Pharma Tutor

JULY 18, 2022

Drug Regulatory Affairs Certificate Institutes in India. Historical Overview of Pharmaceutical Industries and Regulatory Affairs:During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy and thalidomide tragedy have resulted in substantial increase of legislations for drug products quality, safety and efficacy.

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STAT News

MARCH 10, 2023

Enjoy, and see you soon … By law, Medicare will have to take a medication’s efficacy and its research and development costs into account when it starts to negotiate drug prices — but recent research shows pharma companies ignore those factors when they pick prices for their products , STAT explains. Two

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Insulin Pharmacy Pharma Companies Drugs 96

Rethinking Clinical Trials

FEBRUARY 7, 2024

Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. The growing problem of misinformation undermines confidence in science and public health institutions, and the misuse of products can cause harm and confusion.             Speaker Susan C.

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pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

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STAT News

OCTOBER 6, 2022

Meanwhile, here is the latest menu of tidbits to help you on your own journey, which we hope is pleasant and productive.  Even a drug-price watchdog, the Institute for Clinical and Economic Review, deemed the $2.8 And yes, this is made available by the same folks who operate the distillery. Please feel free to join us.

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Rethinking Clinical Trials

JUNE 29, 2022

Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements. ? ? ? ? ? ? ? ? ?. Speaker. Key Points.

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Pharmaceutical Technology

JULY 14, 2022

The commercial investment required to research and develop an innovative drug, prove its safety and efficacy, and bring it to market is staggering. Most famously, the US passed its Orphan Drug Act in 1983, providing innovators with financial motivation to develop orphan drugs and meet the needs of these forgotten patients.

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pharmaphorum

OCTOBER 3, 2022

The third ALS treatment to be given FDA approval, following Mitsubishi Tanabe’s Radicava ($170,000 per year) and generic drug riluzole – Relyvrio is priced at around $12,500 per 28-day prescription. Currently, the ALS drug is priced about five times higher than the top of a value-based range. ALS affects over 30,000 people in the US.

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XTalks

NOVEMBER 3, 2022

Eli Lilly is finding itself in an enviable position with its newly launched diabetes injection Mounjaro (tirzepatide) and blockbuster diabetes med Trulicity due to temporary shortages of competitor Novo Nordisk’s diabetes drug Ozempic (semaglutide). Lilly is also looking to pitch Mounjaro as an obesity drug and directly take on Novo’s Wegovy.

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World of DTC Marketing

JUNE 23, 2021

Source: Fierce Pharma If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. government.

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pharmaphorum

AUGUST 21, 2022

In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD. The post Axsome bounces back as FDA clears depression drug appeared first on.

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pharmaphorum

NOVEMBER 27, 2022

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Automation can be such a solution. Reducing capacity issues. Cutting down on safety stock.

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World of DTC Marketing

JUNE 16, 2021

This includes about one in five who report that they have not filled a prescription or took an over-the counter drug instead, and about one in ten who say they have cut pills in half or skipped a dose. The public sees profits made by pharmaceutical companies as the largest factor contributing to the price of prescription drugs.

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Pharmaceutical Technology

FEBRUARY 22, 2023

The legal dispute is centered around rival cholesterol-lowering drugs produced by the two companies, which were approved in the summer of 2015. Both drugs are monoclonal antibodies that inhibit the protein PCSK9. Both drugs come with a high price tag. But in this case, Amgen has a fully finished product, he adds.

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pharmaphorum

APRIL 26, 2021

The initiative was supported by grants from UCB and Pfizer and provided health information in the form of immersive experiences aimed at patients prescribed biologic drugs to treat the disease. The company halted development before it eventually sold its digital health unit back to Eric Careel, co-founder of Withings, the following year.

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pharmaphorum

NOVEMBER 19, 2021

The cost-effectiveness agency had turned down Evrysdi (risdiplam) in draft guidance published in June, saying it was too expensive, but after negotiations with Roche has reached a deal that will make the drug available to around 1,500 people in England. million price tag make it is the most expensive treatment ever approved for NHS funding.

