Express Pharma

JUNE 5, 2023

Jakafi’s landmark approval in 2011 galvanised intensive drug development efforts by providing a strong positive investment signal for this market, as Jakafi is a blockbuster agent.

Drug Development 97

Drug Development Biosimilars Compounding 97

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. 2011; 36(11):740-57. Trust and risk are interdependent.

Drug Development 98

Drug Development Drug Pricing Communication 98

pharmaphorum

JANUARY 18, 2022

According to Rock Health’s annual digital health funding report, US-based digital health companies enabling life sciences research and development raised $5.8 This is the first time R&D has topped the chart since Rock Health began tracking US digital health funding in 2011, although it nabbed the number two slot in 2018 and 2020.

Drug Development 91

Drug Development 91

pharmaphorum

APRIL 27, 2021

Writing in the New England Journal of Medicine (NEJM) last week, Pazdur and Julia Beaver said that only a small percentage of drugs fail to have their initial benefit confirmed, arguing this should be viewed “not as a failure of accelerated approval but rather as an expected trade-off in expediting drug development that benefits patients with (..)

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Additional concerns for the caregiver include a strain on physical and mental health. 5 While the CDC gathers information on these topics for public health planning, there are immediate needs that pharma can address. . February 2019.

Labelling 98

Labelling Drug Development 98

pharmaphorum

APRIL 26, 2022

Ben Hargreaves speaks to companies that are developing therapies not just in gastrointestinal conditions but also in broader areas, such an immuno-oncology. PubMed cites 1,822 pieces of research relating to the microbiome in 2011, which grew to 25,153 published in 2021.

Immunity 115

Immunity Immunization Diabetes Drug Development 115

European Pharmaceutical Review

JULY 4, 2024

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 13 Currently, over 350 herbal remedies have been granted a THR licence.

Drug Development 103

Drug Development Documentation Labelling Compounding 103

pharmaphorum

OCTOBER 9, 2022

UK-based PureTech – which develops its own therapies and also has interests in a wide range of companies including digital health players Akili and Sonde as well as drug developers Vedanta, Gelesis and Follica – said it has “exchanged indicative, non-binding proposals” with Nektar that have no guarantee of leading to a deal.

Drug Development 59

Drug Development 59

pharmaphorum

FEBRUARY 9, 2021

Researchers can use the information to help better target drug development and to support clinical trials. Since 2011, the company has been designing solutions that accelerate rare disease research and create lasting inter-sector partnerships across the globe. A Decade of Experience.

Compounding 98

Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Development 98

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense software is developed specifically for analysis of data from wearable sensors”, explains Tabakin. “The

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Drug Development Packaging 111

pharmaphorum

JUNE 23, 2021

Savolitinib was discovered by HutchMed (formerly Hutchison China Meditech) and has been partnered by AZ since 2011. Fosun Kite has beaten rival JW Therapeutics – a JV between Bristol-Myers Squibb’s Juno Therapeutics unit and Chinese drug developer WuXi Apptec – to claim the first Chinese CAR-T approval.

Chemotherapy 52

Chemotherapy Drug Development 52

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Documentation 59

Documentation Labelling Drug Development 59

European Pharmaceutical Review

MARCH 8, 2023

After moving to London in 2011, Ekaterina worked in global health and medical philanthropy, focusing on improving outcomes in maternal and child health. At COMPASS, I currently oversee the development of innovative therapies which includes drug development, and innovations more broadly to support drug delivery, such as digital innovation.

Hospitals 52

Hospitals Drug Development 52

pharmaphorum

OCTOBER 12, 2022

“We founded Whitelab Genomics after realising the potential to use data, data science, and AI in a more systematic way to develop genomic therapies,” Del Bourgo says. In 2019, Del Bourgo and co-founder Julien Cottineau launched Whitelab Genomics and its AI platform dedicated to supporting the discovery and design of genomic therapies. “We

Drug Development 105

Drug Development Immunity Immunization Vaccines 105

PharmaTech

JUNE 23, 2025

USP, Guidance for Implementation and Exceptions: The Monograph Naming Policy for Salt Drugs Substances in Drug Products and Compounded Preparations in General Chapter Nomenclature (September 2019). USP, USP General Chapter , “Nomenclature,” USP35–NF30 (Rockville, MD, 2011). FDA, USP Salt Policy (December 2014).

Compounding 52

Compounding Dosage Labelling Drug Development 52

European Pharmaceutical Review

JANUARY 29, 2024

17 Accelerating drug development The first issue of 2023 , 18 dealt with accelerating drug development. Risk assessment for nitrosated pharmaceuticals: A future perspective in drug development. Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility.

Drug Development 111

Drug Development Vaccines Compounding 111

pharmaphorum

SEPTEMBER 16, 2022

Well, Kim believes that “by leveraging the power of genetics and functional genomics, coupled with a ‘human-first’ mindset, innovative analytics, and scalable compute power” there is “the ability to take a fundamentally different approach to drug development”. It also bodes well for improving clinical trial success rates.

Immunity 135

Immunity Immunization Drug Development 135

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.

Medical Records 59

Medical Records Drug Development 59

European Pharmaceutical Review

FEBRUARY 1, 2024

What are the top three trends impacting the cardiovascular drug development space today? His research background encompasses pharmaceutical and nutritional clinical trials including extensive research on statins, novel lipid-lowering drugs, and omega-3 fatty acids.

Documentation 97

Documentation Pharmaceutical Companies Diabetes Pharmaceutical Companies 97

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).

Vaccines 116

Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 116

European Pharmaceutical Review

DECEMBER 14, 2023

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 EMA/95098/2010.

Medical Records 116

Medical Records Vaccines Hospitals Drug Development 116

STAT

DECEMBER 2, 2024

The phrase “value-based care” began circulating during company earnings calls and presentations, and at banking conferences, in the second quarter of 2011, a year after former President Obama signed the Affordable Care Act into law, according to financial search engine and database AlphaSense.

Drug Development 354

Drug Development Hospitals 354