Day: 2 November 2023

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Fortrea Completes Expansion of Clinical Pharmacology Solutions Following Targeted Investments at its Four Clinical Research Units in U.S. and U.K.

Adds speed and agility with cGMP production at on-site pharmacies, adds capacity, improves flexible therapeutic capabilities and enhances experience for study volunteers

DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced that it has completed a multi-year effort to expand its clinical pharmacology solutions and capacity, which are now fully available for customers. The expansion includes a 100,000 square feet state-of-the-art facility in Leeds, U.K. as well as approximately 20,000 square feet of new or renovated space, adding capacity and capabilities across its clinical research units (CRUs) in Dallas, Texas; Daytona, Florida; and Madison, Wisconsin.

“The increasing complexity of clinical pharmacology studies demands fit-for-purpose infrastructure, experience and expertise to protect the safety of study participants and the integrity of critically important data,” said Oren Cohen, M.D., Fortrea’s president of Clinical Pharmacology and chief medical officer. “Our integrated platform of services includes best-in-class infrastructure and experienced professionals who are fully dedicated to clinical pharmacology, including physicians, nurses, clinical scientists, CRAs and pharmacokineticists. The investments we have made target the capabilities and capacity that customers need to accurately assess early pipeline candidates and speed those with promise to later-phase development and ultimately to patients who need them.”

Facility enhancements following the completed expansion include Fortrea’s new CRU in Leeds as well as purpose-built rooms in Madison and Daytona designed for flexibility in executing complex early phase clinical studies. Improvements in recreational, living and “work-from-home” spaces at Fortrea CRUs have been constructed to enhance the experience of volunteers participating in research at the sites.

The expansion of Fortrea’s early clinical development pharmacy services facilities includes new state-of-the-art cGMP pharmacies in the Leeds and Daytona CRUs. All Fortrea CRUs will now have cGMP pharmacies within them. This enables on-site manufacture of sterile and non-sterile drug product. The design of its GMP-compliant facilities provides safe handling and delivery of GMP-quality drug product for the unique demands of clinical pharmacology studies, focusing on efficiency and flexibility with the level of controls expected by regulatory authorities and sponsors.

Enhancements in science and technology include the addition of artificial intelligence-enabled programs that optimize bed space utilization and clinic scheduling, and the application of failure modes and effects analysis to de-risk study execution before a study begins. Following investments in data collection systems, all clinical pharmacology study data collected within Fortrea’s CRUs are input directly into a digital bedside data capture system, which can also be used as an efficient electronic data capture solution.

“I believe Fortrea’s early clinical development solutions set a new standard for what the research industry should expect from its partners,” said Dr. Cohen. “I’m so proud of this team and know they will also benefit from the changes we have made. Just as they are inspired by our mission of bringing life-changing treatments to patients faster, I’m inspired by their dedication each day as we deliver solutions to our customers.”

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services.

Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Cautionary Statement Regarding Forward-Looking Statements

Some of the statements in this press release, particularly those relating to the anticipated financial and other benefits, including, but not limited to, whether the investments at clinical research units in U.S. and U.K. will add capacity, improve therapeutic capabilities, enhance experience for study volunteers, speed development to later-phase trials and improve the integrity of data and whether the addition of artificial intelligence-enabled programs will optimize bed space utilization and clinic scheduling, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Actual results could differ materially from expectations expressed or implied in the forward-looking statements if one or more of the underlying assumptions or expectations prove to be inaccurate or are unrealized. Important factors that could cause actual results to differ materially from such expectations are and will be detailed in Fortrea’s registration statement on Form 10 initially filed with the SEC on May 15, 2023 (as amended and further supplemented), Fortrea’s quarterly report on Form 10-Q filed with the SEC on August 14, 2023, and in Fortrea’s other filings with the SEC. These forward-looking statements are based on management’s current expectations and are subject to certain risks, uncertainty and changes in circumstances. Fortrea does not undertake responsibility for updating these statements, and these statement speak only as of the date of this press release.

