Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Development and Approval : Small Molecules: The pathway for development and regulatory approval is well-established, with clear guidelines for demonstrating safety and efficacy.

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Development Drugs Manufacturing Immune Response 81

World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.

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Generic Drugs Manufacturing Production Drugs 187

Pharmaceutical Technology

MAY 31, 2023

Sym-021 is under clinical development by Les Laboratoires Servier and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. It is developed based on sympress platform technology.

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Generic Drugs Hormones Manufacturing Development 100

The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

FDA Approval 52

FDA Approval Generic Drugs Production Drugs 52

Pharmaceutical Technology

JULY 15, 2022

Nothing epitomises market failures more than the cost of insulin,” Newsom said in a video posted on Twitter. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

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Insulin Manufacturing Contract Manufacturing Production 328

Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

Marketing 52

Marketing FDA Approval Branding Production 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

The rising incidence of long-standing diseases such as hypertension, diabetes, cardiovascular diseases, and cancer requires prolonged medication and, thus, drives the growth and need for retail pharmacies in the market. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs.

Pharmacy 147

Pharmacy Generic Drugs Containment Production 147

FDA Law Blog

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

World of DTC Marketing

DECEMBER 18, 2020

SUMMARY: The “goodwill” that many believe was gained from the development of a Covid-19 may be more of a wish than a reality. Pharma companies are still too focused on profits while people continue to rely on prescription drugs to compensate for unhealthy lifestyles. were dispensed using generic drugs.

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Generic Drugs Drugs Pharma Companies Vaccination 155

Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

Regulation 162

Regulation Clinical Trials Clinical Trials Medicine 162

pharmaphorum

SEPTEMBER 9, 2022

Digital health specialist Kry has teamed up with pharma group Novo Nordisk on the development of resources that can help people with obesity manage their condition and adhere to treatment. It is estimated that more than half (53%) of the adults living in the EU are considered to be overweight or obese. . billion in 2025.

Generic Drugs 114

Generic Drugs Sales Marketing Drugs 114

pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”.

Marketing 106

Marketing Drugs Regulation Development 106

Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow.

Production 52

Production Bioequivalency In-Vivo In-Vitro 52

Delveinsight

SEPTEMBER 15, 2021

Similarly, the rise in various government and non-government initiatives to curb the occurrence of cancer diseases and the availability of cancer therapies has also contributed immensely to market growth. Delveinsight’s Oncology Based Reports provides the latest developments in the Oncology segment.

Marketing 52

Marketing Generic Drugs Development Drugs 52

pharmaphorum

MARCH 16, 2022

Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch plans remain uncertain for now. Generics of Symbicort are already available in some non-US markets, including in Europe.

FDA Approval 59

FDA Approval Generic Drugs Marketing Drug Delivery 59

Drug Discovery World

APRIL 10, 2023

Thanks to a new focus on R&D, increasing digitalisation and government investment, India is establishing itself as a significant player in drug discovery, and the Hyderabad life sciences hub has played a significant role in this. India’s domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 2.

Genome 52

Genome Genomics Drugs Life Science 52

FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A, Section I.C

Drugs 59

Drugs Manufacturing Generic Drugs Production 59

Pharmaceutical Technology

OCTOBER 5, 2008

In addition, one very notable deal with India hints that Asia’s emerging market is also having a growing influence on what is happening in Japan. ’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi.

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Generic Drugs Marketing Branding Drugs 130

FDA Law Blog

MAY 26, 2022

As we noted in a previous post , FDA’s first (of fourteen) legislative proposal targets 180-day generic drug exclusivity, stating: Amend the 180-Day Exclusivity Provisions to Encourage Timely Marketing of First Generics. and it’s perhaps even worse than we thought! and maybe that’s the point!). II) Definitions.-In

Generic Drugs 52

Generic Drugs Marketing Drugs Containment 52

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

Generic Drugs 40

Generic Drugs Drugs Branding Production 40

pharmaphorum

FEBRUARY 2, 2022

Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. Leniolisib is next in line to tap into Pharming’s rare disease infrastructure, and if approved it could have the market to itself.

Trials 52

Trials Drugs Sales Generic Drugs 52

Drug Channels

NOVEMBER 15, 2022

The rise of discount card pricing within pharmacy benefit plans is a positive development. Patients get access to market prices that can be lower than their PBM’s contracted rate. Links below. All out-of-pocket spending with a discount card counts toward a patient's deductibles, and all prescription activity gets captured.

Pharmacy 97

Pharmacy Drugs Marketing Generic Drugs 97

Pharmaceutical Technology

NOVEMBER 29, 2022

On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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Research Trials Drugs Generic Drugs 275

pharmaphorum

JULY 28, 2022

Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

Compliance 111

Compliance Drugs Manufacturing Generic Drugs 111

Drug Channels

MARCH 27, 2023

The rise of discount card pricing within pharmacy benefit plans is a positive development. Patients get access to market prices that can be lower than their PBM’s contracted rate. Links below. All out-of-pocket spending with a discount card counts toward a patient's deductibles, and all prescription activity gets captured.

Pharmacy 92

Pharmacy Drugs Marketing Generic Drugs 92

FDA Law Blog

MARCH 13, 2024

After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. That was the case in the PTO’s April 3, 1995 decision denying a PTE as to U.S. Lehman , No.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

The Pharma Data

DECEMBER 28, 2020

Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product. ” According to IQVIA, the U.S. Company Information. Company Information.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

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. billion in 2021 to a high of $44.7 percent.

Generic Pharmaceutical 69

Generic Pharmaceutical Branding Production Medicine 69

Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. Prescription Market (press release) We’re offering special discounted pricing if you order before March 28, 2022.

Pharmacy 96

Pharmacy Drugs Marketing Licensing 96

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.

Dermatology 52

Dermatology Drugs Hormones FDA Approval 52

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 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.

Production 78

Production Insulin Branding Generic Drugs 78

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Drugs Manufacturing Generic Drugs Production 45

FDA Law Blog

JUNE 28, 2023

This legislation, named the Innovative Feed Enhancement and Economic Development Act (Innovative FEED Act) , is an effort to create an approval process for ingredients with environmental or food safety claims as food additives rather than as animal drugs. 1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023.

Regulation 45

Regulation Drugs Production Generic Drugs 45

pharmaphorum

SEPTEMBER 9, 2022

With its heavy reliance on natural resources for product development and production, and complex supply chains with large carbon footprints, the pharmaceutical industry has been highlighted as one of the biggest contributors to global emissions,” said the authors of a whitepaper from climate intelligence specialists, Cervest. Vulnerability

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Production Pharma Companies Generic Drugs Contamination 105

The Pharma Data

JANUARY 17, 2021

The Company is on the cusp of transformational change as product development programs advance from the laboratory to the clinic. In addition to COVID-19 products, XPhyto and its partner 3a, are developing and commercializing a portfolio of low-cost oral biosensors. Diagnostics.

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Production Drug Delivery Development Drugs 40