BioTech 365

NOVEMBER 12, 2021

–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it will webcast its upcoming virtual R&D Day event on the Investors section … Continue reading →

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BioTech 365

JUNE 9, 2021

–(BUSINESS WIRE)–In the “About QPharma, Inc.” ” section, the last sentence should read: QPharma is a … Continue reading →

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. A ransomware group later claimed responsibility for the incident, which was one of several high-profile cybersecurity breaches in India over the past three years.

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Cloudbyz

FEBRUARY 8, 2021

Whether you’re kicking off your first trial or just migrating from excel to a more sophisticated system, you need to spend some time researching to find that ideal CTMS vendor for your business. But how do you determine which is the right CTMS vendor for your business? Picking the right vendor. Check for service and support.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

FEBRUARY 5, 2021

Whether you’re kicking off your first trial or just migrating from excel to a more sophisticated system, you need to spend some time researching to find that ideal CTMS vendor for your business. But how do you determine which is the right CTMS vendor for your business? Picking the right vendor. Check for service and support.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

JULY 20, 2022

In section 745A(a) of the FD&C Act, Congress granted FDA the authority to implement the Agency’s statutory electronic submission requirements in guidance. This recommendation is consistent with the efforts of Federal Agencies to transition their business processes and record-keeping to a fully electronic environment.

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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Cloudbyz

FEBRUARY 8, 2021

Whether you’re kicking off your first trial or just migrating from excel to a more sophisticated system, you need to spend some time researching to find that ideal CTMS vendor for your business. But how do you determine which is the right CTMS vendor for your business? An alignment of interest and focus with the CTMS vendor .

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Clinical Trials Clinical Trials Trials Research 52

XTalks

NOVEMBER 24, 2022

According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. Furthermore, it is a prohibited act to introduce…into interstate commerce under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C.

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XTalks

NOVEMBER 8, 2023

Food delivery startup Wonder Group has received a substantial financial boost from Nestlé, underscoring the company’s initiative to revolutionize the culinary landscape with state-of-the-art kitchen technology and pre-prepared ingredients catered to businesses like hotels, hospitals and sports arenas. There’s no gas,” Lore told CNBC.

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Marketing Medicine Production Development 59

pharmaphorum

SEPTEMBER 29, 2022

Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act. About the author.

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The Pharma Data

APRIL 11, 2023

Key presentations on Bayer research to be presented at AACR 2023 are listed below: Oral presentation: BAY 2965501: A highly selective DGKzeta inhibitor for cancer immuno-therapy with first-in-class potential Abstract ND04, Session DDT001 – New Drugs on the Horizon: Part 1 Sunday, April 16, 2:05 PM – 2:20 PM (EDT), Tangerine Ballroom 2 (WF2) – (..)

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BioTech 365

AUGUST 24, 2020

LONDON–(BUSINESS WIRE)–Aimmune Therapeutics, Inc.

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Allergies Development 52

XTalks

JULY 12, 2022

Meanwhile, Kellogg’s recently announced plans to separate into three independent public companies, sectioning off its iconic brands into distinct snacking, cereal and plant-based businesses. The company said it is exploring further strategic alternatives, including a potential sale, for its plant-based business.

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Branding Containment Production Sales 96

World of DTC Marketing

SEPTEMBER 7, 2022

According to JAMA , “in a cross-sectional study, between May 1, 2016, and May 31, 2021, there were 207 cancer drug approvals in oncology and malignant hematology. The post The current pharma business model is unsustainable appeared first on World of DTC Marketing.com. The biggest battle arena by far is oncology. ” The U.S.

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Pharma Companies Marketing Drugs Production 210

pharmaphorum

OCTOBER 31, 2022

Getting this right will help deliver accurate and reliable insights to help support business objectives and drive brand or company growth, highlight risk, and quantify opportunity. In addition, a model that does not align with the business decision it supports brings little value. What to do. 3: A model designed for everyone.

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Drug Discovery World

FEBRUARY 8, 2024

Andrea O’Hara, PhD, Strategic Technical Specialist, Azenta Life Sciences led the presentation and was joined by Elizabeth Louie, PhD, Supervisor, Technical Applications, Xiangying Mao, PhD, Team Lead, Bioinformatics, and Crystal Richardson, PhD, Business Partnership Manager – all Azenta Life Sciences – for the questions section.

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Gene Therapy Gene Bioinformatics Life Science 59

The Pharma Data

DECEMBER 1, 2020

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. In order to listen to the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. 2, 2020 11:05 UTC.

FDA Approval 52

FDA Approval Development 52

pharmaphorum

OCTOBER 13, 2020

Ayming surveyed a combination of 330 business executives and R&D managers from 13 countries across North America and Europe. The report covers three sections: The Innovation Landscape, Financing Innovation and Sustainable Innovation. However, the report points out that businesses often underestimate what it takes to collaborate.

