European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 2,10 This data can help to inform the optimal drug candidates to take forward into clinical trials and inform pre-clinical research to iteratively develop medications for different clinical indications.

Compounding 98

Compounding Drug Development Clinical Pharmacology Documentation 98

pharmaphorum

SEPTEMBER 30, 2022

million to the development and study of Relyvrio, using money raised through the 2014 Ice Bucket Challenge. The drug was also filed for approval in Europe in February, with a decision due in early 2023. . — The ALS Association (@alsassociation) September 29, 2022. The organisation contributed $2.2 Bad news for Biohaven.

Specialty Pharmacies 98

Specialty Pharmacies Labelling Hospitals Drug Development 98

Safe Biologics

NOVEMBER 12, 2023

Consider how these perverse incentives could prevent the development of the next Keytruda, the Merck miracle drug perhaps best known for helping former President Jimmy Carter beat cancer. First approved in 2014 to treat one condition, melanoma, Merck now lists 19 separate conditions it can treat — a massive boon for desperate patients.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

pharmaphorum

JANUARY 9, 2023

It also has potential in NDD, although it was discontinued as a treatment of fragile X syndrome in 2014 after disappointing phase 2b trial results.

Compounding 59

Compounding Drug Development 59

pharmaphorum

JULY 28, 2021

The collaboration with Google sister company Calico – formed in 2014 with $1.5 The drug targets a regulator of the integrated stress response pathway, thought to be a valid target for drug develop in not only ALS but also Parkinson’s disease and traumatic brain injury.

Immunity 59

Immunity Immunization Drug Development 59

Pharmaceutical Technology

MAY 30, 2023

In Italy, Abiogen began distributing its bisphosphonates in 2014 and has since seen some successful drug approvals. The biotech transferred the rights for alendronate to Merck which marketed the drug under the brand name Vancapsi.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Hospitals Drug Development 52

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014. The Role of Master Protocols in Pediatric Drug Development. Ther Innov Regul Sci.

Compounding 59

Compounding Labelling Drug Development 59

pharmaphorum

NOVEMBER 22, 2022

Francis, who is currently CEO of gene therapy specialist Purespring Therapeutics and cardiovascular drug developer company Forcefield Therapeutics, is due to take the top job at Teva on 1 January, and will serve as the pharma company’s president. Richard Francis.

Drug Development 59

Drug Development 59

Syner-G

MAY 4, 2022

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. Category: Regulatory Affairs , Drug Development Consulting.

Documentation 52

Documentation Drug Development Communication 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

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.

Drug Development 98

Drug Development 98

Syner-G

SEPTEMBER 18, 2023

About Yumanity Therapeutics, headquartered in Boston, was established in December 2014 as an independent biotechnology company focused on drug development targeting neurological diseases where protein misfolding is a key concept, such as Alzheimer’s, Parkinson’s disease, and Lou Gehrig’s disease (amyotrophic lateral sclerosis).

Drug Development 45

Drug Development 45

Pharmaceutical Technology

JUNE 12, 2023

Leqembi is the second drug developed by Biogen and Eisai for the treatment of Alzheimer’s disease. The two companies previously developed aducanumab, an Alzheimer’s drug marketed as Aduhelm which attracted significant controversy over its accelerated approval in June 2021.

Medical Schools 52

Medical Schools Labelling Drug Development 52

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

JULY 5, 2022

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development. About the author.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

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. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

pharmaphorum

OCTOBER 20, 2021

The benefit of such devices for brain treatment is the ability to integrate small microfluidic channels next to the electrodes to dispense medicine directly where it is needed most in the body – avoiding systemic effects that typically occur with drugs taken orally or through intravenous injection.

