Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

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Gene Therapy Gene Engineer Production 147

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. head of research and development at Biogen, in a statement from the company.

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XTalks

FEBRUARY 27, 2024

The US Food and Drug Administration (FDA) has approved a number of new rare disease drugs in recent years, including gene therapies. In 2020, 31 out of 53 novel drug approvals were for rare or orphan diseases​​. Both therapies were awarded their approvals on the same day in December 2023.

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Research Drugs Gene Therapy Clinical Trials 59

pharmaphorum

NOVEMBER 19, 2020

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

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FDA Approval Marketing Drugs Clinical Development 63

Intouch Solutions

APRIL 11, 2024

Offering the physician support from a virtual assistant during the differential diagnosis process where they have access to a more extensive knowledge and experience base. This process is relatively straightforward when high-value medical-scientific content is readily available. Generating “data-driven” editorial plans.

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Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

DECEMBER 17, 2020

Her videos cover a host of topics from the science behind the immune system, side effects caused by the shots and vaccine hesitancy and the clinical and regulatory path to approval. Additionally, we will soon introduce a new vaccine tag to detect and tag all videos with words and hashtags related to the COVID-19 vaccine,” says Morgan. “We

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Scientist Vaccination Vaccine Medicine 86

Drug Discovery World

DECEMBER 20, 2022

The therapy was also recently approved by the FDA for patients in the US. . Concerns about the high price tag have been raised in an article in Nature, particularly whether it will be affordable for low to middle-income countries. . World’s most expensive drug. A one-time treatment with etranacogene dezaparvovec costs US$3.5

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Gene Therapy Gene Clinical Trials Clinical Trials 52

Rethinking Clinical Trials

FEBRUARY 2, 2023

After enrollment, there is an IRB-approved document that includes information on the trial, the investigators, and contact information that patients receive. – How did you navigate the IRB process? Many of the sites used a single IRB but some chose to approve the IRB locally. This trial used a mixed approach.

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Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

APRIL 27, 2023

The REB approved the MyTEMP request to use an altered patient consent process because the research was deemed of minimal risk to patients. You need to identify the principles before the process. There is a natural assertion of autonomy. Did some of these questions of autonomy vs. risk come up?

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Trials Clinical Trials Clinical Trials Medicine 130

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Build on the rapid responses to COVID-19. The mindset that accomplished this needs to be retained,” Jeremy says.

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Branding Marketing Pharma Companies Life Science 110

pharmaphorum

MAY 10, 2022

The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA could result in an approval before the end of the year. The post Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go appeared first on.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

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Sales Medicine Drugs Marketing 110

pharmaphorum

NOVEMBER 24, 2021

It was approved by the FDA in 2018 as an add-on to pharmacological treatment with buprenorphine to help opioid users stick with their recovery programme, for example by helping them identify triggers that cause them to relapse. The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on.

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Production Development Trials 58

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval. Among responders, after 18.6

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Joanna Carlish, managing director, financial services, Tag Americas. Virtual connections.

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Regulation Marketing Sales Branding 84

Drug Discovery World

MAY 22, 2023

While the global economic landscape faces a major crisis and biotech is not recession-proof, cell and gene therapy (CGT) has continued to progress with acquisitions, breaking ground on new facilities and approvals across the year – not limited to the breakout of the world’s most expensive drug. But are these price tags a barrier to access?

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Gene Therapy Gene Drugs Contamination 52

pharmaphorum

APRIL 27, 2022

Drugs given the designation are hastened through the development process by the FDA, which can grant them a faster six-month review. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

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Sales Drugs Antibody Licensing 58

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Gene Therapy Approvals. Bluebird bio is a notable mention as it secured FDA approvals for two of its gene therapies, Zynteglo and Skysona.

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Life Science Gene Therapy Gene Clinical Trials 52

XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

NOVEMBER 15, 2020

Cytiva will help Clover add two more 2000L bioreactors for a total of 4 x 2000L manufacturing capacity through the Cytiva FlexFactory, which will provide a total solution including process equipment, services, and consumables to ensure safety, efficiency, scaled-up capacity for vaccine development.

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Vaccination Vaccine Manufacturing Life Science 52

pharmaphorum

DECEMBER 23, 2022

Add to this the considerable cost of these medications – the first approved CAR-T, Novartis’ Kymriah (tisagenlecleucel), had a U.S. price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting.

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Development Drugs Clinical Development Antibody 52

Drug Discovery World

NOVEMBER 13, 2023

On Day 3, Thursday 16 November 2023, the tracks include: the second part of machine learning for protein engineering, antibodies against membrane protein targets, engineering bispecific antibodies, next-generation immunotherapies, protein stability and formulation, and protein process development.

