pharmaphorum

MARCH 24, 2022

GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. Greg Verdine – LifeMine.

Compounding 105

Compounding Immunity Immunization Drug Development 105

European Pharmaceutical Review

JULY 7, 2022

Dr Eric Hughes joins Teva with experience in all phases of drug development at global pharmaceutical companies, most recently Boston-based Vertex Pharmaceuticals, which he joined last year. He will be based out of Teva’s US headquarters in Parsippany, New Jersey. . Dr Hughes earned his MD and PhD at Yale School of Medicine.

Research Laboratories 98

Research Laboratories Pharmaceutical Companies Pharmaceutical Companies Hospitals 98

European Pharmaceutical Review

JANUARY 24, 2023

At Parexel, Sandra held roles in Phase I project management and business development, before being promoted to a senior portfolio director in 2015. The company supports global drug development in primarily conducting Phase II and Phase III clinical trials.

Drug Development 98

Drug Development 98

pharmaphorum

AUGUST 17, 2022

Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.”. A recent report from GlobalData predicted that pharma spending on AI drug discovery would hit $3 billion in 2025.

Compounding 97

Compounding Drug Development 97

pharmaphorum

JANUARY 9, 2023

is to acquire the 2015-established Amryt Pharma Plc. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50

Drug Development 98

Drug Development 98

Safe Biologics

NOVEMBER 12, 2023

This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. Read more about the approval here.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

pharmaphorum

SEPTEMBER 29, 2020

As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drug development to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.

Drug Development 132

Drug Development Chemotherapy Pharmaceutical Companies Pharmaceutical Companies 132

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Additional concerns for the caregiver include a strain on physical and mental health.

Labelling 98

Labelling Drug Development 98

Pharmaceutical Technology

NOVEMBER 2, 2022

In 2015, China reformed its regulatory system, which introduced review designations, including fast-track programmes to increase drug development for unmet medical needs such as rare diseases and serious conditions.

Drug Development 59

Drug Development 59

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. 2015; 7(5): 881-90.

Drug Development 98

Drug Development 98

pharmaphorum

OCTOBER 29, 2020

Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA). Note the light service has been incorporated into the standard service. Light was previously aimed at small and medium sized enterprises. Great job!”.

Documentation 101

Documentation Drug Development 101

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 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.”. New cancer cases in China increased from 4 million in 2015 to 4.4 million in 2019, and are estimated to increase to 5.7 million in 2030. of the global oncology market in the same year.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

Express Pharma

SEPTEMBER 6, 2023

In a bid to resolve both physical and financial restrictions inhibiting equitable access to quality medicines, the Jan Aushadhi scheme was launched in 2008 and envisaged the setting up of dedicated Janaushadhi Kendras to provide quality generic medicines at capped prices for the general public.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

Generic Medicine 98

Generic Medicine Drug Development Communication Diabetes 98

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. Green Chem 2015, 17, 123‒145.

Compounding 97

Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

FEBRUARY 3, 2021

billion, with London’s AIM seeing the highest levels of investment (£515 million) since 2015. The third was diagnostics company Verici Dx’s listing on the AIM which raised £14.5 million to support its next-generation sequencing platform to guide kidney transplants.

Vaccines 111

Vaccines Drug Development 111

European Pharmaceutical Review

MARCH 11, 2024

In fact, a study published in 2023 in The Lancet HIV revealed that women and men with HIV at age 40 had an average of 39 and 37 years of life left, respectively – only a few years less than that of the general population – if they started antiretroviral therapy (ART) after 2015. World Health Organization. The Global Health Observatory.

Immunity 98

Immunity Immunization Clinical Pharmacology Drug Development 98

pharmaphorum

JUNE 14, 2022

A representation of the country’s rapidly developing capability can be seen in the example of WuXi Biologics, which is a contract development and manufacturing organisation, that was created in 2015 and is now in the top five companies in terms of manufacturing capacity for biologics.

Vaccines 98

Vaccines Drug Development 98

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. 2015; 35(3):1437-45. Anticancer Res.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

European Pharmaceutical Review

OCTOBER 19, 2022

FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs. Biopharmaceutical Research & Development: The Process Behind New Medicines. Why 90% of clinical drug development fails and how to improve it? link] [Cited 25 September 2022].

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

European Pharmaceutical Review

MAY 29, 2023

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drug development. Yet in 2021, 100 nanomedicines had been marketed.

