World of DTC Marketing

FEBRUARY 21, 2022

A new study estimates the causal effects of coupons for branded drugs without bioequivalent generics using variation in coupon introductions over time and comparing differential responses across enrollees in commercial and Medicare Advantage plans. At this point, one must wonder why the U.S. About those copay cards.

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Regulation Drugs Bioequivalency Vaccine 218

Drug Patent Watch

JANUARY 22, 2025

The Unseen Journey of Generic Drugs: A Look into the Regulatory Pathway Have you ever wondered how generic drugs make it to the market? Once approved, the patent holder enjoys a period of exclusivity, during which generic manufacturers cannot enter the market. But what happens when the patent expires?

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Generic Drugs Bioequivalency Drugs FDA Approval 40

Drug Patent Watch

JANUARY 14, 2025

Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. As consumers, we can look forward to more accessible and affordable medications.

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Generic Drugs Development Drugs Manufacturing 87

FDA Law Blog

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

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Drug Delivery Drugs Bioequivalency Production 105

Camargo

DECEMBER 13, 2021

A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Development Production Immune Response Licensing 161

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.

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Bioequivalency Drugs Production Manufacturing 52

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. billion, three biosimilar products in development targeting products with a market size of approximately $13.0

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Bioequivalency Production Sales Marketing 52

Pharmacy Checkers

FEBRUARY 14, 2020

Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market.

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Branding FDA Approval Pharmacy Bioequivalency 62

FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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Manufacturing Compliance Drugs Clinical Trials 105

FDA Law Blog

JUNE 10, 2024

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

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Compliance Bioequivalency Cosmetics Regulation 111

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.

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Bioequivalency FDA Approval Medicine Bioavailability 40

XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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Production Insulin Branding Generic Drugs 78

The Pharma Data

DECEMBER 17, 2020

TLC’s Ampholipad (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome ® in all three forms, proving its sameness as the originator.

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Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.

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Trials Medicine Production Containment 52

Druggist

MARCH 25, 2021

Before December 2015, Cerazette was protected by a patent, which gave producers of this pill exclusive rights of supply of desogestrel in the UK and other markets. Generic medicines are usually much cheaper because they do not go through the same process of marketing authorisation. I used to be prescribed Cerazette, but not anymore.

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Branding Bioequivalency Pharmacy Generic Drugs 98

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. Smoking Cessation: What are the drugs available in the market? Chantix is also available in the EU and Japanese Smoking Cessation market. Generics in the Market.

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Marketing FDA Approval Branding Production 52

Worldwide Clinical Trials

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials. Director, Therapeutic Area Medical Lead.

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Gene Clinical Trials Clinical Trials Gene Therapy 204

Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. One of the main challenges is ensuring bioequivalence with the innovator drug. EU, and other regions.

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Generic Drugs Development Bioequivalency Drugs 52

The Pharma Data

NOVEMBER 17, 2021

Biogen moment blazoned that the European Commission (EC) has granted marketing authorization for VUMERITY ® (diroximel fumarate) to treat grown-ups with relapsing- remitting multiple sclerosis (MS). Encyclopedically, an estimated2.8 million people live with MS, with further than 1 million people in Europe living with the complaint. “

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Marketing Bioequivalency Clinical Trials Clinical Trials 52

The Pharma Data

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At Chief Medical Officer at Biogen. percent vs. 32.1 percent). Source: Biogen.

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FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

FDA Law Blog

JULY 9, 2024

For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). The status of the DAP submission and any interactions with FDA regarding the DAP should be included in the regulatory history for milestone meetings and marketing submissions.

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Clinical Trials Clinical Trials Development Drugs 59

Pharma in Brief

FEBRUARY 8, 2024

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. Dormant status: A drug listed as “Dormant” in Health Canada’s Drug Product Database means the drug is not presently being sold in Canada, but has not been withdrawn from the market. b) of the Regulations.

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Production Generic Drugs Drugs Bioequivalency 52

The Pharma Data

SEPTEMBER 26, 2021

The CHMP’s positive opinion will now be mentioned the ecu Commission (EC), which grants marketing authorizations for medicines in Europe. “We VUMERITY may be a next-generation oral fumarate for the treatment of adults with relapsing-remitting MS (RRMS). Head of Research and Development at Biogen.

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Clinical Trials Clinical Trials Bioequivalency Medicine 40

Drug Patent Watch

DECEMBER 11, 2024

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S.

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Generic Drugs Production Development Bioequivalency 95

Drug Patent Watch

FEBRUARY 17, 2025

But have you ever wondered what it takes for a generic drug to hit the market? Once the patent expires, other companies can apply to manufacture and market generic versions of the drug. The ANDA must also demonstrate that the generic drug is bioequivalent to the brand-name drug.

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Generic Drugs Bioequivalency Drugs Branding 52

Pharmaceutical Technology

FEBRUARY 23, 2023

The sooner challenging and unfixable compounds are identified and killed in development, the less R&D expenditure will be incurred, allowing you to focus on compounds that have the legs to make to it market. However, if drug Y has a high F abs (90%) but low F (e.g. Please check your email to download the Whitepaper.

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Pharmaceutical Technology

JANUARY 6, 2023

It is important for a CDMO to understand the market it serves and, in the dermatologic arena, that means the demand for topical agents across a broad array of indications. In vitro release testing to demonstrate bioequivalence. Simplicity matters. Staying up-to-date on the latest science and emerging technology is also essential.

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The Pharma Data

MAY 3, 2021

Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ).

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Gene Therapy Vaccine Vaccination Bioequivalency 52