The Pharma Data

MAY 13, 2021

CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ). US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ). Covid vaccines may not protect people with immune disorders. In Focus: US.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. TNX-801 , live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.

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The Pharma Data

JANUARY 9, 2021

This growth primarily reflects increased sales of contract development and manufacturing (CDMO) services to pharmaceutical and biotechnology innovators and government/non-government organization (NGO) customers, as well as higher product sales. • Anthrax Vaccines. $475 — $525.

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The Pharma Data

JULY 23, 2021

In December 2020, Chugai obtained development and exclusive commercialisation rights in Japan from Roche, and is working with the Japanese government to ensure an appropriate and timely supply of Ronapreve. About Ronapreve (casirivimab and imdevimab).

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The Pharma Data

SEPTEMBER 8, 2020

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

SEPTEMBER 8, 2020

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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The Pharma Data

MARCH 4, 2021

We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI).

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The Pharma Data

MARCH 22, 2021

Earlier this year, the EMA’s Committee for Medicinal Products for Human Use issued a scientific opinion under Article 5(3) of Regulation 726/2004, supporting the use of casirivimab and imdevimab as a treatment option for patients with confirmed COVID-19. Key results from phase III REGN-COV 2067 trial in non-hospitalised patients 1-3.

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Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. The regulation of dietary supplements in the U.S. a probiotic in yogurt) may be used as a dietary ingredient in a dietary supplement.”

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The Pharma Data

JANUARY 15, 2021

and Genmab A/S entered into a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. This program is not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Learn more at www.janssen.com. Janssen Biotech, Inc.

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Drug Discovery World

SEPTEMBER 16, 2022

One example the Cell and Gene Therapy Catapult regards as a benefit for developers in the UK is the effort the government puts in to support the industry. . The research excellence of the UK’s academic institutions, and the expertise of the Cell and Gene Therapy Catapult enable the UK to compete globally. Key comment US . “We

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The CMS regulation (unlike the statute) would expansively define a “misclassification” to include, not only misclassifying the drug category (e.g.,

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The Pharma Data

OCTOBER 14, 2020

Study May Lead to Biomarkers for Tailoring COVID-19 Vaccines and Therapeutics. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and may lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19. CHATHAM, N.J., About TNX-1800. 1 Noyce RS, et al.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. The MOH has secured 6 million doses of the COVID-19 Vaccine Moderna.

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The Pharma Data

NOVEMBER 9, 2020

TScan Therapeutics announced the signing of a research license and option agreement with QIAGEN to develop T cell-based laboratory tests for detecting prior exposure to the novel coronavirus, SARS-CoV-2, using discoveries from TScan’s high-throughput TCR/Target discovery platform. Testing Therapies, Antivirals and Vaccines.

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The Pharma Data

NOVEMBER 9, 2020

. “The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.” government’s allocation program.

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The Pharma Data

APRIL 26, 2021

billion declined, mainly due to the USD 650 million upfront payment to in-license tislelizumab from BeiGene. Furthermore, Novartis joined industry-wide efforts to meet global demand for COVID-19 vaccines and therapeutics. Net income declined -7% (cc, -5% USD) , mainly due to lower operating income. Free cash flow¹ of USD 1.6

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The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Adjusted Income (2).

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Drug Discovery World

FEBRUARY 22, 2024

ARUK 3 adds that while the UK government increased funding in dementia research from £28.2m They focused on miRNAs, which regulate multiple target proteins controlling the cellular processes in the amygdala. to £104.7m per year there are additional issues.

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The Pharma Data

MAY 4, 2021

. Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine ( NYTimes ) ( WSJ ) ( Endpoints ) ( Reuters ).

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The Pharma Data

DECEMBER 30, 2020

Food and Drug Administration (FDA), noted in December 2020 that he expected the pandemic could “effectively” be ended in 2021 with the launch of the Pfizer-BioNTech and Moderna vaccines. AstraZeneca and University of Oxford COVID-19 vaccine authorization. Johnson & Johnson’s COVID-19 vaccine. Now that in the U.S.

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The Pharma Data

DECEMBER 2, 2020

Yet, despite the push, the UK is set to administer the first Western vaccine before the FDA’s vaccine review committee even meets, leaving an increasingly skeptical public wondering why. For the COVID-19 vaccines, Pfizer and Moderna are still collecting data from Phases I and II. Most vaccines take 20 to 30 years to be licensed.

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The Pharma Data

MAY 13, 2021

That took me through the dark underbelly of the multi-billion dollar weight loss industry controlled by government and elite societies…. Then these hormones can’t regulate your metabolism like they should…. Along with the amount of estrogen-regulating DIM that he added as well. But might very well save your life too.

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The Pharma Data

DECEMBER 16, 2020

AstraZeneca has seen a few setbacks with the COVID-19 vaccine it has developed with Oxford University, including a confusing efficacy outcome that resulted from the inclusion of a half-dose. Despite those setbacks, the company anticipates its vaccine could be available for use in the United Kingdom within the next several weeks.

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Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Polansky v. UnitedHealthcare, Inc. ,

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Drug & Device Law

DECEMBER 14, 2022

On Monday, Bexis blogged about a very bad vaccination decision — bad in its reasoning and bad in its maleficent effect on vaccine policy in this country. Over the past couple of years, we’ve written quite a few posts on vaccination cases. Some also claimed family histories of adverse reactions to vaccines. Zucker , 43 F.4th

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Drug & Device Law

FEBRUARY 20, 2023

For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims. Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v.

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Drug & Device Law

FEBRUARY 29, 2024

It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote same) to be a pretty interesting topic. 247d-6d(a)(2)(B).

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Drug & Device Law

NOVEMBER 4, 2023

Next up is Bexis , who, along with our colleague Jenn Eppensteiner , will present “ Preemption in Perspective: A Balanced Review of Preemption Issues Affecting Drugs, Medical Devices, and Vaccines as 2023 Draws to a Close.” Preemption remains the most powerful defense in prescription medical product liability litigation.

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