H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game. Here is what they learned.

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The Premier Consulting Blog

NOVEMBER 12, 2023

In 2019, the FDA published a discussion paper on a proposed regulatory framework for modification to AI/ML-based software as a medical device (SaMD), which received a significant amount of feedback from stakeholders. FDA Discussions As a result of the feedback received in 2019, the FDA outlined the five-pillar approach to regulating AI/ML.

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Drug Target Review

SEPTEMBER 4, 2023

17 Drug target site Kinase targets have been addressed by the pharmaceutical industry and offer the potential for the development of new drugs in several therapeutic areas with kinases and/or phosphatases according to this report. 2019): CRISPR in Parasitology: Not Exactly Cut and Dried! References: Antunes Luisa (2023). Sebastian, B.,

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. CHATHAM, N.J., Holding Corp. 175:1091-1101 (1992) 2 Karpusas, M et al.,

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The Pharma Data

APRIL 28, 2021

NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., The acquisition of Amplyx follows an initial equity investment by Pfizer in December 2019 as part of Amplyx’s Series C financing. Opportunity to advance Pfizer’s expertise and deep heritage in infectious disease.

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Providing a broad view.

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. ” About Hepion Pharmaceuticals. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases. Source link.

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The Pharma Data

NOVEMBER 19, 2020

In 2019, 95 000 AIDS-related deaths occurred in children, two-thirds of those deaths in 21 focus countries. In 2019, 95 000 AIDS-related deaths occurred in children, two-thirds of those deaths in 21 focus countries. In 2019, an estimated 36 000 children who were. 850 000 children living with HIV were not.

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Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. 22:669-679 (2019). Pharmaceutics. Pharmaceutics. TS has been studied through the generation of “assembloids”, glutamatergic and GABAergic organoids fused together. Nature Neuroscience. link] Giorgi C, et al.

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The Pharma Data

NOVEMBER 5, 2020

05, 2020 (GLOBE NEWSWIRE) — Collegium Pharmaceutical, Inc. Nasdaq: COLL), a specialty pharmaceutical company committed to being the leader in responsible pain management, today reported its financial results for the quarter ended September 30, 2020 and provided a corporate update. million for the 2019 Quarter and $44.5

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The Pharma Data

DECEMBER 28, 2020

” About Hepion Pharmaceuticals. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. SOURCE: Hepion Pharmaceuticals, Inc. .

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The Pharma Data

AUGUST 31, 2020

one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has agreed in principle to supply the Government of Canada with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S. Company working to ensure broad Canadian access to COVID-19 vaccine candidate, following approval from Health Canada.

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The Pharma Data

AUGUST 19, 2020

August 19, 2020 – Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. NEW BRUNSWICK, N.J.,

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Drug Discovery World

MARCH 29, 2023

The commission is proposing the introduction of temporary emergency marketing authorisations 1. Extra foreign inspections Since July 2019, the MRA (Mutual Recognition Agreement) between the EU and the US FDA has been fully in force. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

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Agency IQ

NOVEMBER 3, 2023

Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. See AgencyIQ’s analysis of the proposed regulation.] wide level.

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Drug Target Review

MARCH 6, 2024

LSD1 demethylates histones which play a critical role in regulating the expression of genes that suppress differentiation and drive the proliferation and survival of several tumour types.

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Agency IQ

JULY 5, 2023

What we expect the EPA to do in July 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. The integration of technology in healthcare not only promises advancements but also raises concerns about security, regulation and potential disparities in access.

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Agency IQ

DECEMBER 15, 2023

Shortages increased by 60% between 2017 and 2019 in select European countries, the U.S., In 2020, the European Commission adopted the Pharmaceutical Strategy for Europe , noting that medicines shortages “have been a serious concern in the EU for several years.” See AgencyIQ’s analysis of the proposed regulation here.]

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. August 05, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. New Brunswick, N.J., Learn more at www.jnj.com.

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The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. In September 2019 , the New Drug Application (NDA) of Chiglitazar Sodium was accepted by Center for Drug Evaluation.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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The Pharma Data

AUGUST 19, 2020

19, 2020 /PRNewswire/ — Johnson & Johnson (NYSE:JNJ) today announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. NEW BRUNSWICK, N.J. ,

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The Pharma Data

FEBRUARY 25, 2021

Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

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The Pharma Data

FEBRUARY 25, 2021

In March 2019, Merck Animal Health invested in Poultry Sense Ltd., In December 2019, the company acquired Vaki, a leader in fish farming and wild fish conservation monitoring equipment and real-time video monitoring technology to advance fish health and welfare. Kenilworth, N.J., from its founding shareholders. Poultry Sense Ltd.

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New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] June 2019). “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. 1] It is taken by mouth. [1] 20 (4): 413–420.

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The Pharma Data

AUGUST 5, 2020

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. NEW BRUNSWICK, N.J., Follow us at @JNJNews.

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The Pharma Data

AUGUST 18, 2020

In this role, we are helping bring together Europe’s best and brightest scientific minds from 37 renowned academic institutions, research organizations and pharmaceutical companies, together with partners from the United States and China. Source link.

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The Pharma Data

SEPTEMBER 9, 2020

Additional applications are under review with numerous regulators, including in the EU and China. Results from the SAkuraSky study were published in the November 28, 2019 edition of the New England Journal of Medicine (NEJM). Applications are under review with numerous regulators, including in the EU and China. Europe and Japan.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth). During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn. This press release features multimedia.

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The Pharma Data

JANUARY 19, 2021

Prior to joining Ipsen, Gwenan was the Global Head of Pharma Communications and Patient Advocacy at Novartis Pharmaceuticals. billion in 2019, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen also has a well-established Consumer Healthcare business. Source link.

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The Pharma Data

MAY 15, 2023

Before joining Nestlé he served as CFO at Takeda Pharmaceuticals, one of the largest publicly listed companies in Japan, between 2013 and 2015, and CFO at Millicom, a NASDAQ listed global mobile phone operator based in Luxembourg, between 2008 and 2013. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

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The Pharma Data

NOVEMBER 3, 2020

Infringement litigation against Sun Pharmaceutical was commenced in response to Sun Pharmaceutical, that has filed an Abbreviated New Drug Application with the US FDA for ZUBSOLV® in the US. 2019 Jul-Sep. 2019 Jan-Sep. -35%.

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Drug Discovery World

JULY 11, 2022

As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. For regulatory purposes, they may be treated more like a pharmaceutical or a blood product. 2019,January 15). A quality system that is set up to handle both is required.

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Drug Discovery World

APRIL 14, 2023

as a master regulator of prostate differentiation and cancer initiation and progression, for generating unique and reliable murine bladder and prostate cancer models, and for steadfast commitment to serving as a leader, mentor, and supporter of women in cancer research. Mak’s award lecture will be held on Sunday April 16 at 12pm ET.

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The Pharma Data

OCTOBER 27, 2020

Pharmaceutical-Grade Hand Sanitizer Available for Sale Across Canada. According to Statista.com in late 2019, e-commerce retail trade sales amounted to almost 1.85 DermSafe is a pharmaceutical-grade hand sanitizer lotion made without alcohol and backed by science. The product listing offered on Amazon.ca

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The Pharma Data

AUGUST 24, 2020

TGF-beta is a key cytokine that regulates various cell processes, including regulation of the immune system. In contrast, TGF-beta 2 is a positive regulator of hematopoiesis and normal cardiac function, and blockade of TGF-beta 2 is therefore undesirable. AVID200 neutralizes TGF-beta 1 and -beta 3 with picomolar potency.

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