Fortrea Contacts:

Fortrea Media: Sue Zaranek – 919-943-5422, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com
Fortrea Investors: Hima Inguva – 877-495-0816, hima.inguva@fortrea.com

GlobeNewswire Distribution ID 8971131

Posted on

Fortrea Completes Expansion of Clinical Pharmacology Solutions Following Targeted Investments at its Four Clinical Research Units in U.S. and U.K.

Adds speed and agility with cGMP production at on-site pharmacies, adds capacity, improves flexible therapeutic capabilities and enhances experience for study volunteers

DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced that it has completed a multi-year effort to expand its clinical pharmacology solutions and capacity, which are now fully available for customers. The expansion includes a 100,000 square feet state-of-the-art facility in Leeds, U.K. as well as approximately 20,000 square feet of new or renovated space, adding capacity and capabilities across its clinical research units (CRUs) in Dallas, Texas; Daytona, Florida; and Madison, Wisconsin.

“The increasing complexity of clinical pharmacology studies demands fit-for-purpose infrastructure, experience and expertise to protect the safety of study participants and the integrity of critically important data,” said Oren Cohen, M.D., Fortrea’s president of Clinical Pharmacology and chief medical officer. “Our integrated platform of services includes best-in-class infrastructure and experienced professionals who are fully dedicated to clinical pharmacology, including physicians, nurses, clinical scientists, CRAs and pharmacokineticists. The investments we have made target the capabilities and capacity that customers need to accurately assess early pipeline candidates and speed those with promise to later-phase development and ultimately to patients who need them.”

Facility enhancements following the completed expansion include Fortrea’s new CRU in Leeds as well as purpose-built rooms in Madison and Daytona designed for flexibility in executing complex early phase clinical studies. Improvements in recreational, living and “work-from-home” spaces at Fortrea CRUs have been constructed to enhance the experience of volunteers participating in research at the sites.

The expansion of Fortrea’s early clinical development pharmacy services facilities includes new state-of-the-art cGMP pharmacies in the Leeds and Daytona CRUs. All Fortrea CRUs will now have cGMP pharmacies within them. This enables on-site manufacture of sterile and non-sterile drug product. The design of its GMP-compliant facilities provides safe handling and delivery of GMP-quality drug product for the unique demands of clinical pharmacology studies, focusing on efficiency and flexibility with the level of controls expected by regulatory authorities and sponsors.

Enhancements in science and technology include the addition of artificial intelligence-enabled programs that optimize bed space utilization and clinic scheduling, and the application of failure modes and effects analysis to de-risk study execution before a study begins. Following investments in data collection systems, all clinical pharmacology study data collected within Fortrea’s CRUs are input directly into a digital bedside data capture system, which can also be used as an efficient electronic data capture solution.

“I believe Fortrea’s early clinical development solutions set a new standard for what the research industry should expect from its partners,” said Dr. Cohen. “I’m so proud of this team and know they will also benefit from the changes we have made. Just as they are inspired by our mission of bringing life-changing treatments to patients faster, I’m inspired by their dedication each day as we deliver solutions to our customers.”

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services.

Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Cautionary Statement Regarding Forward-Looking Statements

Some of the statements in this press release, particularly those relating to the anticipated financial and other benefits, including, but not limited to, whether the investments at clinical research units in U.S. and U.K. will add capacity, improve therapeutic capabilities, enhance experience for study volunteers, speed development to later-phase trials and improve the integrity of data and whether the addition of artificial intelligence-enabled programs will optimize bed space utilization and clinic scheduling, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, many of which are beyond the Company’s control. Actual results could differ materially from expectations expressed or implied in the forward-looking statements if one or more of the underlying assumptions or expectations prove to be inaccurate or are unrealized. Important factors that could cause actual results to differ materially from such expectations are and will be detailed in Fortrea’s registration statement on Form 10 initially filed with the SEC on May 15, 2023 (as amended and further supplemented), Fortrea’s quarterly report on Form 10-Q filed with the SEC on August 14, 2023, and in Fortrea’s other filings with the SEC. These forward-looking statements are based on management’s current expectations and are subject to certain risks, uncertainty and changes in circumstances. Fortrea does not undertake responsibility for updating these statements, and these statement speak only as of the date of this press release.

