Pharmaceutical Technology

MARCH 14, 2023

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years.

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Vaccination Vaccine Clinical Trials Clinical Trials 286

Pharmaceutical Technology

APRIL 19, 2023

This proposed acquisition complements our portfolio of speciality medicines and builds on our expertise in respiratory therapies.” Subject to approval from regulatory agencies, the transaction is anticipated to be completed in the third quarter of 2023 at the latest.

Medicine 243

Medicine Sales Clinical Development Trials 243

XTalks

MARCH 21, 2024

percent from the previous year’s funding, the FDA food budget for 2025 sets a clear path for the agency’s priorities in safeguarding human and animal health. Moreover, a $2 million increase is dedicated to agency modernization activities, focusing on business process improvements and data optimization.

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Cosmetics Production Regulation Manufacturing 52

Pharmaceutical Technology

JUNE 5, 2023

PharmaEssentia founder and CEO Ko-Chung Lin stated: “Expanding our geographic reach is critical to our mission to address clear gaps in therapeutic options for people with myeloproliferative neoplasms (MPNs). This regional expansion is a logical extension of our growing leadership in the Americas, led by Meredith Manning.”

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Marketing Licensing Licensing Sales 130

Pharmaceutical Technology

APRIL 17, 2023

The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Pfizer also stated that RSV is the most common respiratory viral pathogen among young children and infants.

Vaccination 162

Vaccination Vaccine Medicine Drugs 162

Intouch Solutions

APRIL 15, 2024

Today’s announcement comes following the October 2023 acquisition of Healthware Group , an agency and innovation consultancy headquartered in Salerno, Italy. The new affiliate will operate from multiple offices across Italy, Finland, the United Kingdom and the United States, focused on innovation, transformation and client delight. .

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Life Science Branding Marketing Production 52

Intouch Solutions

NOVEMBER 16, 2023

Ad maiora!” “It was truly magical to be together, in such a special place in our wonderful Rome,” said Michela D’Amelia, Client Services Director, Healthware Group. “It Putting a face to a name and having a chance to connect face-to-face with our colleagues helps foster a stronger community and culture.

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Intouch Solutions

OCTOBER 12, 2023

To wrap up Q3, our U.S.-based Most importantly, these gatherings gave us time away from our desks to spend time with one another. At EVERSANA INTOUCH we value building relationships with one another and keeping our one-of-a-kind culture alive. Visit our careers page  and join our team!

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Pharmaceutical Technology

FEBRUARY 23, 2023

This collaboration will enable us to utilise our cutting-edge GMP plasmid manufacturing platform technology to support the development of mRNA-based Covid-19 vaccine and its therapeutic candidates.” The GenScript ProBio team also offers consultative and expert guidance concerning the regulatory and quality expectations of agencies globally.

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Vaccination Vaccine Gene Therapy Manufacturing 289

Pharmaceutical Technology

MARCH 2, 2023

The European Medicines Agency (EMA) is also reviewing Reata’s marketing authorisation application (MAA) for SKYCLARYS in Europe. We are grateful to Friedreich’s ataxia patients, investigators, US regulators, and our scientists and employees who made this approval possible. “As

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FDA Approval Trials Genetics Drugs 264

Pharmaceutical Technology

MAY 10, 2023

“This designation also comes at a pivotal time as we prepare to initiate our Phase 3 trial for PKU – Synpheny-3 – in the first half of 2023.” SYNB1934 has also gained rare paediatric disease designation (RPDD) from the FDA and orphan drug designation from the European Medicines Agency (EMA).

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Genetic Engineering Drugs Engineer Genetics 261

STAT News

SEPTEMBER 13, 2022

The skies over the Pharmalot campus remain gloomy this morning, but our spirits are sunny, nonetheless. Our choice today is, once again, chocolate raspberry. The announcement comes as ARPA-H advocates debate where the multibillion-dollar agency should be headquartered and which elusive disease areas should be prioritized.

