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.

Drug Development 59

Drug Development 59

pharmaphorum

AUGUST 8, 2022

GBT won FDA approval for Oxbryta (voxelotor) as a daily tablet for the treatment of SCD in patients aged 12 and over in 2019, extending its use to include younger children aged four and over last December, and earlier this year also got a green light from regulators in Europe for the over 12s. billion takeover bid for Biohaven.

Drug Development 52

Drug Development Vaccines 52

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing 52

Pharmaceutical Business Review

JANUARY 10, 2024

“Our dedicated research and development efforts, supported by our Drug Studio AI platform, have focused on enhancing target selectivity and tissue targeting to minimize off-target effects, enabling the development of innovative and safer drugs.” It has two drug candidates in pipeline to provide pain relief.

Drug Development 95

Drug Development 95

European Pharmaceutical Review

JANUARY 9, 2024

Accelerated drug discovery: Simulations and predictive models powered by AI will speed up the drug development process, effectively slashing time to market for drugs. Internet] US Food and Drug Administration (FDA). 2019; 380(14):1347-1358. 2019; 16(9):1297-1299. cited 2023Dec]. N Engl J Med.

Pharmaceutical Manufacturing 122

Pharmaceutical Manufacturing Drug Development 122

Pharma Mirror

JANUARY 24, 2023

Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development. billion by 2026, up from $186 billion in 2019 according to the Evaluate Pharma report.

Diabetes 52

Diabetes Drug Development 52

European Pharmaceutical Review

JANUARY 2, 2024

Pharma pushes for UK medicine scheme revision Drug pricing was considered as the most negative emerging regulatory and macroeconomic trend, impeding growth for the industry, based on GlobalData’s 2019, 2020, 2021, and 2022 industry outlooks.

Drug Pricing 78

Drug Pricing Drug Development 78

Pharmaceutical Technology

NOVEMBER 2, 2022

According to the GlobalData’s Drug Database, the number of innovator small molecule approvals for rare diseases rose steadily over three years, from three approved in 2019 to 12 last year.

Drug Development 59

Drug Development 59

pharmaphorum

JULY 21, 2021

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market.

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Data Entry Drug Development Compounding 105

Pharmaceutical Technology

MAY 12, 2023

We’re excited to partner with SFJ, recognised leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.” The US FDA granted breakthrough therapy designation to bentracimab in 2019.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Drug Development 52

pharmaphorum

APRIL 19, 2021

With her patient engagement leadership and focus on incorporating patient voice throughout the drug development journey, I look forward to working with her.”. Peter Agathangelou, executive director of strategy and innovation at Prime Global, said, “I’m thrilled to welcome Emma!

Communication 59

Communication Drug Development 59

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 40

Drug Development 40

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 40

Drug Development 40

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. February 2019. There is a diminishing number of people available for caregiving and 1 in 6 adults expects to become a caregiver within 2 years.

Labelling 98

Labelling Drug Development 98

European Pharmaceutical Review

NOVEMBER 1, 2023

He is an experienced biotech and technology industry executive with international experience in drug development, data science, sales and marketing, and business management. Bacterial vaccines in clinical and preclinical development 2021 [Internet]. 2019 Jan; 7(1): e58-e67. 2019 Oct 16;7(4):151. The Lancet.

Vaccines 97

Vaccines Immunity Immunization Drug Development 97

Pharmacy Is Right For Me

MAY 1, 2023

So, whether it’s research and drug development, consulting, analytics, government service, or economics, pharmacists are using their skills in a multitude of ways. Pharmacists have the opportunity to specialize in fields like pediatrics, cardiology, oncology, geriatrics, and psychiatry. They each perform many different functions.

Community Pharmacies 130

Community Pharmacies Hospitals Vaccines Drug Development 130

pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

Immunity 97

Immunity Immunization Drug Development 97

pharmaphorum

JANUARY 3, 2023

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019. ” The new data could accelerate partnering efforts of the drug this year.

Labelling 105

Labelling Drug Development 105

pharmaphorum

SEPTEMBER 20, 2022

The two companies have been talking to each other since 2017 and formally working together since 2019, when Pfizer started using CytoReason’s biological models in research aimed at developing new drugs for immune-mediated diseases and cancer immunotherapies.

Drug Development 52

Drug Development Immunity Immunization Pharmaceutical Companies 52

pharmaphorum

JANUARY 20, 2021

GlaxoSmithKline’s big gamble on a cancer drug developed by Germany’s Merck KGaA looks unlikely to pay out, after bintrafusp alfa failed to outperform US-based Merck & Co’s Keytruda in a lung cancer trial. billion for the cancer immunotherapy in early 2019. billion for the cancer immunotherapy in early 2019.