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Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . World’s most expensive drug. million, making it the world’s most expensive drug. . A one-time treatment with etranacogene dezaparvovec costs US$3.5

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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. With blood cancers, you inject the product, and the cells are there, and the target is there.

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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. billion by 2028.

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XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. Obenshain said the company will book revenue when the final product is infused, and that the product manufacturing could take 70 to 105 days. million after discounts.

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XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Zynteglo’s hefty price tag of $2.8

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Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. The drug was approved to treat type 2 diabetes mellitus in May. The drug was approved to treat type 2 diabetes mellitus in May. million in Q3.

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Pharmaceutical Technology

MARCH 17, 2023

These agreements have been particularly propelled by the recent rise in inflationary pressures and pharmaceutical market instability, pushing healthcare systems to find new ways to reduce risks associated with new drugs. Thus, a higher risk score reflects a more hostile market access environment and drug launch in a geographical area.

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Drug Discovery World

JULY 25, 2023

DDW recently hosted Where are the breakthroughs in mRNA drug discovery and development? In this webinar, sponsored by Elegen, attendees learnt about the breakthroughs in mRNA drug discovery and development. We have shown that the excipient does not only work for our SNAP-tag lipid (SNaP) LNP, but also for the commercialised vaccines.

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XTalks

MAY 2, 2024

The day concluded with insights from the US Food and Drug Administration’s (FDA) Peter Koufopoulos and a panel on innovative training techniques led by Gwynne Sitsker of Embassy Ingredients and Lennie Ouimette of Kawartha Dairy. The panel emphasized the importance of staff training in maintaining high safety standards. .

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Pharmaceutical Technology

NOVEMBER 30, 2022

In what’s being called a “medical bypass”, new anti-obesity drugs are almost matching efficacy rates in weight loss that have previously only been seen with weight loss surgeries. The drug was approved to treat type 2 diabetes mellitus in May. The drug was approved to treat type 2 diabetes mellitus in May. million in Q3.

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Pharmaceutical Technology

JANUARY 27, 2023

On January 18, Sanofi launched a new warranty program for its rare blood disorder drug Cablivi (caplacizumab), which tackles value-based agreements in a slightly different way. Cablivi stops platelets from clumping together, which prevents small clots, and can be used along with other drugs that suppress the immune system.

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Drug Discovery World

OCTOBER 31, 2023

The UK Medicines and Healthcare Products Regulatory Agency (MHRA), Research Ethics Committee (REC), and Health Research Authority (HRA) have all approved the clinical trial application that was submitted by The University of Manchester in August 2022.

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pharmaphorum

NOVEMBER 19, 2020

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

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The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. About Dynavax.

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pharmaphorum

JANUARY 11, 2021

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. million price tag. Meanwhile the as-yet unnamed oncology company will spin off under the leadership of bluebird’s current chief executive Nick Leschly.

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pharmaphorum

FEBRUARY 26, 2021

Both these factors can be tied in part to J&J’s strong presence in the consumer sector – but behind household name products is a strong pharmaceutical backbone that has emerged over the company’s long and varied history. It was incorporated as a separate company in 1949 so as to expand and diversify the J&J product line.

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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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XTalks

APRIL 29, 2022

Eli Lilly announced that its obesity drug tirzepatide has scored favorably in a late-stage clinical trial, with results showing that people who took the drug lost an average of 50 pounds, or 21 percent, of their body weight compared to placebo. percent and 22.5 percent, respectively, compared to placebo.

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Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. During the COVID-19 pandemic, several regulatory authorities around the world introduced guidance on DCTs.

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pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). While this is not cheap by anybody’s reckoning, Roche hopes that the less intimidating price tag, plus the patient-friendly oral administration method will give it a competitive edge.

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Drug Discovery World

JANUARY 30, 2024

One option is that manufacturers will need to provide a product guarantee or refund the cost in a pay-for-performance model. According to Matthew Hewitt, PhD,  VP, Technical Officer Cell & Gene Therapy & Biologics , Charles River, the FDA may approve 10 or more CGT products in 2024 following eight US approvals in 2023.

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