Pharmaceutical Technology

MAY 16, 2023

during Q1 2023 largely due to the advancement of a pair of Phase III trials, Oceanic-AF and Oceanic-Stroke, for their blood-thinning drug, Asundexian. Although Sanofi may face generic drug competition this year for its multiple sclerosis drug, Aubagio, the company is expected to maintain their sales of Dupixent, accounting for 43.3%

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FDA Law Blog

JANUARY 22, 2024

OC had a major hand in drafting some key guidances this year, including the recent draft guidance on Post-Warning Letter Meetings Under GDUFA , a potentially important enforcement guide for generic drug makers that we blogged on back in September. Clinical Trials.

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Compliance Clinical Trials Clinical Trials Regulation 59

Camargo

NOVEMBER 11, 2020

The speed of the submission in January 2020 and approval in October 2020 was attributed to the retrospective testing of available tumor tissue samples from patients enrolled in three clinical trials that led to the accelerated approval of larotrectinib.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The company now plans to move this approach into a Phase III trial. According to PharmatTher’s November 14 press release, all 10 patients in the Phase I/II trial reported a reduction in dyskinesias after receiving ketamine. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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pharmaphorum

OCTOBER 12, 2021

A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients with Alzheimer’s disease.

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Gene Expression Drugs FDA Approval Gene 111

pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry.

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Drugs Generic Drugs FDA Approval Trials 52

Camargo

MAY 10, 2021

The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. Drug Product. The meeting was prompted by a publication by Richard Pazdur, M.D., Indication. 7 Yes, 2 No.

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pharmaphorum

DECEMBER 1, 2021

Sanofi said it would also apply its mRNA vaccine platform – acquired along with Translate Bio earlier this year – to find other acne vaccine candidates that could start clinical trials in 2023. Origimm’s expertise in the skin microbiome and antigen discovery will be central to that effort, it added.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Camargo

OCTOBER 14, 2021

Continued development of the use of complex innovative trial designs. If you are developing a generic drug, Camargo has extensive experience with ANDA strategies and FDA interactions and can assist you with your development program. Improved predictability in Human Factors and User-Related Risk reviews.

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Pharmaceutical Technology

NOVEMBER 21, 2022

A lower number of clinical trials and regulatory filings were other important influences behind the decision. In terms of the influence caused by negative changes in international investment in Japan, the pharmaceutical companies that decided to lower their business priority in Japan reported lower pharmaceutical sales.

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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pharmaphorum

OCTOBER 28, 2021

There were also numerically fewer deaths with the antidepressant – 17 out of 741 treated with fluvoxamine and 25 out of 756 allocated to placebo – in the TOGETHER trial, which has now been published in The Lancet. The results back up earlier, smaller studies that also found a benefit with the selective serotonin reuptake inhibitor (SSRI).

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Generic Drugs Sales Licensing Licensing 97

Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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pharmaphorum

MARCH 16, 2022

They said at the time that the trial court decision prevented a commercial launch, but added they were “committed to bringing a generic Symbicort to market as soon as possible.”

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FDA Approval Generic Drugs Marketing Drug Delivery 59

XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030. Related: Cyltezo Becomes First FDA-Approved Interchangeable Humira Biosimilar.

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pharmaphorum

AUGUST 28, 2020

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

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Dermatology Drugs Hormones FDA Approval 52

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. It is not known if lenalidomide capsules are safe and effective in children.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

MAY 7, 2021

Amid virtual trial craze, Science 37 earns unicorn status and a trip to Nasdaq on the back of SPAC deal ( Endpoints ). Another failed trial for Orphazyme’s ‘pipeline-in-a-product’ leaves shadow on drug’s future ( Endpoints ). Generic Drug Cos. .

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Vaccination Vaccine Drugs Regulation 52

Druggist

SEPTEMBER 30, 2020

Ongoing treatment of irritable bowel syndrome Drug treatment can be considered on a trial basis alongside dietary and lifestyle adjustments , such as eating regular, healthy and well-balanced meals. Symptoms of diarrhoea and constipation can be managed with different drugs which are not reviewed in this post. 73rd edn.

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The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

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FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

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Generic Drugs Production Drugs Branding 52

FDA Law Blog

AUGUST 16, 2021

While generic drugs as we know them are a creation of the 1984 Hatch-Waxman Amendments, the Federal Register Notice explains that FDA first introduced the concept of an ANDA in 1968 to facilitate approval of Drug Efficacy Study Implementation (DESI) drugs.

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Production Drugs Generic Drugs Cosmetics 52

pharmaphorum

JUNE 8, 2021

While all of the top ten best-selling oncology drugs in the US in 2019 were innovative therapies, four out of the top ten best-selling oncology drugs in China were for conventional chemotherapy. “In In addition, the pharmaceutical industry in China is still heavily dependent on generic drugs.”.

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Cloudbyz

MARCH 5, 2024

Monitoring and managing immunogenicity is a complex aspect of clinical trials for biologics. Additionally, the complexity of biologics makes them harder to replicate, which means that biosimilars (the biologic equivalent of generic drugs) are less of a competitive threat in the immediate aftermath of patent expiration.

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Pharmaceutical Technology

JULY 10, 2008

The industry sits at a pivotal point in its evolution and analysts say it can no longer rest on its laurels happy to produce generic drugs while expending vast sums on marketing at the expense of R&D.

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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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FDA Law Blog

APRIL 26, 2021

To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. In February 2017, FTC had the opportunity to test out the Actavis framework.

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FDA Law Blog

JULY 21, 2022

In the July 2021 Executive Order on Promoting Competition in the American Economy , the White House noted that patent laws “have been misused to inhibit or delay—for years or even decades—competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

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Generic Drugs Production Drugs Marketing 98

World of DTC Marketing

JANUARY 31, 2021

So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). I have been recruited by these companies who promise huge payouts when they are acquired if their drug shows promise in clinical trials. In pharma R&D returns have declined to 1.8

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XTalks

JUNE 16, 2023

XTALKS WEBINAR: Fostering Patient-Centricity: Clinical Supply Chain Strategies and Sourcing Solutions Live and On-Demand: Thursday, July 20, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to review clinical trial trends and supply strategies that impact the patient experience.

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The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com.

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Druggist

OCTOBER 13, 2020

One important message to take away is that Truvada and equivalent generic drugs are not 100% effective. The effectiveness of Truvada for PrEP has been subject to different clinical trials. The ‘official’ NICE guidelines on the use of Truvada for PrEP looked at four clinical trials.

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Generic Drugs Pharmacy Branding Doctors 98

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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FDA Approval Drugs Sales Development 101

XTalks

SEPTEMBER 20, 2023

Cost Plus Drugs Initiative by Mark Cuban The Mark Cuban Cost Plus Drug Company is a public-benefit corporation launched by billionaire entrepreneur Mark Cuban with a mission to improve public health by revolutionizing pharmaceutical industry operations.

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