Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. that could arise from that same population.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

Pharmaceutical Technology

JULY 25, 2022

But this also reflects a wider trend within the broader market, which is moving towards complex biological and non-biological products, he adds. Supply chain issues also come into play, meaning that owning proprietary API production is an advantage, he says. Thus, manufacturers stand to gain greater profit margins over a longer period.

Drugs 298

Drugs Manufacturing Production Marketing 298

Camargo

JULY 8, 2021

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The report is a useful read to keep current on a topic of interest at the FDA and in drug development as a whole.

Development 130

Development Bioequivalency Gene Expression Drugs 130

Pharmaceutical Technology

FEBRUARY 23, 2023

EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion. The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules. Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials.

Bioequivalency 130

Bioequivalency Trials Medicine Production 130

Drug Patent Watch

DECEMBER 12, 2024

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.

Licensing 96

Licensing Licensing Branding Drugs 96

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Additionally, the Company sells insulin API products. ” According to IQVIA, the U.S.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

Bioequivalency 52

Bioequivalency Drugs Production Manufacturing 52

FDA Law Blog

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

Production 59

Production Bioequivalency Drugs Containment 59

FDA Law Blog

JULY 24, 2022

In recently published guidance document, titled “ Evaluation of Therapeutic Equivalence ,” FDA explains the evaluation and assignment of TE Codes for therapeutically equivalent products. Evaluation of therapeutic equivalence is product-specific. Evaluation of therapeutic equivalence is product-specific.

Bioequivalency 40

Bioequivalency Production Drugs Packaging 40

The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Ampholipad received scale-up production approval in June 2020, allowing a production capacity of over a million vials a year. SOUTH SAN FRANCISCO, Calif.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. You should not place undue reliance on these statements.

Trials 52

Trials Medicine Production Containment 52

XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78

XTalks

NOVEMBER 6, 2024

To address growing demand, Gelteq is expanding production capacity with a Good Manufacturing Practice (GMP)-certified facility, aiming for scalable, reliable output by 2025. This regulatory strategy leverages bioequivalence studies to expedite approval, positioning Gelteq’s gel as an alternative to traditional oral delivery forms.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

World of DTC Marketing

FEBRUARY 21, 2022

Reportedly, the cost of production for molnupiravir stands at about $17.74. didn’t just offer to pay for the drug’s development cost so that the price could be set very low, but it’s about investors who penalized the company stock when they learned that COVID might be on the decline. costs about $700.

Regulation 218

Regulation Drugs Bioequivalency Vaccination 218

Delveinsight

FEBRUARY 5, 2021

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. The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products.

Marketing 52

Marketing FDA Approval Branding Production 52

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

FDA Law Blog

JANUARY 23, 2023

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Now, FDORA makes these plans mandatory for most drug and device studies.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59

The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. percent).

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

The Pharma Data

SEPTEMBER 26, 2021

Head of Research and Development at Biogen. or visit your respective country’s product website. The CHMP also assessed findings from EVOLVE-MS-2, a large, randomized, double-blind, five-week, multi-center Phase 3 study to guage the gastrointestinal (GI) tolerability of VUMERITY compared to TECFIDERA in patients with RRMS.

Clinical Trials 40

Clinical Trials Clinical Trials Bioequivalency Medicine 40

Worldwide Clinical Trials

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. .” The U.S. 2 It affects an estimated 7.5

Bioequivalency 52

Bioequivalency Vaccination Vaccine Medicine 52

Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

Bioequivalency 81

Bioequivalency Generic Drugs Drugs Branding 81

Drug Patent Watch

DECEMBER 11, 2024

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. ” – Dr.

Generic Drugs 95

Generic Drugs Production Development Bioequivalency 95

The Pharma Data

DECEMBER 27, 2020

The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer. GA Depot is a long-acting injection of the approved Glatiramer Acetate products (Copaxone and its generic formulations). The drug is an autologous IL13Ralpha2-CAR-T cell product.

Trials 52

Trials Antibody Gene Therapy Gene 52

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. What Are Generic Drugs?

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89