The Pharma Data

MAY 27, 2022

federal government spent an estimated $1.8 billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019.

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Drug Channels

JULY 9, 2020

In Drug Channels Institute's list of the top 15 pharmacies of 2019 , we show that many of the largest U.S. However, the increasing role of government payers may create opportunities for smaller pharmacies. This week (Monday through Thursday), I’m rerunning some popular posts.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.

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The Pharma Data

AUGUST 31, 2020

Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. Johnson & Johnson Announces Agreement in Principle with Government of Canada to Supply its COVID-19 Vaccine Candidate. MONTRÉAL, QC – August 31, 2020 – Janssen Inc.,

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The Pharma Data

JULY 15, 2021

– Victorian State Government extends financing of JJIPO@Monash for an additional two years. Johnson & Johnson Innovation announced today the extension of the Johnson & Johnson Innovation Partnering Office at Monash University’s Clayton Campus in Melbourne (JJIPO@Monash) in collaboration with the Victorian State Government.

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The Pharma Data

AUGUST 5, 2020

Government for 100 Million Doses of Investigational COVID-19 Vaccine. Government for 100 Million Doses of Investigational COVID-19 Vaccine. government for the large scale domestic manufacturing and delivery in the U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S New Brunswick, N.J.,

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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. government under its existing supply agreement to 500 million. government with 500 million doses of the companies’ COVID-19 vaccine for donation to the world’s poorest nations. This press release features multimedia. Eligible U.S.

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Drug Channels

JUNE 9, 2020

billion in 2019. Medicaid rebates directly and transparently lower drug costs for the government, while 340B discounts disappear into providers’ financial statements. The 340B Drug Pricing Program has logged another year of incredible growth. That figure is an astonishing 23% higher than its 2018 counterpart.

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Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.

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Common Sense for Drug Policy Blog

JULY 16, 2023

Government does not have an estimate of the share of the total cocaine flow that passes through land POEs, but the U.S. Government estimate of cocaine departing South America towards the United States, and additionally incorporates estimates of cocaine movement, cocaine production, and U.S. Government agencies. 15 The U.S.

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The Pharma Data

DECEMBER 16, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax’ candidate vaccine against COVID-19.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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The Pharma Data

AUGUST 5, 2020

government for the large scale domestic manufacturing and delivery in the U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. NEW BRUNSWICK, N.J.,

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The Pharma Data

DECEMBER 8, 2020

On 4 December 2020, the Government of the Grand Duchy of Luxembourg and WHO convened their annual strategic dialogue. The Government of Luxembourg is a strong supporter of WHO priority programmes,” said Ms Jane Ellison, WHO Executive Director for External Relations and Governance. “We Source link.

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FDA Law Blog: Biosimilars

MAY 31, 2023

The government, while opposing the stay, stated it was willing to enter settlement discussions. On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances.

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Drug Channels

AUGUST 11, 2020

When rebates and discounts were factored in, drug prices declined—or grew slowly—in 2019. These data also highlight the lunacy of inflationary rebates that are based on a government pricing metric that approximates a brand-name drug's list price. You can find links to each company’s data below.

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The Pharma Data

DECEMBER 17, 2020

in 2019 to 19.6% in 2020, according to new government data. of middle school kids vaped in 2019, just 4.7% teens have leveled off this year, after a steady climb from 2017 to 2019. ” Finally, vaping got a lot of bad press in 2019, Folan pointed out. million) in 2019. THURSDAY, Dec.

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DrugBank

OCTOBER 4, 2024

The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities. For instance, Bristol-Myers Squibb's $74 billion acquisition of Celgene in 2019 involved a complex structure of cash and stock, along with Contingent Value Rights (CVR).

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The Pharma Data

JANUARY 11, 2021

China’s National Health Commission said the WHO team will meet with Chinese counterparts, but it was not clear if they will go to the city of Wuhan, where the new coronavirus was first detected in late 2019, the Associated Press reported.

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Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. Common Rule Single IRB Policy. Nonexempt human subjects research.