Drug Development 52

Drug Development 52

pharmaphorum

JUNE 9, 2022

In order to reduce the global healthcare impact of the evolving AMR situation, companies such as Micreos Pharmaceuticals are taking a novel and highly innovative approach to antibacterial drug development by developing targeted antimicrobial products. Centers for Disease Control and Prevention 2019. Blood 2019 Vol.

Drug Development 93

Drug Development Diabetes Chemotherapy 93

pharmaphorum

FEBRUARY 3, 2021

billion in 2019. BIA points to a sharp dip in the number of new biotechs formed in 2020 – just eight compared to 30 in 2019 and 47 in 2018 – suggesting that the pandemic had a dramatic impact on entrepreneurship. billion ($3.8 billion) from a level of £1.3 Fewer companies founded. Not all the data points are positive.

Vaccines 110

Vaccines Drug Development 110

FDA Law Blog: Biosimilars

JUNE 11, 2023

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”). Tobolowsky & David B.

Labelling 40

Labelling Drug Development 40

pharmaphorum

JUNE 24, 2021

Lucentis has been approved by the FDA since 2006 for wet AMD and is a big earner for both Roche and Novartis, who share rights to the product with Roche selling the drug in the US and Novartis selling it in Europe and other markets. It launched in October 2019 in the US with sales predictions of $2.5

Diabetes 74

Diabetes Biosimilars Drug Development 74

European Pharmaceutical Review

DECEMBER 21, 2022

What sponsors should know about psychedelic drug development. Although some psychedelics have a long history in traditional medicine, regulatory agencies must evaluate psychedelic compounds the same way they assess any other drug. Fast track designation. Accelerated approval. Psychedelic research: progress through collaboration.

Compounding 107

Compounding Controlled Substances Drug Development 107

pharmaphorum

NOVEMBER 4, 2022

“Lykke brings more than 20 years of pharmaceutical experience, ranging from early-stage drug development to post-approval lifecycle management,” said Boehringer in a statement. Shahidi, meanwhile, rose through the ranks during a 16-year career at Boehringer to become CMO in 2019.

Drug Development 59

Drug Development 59

European Pharmaceutical Review

FEBRUARY 22, 2023

Parenteral delivery of oligonucleotide drugs All marketed oligonucleotide products are delivered as sterile preparations for parenteral delivery. The authors highlighted that there is a clear regulatory expectation that TS is the preferred method for sterilising parenteral products.

Communication 83

Communication Drug Development 83

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.”. That same report noted that the number of companies in the AI drug discovery space increased tenfold between 2015 and 2021.

Compounding 87

Compounding Drug Development 87

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

Immunity 99

Immunity Immunization Drug Development Vaccines 99

pharmaphorum

FEBRUARY 1, 2021

Development of aducanumab has been far from straight forward. It was among the last of a batch of drugs developed by pharma companies over the last decade or so that target the amyloid plaques that are found in the brains of people with Alzheimer’s.

Drug Development 77

Drug Development 77

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

pharmaphorum

JANUARY 6, 2021

Two years after starting to work together, Novo Nordisk and Dicerna have selected the first candidate from a joint project to find new, gene-silencing drugs for liver-related cardiometabolic diseases. Danish drugmaker Novo Nordisk signed a deal with the US biotech in 2019 valued at up to $675.5

Diabetes 60

Diabetes Drug Development 60

pharmaphorum

NOVEMBER 24, 2022

In 2021, LifeArc held a workshop (PDF) to explore the opportunities and challenges of repurposing drugs, developing a toolkit with the Medical Research Council (MRC). In 2019, the charity received a windfall of nearly $1.3

Hospitals 59

Hospitals Compounding Drug Development 59

Pharmaceutical Technology

JANUARY 23, 2023

Mirikizumab has lost significant ground in the anti-IL23 drug class to AbbVie’s Skyrizi, and to a lesser extent Janssen’s Tremfya. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively. Ther Innov Regul Sci.

Compounding 59

Compounding Labelling Drug Development 59

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.”. of the oncology market in China in 2019, compared to 17.1% Mei says that oncology is one of the key region-specific unmet medical needs Antengene is hoping to address with innovative drugs.

Chemotherapy 105

Chemotherapy Pharmaceutical Companies Pharmaceutical Companies Immunity 105

pharmaphorum

SEPTEMBER 21, 2022

In 2019, ZS Associates carried out a global survey of pharmaceutical companies to get a better idea of patient centricity perceptions and behaviours. Now, pipelines are changing, competition is increasing, and the return on investment of research and development is continuing to decline,” she says. And that is driving change.”.

Drug Development 97

Drug Development Pharmaceutical Companies Pharmaceutical Companies 97

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