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. Continue to STAT+ to read the full story…

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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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Generic Drugs Sales Branding Medicine 164

XTalks

MARCH 15, 2024

LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab).

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Pharmacy Drugs Insulin Branding 111

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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Generic Drugs FDA Approval Drugs Branding 48

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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Pharmacy Generic Drugs Medicine Drugs 66

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

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. ©GlobalData.

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Manufacturing Generic Drugs Contract Manufacturing Production 130

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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pharmaphorum

JANUARY 25, 2022

Mark Cuban, billionaire owner of the Dallas Mavericks basketball team, just got involved in the online pharmacy business, promising to “shield consumers from inflated drug prices.” If you are looking for lower pricing on your generic drug purchases, go to [link] and sign up ! All drugs are priced at cost plus 15% !

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Medicine Pharmacy Generic Drugs Drugs 52

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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Generic Drugs Drugs 76

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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Contamination Manufacturing Generic Drugs Medicine 98

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). It isn’t very likely.

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Pharmacy Generic Drugs Medicine Drugs 226

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

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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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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

MAY 31, 2023

According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Sym-021’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

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pharmaphorum

JUNE 6, 2022

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. . “Manufacturers get a bad rap as being the source of high pricing for patient meds.

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World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm.

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Pharmacy Generic Drugs Life Science Branding 227

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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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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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Businesses are facing challenges in obtaining raw ingredients for medicines. The stakes are high. Logistical challenges.

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Camargo

NOVEMBER 11, 2020

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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pharmaphorum

JULY 29, 2021

The UK has levied another big fine for anticompetitive activity in the pharma market in a fortnight, with Advanz Pharma and former owners on the hook for more than £100 million ($140 million) after increasing the price of a thyroid disease drug by 1,110% over an eight-year period. ” Advanz itself was directly fined £40.9

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World of DTC Marketing

DECEMBER 18, 2020

Pharma companies are still too focused on profits while people continue to rely on prescription drugs to compensate for unhealthy lifestyles. When a new drug is on the horizon stories, the effect, the drug will have on its stock price, not on patients. Then there is the case of high drug prices. trillion every year.

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Generic Drugs Drugs Pharma Companies Vaccination 155

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. We address each below.

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Drugs Manufacturing Generic Drugs Production 45

Pharmacy Checkers

MAY 22, 2020

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.

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Manufacturing Drugs Generic Drugs Branding 98

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. There are many variabilities with biosimilars and the brand name protein drug.” For biosimilars, however, this process is slightly more complex.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.

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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. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

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Pharma in Brief

APRIL 29, 2021

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme. [1]. 1, particularly section 80.2, 13, [link].

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Manufacturing Drugs Regulation Branding 52

Drug Discovery World

APRIL 10, 2023

Could India become an important centre of drug discovery innovation? India is traditionally known as ‘the pharmacy of the world’ due to its huge pharmaceuticals manufacturing capacity and high quantity of exports, particularly generic medicines and vaccines.

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Genome Genomics Drugs Life Science 52

Pharmaceutical Technology

NOVEMBER 21, 2022

Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.

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FDA Law Blog

MARCH 6, 2024

He’ll be speaking on “Bridging the Gap: From Pre-Commercialization Research to Regulatory Approval for Novel Therapeutics and Regenerative Medicines.” Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.

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XTalks

JUNE 15, 2022

The drug was recently approved (under the brand name Mounjaro) by the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes. The editorial team also discussed a new global biosimilars awareness campaign launched by Sandoz, Novartis’ biosimilars and generics drug division.

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Life Science Generic Drugs Branding Drugs 52

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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Drug Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

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