Process Improvement 95

Process Improvement Packaging Vaccines Drug Development 95

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

European Pharmaceutical Review

MAY 11, 2023

Sitra joined Avexis in 2019 as Head of Clinical Development for SMA. In 2015, she joined Astellas Pharma, Northbrook, IL, and served as Global Lead for Immunology, CNS and Neuromuscular Indications and eventually as Global Medical Lead for the Muscle TA.

Drug Development 95

Drug Development 95

pharmaphorum

SEPTEMBER 27, 2021

An analysis of FDA data into trials of cancer drugs approved since 2015 found that 24 out of 31 cancer drug trials had fewer than 5% black trial participants – and this is despite black women being disproportionately affected. The same goes for filling quotas versus purposeful hiring. About the author.

Vaccines 122

Vaccines Communication Drug Development 122

pharmaphorum

APRIL 11, 2022

Delivering value for patients doesn’t start and end in our R&D labs; actions can be implemented across all stages of the drug development lifecycle to encourage and embrace a pro-innovation environment. Prior to joining Janssen in 2015, she held positions in UK, EMEA regional and global medical affairs at Pfizer and Astellas.

Pharmaceutical Companies 115

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 115

European Pharmaceutical Review

APRIL 10, 2024

Prior to joining the company in 2015, Emilie was a PhD student, where she studied the relationship between the gut microbiota and the immune system in mice models of sterile inflammation (contact hypersensitivity, type 2 diabetes).

Immunity 95

Immunity Immunization Chemotherapy Diabetes 95

European Pharmaceutical Review

DECEMBER 19, 2022

A 2015 epidemiology study looking at 10 prevalent NMDs found most occurred in one to 10 per 100,000 people in the population. So I think fundamentally the most important reason why neuromuscular disease is an important area for development is that there is a need,” commented Ferguson. Simply put, it is difficult. About the author.

Drug Development 103

Drug Development 103

Express Pharma

JULY 10, 2024

She also suggests, “India can foster collaboration between the IT and the biopharma companies through government or private initiated collaborative channels – these can help facilitate discussions around latest technological advancements available that could help in overcoming challenges in biopharma drug development and advancement.”

Vaccines 96

Vaccines Drug Development Process Improvement Biosimilars 96

European Pharmaceutical Review

FEBRUARY 14, 2024

He is an inventor of six patents and serves as a Visiting Lecturer at Manchester University on Product Development. He has 30 years knowledge of drug development and manufacturing for small molecules and biologicals. 2015; 69(1):381–403 5. Ryan Wilson is Head of Microbiome Services at SGS Quay Pharma. 2021; 19:100306 4.

Dosage 97

Dosage Packaging Labelling Compounding 97

pharmaphorum

SEPTEMBER 9, 2021

In his 2015 TED talk, Bill Gates surmised that a highly infectious virus, rather than a war, was our greatest risk of global catastrophe. COVID-19 hit us hard. Harder, probably, than most of us would have imagined. And there were warnings. The World Health Organization had stated our vulnerability to a viral threat.

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

Pharmaceutical Technology

SEPTEMBER 26, 2022

These highlight the parent company’s focus on innovative and high-value drug development. Innovative drug development can be costly and risky due to clinical trial attrition of unproven drugs, but can provide a high return on investment when successful. The company had revenues of $9.6bn both in 2020 and last year.

Biosimilars 64

Biosimilars Drug Development Vaccines Dosage 64

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

Pharmaceutical Technology

JULY 23, 2008

.” Supply and revenue Cancer drugs can plug revenue gaps created by loss of patents in other areas, as Pfizer hopes to do when competition for its cholesterol fighter Lipitor opens up in two years’ time. “Companies shelve research on a regular basis,” she says.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Compounding Biosimilars 40

Pharmacy Is Right For Me

AUGUST 10, 2022

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! Prior to my current role, I served as Scientific Director for Janssen Research and Development, leading two large Phase III trials and several Phase I studies.

Vaccines 130

Vaccines Pharmaceutical Companies Pharmaceutical Companies Drug Development 130

Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. The economic contribution of university/nonprofit inventions in the United States: 1996-2015. Patient and public perspectives on cell and gene therapies: a systematic review. Nature Communications, 11(6265). link] 3 Cummings, J., and Kumar, P.

Communication 40

Communication Documentation Drug Development 40

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