Pharma in Brief

APRIL 29, 2021

Among the new prohibitions was one that would prohibit a manufacturer from offering any financial assistance to patients to help cover the cost of a drug on the provincial List of Medications (Quebec’s formulary). Notably, the coming into force of the prohibition was suspended pending the adoption of such regulation. 13, [link].

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FDA Law Blog

AUGUST 4, 2022

Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago!

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Pharmacy Checkers

SEPTEMBER 10, 2020

While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Because they don’t do adequate testing to prove safety and effectiveness of drugs. Furthermore, the agency’s position that FDA-approved generic drugs work just as well as the brand is often not true.

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Pharmacy Checkers

JANUARY 10, 2020

A friend of mine, who has very difficult to control cholesterol, was prescribed Livalo, an FDA-approved brand of the drug pitavastatin. He went to our site to discover that brand-name Livalo ( pitavastatin ). He went to our site to discover that brand-name Livalo ( pitavastatin ). Is the drug safe?

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FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. But it is not always clear which types of patents are eligible for listing in the Orange Book. The FDA Commissioner is quoted as saying that “[t]he FDA stands ready to assist the FTC.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market.

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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.

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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FDA Law Blog

MARCH 26, 2024

Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

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Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market.

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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 87% of doctors say patients’ conditions have worsened because of red-tape regulations, and 83% worry the patients will suffer prolonged pain. Prior authorization is out of control. The result:?

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FDA Law Blog

FEBRUARY 1, 2022

To that end, FDA announced that it would take the public input it has received and form a working group to address efforts to “modernize the Orange Book, improve transparency, and provide useful information to regulated industry and the public” by…considering the comments that it has supposed to have been considering all along.

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The Pharma Data

OCTOBER 14, 2020

The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. © 2020 10/20.

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Pharmaceutical Technology

JULY 25, 2022

The only way forward for generics producers. Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. Copaxone first went generic in 2015 , sold under the name Glatopa by Novartis’s subsidiary Sandoz.

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Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

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Druggist

MARCH 8, 2021

Modafinil (brand name Provigil) is one of the primary drugs used in the management of narcolepsy in the UK. The public’s interest in modafinil comes from the drug’s association with a class of medicines called ‘ smart drugs ‘, also called nootropics and cognitive enhancers. Atomoxetine.

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

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XTalks

FEBRUARY 5, 2024

million the drug made during the same time in 2022. Alimta was shielded by exclusivity in the US until 2022, after which it faced fierce competition from generic drugs. Zoladex is an artificial form of a hormone that regulates many processes in the body. million, a significant decrease compared to the $691.1

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XTalks

FEBRUARY 5, 2024

million the drug made during the same time in 2022. Alimta was shielded by exclusivity in the US until 2022, after which it faced fierce competition from generic drugs. Zoladex is an artificial form of a hormone that regulates many processes in the body. million, a significant decrease compared to the $691.1

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The Pharma Data

MAY 4, 2021

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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Pharmacy Checkers

JUNE 21, 2019

Amazon’s support for The Affordable and Safe Prescription Drug Importation Act , introduced by Senator Bernie Sanders (I-VT)—to allow for the importation of lower-cost prescription drugs—would be the game changer that would have American patients cheering and the pharmaceutical industry crying. prescription drugs. regulations.

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Pharmacy Checkers

DECEMBER 26, 2019

International Prescription Drug Prices” (“Committee Report”) – that shined a bright light on the glaring drug price disparities between the U.S. Your report showed that ex-factory drug prices on 79 brand name drugs in 11 countries are almost 75% less on average than in the U.S. Brand Drug Strength.

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Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. for drug safety. counterparts. J)(2) Waiver authority.

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XTalks

SEPTEMBER 14, 2020

For example, Tailored Brands, the parent of Men’s Wearhouse and K & G, have declared they may have to file for bankruptcy protection, joining almost 7,000 other companies that filed for Chapter 11 bankruptcy protection last year. Meanwhile, the Congressional Budget office predicted that the US economy would expand at an annual rate of 12.4

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