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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XTalks

JANUARY 20, 2025

Among these, mergers and acquisitions (M&As) have played a pivotal role in reshaping the industry landscape, enabling companies to bolster their portfolios, enhance R&D capabilities and expand their global market reach. While the deal required regulatory divestitures, including the sale of Otezla (apremilast) to Amgen for $13.4

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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! Buying Drugs Online from Retail Platforms is Legal.

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pharmaphorum

SEPTEMBER 9, 2022

The partners anticipate that the digital obesity programme will launch later this autumn in Sweden, ahead of a broader rollout in other European markets before the end of the year. Novo Nordisk recently predicted its obesity sales could reach $3.7 billion in 2025.

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pharmaphorum

MARCH 5, 2021

Copaxone (glatiramer) was once a mainstay of Teva’s portfolio with blockbuster sales that the Israel-based pharma fought hard to protect, including releasing a long-acting version to counter cheaper copycat drugs. In the end it wasn’t enough and sales last year were $213 million, a fraction of the $4.3

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pharmaphorum

AUGUST 20, 2020

Shares in Teva were down sharply this week after the US Department of Justice filed a complaint that the company paid illegal kickbacks to patient groups to boost sales of its multiple sclerosis drug Copaxone (glatiramer). The allegation is that Teva’s subsidiaries Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

The rising incidence of long-standing diseases such as hypertension, diabetes, cardiovascular diseases, and cancer requires prolonged medication and, thus, drives the growth and need for retail pharmacies in the market. The list includes companies offering various products and services, including but not limited to: · Over-the-counter drugs.

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Camargo

DECEMBER 9, 2020

Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. Unapproved Drug Initiative Ends. In November, the FDA ended its Unapproved Drug Initiative.

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Pharma in Brief

FEBRUARY 8, 2024

The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).

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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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pharmaphorum

JULY 29, 2021

Now, interchangeable status means that is considered to have no clinically meaningful difference to Lantus in safety, purity or potency, so can be substituted for the reference drug without any prescriber intervention – just like a regular generic drug can in many US states.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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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. Once formed, Viatris will be a generics behemoth with annual sales of around $19 to $20 billion and operations in 165 markets around the word.

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pharmaphorum

NOVEMBER 26, 2020

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives. About the interviewee.

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pharmaphorum

MARCH 16, 2022

Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery and called Breyna – has been cleared for the same indications as the brand, namely maintenance treatment for asthma and chronic obstructive pulmonary disease (COPD).

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FDA Law Blog

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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pharmaphorum

FEBRUARY 2, 2022

Pharming has taken a step closer to getting a second product to market, after its rare disease therapy leniolisib met its objectives in a pivotal trial, setting up regulatory filings in the coming months. For comparison, Takeda reported sales of around $415 million in the first six months of the 2021-22 fiscal year.

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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. It has however been contraindicated in people taking opioids.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. billion in pharmaceutical sales from 2021. billion, a 42.74

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Pharmaceutical Technology

JULY 10, 2008

As the blockbuster drugs of the 90s that earned the industry billions reach their patent shelf lives, pharmaceutical companies require new medicines to sustain an estimated $157bn worth of sales. Even so, current figures show firms’ biggest portion of spend is still on marketing and administration at 33.1%,

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The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the overall U.S. Company Information.

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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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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Labelling.

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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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The Pharma Data

MARCH 9, 2021

This first-to-market generic version of AZOPT ® (brinzolamide ophthalmic suspension) 1% in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, one in ten generic prescriptions dispensed in the U.S.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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FDA Law Blog

AUGUST 29, 2024

After all, as we have written before in other contexts ( i.e. , the BLOCKING Act), “[I]f you limit a generic drug manufacturer’s ability to settle cases, that manufacturer does not settle fewer cases, it submits fewer Paragraph IV ANDAs. And fewer ANDAs means less, not more, generic drug competition.”

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Pharma in Brief

JUNE 21, 2020

They include: (1) new factors for assessing excessive pricing, (2) new powers to collect information regarding these factors, (3) new obligations to report indirect price adjustments, (4) risk-based reporting obligations for OTC and generic drugs, and (5) a revised list of international price comparator countries (the PMPRB11 ).

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FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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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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Creogenic Pharma

APRIL 15, 2023

The Indian pharmaceutical market reached a value of around $27 billion by the end of 2017 and is predicted to experience a CAGR of over 5% for the next five years, reaching over $60 billion by 2022. India is a major player in the global pharmaceutical industry, accounting for almost 20% of the export volume of generic drugs worldwide.

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The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

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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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The Pharma Data

JANUARY 27, 2021

The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business. In 2020, XPhyto reported significant advancements in four drug formulation development programs.

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The Pharma Data

MARCH 7, 2022

“The launch of our first generic version of Revlimid® in the U.S. This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization.”. Currently, 1 in 12 generic prescriptions dispensed in the U.S.

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The Pharma Data

MAY 7, 2021

. Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ).

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The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Drug Formulations and Delivery.

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