US admits multiple molecular formulations effective in cardiovascular diseases

Recently, the chairman of the mega exhibition of the Pharmaceutical Export Promotion Council of India said that the US and other advanced countries which initially opposed benefits of multiple molecular formulations for cardiovascular and diabetic treatment, have now started realizing and accepting them The Indian pharmaceutical industry has been successful in engineering multiple molecular formulations for cardiovascular and diabetic treatment, which the US and other advanced countries had initially opposed.“When the Indian companies came out with multiple molecule formulations, the US and other advanced countries had vehemently opposed it but now they have started realizing and accepting the benefits of it,” Vijay Shah, the chairman of the mega exhibition of the Pharmaceutical Export Promotion Council of India.The seventh edition of this flagship exhibition of the Council, which showcases the best of Indian pharma capability to global buyers, will be held at the Mahatma Gandhi exhibition ground in the state capital Gandhinagar from June 10 to June 12. The union commerce ministry is sponsoring the event, providing for the travel and accommodation expenses of all the 738 buyers from across 130 countries, while the Gujarat government has provided the exhibition venue at subsidized rates.“Gujarat is the hub of pharmaceutical industry in India, with a share of about 30 per cent of the total exports. Recognizing this, we are holding this event for the first time in the state. This year, our focus is on the Medium and Small Enterprises (SMEs),” Shah said. The export promotion council’s Executive Director Raghuveen Kini said, “We will help the SMEs in resolving issues and hindrances faced by them in exporting their products abroad and participation in global pharma events.”“We are also sending delegations to Australia, New Zealand, China, Latin American countries like Mexico and Peru as well as CIS countries, including Russia, Belarus, Uzbekistan, Kazakhstan and Armenia,” Kini added. The Indian pharma industry is hoping for 15 per cent growth in exports over the previous years, Kini said. India is the third largest pharma exporter in the world and its export business is valued at over 19 billion US dollars.

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Cytel continues expansion of market access and medical communication capabilities with the acquisition of co.faktor

Business Wire | September 28, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support. Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization. “The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.” “Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.” About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia. About co.faktor For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.

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Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

GlobeNewswire | September 12, 2023

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TailorMed Partners with Eagle Pharmaceuticals to Streamline Patient Financial Assistance Enrollment

Business Wire | October 25, 2023

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