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Protein Antibody Engineer Scientist 59

Intouch Solutions

JULY 27, 2021

” they pointed out that the COVID-19 vaccines, and the controversial approval of aducanumab for the treatment of Alzheimer’s disease, represented polar opposites in terms of drug pricing reform. In the case of the vaccines, the U.S. government lowered risk by supporting trials, guaranteeing contracts, and negotiating a lower price.

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Drugs Marketing Vaccination Vaccine 52

XTalks

AUGUST 23, 2021

AAt this year’s Alzheimer’s Association International Conference ( AAIC ), entire sessions were dedicated to discussions of Biogen’s recently-approved, controversial drug Aduhelm (aducanumab), but their focus wasn’t what you’d expect. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Clinical Trials Clinical Trials Trials Drugs 52

pharmaphorum

JANUARY 31, 2023

With the recent rapid rollout of Covid-19 vaccines, many people have raised questions about whether adequate research was conducted on these vaccines before approval. What people did not understand was that “fast tracking” approval does not limit the rigorous process involved in ensuring that a medication or vaccine is safe for market use.

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Clinical Trials Clinical Trials Trials Vaccination 52

Cloudbyz

JUNE 1, 2023

Configurable Workflow Engine Salesforce Workflow Automation is a robust feature that allows businesses to automate standard internal procedures and business processes. Approval Processes: You can create multi-step approval processes with different levels of approval required for certain actions, like discounts or contract modifications.

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Compliance Development Branding Production 82

Pharmaceutical Technology

JUNE 21, 2023

CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). Hemgenix is the first and only gene therapy approved for haemophilia B. Despite the limited market, the price tags of haemophilia make it potentially lucrative.

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Gene Therapy Gene Sales Protein 246

pharmaphorum

MAY 24, 2021

Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. Modular content, or ‘atomic’ design as it’s sometimes known, is the process of creating modules of content to be assembled in any way the user requires. Robb DeFilippis. ” Robb DeFilippis.

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Marketing Branding Sales Life Science 85

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

pharmaphorum

DECEMBER 2, 2020

They developed a deep tank fermentation process, the principles of which would later be applied to the production of penicillin. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. Pfizer initiated its first major internationalisation at this stage, moving into nine new countries in 1951.

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Sales Production Drugs Marketing 128

pharmaphorum

NOVEMBER 16, 2022

It is no secret that the drug development process for the pharmaceutical industry has undergone a major transition in the last few decades. Previously, the discovery of small molecule treatments had been the priority, with their development and manufacturing process being an established formula. However, with a price tag of €1.58

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Gene Therapy Gene Marketing Development 128

The Pharma Data

MAY 13, 2021

After all, the ingredients we’ve chosen to include in Spade SB-66 are premium ingredients and come with a hefty price tag. And when that process is inhibited… You can begin the process of managing weight on a cellular level. We’ll process your order and get your supply of Spade SB-66 shipped to your front door.

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Packaging Packaging Containment Production 52

Pharmaceutical Technology

JANUARY 27, 2023

In 2019, Cablivi became the first FDA-approved , nanobody-based medicine for acquired thrombotic thrombocytopenic purpura (aTTP), an ultra-orphan condition that causes blood clots in small blood vessels around the body. Furthermore, he said extracting data to validate the criteria for a warranty reimbursement could be an onerous process.

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XTalks

AUGUST 17, 2020

T cell transfer or adoptive/immune cell therapy : these enhance the natural ability of T cells to fight infection, cancer or other disease processes. In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The co-stimulatory IL-2 signal is the same for all of the 100 series molecules (i.e.

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Protein Engineer Immune Response In-Vivo 98

Roots Analysis

SEPTEMBER 13, 2023

Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. These conjugates lead to elucidation of complex biological processes via signal amplification and high biological specificity.

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Development Antibody Protein Drug Delivery Systems 40

The Pharma Data

MAY 4, 2021

up 28%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications, as well as the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. The FDA action converts the 2018 accelerated approval to full approval.

Vaccination 40

Vaccination Vaccine Production Sales 40

pharmaphorum

SEPTEMBER 30, 2022

Over the years, pharmaceutical companies seeking product approvals have submitted increasingly vast amounts of information to regulatory agencies. Regulatory agencies are embracing standardized review processes (such as the FDA’s KASA project) that benefit from direct data collection and incorporate review metrics. Making it happen.

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Compliance Life Science Marketing Production 52