STAT

DECEMBER 21, 2023

Congress in late 2022 passed a law requiring companies to give FDA their plans for diversifying clinical trials. If everything proceeds on time, drug and medical device makers will be required to submit plans for meeting diversity standards by the end of March 2025. Continue to STAT+ to read the full story…

Drug Development 308

Drug Development 308

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Drug Development 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Small companies will need to either defer development or find a partner willing to fund the confirmatory Phase III programme. 5 Psychedelic research: evaluating the fast-evolving regulatory roadmap Experience of accelerated drug development The other impediment to accelerated development is an increased focus on “long-term patient outcomes”.

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Drug Development 97

STAT

OCTOBER 10, 2024

Between 2020 and 2022, 1,155 of the 1,962 experts who reviewed studies for The BMJ, JAMA, The Lancet, and The New England Journal of Medicine received some form of payment.

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Drug Development 349

STAT

MARCH 12, 2024

An earlier study had shown that patients who took the drug for six months experienced significantly less decline than people on the placebo in physical function, such as the ability to speak, use utensils, or climb stairs. Read the rest…

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Drug Development 322

European Pharmaceutical Review

DECEMBER 13, 2022

DRUG DEVELOPMENT. The post <em>European Pharmaceutical Review </em> Issue 6 2022 appeared first on European Pharmaceutical Review. Giana Carli Lorenzini, Technical University of Denmark. REGULATORY INSIGHT. Interchangeability of biosimilars in the EU – the industry impact. UPSTREAM BIOPROCESSING.

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Packaging Biosimilars Drug Development 98

pharmaphorum

OCTOBER 28, 2022

During Reuters Pharma 2022, in Nice, France, pharmaphorum web editor Nicole Raleigh briefly spoke to Within3’s CEO Lance Hill, following his talk, “Medical affairs takes over: technologies to help unlock the power of insights and gain strategic ground”.

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Drug Development 98

STAT

MARCH 8, 2024

” The question now is whether Relyvrio, approved in 2022, should be removed from the market entirely — and whether the Food and Drug Administration made a mistake by authorizing it in the first place.

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Drug Development 357

STAT

SEPTEMBER 30, 2024

billion combined last year , compared with $4 billion in 2022. million in 2022. For 2023, we input data for 313 health care CEOs and found they made $3.5 The average chief executive brought home $11 million, while the median was $4.1 Those figures compared to an average of $13 million and median of $4.3 What’s happening?

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Packaging Drug Development Hospitals 230

PhRMA

MAY 8, 2023

To help advance the development of pediatric medicines, Congress, in a bipartisan fashion, passed provisions ultimately permanently reauthorization in two laws: the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). The BPCA has been successful in advancing pediatric research. 

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Drug Development 104

European Pharmaceutical Review

JUNE 24, 2022

2022 is probably the biggest year in EU pharmaceutical law that I have seen in 30 years. 2022 is undeniably a critical year for change in the pharmaceutical industry: for the first time in several decades, the European Union (EU)’s pharmaceutical legislation is up for review. Key areas of potential legislative change. Future outlook.

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Compounding Drug Development Drug Pricing Dosage 105

Safe Biologics

DECEMBER 8, 2022

ASBM Presents at Festival of Biologics 2022 Europe From November 2nd-4th, ASBM representatives participated in the Festival of Biologics 2022 Europe, held in Basel, Switzerland. Read more about the 2022 GRx+Biosims Conference here.

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Biosimilars Communication Drug Development 100

STAT

JUNE 17, 2024

The vote means the board will decide in a follow-up meeting whether to pursue an upper payment limit for the drug, which an affordability review found cost an average of roughly $47,000 per patient in 2022. Some drug makers are halting or reshaping research into rare disease drugs over concerns they may not recoup their costs.

Drug Development 257

Drug Development 257

STAT

MARCH 4, 2024

Akero Therapeutics said Monday that extending treatment with its experimental drug for the liver disease known as MASH from six months to two years resulted in better outcomes for patients — most notably reductions in liver scarring at a rate three times higher than placebo without worsening other symptoms.

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Drug Development 301

STAT

FEBRUARY 14, 2023

… The biotech industry is in shake-out mode after the ranks of public drug developers swelled in recent years amid an IPO boom , Bloomberg News tells us. A The total number of publicly traded biotechs contracted in 2022 after years of expansion, according to Wedbush Securities analysts.

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Drug Development 238

STAT

MARCH 6, 2023

In opposing a fix to the 2022 Inflation Reduction Act, a leading voice in the effort to move the U.S. biopharmaceutical system toward European-style price controls cited “complicated details” in his reasoning for changing the law, adding that “getting it straight is critically important.” Read the rest…

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Drug Development 241

pharmaphorum

NOVEMBER 7, 2022

Saturated with the latest advances in validating non-invasive biomarkers, exploring combination therapy, and novel strategies to leverage GLP-1 receptor agonists, the 6th Obesity & NASH Drug Development Summit (previously the NASH Summit) is dedicated to reuniting industry leaders in person to share cross-industry insight.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Alzheimer’s disease is considered a type of dementia. Please check your email to download the Report.