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Research Engineer Scientist 98

World of DTC Marketing

APRIL 8, 2022

When I go into depth and explain that their online paid media is losing money, they usually respond with, “why didn’t my agency tell me about this?” Any agency that uses impressions and even click-through rates as a KPI should be fired because they ddon’tmean a damn thing. ” That’s a good question.

Branding 199

Branding Marketing Drugs Production 199

Fierce Pharma

AUGUST 15, 2023

Responding to recent acquisition rumors, Stada Arzneimittel's CEO Peter Goldschmidt told the German Press Agency, “Whether and when STADA might be sold is solely the decision of our owners; Bain Capital and Cinven.”

Sales 89

Sales 89

Intouch Solutions

NOVEMBER 6, 2023

CHICAGO (November 6, 2023) – EVERSANA ®, a leading provider of commercial services to the global life sciences industry, today announced that its agency network, EVERSANA INTOUCH , has been named the Global Independent Pharma Agency of the Year by the London International Awards (LIA).

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Life Science Marketing Production 64

Intouch Solutions

DECEMBER 7, 2023

We are fortunate that our leadership at EVERSANA INTOUCH strives to grow and develop forward-thinking and innovative teams, all while keeping an eye on business growth and providing top-notch services to our clients. Looking to join our EVERSANA INTOUCH team? Check out the careers page to learn more.

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Branding Development Marketing 105

Intouch Solutions

DECEMBER 1, 2022

Finding an agency job after graduating college can feel overwhelming, but it doesn’t have to. Jumpstart your career at EVERSANA INTOUCH and be set up for success as part of our Account Incubator program where you can dip your toes into an Account Services role! It’s been amazing to experience just how people-centered this agency is.

Marketing 98

Marketing 98

Pharmaceutical Technology

MAY 22, 2023

The European Medicines Agency (EMA) has accepted and verified Sobi’s marketing authorisation application for a new factor VIII (FVIII), efanesoctocog alfa, to treat haemophilia A patients of all ages.

Marketing 217

Marketing Genetics Trials Medicine 217

Pharmaceutical Technology

MAY 9, 2023

Trevena president and CEO Carrie Bourdow stated: “We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from Olinvyk. “We The regulatory agency in China accepted the new drug application (NDA) for Olinvyk in January 2022.

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Clinical Trials Clinical Trials Trials Sales 130

Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera CEO Dr Shengfeng Li stated: “Bio-Thera is pleased to expand our partnership with Biomm to commercialise our ustekinumab biosimilar programme in Brazil. “By It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.

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Licensing Licensing Clinical Trials Clinical Trials 130

World of DTC Marketing

DECEMBER 8, 2020

SUMMARY: Pharma has been relying on digital agencies for too long but agencies can’t begin to understand your audience like brand team members. Having a brand digital marketer constantly communicating with digital agencies is a waste of time and money. Marketing Strategy Business concept. A VP is not a good start.

Branding 154

Branding Marketing Pharma Companies Development 154

Pharmaceutical Technology

MARCH 27, 2023

Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualised, one-time cell therapy for a solid tumor,” said Frederick Vogt, interim president and CEO of Iovance. Our preparations for commercialization remain on track to support a launch later this year.

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Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 1 (mRNA-1273.214) booster for usage in children aged six to 11 years.

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Gene Therapy Vaccination Vaccine Clinical Trials 304

Pharmaceutical Technology

APRIL 12, 2023

Panbela will lead the global trial protocol design and submit it to the US Federal Drug Administration (FDA) and European Medicines Agency (EMA) for agreement on the registration pathway. The trial will also be designed to show the potential efficacy and safety of Flynpovi in the treatment of patients with FAP.

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Pharmaceutical Technology

JUNE 8, 2023

The EC approval follows a positive opinion from the European Medicines Agency’s committee on medicinal products for human use (CHMP) in April 2023. Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch.”