Drug Development 97

Drug Development 97

pharmaphorum

JUNE 8, 2021

All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. He has been reporting on the pharma industry since 2014 and has worked at a number of leading publications in the UK. About the author. He can be contacted on LinkedIn.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

European Pharmaceutical Review

FEBRUARY 7, 2023

Regulation of clinical trials Eight years following its adoption in 2014, the Clinical Trials Regulation 536/2014 (CTR) entered into application on 31 January 2022. Some of the current and anticipated proposals will not be adopted in 2023, or even before the end of tenure of the current European Commission in late 2024.

Packaging 117

Packaging Drug Development 117

FDA Law Blog: Biosimilars

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Documentation 59

Documentation Vaccines Drug Development 59

European Pharmaceutical Review

DECEMBER 21, 2022

He is currently group leader of the Technology Development and Discovery Group at the Bioprocess Laboratory of the ETH. His research activities led to the foundation of five startup companies active in disciplines ranging from drug development to industrial biotech within the past 15 years. Chem Commun 2014, 50, 9650‒9652.

Compounding 97

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

SEPTEMBER 9, 2021

Janssen currently has more than 150 partnerships in play , with a view to developing and delivering new products that can advance scientific research and provide value to patients, physicians, and healthcare systems around the world. The post Preparing for a post-pandemic world appeared first on.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

pharmaphorum

MAY 18, 2021

Hale has noticed that pre-commercial companies tend to start launch planning a little too late in their drug development process. Ideally, companies should begin engaging KOLs around 24 months before the planned launch, during phase 2 of the drug’s development. About the author.

Drug Development 52

Drug Development 52

PharmaShots

FEBRUARY 21, 2023

The company is developing PPMX-T002, an anti-cancer drug with an antibody targeting CDH3 connected with a radioisotope yttrium 90 (90Y). Perseus has been discussing the collaborative development of PPMX-T002 with various RI medical drug-developing companies, including PeptiDream and its subsidiary PDRAdhiopharma.

Dosage 56

Dosage Labelling Immunity Immunization 56

PharmaShots

APRIL 10, 2023

Moreover, the ceaseless trials of pharmaceutical companies in the research of drugs for several disease conditions have transformed the course of therapeutics. The fine insulin powder is inhaled and goes to the lungs, which further infuses into the blood through tiny blood vessels. It works for T1DM and T2DM.

Diabetes 40

Diabetes Biosimilars Pharmaceutical Companies Pharmaceutical Companies 40

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. Patient and public perspectives on cell and gene therapies: a systematic review. Nature Communications, 11(6265). link] 3 Cummings, J., and Kumar, P. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 4 , 330-343.

Communication 40

Communication Documentation Drug Development 40

PharmaShots

JANUARY 31, 2023

Shots: Immutable capital demands and high-spending drug development plans are the most common drivers in encouraging fully-fledged private healthcare companies to go public. Founded Year: 2014 No. PepGen pulled in $122.9M in gross proceeds in its IPO selling shares at $12/share. Funding Value: $142.3M of Shares: 9.4M

Vaccines 40

Vaccines Immunity Immunization Diabetes 40

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. Anti-obesity therapeutic landscape.

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

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. Anti-obesity therapeutic landscape.

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Big Molecule Watch

MARCH 12, 2025

With 10 years of litigation since the first BPCIA complaint on NEUPOGEN (filgrastim) was filed in 2014, trends are becoming apparent that should cause all biopharma companies to reassess how they protect biologics and plan for biosimilar launch.

Biosimilars 52

Biosimilars Drug Development 52

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Drug Development 64

Drug Development Communication Labelling 64

European Pharmaceutical Review

FEBRUARY 28, 2025

For documents published in 2014 this number was just six; in 2024 it was 157 ( Figure 2 ). 2014-2024 (Credit: Elsevier BV – Scopus) Figure 2 : Documents by year. 2014-2024 (Credit: Elsevier BV – Scopus) Regionally, the US is dominating rare disease research. 1 Figure 1 : Documents by year.

Documentation 88

Documentation Drug Development 88

FDA Law Blog: Biosimilars

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

Drug Development 105

Drug Development Documentation 105