Fortrea Contacts:

Fortrea Media: Sue Zaranek – 919-943-5422, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com
Fortrea Investors: Hima Inguva – 877-495-0816, hima.inguva@fortrea.com

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UN Committee on the Rights of the Child condemns Israel’s targeting of children in Gaza

The UN Committee on the Rights of the Child has expressed its outrage at the Israeli occupation’s grave human rights violations against children in the Gaza Strip, saying there are no winners in a war where thousands of children are killed. The Committee strongly condemned in a press statement “the escalation of attacks by Israel against civilian targets in the Gaza Strip, which had resulted in the deaths of more than 3,500 children since 7 October 2023.” “Despite the protection that should be provided to all children by international law,” the statement added, “during the first month of this war, there have been devastating reports of acts that are forbidden by international humanitarian law, including maiming, injury, forcible displacement, deprivation of medical care, food, and water.” The Committee called for an end to the devastating harm being wreaked on children’s lives in the occupied Palestinian Territory, calling for an immediate ceasefire in Gaza to save innocent lives. The Committee also pleaded for all humanitarian convoys be permitted to enter the Gaza Strip and provide humanitarian aid to all children in need, as required by international law.

Source: En – Palestine news & Information Agency – WAFA

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Saudi Foreign Minister, Colombian Counterpart Discuss Developments in Gaza

Doha, – Saudi Minister of Foreign Affairs Prince Faisal bin Farhan bin Abdullah discussed in a telephone call with his Colombian counterpart Alvaro Leyva Duran the developments in Gaza and its surroundings.

During the phone call, the two sides discussed the continuing military escalation and the harm to the defenseless civilians. They also discussed the need for the international community to fulfil its responsibility to stop all military actions and return to the path of just and comprehensive peace for the Palestinian issue, in a way that achieves international peace and security.

Source: Qatar News Agency

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Kuwait-based charities ramp up Gaza aid amid Israeli attacks

By Salman Al-Mutairi KUWAIT, – Kuwait-based charities are ratcheting up humanitarian aid for the Gaza Strip as the death toll from continued Israeli attacks on the densely-populated Palestinian enclave remains on an upward trajectory.

Kuwait’s response to the humanitarian crisis unfolding in the Gaza Strip was prompt, being one of the first countries to provide urgent aid there, Al-Najat charity’s public relations chief Abdullah Al-Shehab said.

Speaking to KUNA, he pointed out that more than 36,000 Palestinians have been the beneficiaries of such assistance.

Another Kuwaiti charity, Al-Nama, said it was quick to respond with aid as well, providing the Palestinians in Gaza with assistance running the gamut from healthcare supplies to urgent daily essentials, according to its technological department head Abdulaziz Al-Kanderi.

Kuwait’s Al-Rahma Interanational was also among the local aid bodies to provide assistance, saying its aid supplies included providing food and water to Palestinians suffering from shortages there, its deputy telecommunications chief Dr. Adnan Al-Hadad said.

Also speaking to KUNA, he acknowledged the efforts of state bodies in facilitating the aid to Gazans, in line with the country’s long-standing penchant for humanitarian endeavors.

Source: Kuwait News Agency

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Kuwait DM, US counterpart discuss latest developments

KUWAIT, – Kuwaiti Deputy Prime Minster and Minister of Defense Sheikh Ahmad Fahad Al-Ahmad Al-Sabah received on Thursday a phone call from US Secretary of Defense Lloyd J. Austin to discuss the latest development in Palestine.

