Bio Pharma Dive

FEBRUARY 7, 2025

“There is not a single member of AAM who has not raised concerns about the tariff situation,” said the CEO of the generic drug lobby Association for Accessible Medicines.

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Drug Patent Watch

SEPTEMBER 5, 2024

This alarming trend has led to a growing need for sustainable practices in the industry, particularly in the development of generic drugs. The pharmaceutical industry is a significant contributor to global carbon emissions, with a projected increase of over 300% by 2050 if left unchecked.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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STAT News

MARCH 30, 2023

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. For instance, a generic drug could be marketed to treat one type of heart problem, but not another.

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Drug Patent Watch

OCTOBER 12, 2021

Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. This paper was originally published by Md.

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Fierce Pharma

DECEMBER 12, 2023

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages.

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Bio Pharma Dive

OCTOBER 26, 2021

The generic drug unit has struggled in recent years, while Novartis has moved to focus more narrowly on higher-margin branded medicines.

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pharmaphorum

FEBRUARY 15, 2024

The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines

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FDA Law Blog

SEPTEMBER 25, 2024

These days, Al (as we have come to know him) is a Trustee for The Engelberg Foundation, a private foundation that supports the Icahn School of Medicine at Mt. But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments.

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Pharmaceutical Technology

DECEMBER 15, 2022

On November 16, 2022, Medicines for Europe (MFE), the generics and biosimilars body, called for EU and national reforms to improve the security of medicine supplies, including tackling the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy.

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Pharma in Brief

APRIL 25, 2021

These amendments permit patents claiming different forms of a medicinal ingredient (e.g., As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,

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STAT News

AUGUST 3, 2022

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S.

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Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. FAQs Q: What is the difference between a biosimilar and a generic drug? from 2020 to 2025[1].

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Pharmaceutical Technology

AUGUST 12, 2022

Each month, an estimated 37 million packs of medicines are shipped between the EU and the UK, with 45 million traded in the opposite direction. Following the introduction of customs controls in January 2021, medicine imports from the EU fell to their lowest levels in years. Industry figures have spoken out against this prospect.

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Pharma in Brief

FEBRUARY 25, 2024

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. In Canada, the ANDS pathway is used to review and approve generic prescription drugs (but not biosimilars).

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World of DTC Marketing

JULY 27, 2022

anti-kickback law that the drugmaker said prevented it from helping heart failure patients, many with low incomes, afford the medicine that costs $225,000 annually. A drug’s out-of-pocket cost is primarily the result of decisions made by insurance companies and pharmacy benefit managers (PBMs).

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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 Similarly, the same number of doctors agree insurers engage in “non-medical switching,” which forces patients to take less costly — but potentially less effective — medicines. The result:? Not our system.

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World of DTC Marketing

JUNE 22, 2022

Then there is the cost of generic drugs. Mark Cuban made a big splash in the world of gener­ic medications when he launched a new com­pa­ny ear­li­er this year, pledg­ing to on­ly charge a 15% mark-up for its gener­ic medicines, Wide­spread cost sav­ings from us­ing Cuban’s new com­pa­ny could be steep.

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Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.

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Pharmacy Checkers

JULY 11, 2019

I’m proud to share that PharmacyChecker has published a white paper that examines prices and availability of newly approved generic drugs. Our report, based on 40 generic medications that were approved from 2017-2018, clearly shows that generic drug approvals often don’t lead to greater affordability or even access here in the U.S.

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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. US reliance on India for generic drugs could have supply chain security and quality implications for critical medicines.

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BioSpace

JUNE 20, 2022

Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.

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Pharmaceutical Technology

OCTOBER 5, 2008

’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi. ” The move, which came in June, also gives Japanese drugs maker Daiichi Sankyo a foothold in the Indian market through Ranbaxy’s location. .”

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STAT News

AUGUST 22, 2022

federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. After a decade of manufacturing problems, a U.S. However, the U.S.

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STAT News

AUGUST 19, 2022

Sun Pharmaceutical, which is one of the largest purveyors of generic drugs, allegedly falsified various documents that were maintained by employees at one of its plants in India, according to an inspection report issued by the U.S. Food and Drug Administration.

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Pharmaceutical Technology

JULY 25, 2022

Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman.

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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. She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation.

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JAMA Internal Medicine

JULY 5, 2021

This cross-sectional study uses 2017 and 2018 Medicare Part D clams to compare the amount Medicare pays for common generic prescriptions in Part D with prices available to patients without insurance at Costco.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Genomic data plays a central role in the future of the field, especially as new cell therapies and more personalised medicine comes of age.

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Scienmag

JANUARY 13, 2022

A University of Calgary study has found promising results for the generic drug hydroxychloroquine when used to treat the evolution of disability of primary progressive multiple sclerosis (MS), the least treatable form of the autoimmune disease.

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World of DTC Marketing

DECEMBER 18, 2020

were dispensed using generic drugs. When both brand and generic versions of the prescribed medication were available, the generic was chosen 97 percent of the time, resulting in significant patient savings. healthcare system saved almost $2 trillion from 2009 to 2019 in healthcare costs due to generic drugs.

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Pharmacy Checkers

DECEMBER 5, 2019

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! Decriminalizing Personal Drug Importation and Redefining “Counterfeit”.

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pharmaphorum

JANUARY 25, 2022

.” The online pharmacy launch comes a few weeks after Cuban set up a pharmacy benefit manager (PBM) operation – the Mark Cuban Cost Plus Drug Company (MCCPDC) – promising to cut out the middleman in the medicines supply chain so it can eliminate markups on generic drugs and pass savings on to its customers.

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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%). Ex vivo (where cells are genetically modified outside the body) cell and gene therapies have generated considerable excitement on their potential to cure previously incurable diseases.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The study of ketamine’s antidepressant effects has inspired research for different conditions, says Dr. Gerard Sanacora, director of the Depression Research Program at Yale School of Medicine, Connecticut. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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pharmaphorum

AUGUST 20, 2020

“This case brought by the Department of Justice regarding these charitable contributions only seeks to further restrict patients’ access to important medicines and healthcare. The company will vigorously defend itself against these allegations.”

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