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 In many cases, one drug may drive your decision — typically a brand name or a high-tier generic that only a few plans cover effectively. Prior authorization is out of control. The result:?

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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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World of DTC Marketing

JANUARY 28, 2022

.” Essentially, if certain circumstances are met, the government can act (“march-in”) and use its authority under the Bayh-Dole Act to grant a license to generic drug manufacturers to produce a drug in the United States—in this case,,, a generic version of Xtandi.

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The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

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Delveinsight

FEBRUARY 5, 2021

According to the CDC, in 2018, tobacco companies spent over USD 9 Billion in just promoting and marketing their cigars and cigarettes in the US. This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products.

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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. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

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FDA Law Blog

MARCH 30, 2022

1463 ) and the “ Simplifying the Generic Drug Application Process Act ” ( S. We intended to quickly follow up that post with another post addressing a couple of bills that we thought fit the role of Lee Van Cleef as “the Bad,” and Eli Wallach as “the Ugly”: the “ Prompt Approval of Safe Generic Drugs Act ” ( H.R.

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Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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Pharmaceutical Technology

NOVEMBER 29, 2022

For several decades, researchers have been investigating the role of ketamine in treating depression. Depression research spurs efforts for other conditions. That research led to a substantial amount of evidence suggesting that ketamine can have rapid effects on a host of measures associated with neuroplasticity,” he says.

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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.” His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations.

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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. It is estimated that more than half (53%) of the adults living in the EU are considered to be overweight or obese. billion in 2025.

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pharmaphorum

JUNE 8, 2021

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”.

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Delveinsight

SEPTEMBER 15, 2021

Similarly, the rise in various government and non-government initiatives to curb the occurrence of cancer diseases and the availability of cancer therapies has also contributed immensely to market growth. It covers the in-depth analysis of epidemiology as well as the emerging therapies in the market.

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Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. It is part of the good manufacturing practice (GMP) quality assurance system, and is undertaken by laboratories, usually at contract research organisations (CROs).

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. In Section I.A,

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Pharmaceutical Technology

OCTOBER 5, 2008

In addition, one very notable deal with India hints that Asia’s emerging market is also having a growing influence on what is happening in Japan. ’ Generic drug renaissance Shionogi’s acquisition of Sciele was partly due to the US business experience of Shionogi’s chief executive, Isao Teshirogi.

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pharmaphorum

JUNE 4, 2021

Researchers in the UK have found that there was a four million rise in prescriptions for antidepressants in England during 2020, adding £139 million to NHS costs. Shortage-related price concessions data published last May indicated the price of sertraline was up 823% to £14.32

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

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FDA Law Blog

APRIL 30, 2021

Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “ Addressing Anticompetitive Conduct and Consolidation in Health Care Markets ,” while others found their way into the Bill Hopper because of a renewed interest in Congress to address drug prices (see a recent U.S. Both bills – S.

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Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. billion, about 50% was dedicated to regulating medical products, including prescription drugs. There are 19,000 approved prescription drugs for marketing in the U.S.

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Drug Discovery World

APRIL 10, 2023

Thanks to a new focus on R&D, increasing digitalisation and government investment, India is establishing itself as a significant player in drug discovery, and the Hyderabad life sciences hub has played a significant role in this. India’s domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 2.

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Drug Discovery World

AUGUST 22, 2023

In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.

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Druggist

MARCH 25, 2021

Before December 2015, Cerazette was protected by a patent, which gave producers of this pill exclusive rights of supply of desogestrel in the UK and other markets. As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). PMID: 19776300. EMA (2012).

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Pharmaceutical Technology

MARCH 22, 2023

During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages. Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report.

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FDA Law Blog

SEPTEMBER 13, 2021

Readers following drug pricing activity will recognize several strategies already associated with Senate Democrats (e.g., Medicare negotiation authority; encourage biosimilars and generic drug utilization). The HHS plan’s proposals are defined in general terms, without estimates of taxpayer savings or timelines.

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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. But what does this all say about where our drugs really come from?

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Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. Prescription Market (press release) We’re offering special discounted pricing if you order before March 28, 2022.

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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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Cloudbyz

MARCH 5, 2024

The choice between developing a biologic or a small molecule drug often depends on the nature of the disease target, the desired mechanism of action, and the feasibility of manufacturing and delivery. In both cases, clinical research must be meticulously designed to address these complexities.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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The Pharma Data

JANUARY 27, 2021

” Vektor is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business.

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pharmaphorum

NOVEMBER 26, 2020

He was a partner at McKinsey & Company where he specialised in pharmaceuticals and medical products with a focus on generic drug manufacturers. Prior to joining McKinsey, Christian was a neuroscience researcher at the university of Freiburg, Germany. Before he joined Sandoz, Christian was a start-up entrepreneur.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The agency also aims to prevent misinformation and disinformation with this clearer form of patient communication.

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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. Source link: [link].

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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 6, 2021

FDA extends research agreement with MIT-licensed organ-on-chip systems ( Endpoints ). Sherrill, Kinzinger Lead Bipartisan Letter to House Appropriations Committee Urging Them Not to Block E-Labeling of Prescription Drugs ( Press ). million to resolve claims it paid drug kickbacks through charity ( STAT ).

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Pharmacy Checkers

JANUARY 10, 2020

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations.

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