In a press release, the Ministry of Defense said that both sides discussed bilateral ties, ways to enhance cooperation between Kuwait and the US, topics of common interests and latest regional and international developments.

During the phone call, the Kuwaiti defense minister affirmed the necessity for an immediate action to lift off the siege on Gaza, to end the unjustified military operations and to work on facilitating the entry of humanitarian aid to the Palestinian people.

Source: Kuwait News Agency

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Russia pres. signs bill to revoke ratification of nuclear test ban treaty

MOSCOW, – Russian President Vladimir Putin signed a bill revoking Russia?’s ratification of the Comprehensive Nuclear Test Ban Treaty (CTBT), ratified by 183 countries, excluding the US.

According to the Russian presidency website, this step is important in protecting the security of Russia, and is a proper response to the US, which does not wish to ratify the treaty.

Last month, the Russian parliament approved the revoking of the ratification, while ensuring that Russia is still a member in the treaty.

The treaty, issued by the UN in 1996, was ratified by 183 countries out of 193 who signed the treaty. There are 13 countries who did not join the treaty yet.

Source: Kuwait News Agency

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Israeli occupation kills Palestinian in West Bank, death toll up to 134

RAMALLAH, – Palestinian Health Ministry said that a Palestinian man was killed in clashes with Israeli occupation forces, raising the number of deaths in the West Bank on Thursday to four.

This raises the number of Palestinians killed by Israeli aggression force in the West Bank to 134, since October 7.

Meanwhile, Gaza health authorities announced that the death toll from the Israeli attacks reached 9,061, among them 3,760 children and 2,326 women, as well as 32,000 injured.

They added that the Israeli occupation force executed 15 massacres in the past 24 hours, killing 256 Palestinians.

They called for providing a safe passage to urgently deliver medical aid to the strip, warning of a nearing health catastrophe as power is about to run out at Al-Shifa Hospital.

In the same context, Gaza officials said that they had retrieved the bodies of 27 Palestinians who were buried under rubble, after Israeli forces attacked a school in Jabalia camp.

Source: Kuwait News Agency

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Iraq Participates In The 37 Arab Conference of Heads of Anti-Narcotics Agencies

Baghdad / NINA/- Major General Ahmed Al-Zarkani, Director General of Narcotics and Psychotropic Substances Affairs, participated in the 37th Arab Conference for Heads of Arab Anti-Narcotics Agencies, which was organized by the General Secretariat of the Council of Arab Interior Ministers, in the presence of the Secretary-General of the Council of Arab Interior Ministers, Dr. Muhammad bin Ali Koman.

During the conference, which was attended by representatives of the ministries of interior in Arab countries, the United Nations Office on Drugs and Organized Crime, the International Criminal Police (Interpol), and the General Secretariat of the Council of Arab Interior Ministers, according to the directorate’s statement, a number of topics related to strengthening cooperation in drug prevention and control and the experiences of member states participated and their plans in the field of combating drugs and psychotropic substances and international developments in the field of drugs.

Source: National Iraqi News Agency

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Al-Mohammadawi: The Popular Mobilization Forces Enters A State Of Alert (C) Starting Today

Baghdad / NINA/- The Chief of Staff of the Popular Mobilization Forces, Abdul Aziz Al-Muhammadawi, announced that the Popular Mobilization Forces units have entered a state of alert (C) starting today.

A statement by the Popular Mobilization Commission stated that the Popular Mobilization Commission held an expanded meeting headed by the PMF’s Chief of Staff, Abdulaziz al-Muhammadawi, and in the presence of the Secretary-General, the Secretary, operations commanders, commanders of brigades and formations, and directors of the PMF’s supporting ranks.

The statement explained that at the beginning of the meeting, the PMF’s Chief of Staff praised the results achieved by the Al-Aqsa Flood epic, which defeated the myth of the defeated entity and confirmed the fact that it was weaker than a spider’s web and put its military and security agencies in a state of confusion and shock, despite the passage of nearly a month since that heroic operation.