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Production Development Regulation Marketing 114

Pharma Marketing Network

OCTOBER 18, 2023

It is becoming increasingly important for businesses to have a website that is mobile-friendly, as more and more people are using mobile devices to access the internet. Additionally, the website should be designed to be easily navigable, with clear and concise menus and sections.

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Engineer Development Marketing 52

The Pharma Data

OCTOBER 26, 2020

NYSE: AVNS) will webcast its conference call discussing financial results and business highlights for the third quarter 2020 on Tuesday, Nov. A simultaneous webcast of the call and a related presentation will be accessible via the Investors section of the Avanos Medical website, [link]. ALPHARETTA, Ga. , 3 at 9 a.m.

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The Pharma Data

APRIL 14, 2021

The Offeror will publicly announce the results of the Post-Closing Acceptance Period and the total number and total percentage of Shares held by it in accordance with Section 17, paragraph 4 of the Decree ultimately on the third Business Day following the last day of the Post-Closing Acceptance Period. Source link:[link].

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The Pharma Data

OCTOBER 20, 2020

–( BUSINESS WIRE )– Cardiovascular Systems, Inc. To access the live webcast, go to the events section of CSI’s investor relations website, [link] , on the day of the conference, and click on the webcast link. 21, 2020 11:00 UTC. PAUL, Minn.–( CT (4:30 p.m. A webcast replay will be available beginning at 6:30 p.m.

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The Pharma Data

OCTOBER 27, 2020

LOS ANGELES–( BUSINESS WIRE )– ChromaDex Corp. Investor Conference Call: ChromaDex management will host an investor conference call to discuss the third quarter results and provide a general business update on Wed., 28, 2020 10:35 UTC. NASDAQ:CDXC) announced that it will hold a conference call on Wed.,

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FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA recently shared some statistics on the impact of ASCA during the FDA Small Business Regulatory Education for Industry (REdI) Annual Conference held on June 5-9, 2023.

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The Pharma Data

OCTOBER 21, 2020

ET to report its third quarter 2020 financial results and other business highlights. A live webcast can be accessed under “Events & Presentations” in the Investors section of the company’s website at www.agios.com.

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Genetic Disease Genetics Medicine Development 52

Advarra

MARCH 5, 2024

When working with Advarra, your best source for this kind of information is the IRB Handbook, available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform. While these examples are unique to Advarra’s IRB, they were developed based on best practices and in consultation with other IRB professionals.

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Regulation Research Clinical Research Compliance 52

Drug Discovery World

OCTOBER 3, 2023

Andrea O’Hara, PhD, Strategic Technical Specialist, Azenta Life Sciences led the presentation and was joined by Elizabeth Louie, PhD, Supervisor, Technical Applications, Xiangying Mao, PhD, Team Lead, Bioinformatics, and Crystal Richardson, PhD, Business Partnership Manager – all Azenta Life Sciences – for the questions section.

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Gene Therapy Gene Life Science Bioinformatics 52

The Pharma Data

JANUARY 7, 2021

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. EST. In order to listen to the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. 8, 2021 11:05 UTC.

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FDA Approval Clinical Trials Clinical Trials Development 52

pharmaphorum

OCTOBER 28, 2020

In July 2020, the company closed a $257m series B funding round, led by Casdin Capital and Section 32. Exact Sciences Cologuard business also received a boost from updated guidelines released by the United States Preventive Services Task Force. The start-up uses DNA methylation analysis to detect cancer in its early stages.

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The Pharma Data

OCTOBER 27, 2020

–( BUSINESS WIRE )– Five Prime Therapeutics, Inc. PT) to provide a general business update and discuss the company’s financial results. The live audio webcast may be accessed through the “Events & Presentations” page in the “Investors” section of the company’s website at www.fiveprime.com.

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Pharma in Brief

JANUARY 10, 2024

The Supreme Court of Canada dismissed an application for leave to appeal a decision affirming that innovators are not liable beyond damages under section 8 of the Regulations for the legitimate exercise of their rights under the Regulations (see here ). Section 8 damages refused. Artificial intelligence.

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FDA Law Blog

SEPTEMBER 28, 2023

333(a)(2): “[I]f any person commits such a violation after a conviction of him [of a prohibited act listed in section 331] has become final, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.” See FDC Act § 303(a)(2), 21 U.S.C. §

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FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

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Manufacturing Production Drugs Marketing 59

The Pharma Data

JANUARY 10, 2021

–( BUSINESS WIRE )– Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod ® Insulin Management System, today announced plans to release its financial results for the fourth quarter and full year of 2020 on February 23, 2021 after the close of the financial markets.

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Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). FDA Guidance Addresses Real-World Evidence Data Standards. Emphasis in the original).

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XTalks

MAY 11, 2023

Webinar accessibility is not only ethical but also a sound business practice. This can include cutting out sections that are not relevant, adding transitions and color correction. Once your webinar is posted, it will appear in the on-demand sections of xtalks.com.

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