Drug Discovery World

MAY 6, 2024

Europe is traditionally a life sciences powerhouse, with a strong tradition in pharmaceutical discovery. The oldest, still active pharmaceutical company worldwide, Merck, started life in 1668 in Darmstadt, Germany. Members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) spent €41.5 billion ($7.9

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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The Pharma Data

JANUARY 8, 2021

For example, pharmaceutical regulatory bodies are working tirelessly to fast track the approval of vaccines to treat Covid-19, doctors are now better prepared to handle patients with coronavirus and testing is becoming faster and more accessible. The New Year brings new hope as UK regulators approve Oxford vaccine for emergency use.

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The Pharma Data

MAY 7, 2021

Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). The US opened pandora’s box on IP waivers for Covid-19 vaccines. . In Focus: US. What happens now?

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The Pharma Data

JUNE 17, 2022

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. Ugur Sahin, M.D.,

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The Pharma Data

MARCH 2, 2021

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has entered into multiple agreements to support efforts to expand manufacturing capacity and supply of SARS-CoV-2/COVID-19 medicines and vaccines. Merck has also entered into agreements with Janssen Pharmaceuticals, Inc., About Merck.

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The Pharma Data

NOVEMBER 16, 2020

We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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H1 Blog

SEPTEMBER 26, 2023

ramps up for release of the latest COVID-19 vaccine booster, the Centers for Disease Control and Prevention (CDC) recommends that all Americans aged 6 months and older receive the updated COVID booster amid rising cases and hospitalizations across the country. Additionally, how do you ensure that the vaccine distribution is equitable?

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The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Preparations for the start of production, technology transfer and test runs are already underway.

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The Pharma Data

MARCH 25, 2021

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. The proposed supply agreement with the European Commission would represent the largest initial order of vaccine doses for Pfizer and BioNTech to date. billion doses by the end of 2021.

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The Pharma Data

APRIL 28, 2021

Initial agreement covers reservation of the large-scale state-of-the-art biologics facility in Singapore site for the production of the active pharmaceutical ingredient for Roche’s Actemra/RoActemra®. Follows recent initial agreements for providing manufacturing capacity for CureVac and BioNtech .

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Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products.

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Drug Discovery World

OCTOBER 9, 2023

Akin to a computer’s central processing unit, mitochondria orchestrate broad ranging processes pertaining to cellular health, including metabolism, energy, and immune regulation. In their paper, Guarnieri et al. Biography Bill Hinshaw joined Axcella as CEO in May 2018.

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The Pharma Data

JANUARY 24, 2021

(NYSE: MRK), known as MSD outside the United States and Canada, today announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. CHATHAM, N.J., Holding Corp. Cimzia® is a trademark of UCB S.

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The Pharma Data

APRIL 28, 2021

NYSE: PFE) announced today that it has acquired Amplyx Pharmaceuticals, Inc., We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Opportunity to advance Pfizer’s expertise and deep heritage in infectious disease.

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Agency IQ

DECEMBER 15, 2023

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.” The Pharmaceutical Strategy document notes that the Covid-19 pandemic compounded medicines shortages that had already impacted patient health and the E.U.

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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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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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The Pharma Data

MAY 27, 2022

.’ This groundbreaking initiative aims to provide all of Pfizer’s patented, high-quality medicines and vaccines available in the U.S. “As we learned in the global COVID-19 vaccine rollout, supply is only the first step to helping patients. or the European Union on a not-for-profit basis to 1.2

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The Pharma Data

APRIL 28, 2021

The launch of Cabenuva for HIV and Phase III starts for our RSV vaccine and a new long-acting treatment for severe asthma are key milestones as we continue to strengthen our growth prospects. Separation plans are also well underway and we look forward to sharing our strategy and growth outlook for New GSK with investors in June.”.

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The Pharma Data

MARCH 18, 2022

Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofi’s Board of Directors unanimously proposed, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI.

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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

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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Agency IQ

NOVEMBER 3, 2023

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. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

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The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. 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.

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Drug Discovery World

MARCH 29, 2023

International competitiveness The EFPIA’s reaction to the leak legislation includes concern about how Europe’s leading companies are reporting difficulties in researching and developing medicines and vaccines in Europe and their intent to take that research to the US and Asia 4. appeared first on Drug Discovery World (DDW).

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The Pharma Data

FEBRUARY 25, 2021

Our goal is to improve the detection of animal illness and enable more preventative solutions, including vaccination, to maintain the health of livestock. For 130 years, Merck, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases.

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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

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011. François-Xavier Roger, Chief Financial Officer of Nestlé S.A.,

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The Pharma Data

MAY 6, 2021

& OSAKA, Japan, May 6, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) will host a series of conference calls on May 11, 2021 to present financial results for the fourth-quarter and full-year of their fiscal year 2020, which ended March 31, 2021. CAMBRIDGE, Mass. & 5:15 p.m.

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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

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

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec. Diamyd Medical develops therapies for type 1 diabetes.

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The Pharma Data

JANUARY 26, 2021

(BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms.

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