The Chief of Staff also renewed his condemnation and denunciation of the crimes and massacres of the Zionist occupation against our defenseless Palestinian people in the Gaza Strip and the tragic situation there as a result of the occupation’s practices, praising the statement of the Supreme Religious Authority in supporting the cause of the Palestinian people and the positions of the Iraqi government and the Prime Minister in solidarity, support and sending aid, as well as the rest of popular and community activities denouncing the brutal aggression against our people in Gaza remain steadfast.

During the meeting, the most prominent security developments and challenges in various sectors of operations were reviewed, and the extent of the high readiness enjoyed by the Popular Mobilization Forces, along with the rest of the security sectors, to maintain the state of great security stability that Iraq is witnessing.

The Chief of Staff directed that the state of maximum alert be raised in preparation to deal with any emergency in the coming days and to emphasize the high readiness of all our fighters in the various sectors and formations and the full readiness to defend the country’s sovereignty and national borders.

On the occasion of the one-year anniversary of the formation of the National Service Government, the attendees praised the support given by the Prime Minister, Commander-in-Chief of the Armed Forces to the security file, which culminated in important achievements represented by building the capabilities of our security forces and contributed to continuing to destroy strongholds of terrorism and overthrowing terrorists and wanted persons.

Source: National Iraqi News Agency

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The President Of The Republic Receives The Credentials Of The Ambassadors Of Azerbaijan And Armenia

Baghdad – Today, Thursday, at Baghdad Palace, the President of the Republic, Abdul Latif Jamal Rashid, received the credentials of the Ambassador of the Republic of Azerbaijan, Naseer Natiq Mammadov, and the Ambassador of the Republic of Armenia, Misak Balasanyan.

According to a presidential statement, the President of the Republic expressed his wishes to the two ambassadors for success in performing their diplomatic duties in a way that improves relations with their countries in areas of common interest.

According to the statement, the two ambassadors conveyed to the President of the Republic the greetings and appreciation of the President of the Republic of Azerbaijan, Ilham Aliyev, and the President of the Republic of Armenia, Vahagen Khachaturian, and their wishes for him good health and success, and for the people of Iraq further progress.

Source: National Iraqi News Agency

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PM Directs The Necessity Of Preparing Accurate Statements And Conducting Laboratory Tests During Implementing Projects

Baghdad – Prime Minister Muhammad Shiaa Al-Sudani directed the necessity of preparing accurate statements and conducting laboratory tests during implementation to obtain the required specifications and implementation standards, while adhering to all the observations of the consulting body represented by the Engineers Syndicate.

A statement from his media office stated that Al-Sudani chaired, this morning, Thursday, a meeting of the service and engineering effort team, in the presence of the Governor of Baghdad and the head of the Board of Advisors in the Office of the Prime Minister.

The statement said, “During the meeting, the completion rates of projects for the year 2023 were studied, according to the plan prepared in advance, and in light of the financial allocations for each service sector or ministry, and the completion rates in Baghdad and governorate projects were reviewed.”

According to the statement, Al-Sudani reviewed the team’s work process in the first year of the government’s life, in which the service and engineering effort, despite its limited allocations, became a distinctive feature of its work, and represented a glimmer of hope for many residents of unserved areas, and strengthened trust between the citizen and the state. He appreciated the efforts made to serve poor areas, and praised everyone who contributed to this distinguished experience.”

The Prime Minister stressed the importance of choosing the projects on the basis of which this team was formed, and not getting involved in projects that represent the core of infrastructure, which are currently being implemented by ministries and governorates, stressing the completion of municipal services projects and roads, including schools and health centers in the targeted areas.

Al-Sudani also directed, according to the statement, the necessity of preparing accurate statements and conducting laboratory tests during implementation to obtain the required specifications and implementation standards, while adhering to all the observations of the consulting body represented by the Engineers Syndicate.”

Source: National Iraqi News Agency