European Pharmaceutical Review

APRIL 21, 2025

The ultimate goal of QbD is to manage high quality of product during lifecycle management of the drug. In this regard, CDMOs can support various drug developers through QbD. Available from: [link] Guidance for Industry – Q8(R2) Pharmaceutical Development. Internet] Samsung Biologics. Internet] FDA.

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pharmaphorum

MARCH 29, 2021

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? At the end of the day, medicines are developed for patients, so understanding what they want and what they need remains absolutely crucial,” says Dr Catchpole.

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pharmaphorum

NOVEMBER 6, 2020

At the same time, the industry is looking to develop digital medicines that improve patient outcomes. Shah has been at Lilly since 1994, joining the company as a senior statistician, rising to become vice president for biometrics in 2009.

Drug Development 56

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pharmaphorum

JULY 2, 2025

The ability to streamline clinical trials, personalise treatments, and accelerate drug development is groundbreaking. A recent report found that 64% of pharmaceutical executives are hesitant to integrate AI into drug development due to concerns over security. The opportunity ahead is enormous.

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pharmaphorum

JUNE 17, 2025

Its precision medicine approach – directed mainly at cancer – is being deployed in the development of tools for detection, diagnosis, monitoring, therapy selection, and drug development, driven by genomic data, clinical data, digitised medical images, and tissue samples. pharmaphorum – an EVERSANA company

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European Pharmaceutical Review

SEPTEMBER 20, 2023

Although this evolution has led to life-changing medications, it also calls on drug development and manufacturing experts to identify new, more efficient ways to deliver high‑quality products. Pharmaceutical development is driven by quality by design (QbD) – an approach recommended by regulatory agencies.

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Drug Development 98

pharmaphorum

JUNE 10, 2025

Image Phil Taylor 10 June, 2025 customer engagement Bookmark this R&D Transforming drug development with statistical methodologies The product development lifecycle is long and challenging. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved.

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pharmaphorum

JUNE 24, 2025

All this recent excitement has confirmed that RWE will continue to play a pivotal role in drug development, yet questions still remain for the experts responsible for its application. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved.

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pharmaphorum

JUNE 17, 2025

If completed, it will be Lillys third major acquisition in 2025, coming after it agreed to buy cancer drug developer Scorpion Therapeutics for up to $2.5 Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company

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Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality.

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Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

pharmaphorum

OCTOBER 11, 2022

Instead, he shifted to consulting and, after a period of time, the launch of pharmaphorum in 2009. “[My] If you look at companies like Amazon and Google, the big tech companies, whenever they’ve gone into drug development on that side, they’ve found it incredibly hard. It’s very risky; it’s very hard to do.

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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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European Pharmaceutical Review

DECEMBER 22, 2022

4 One of the first activities to fall onto the critical path, and potentially cause substantial drug development delays, is clone selection. Rapid development of clonal cell lines is required to facilitate material manufacture for non-clinical toxicological studies, and master cell bank (MCB) creation to enable clinical manufacture.

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pharmaphorum

JUNE 30, 2025

Can you give a brief overview of why the historical development of new treatments for neurodevelopmental disorders has faced significant challenges? With the right teams and experience in place, drug developers can unlock their full potential, streamline efforts to advance them quickly, and bring more, new options to patients.

Diabetes 52

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pharmaphorum

MARCH 30, 2021

“There’s a lot that drug development for more common diseases could learn from rare disease R&D”. I think there’s a lot that drug development for more common diseases could learn from rare disease R&D.”. We have to be innovative to get around those challenges. Rare diseases during COVID. About the author.

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PharmaShots

FEBRUARY 21, 2023

Market Cap: $8.57M Founded Year: 2009 Total Employees: ~40 Headquarters: Oslo, Norway Stock Exchange: OSE Nordic Nanovector is a biotech company committed to developing and commercializing antibody-radionuclide conjugates to address significant unmet medical needs.

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Pharmaceutical Technology

FEBRUARY 1, 2023

During the 2009–19 period, children in the US ages five years and younger accounted for 58, 000 annual RSV-related hospitalisations and 100–500 annual deaths. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind. GlobalData is the parent company of Pharmaceutical Technology.

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pharmaphorum

SEPTEMBER 18, 2020

However, it withdrew its neuropharmacological drug, Zelmid, which was an SSRI, due to concerns over side effects only a year after it was introduced in 1982. In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide).

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Pharmaceutical Technology

MARCH 22, 2023

Several drug development trends are driving injectables demand. This includes the rising number of biologic drugs on the market, which are mostly administered parenterally. FirstLine was developed with a zero-defect philosophy,” explains Santambrogio. This was higher than the number of approvals in 2019 and 2020.

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PharmaTech

JUNE 24, 2025

The LNP-encapsulated small interfering RNA (siRNA) was approved by FDA for the treatment of hereditary transthyretin amyloidosis (ATTR), and this opened the door for mRNA-based drugs in many applications.

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PharmaShots

FEBRUARY 20, 2023

According to a survey, a majority from a cohort of pharmaceutical leaders expressed that the drug development plans, which ideally takes years of research, when asked to prepare in haste, may cause serious implications on the health of the population.

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pharmaphorum

FEBRUARY 16, 2021

Slaoui rose through the ranks at the big UK pharma and was appointed head of the company’s vaccines division in 2009, leaving in 2017 when Emma Walmsley took over as CEO at GSK. The post Mega biotech Centessa beams up ex-Warp Speed science chief Slaoui appeared first on.

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Pharmaceutical Technology

AUGUST 26, 2008

In December 2006 it acquired MacroMed Inc, a privately owned speciality drug development and manufacturing company based in the US, for its lead product OncoGel™ for the treatment of oesophageal and brain cancers. The blood pressure results are expected in the first half of 2009.

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