Pfizer

AUGUST 11, 2022

Risks and uncertainties include, among other things, the risk and impact of an adverse decision or settlement and the adequacy of reserves related to legal proceedings; the uncertainties inherent in research and development; uncertainties and variables inherent in business operating and financial performance, including, among other things, competitive (..)

Containment 49

Containment Vaccination Vaccine Development 49

The Pharma Data

DECEMBER 17, 2020

In this study, data from the RADARS ® System’s Survey of Non-Medical Use of Prescription Drugs (NMURx) Program online cross-sectional general population national surveys are analyzed from 2018 from four countries, Germany, Italy, Spain, and the UK, with 45,000 total responses.

Containment 52

Containment Production Drugs Development 52

FDA Law Blog

AUGUST 23, 2021

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. Other, less extensive changes have been made to Code sections on topics other than speaker programs.

Compliance 52

Compliance Manufacturing Production Drugs 52

The Pharma Data

OCTOBER 26, 2020

Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. The conference ID number for the call is 8557525. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

Clinical Trials 52

Clinical Trials Clinical Trials Containment Clinical Development 52

The Pharma Data

NOVEMBER 18, 2020

Gender Section of UN Human Rights. “The achievement of the 2030 Agenda for Sustainable Development hinges on the realization of human rights, which necessitates action across sectors and disciplines,” said Veronica Birga, Chief of Women’s Human Rights and. sustainable development.” .

Development 52

Development Research 52

Imperical Blog

AUGUST 24, 2021

The optimal balance between direct and polite can vary widely based on the individual’s personal and cultural background. For example, there may be a mistake in a visit schedule or a section that only applies to a few countries. In a translated document, the emotions are amplified.

Compliance 52

Compliance Clinical Trials Clinical Trials Regulation 52

The Pharma Data

AUGUST 7, 2020

Risks and uncertainties include, among other things, the uncertainties inherent in research and development; uncertainties regarding the commercial success of and the ability to realize the anticipated benefits of the manufacturing and supply agreement; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other (..)

Manufacturing 52

Manufacturing Containment Contract Manufacturing Development 52

Triage Cancer

OCTOBER 28, 2021

Title VII does not cover your social, political, economic, or personal preferences. For more information, review Section K. However, if the accommodation would have more than a minimal cost or burden to your employer, they may be able to deny the request. Your state may have additional laws related to vaccine mandates and employment.

Vaccination 98

Vaccination Vaccine Doctors Doctor 98

The Pharma Data

OCTOBER 21, 2020

Replimune’s Immulytic platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes.

Gene Therapy 40

Gene Therapy Immune Response Sales Gene 40

The Pharma Data

OCTOBER 25, 2020

. PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the eligible patient base and commercial potential of PTC’s products and product candidates; the outcome (..)

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

The Pharma Data

OCTOBER 28, 2020

Eastern Time) on Thursday, October 29 that will be accessible through the Investor Relations section of the LivaNova corporate website at www.livanova.com. The Company will host a live audio webcast for interested parties commencing at 12 p.m. London time (8 a.m. or Canada) or 512-961-6524 (if dialing from outside the U.S. or Canada).

Sales 40

Sales Production Compliance Marketing 40

FDA Law Blog

JANUARY 6, 2022

The Court relied on Section 1301(c) to define “remuneration” as including payments from an employer to an employee. . § 1301(a)(3)) and concluded that “for purposes of the anti-kickback statute, an “individual” is not an artificial entity.” 1301(c) (emphasis added). 1301(c) (emphasis added).

Containment 52

Containment Drugs 52

The Pharma Data

DECEMBER 9, 2020

Accordingly, you should not place undue reliance on these forward-looking statements.

Gene Therapy 40

Gene Therapy Genetics Genetic Disease Sales 40

The Pharma Data

APRIL 28, 2021

Risks and uncertainties include, among other things; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; (..)

Clinical Trials 40

Clinical Trials Clinical Trials Containment In-Vitro 40

FDA Law Blog

JANUARY 6, 2022

The Court relied on Section 1301(c) to define “remuneration” as including payments from an employer to an employee. . § 1301(a)(3)) and concluded that “for purposes of the anti-kickback statute, an “individual” is not an artificial entity.” 1301(c) (emphasis added). 1301(c) (emphasis added).

Containment 40

Containment Drugs 40

The Pharma Data

NOVEMBER 5, 2020

Conference Call and Webcast Details: Management will host a conference call and webcast with slides at 11:00 AM Eastern Time on Friday, November 6, 2020, for investors regarding this announcement with details as follows: The archived webcast will be available on the Investors section of the Ocuphire website. About Ocuphire Pharma.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

NOVEMBER 19, 2020

No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. In connection with the proposed merger pursuant to the Merger Agreement, Petros has filed with the SEC a registration statement on Form S-4 (File No.