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Common Sense for Drug Policy Blog

JANUARY 1, 2024

19 In 2019, HIV care and treatment cost the US government more than $20 billion. 18 A 2019 study in Philadelphia found that SSPs averted 10 582 HIV infections during a 10-year period. The estimated cost of providing health care services to persons living with chronic HCV infection is $15 billion annually.

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Drug Target Review

SEPTEMBER 21, 2023

Due to financial burden, most of these individuals live with the nodules and settle for the mass government annual distribution of free ivermectin for as long as they can. February 2019, pp. Prolong use of drugs also has their own side effects on organs, which these individuals unknowingly are at risk of. 1–13, 2020, [Online].

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Common Sense for Drug Policy Blog

AUGUST 22, 2023

Drug Checking Services and Image and Performance Enhancing Drugs "The Global Commission on Drug Policy recently advised governments to make harm reduction measures, including drug checking services, widely accessible ( Bewley-Taylor & Tinasti, 2020 ; Buxton et al., 2018 ; Olsen et al., 2018 ; Olsen et al.,

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The Pharma Data

FEBRUARY 1, 2021

They spent about an hour at the Huanan Seafood Market, which was the site of an outbreak of the virus in December 2019, the Associated Press reported. “Very informative & critical for our joint teams to understand the epidemiology of COVID as it started to spread at the end of 2019.” MONDAY, Feb.

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The Pharma Data

FEBRUARY 24, 2022

This vaccine is indicated for active immunization to prevent coronavirus disease 2019 (COVID?19) We’re also grateful for the Government of Canada’s support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order.”. 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS?CoV?2)

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The Pharma Data

OCTOBER 15, 2020

Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. The Cambridge, Mass.-based

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The Pharma Data

NOVEMBER 5, 2020

million for the quarter ended September 30, 2019 (the “2019 Quarter”) and $33.6 million for the 2019 Quarter and $44.5 million for the 2019 Quarter, representing a decrease of 12%. loss per share (basic and diluted), for the 2019 Quarter. million for the 2019 Quarter. million for the 2019 Quarter.

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Common Sense for Drug Policy Blog

DECEMBER 20, 2023

The opening of a MDCR, which is part of a larger initiative by the city government and harm reduction NGOs to open 3 DCRs, two fixed and one mobile, allows service of the densely populated urban center. Harm Reduct J 16 , 49 (2019). DCRs are among the harm reduction measures detailed. dwf_admin Wed, 12/20/2023 - 17:34 Source Taylor, H.,

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The Pharma Data

JANUARY 3, 2021

InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs, such as TLC19 for the treatment of Coronavirus disease 2019 (COVID-19) as well as other programs for severe acute and chronic pulmonary diseases. Cautionary Note on Forward-Looking Statements.

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The Pharma Data

NOVEMBER 19, 2020

million for the same period in 2019, or a 28.8% million for the same period in 2019, or a 20.5% million for the same period in 2019, or a 20.5% increase from 6,769 for the same period in 2019, or a 19.2% million for the same period in 2019, or a 41.6% million for the same period in 2019. million (US$18.2

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The Pharma Data

MARCH 26, 2021

It comes at an important point in time, as governments now have more flexibility to move from inoculations in vaccination centers to a more decentralized vaccine roll-out through local doctors and general practitioners to accelerate our path out of the pandemic.”.

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Agency IQ

OCTOBER 12, 2023

These 2020 bans stemmed from an April 2019 meeting , held as part of the standard renewal process for pesticide active substances, between experts from EU member states and EFSA. These statements emboldened member states to vote in favor of draft implementing acts denying renewal for both active substances in December 2019.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. Results included global public and private financing from regenerative medicine and advanced therapy developers, and highlighted a 120 per cent increase over the first half of 2019.

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Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

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The Pharma Data

OCTOBER 22, 2020

All institutions, from governments to international health agencies, scientific bodies to Wikipedia, must do our part to ensure everyone has equitable and trusted access to knowledge about public health, regardless of where you live or the language you speak.”.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older.

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The Pharma Data

JULY 22, 2021

The process, conducted over six months and supported by two leading global search firms, was overseen by the Nominations & Corporate Governance Committee and resulted in direct evaluation and interview of several external and internal candidates for the position. Consumer Healthcare Board.

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