sales in 2022, and Comirnaty generating $37 million for Pfizer in 2022. These vaccines have proven to be blockbusters, with Moderna earning $18.4

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Pharmaceutical Technology

JANUARY 26, 2023

“That is a huge step for RoslinCT, because it means that we can take clients from the very beginning of their journey to the very end, with a fully integrated process development and manufacturing service offering,” adds Brownfield. We are all aligned and in frequent communication with each other.

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Putting Patients First Blog

APRIL 14, 2023

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. Rutta Chief Executive Officer 1 “Externally-Led Patient-Focused Drug Development Meetings.” He is reachable via e- mail at egascho@nhcouncil.org. Sincerely, Randall L.

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Putting Patients First Blog

APRIL 30, 2024

This method not only prioritizes the participant’s comprehension but also aligns with best practices in health communication that suggests a focused approach can significantly enhance understanding and retention of important information. The importance of using plain language in health communications is well-documented in literature.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. per 100,000 people were hospitalised for RSV-related reasons in the 2022–23 RSV season. per 100,000.

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Putting Patients First Blog

SEPTEMBER 26, 2024

This includes being aware of historical injustices that may have contributed to mistrust in the medical system and understanding the unique needs and concerns of different communities. Effective communication with diverse populations is essential for ensuring that all individuals can participate in clinical trials. Williams, S.,

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FDA Law Blog: Biosimilars

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. In addition, in 2022, non-new molecular entity (NME) injectables approvals were the highest they have been for the last decade.

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Pharmaceutical Technology

APRIL 27, 2023

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. GlobalData pharmaceutical analysts project that RNA-based gene therapies for oncology will grow from zero in 2022 to $4.6 billion by 2028.

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Pharmaceutical Technology

FEBRUARY 20, 2023

We are delighted to deepen our partnership with Teddy Lab that will enable us to build on existing knowledge and increase services within China to support customers with their global drug development programmes. Teddy Lab has been a trusted partner for many years and mirrors our commitment to high-quality, patient-centric solutions.

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Pharmaceutical Technology

FEBRUARY 20, 2023

On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. This may sound obvious, but it is still a major hurdle in drug development.

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PharmaShots

APRIL 3, 2023

at current exchange rates In Oct 2022, the acquisition was initiated and the transaction is expected to be adjusted per share by $0.07 greater China region & certain other countries already out-licensed by SCYNEXIS to third parties Related Post: PharmaShots' Key Highlights of Fourth Quarter 2022 events/100 patient-yrs.)

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Drug Patent Watch

DECEMBER 11, 2024

In this article, we will delve into the key criteria for selecting a CDMO, highlighting the essential factors to consider and the importance of effective communication and cultural fit. Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. 2022, November 29).

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Drug Patent Watch

JANUARY 6, 2025

The biopharmaceutical industry is witnessing unprecedented growth, with the Contract Development and Manufacturing Organization (CDMO) market expected to reach $289.64 As companies increasingly rely on CDMOs to expedite drug development and manufacturing, aligning these services with business goals becomes crucial for success.

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