Containment 52

Containment Marketing Sales Clinical Trials 52

The Pharma Data

MAY 4, 2021

Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

Production 52

Production Sales Manufacturing Development 52

FDA Law Blog

JUNE 21, 2022

360j), as described in section 709(b) of the FDA Reauthorization Act of 2017 (Public Law 115–52). 360j), as described in section 709(b) of the FDA Reauthorization Act of 2017 (Public Law 115–52). One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids.

Regulation 52

Regulation Licensing Licensing Sales 52

The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

Production 52

Production Sales Manufacturing Development 52

FDA Law Blog

NOVEMBER 1, 2023

FDA supports its argument with what it calls a straightforward reading of section 201(h)(1) of the FD&C Act, as well as references to “test systems” in FDA regulation and legislative history dating back to the 1970s. Premarket Approval or De Novo pathways). If finalized, the PR may also be subject to broader challenges.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

MAY 4, 2021

Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

Licensing 40

Licensing Licensing FDA Approval Development 40

The Pharma Data

NOVEMBER 18, 2020

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event. The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

Trials 40

Trials Production Development Marketing 40

The Pharma Data

AUGUST 6, 2020

A discussion of the non-GAAP financial measures is included under the “Use of Non-GAAP Financial Information” section. We routinely post important information for investors on our website, BMS.com, in the “Investors” section. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.8 billion, or $1.63

Production 52

Production Branding Marketing Licensing 52

The Pharma Data

OCTOBER 18, 2020

Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Development 40

The Pharma Data

JANUARY 19, 2021

These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Sales 52

The Pharma Data

DECEMBER 21, 2020

Comorbidity in severe asthma requiring systemic corticosteroid therapy: cross-sectional data from the Optimum Patient Care Research Database and the British Thoracic Difficult Asthma Registry. Healthcare resource utilization and costs associated with incremental systemic corticosteroid exposure in asthma. 2019;74 (2): 273-283.

Trials 40

Trials Production Sales Manufacturing 40

Pharmacy Checkers

SEPTEMBER 25, 2020

Well, as I was writing this post about the politics of importation, the FDA published its final rule on drug importation. Find it here: Section 804 Final Rule. As I see it, now that Section 804 in its entirely is in effect, personal importation is more expressly permitted than before. siphoning off their drug supplies.

Drugs 80

Drugs Pharmacy Cosmetics Licensing 80

The Pharma Data

MAY 14, 2021

” Before Prasara Yoga, I had studied the science of flow with the top researchers in the former Soviet Union, where sport was a political platform. In addition to an instructional section that dissects each of the transitional. in the “bible” of yoga, The Yoga Sutras. The five workouts.

Packaging 52

Packaging Packaging Production Doctors 52

The Pharma Data

APRIL 26, 2021

At present, drug development operations are continuing with manageable disruptions (see the Innovation Review Section of the Condensed Interim Financial Report for further information), with our range of digital technologies allowing us to proactively manage our clinical trials portfolio and rapidly mitigate any disruptions.

Sales 40

Sales Medicine Production Manufacturing 40

The Pharma Data

MAY 4, 2021

Changes in Adjusted (2) costs and expenses in first-quarter 2021 compared to the prior-year quarter were driven primarily by the factors listed in the Reported (1) costs and expenses section above. RECENT NOTABLE DEVELOPMENTS (Since February 2, 2021). 8) The U.S.

Vaccination 40

Vaccination Vaccine Production Sales 40

The Pharma Data

DECEMBER 15, 2020

These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

pharmaphorum

SEPTEMBER 10, 2020

AZ hasn’t confirmed the nature of the adverse reaction, but it was reportedly a case of transverse myelitis – an inflammation of both sides of one section of the spinal cord – which can cause pain, muscle weakness, paralysis, sensory problems, and bladder or bowel problems.

Vaccination 58

Vaccination Vaccine Trials DNA 58

Pharmaceutical Technology

MARCH 16, 2023

Possible consequences Last year, the Biden administration proposed the implementation of a rule in section 1557 , that would protect against limiting access to care by stating that “categorically refusing to provide treatment to an individual based on their gender identity is prohibited discrimination”.

Drugs 360

Drugs Hormones Trials FDA Approval 360

Pharmacy Checkers

JANUARY 30, 2020

The Trump administration’s current drug importation plan seeks to operationalize Section 804 of the Food, Drug and Cosmetic Act to permit states to run wholesale drug importation programs – importing from Canada only, called Pathway I. But this idea is no where to be found in the current drug importation proposals of the Trump administration.

Drugs 54

Drugs Generic Drugs Cosmetics FDA Approval 54

World of DTC Marketing

JANUARY 27, 2022

He could have invoked a law known as Section 1498, which is most often used in military procurement. That law, like Section 1498, gives our government power to “march in” and seize control of a drug patent developed with taxpayer funding when the owner charges excessively high prices or holds back supply.

Drugs 228

Drugs Insulin Vaccination Vaccine 228