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Vaccination Vaccine Marketing Manufacturing 147

Worldwide Clinical Trials

APRIL 3, 2024

Direct agency engagement is necessary, as well as working with a CRO with specialized knowledge in navigating the radiopharmaceutical regulatory process. For example, at Worldwide, we have a specific Radiopharmaceutical Feasibility questionnaire we use with our sponsors.

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Trials Clinical Trials Clinical Trials Compliance 183

Pharmaceutical Technology

JULY 6, 2022

The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in June this year. Novavax president and CEO Stanley Erck said: “With this authorisation, we are extremely pleased to be able to offer our Nuvaxovid Covid-19 vaccine to adolescents in the EU.

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Pharmaceutical Technology

JULY 28, 2022

If the regulatory agency accepts to review the NDA, Cidara anticipates a decision on the approval in the first quarter of next year. Melinta Therapeutics president and CEO Christine Ann Miller said: “The addition of rezafungin expands and diversifies our existing portfolio and serves as fuel for accelerating our long-term growth strategy. “By

Licensing 147

Licensing Licensing Clinical Trials Clinical Trials 147

World of DTC Marketing

AUGUST 5, 2020

Trade magazine awards don’t mean anything if one company makes a bad decision that stains our industry. Then there is the agency side. While most are OK some are so far off the mark that you can tell the agency wants their business just for the sake of business. First, let me say that I meant no disrespect.

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Vaccination Vaccine Pharma Companies Clinical Trials 180

STAT News

JULY 13, 2022

WASHINGTON — Two key senators say the FDA “appears to be on the brink of failing yet again at protecting our nation’s children,” because the agency has not yet taken action against certain illegal vaping companies despite a clear congressional directive to pull these products off the market.

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Production Marketing Drugs 98

Pharmaceutical Technology

MAY 24, 2023

This makes INO-3107 the first RRP product candidate to receive designations from both the EU and the US regulatory agencies.

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Drugs DNA Medicine Regulation 130

STAT News

DECEMBER 15, 2022

The four-hour hearing came as agencies, companies, and researchers face a fundamental mismatch: The virus is evolving faster than our ability to develop interventions under normal — or even normal emergency — procedures. Biotech executives and a handful of academics pleaded with U.S.

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Regulation Antibody Drugs Development 98

Pharmaceutical Technology

APRIL 6, 2023

Mirum Pharmaceuticals has submitted a marketing authorisation variation application to the European Medicines Agency (EMA) for expanding the use of LIVMARLI (maralixibat) to treat progressive familial intrahepatic cholestasis (PFIC) patients aged two months and above.

Genetics 130

Genetics Trials Medicine Marketing 130

Pharmaceutical Technology

APRIL 3, 2023

Additionally, the company intends to submit an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in 2023. The findings showed that fruquintinib treatment reduced the risk of death by 34%.

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Clinical Trials Clinical Trials Trials Development 130

Intouch Solutions

NOVEMBER 17, 2023

Our unique culture across EVERSANA, especially within our agency team at EVERSANA INTOUCH, is something we’re all proud of creating together and reflecting with our clients. And if you or someone you know is interested in joining the EVERSANA INTOUCH team, visit our Careers page for current openings.

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Intouch Solutions

SEPTEMBER 13, 2023

As summer comes to a close, we’re recapping a few of the employee virtual events hosted through our Virtual Vibes program. Hear from a few of our team members about their European summer virtual experiences: “I love all the Virtual Vibes events Michael puts together,” said Hillary Ruth Anderson, Sr. Project Manager.

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Development 105

Pharmaceutical Technology

DECEMBER 5, 2022

Mayne will oversee the development, the filings with regulatory agencies, and the production and marketing of the products following the closing of the deal. Mayne will make royalty payments of up to nearly $42.6m and further milestone payments of up to $30m.

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Licensing Licensing Production Marketing 130