Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.

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FDA Law Blog

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023). ©GlobalData.

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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. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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FDA Law Blog

NOVEMBER 16, 2021

That section of the bill – along with the other accompanying sections and parts of the bill – would amend Title XI of the Social Security Act to create a new part – Part E – requiring the HHS Secretary to establish a “Fair Price Negotiation Program” intended to lower prices for certain high-priced single-source drugs and biological products.

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STAT News

DECEMBER 14, 2022

Once again, we hope you have a meaningful and productive day. … The Biden administration signaled it will require health plans on federal exchanges to cover more of the costs of generic drugs, a small tweak that nevertheless has industry groups divided on how best to manage drug costs , STAT reports.  The

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. for the treatment of diabetes. Biosimilars marketed in the U.S.

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.

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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.

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Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. Inflation can damage production viability of European drugs.

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World of DTC Marketing

APRIL 12, 2021

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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Drug Channels

OCTOBER 18, 2022

The biosimilar boom for provider-administered drugs continues to accelerate. Some major biological reference products have now lost a majority of their unit sales to their biosimilars. Below, we share our estimates for wholesalers’ gross margins for brand-name, generic, and biosimilar drugs. drug distribution.

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Outsourcing Pharma

OCTOBER 20, 2020

The generic drug manufacturer is working with Kit Check to incorporate the company's drug supply-chain management technology into two of its products.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs. Prescription refill and generic drug programmes. Proprietary pharmaceutical, nutraceutical, and cosmeceutical products. Speciality care. Compounding services. Pharmacogenetics testing.

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Pharmaceutical Technology

JULY 15, 2022

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. This CMO will be responsible for product roll-out and distribution. In-house manufacturing the norm.

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Pharmaceutical Technology

MAY 31, 2023

Les Laboratoires Servier overview Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company also provides generic drugs and contract development and manufacturing services across its global network.

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Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

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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. Broadly, complex drugs are treatments with complicated active pharmaceutical ingredients (APIs), formulations, or drug/device combinations.

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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. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

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XTalks

MARCH 15, 2024

Lilly’s move is a significant shift in strategy as drugmakers have traditionally steered clear of delivering products to people’s homes or connecting them with healthcare providers. It is estimated that more than 8 million Americans rely on insulin products to manage their diabetes. More than 40 percent of Americans are obese.

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FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Hyman, Phelps & McNamara, P.C.

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Pharma in Brief

NOVEMBER 5, 2023

Background A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit ( ODB ) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.

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FDA Law Blog

AUGUST 17, 2023

FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §

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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.”

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Pharmaceutical Technology

SEPTEMBER 23, 2022

These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones. Narrower Product Focus Emphasis on Development End-to-End Support and Manufacturing Flexibility Manufactured in the USA Continuous Reinvestment. Narrower product focus.

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Camargo

DECEMBER 9, 2020

Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.

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Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

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Pharmaceutical Technology

AUGUST 12, 2022

And while the gloomiest predictions around medicine shortages do not appear to have come to pass, shortfalls in drugs like HRT products have been partially attributed to Brexit. Because the products would already have been tested within the exporting country, the testing would be duplicative and (to many people’s minds) unnecessary.

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FDA Law Blog

MAY 25, 2022

That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. And now there’s a report and analysis to back up that claim!

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Pharmaceutical Technology

MAY 16, 2023

Novo Nordisk’s semaglutide obesity treatment, Wegovy, has also experienced a significant increase in demand, prompting the company to announce plans to increase production to meet supply demands this year. million by 2029. Sanofi and Regeneron’s market capitalisation grew by 12.4%

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Camargo

OCTOBER 14, 2021

The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.

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pharmaphorum

NOVEMBER 2, 2020

Mylan’s $12 billion takeover of Pfizer’s Upjohn unit has been cleared by the US authorities, but on the condition that the two companies divest various generic drug products. Mylan meanwhile will benefit from Upjohn’s greater global reach, allowing its generics to grow more quickly, according to the companies.

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World of DTC Marketing

AUGUST 7, 2022

Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Medicare drug insurance is a product of compromise after decades of debate in Congress. Generic drugs may also be cheaper with a coupon than your drug insurance. The result:?

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FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

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pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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