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Drug Development Communication Immunity Immunization 105

Express Pharma

JULY 14, 2023

billion in 2022 to $12.8 They agreed that an important unmet need in the management of AF will be the development of safer and more effective rhythm-control drugs that directly interdict the primary underlying drivers of AF progression, such as atrial remodeling—an area of drug development that remains largely untouched.” *8MM:

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Compounding Drug Development 98

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Alzheimer’s disease is considered a type of dementia. Please check your email to download the Report.

Drug Development 98

Drug Development Communication Immunity Immunization 98

STAT

MARCH 29, 2023

In fiscal year 2022, 41% of trial results were submitted to the federal database ClinicalTrials.gov, compared with 34% in the previous year and just 29% in fiscal year 2020. In fact, the vast majority of results — 96%, on average — were eventually submitted to the database.

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Drug Development 240

pharmaphorum

DECEMBER 14, 2022

Drug development consultancy Boyds has tapped Dr Patrick Ginty as senior director of regulatory affairs. The post Changing Faces: agency, consultant, and investor hires from November 2022 appeared first on. Boyds hires cell and gene therapy expert. She previously worked at Johnson & Johnson.

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Drug Development 98

STAT

OCTOBER 17, 2023

Meanwhile, people with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population , STAT reports.

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Drug Development 224

Express Pharma

APRIL 8, 2025

The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing. based Bionique Testing Laboratories (2021), and biologics CDMO Bionova Scientific (2022).

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Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Drug Development 76

pharmaphorum

MARCH 21, 2022

Neuroscience is arguably the next great frontier in medicine and 2022 dawned with a wave of exhilarating progress for the neurodegenerative drug development community. The post Welcome to 1st Rare & Genetic Neurodegenerative Drug Development Summit appeared first on.

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Drug Development 52

pharmaphorum

OCTOBER 27, 2021

areas for 2022 include: Understanding the Pre- Clinical & Clinical Developments of Microbiome-based Therapeutics – INCLUDING a Range of Disease-Specific Case Studies. The post 6th Microbiome Movement – Drug Development Summit Europe appeared first on.

Drug Development 52

Drug Development 52

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. ” Scientific Research Publishing , 2024. ” U.S.

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Drug Development Communication 52

pharmaphorum

NOVEMBER 11, 2022

Pick the brains of 140+ senior level drug developers across industry and academia at the physical return of the only meeting dedicated to overcoming challenges in biomarker understanding, disease selection and clinical translation in inflammasome-centered drug development.

Medical Schools 52

Medical Schools Immunity Immunization Hospitals 52

pharmaphorum

JANUARY 28, 2022

Turbocharge the Development of Best-In-Class Treg-Directed Therapies, Maximising Stability and Function to Deliver Safe, Scalable and Efficacious Therapies Globally. As Biopharma turn their focus to autoimmune drug development, there has been an explosion of interest and investment into Treg directed therapies.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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Drug Development 59

European Pharmaceutical Review

DECEMBER 21, 2022

But in early 2022, the country’s health minister announced his approval of research into psychedelic therapies and increased funding for mental health research. 3 This notice came on the heels of a January 2022 notice that clarified Health Canada’s desired approach to psilocybin research. Fast track designation. Accelerated approval.

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Compounding Drug Development Controlled Substances 119

PharmaShots

JUNE 14, 2023

In the year 2022, Roche ranked the top among the Diagnostic Companies with a total revenue of $19.17B followed by GE Healthcare and Siemens Healthineers with $17.72B and $17.64B PharmaShots brings an informative report on the Top 20 Diagnostic Companies Based on the Total Revenue generated in the year 2022 Diagnostic Revenue: $674.7M

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Hospitals Documentation Drug Development 56

pharmaphorum

JULY 8, 2022

PharmStars , the pharma-focused accelerator for digital health startups, is pleased to announce that it is now accepting applications for its Fall 2022 cohort with the theme, “Innovations in Real-World Evidence.”. The benefits of using RWE in drug development and in the post-marketing space are starting to be realized.

Drug Development 52

Drug Development 52

European Pharmaceutical Review

MAY 23, 2023

2022 statistics by the Swiss federal government confirm that the trend to base here is continuing. Emerging biotech companies responsible for a record 65 percent of the molecules in the R&D pipeline in 2022” made common infrastructure choices to prepare for a European launch, stated Isma Hachi, Director Emerging Biopharma for IQVIA.

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Drug Development 124

STAT

FEBRUARY 27, 2024

 Reforming how pharmacy benefit managers operate has been a top lobbying priority for the pharmaceutical industry since Democrats passed a major package aimed at lowering the costs of medicines in 2022. Drug makers and pharmacy benefit managers have fought a very public battle on the airwaves.

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Packaging Drug Development 220

pharmaphorum

MAY 4, 2022

September 19 – 20, 2022 | San Francisco, CA, USA. The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. Smart device developers.

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Packaging Drug Development 52

Express Pharma

JANUARY 17, 2025

Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.

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Dosage Pharmaceutical Manufacturing Packaging Drug Development 104