AZ appeals against NICE rejection of Tagrisso in untreated lung cancer

Pharmaphorum | July 05, 2019

AstraZeneca is appealing against NICEs decision not to recommend funding for its lung cancer drug Tagrisso (osimertinib) in untreated patients with epidermal growth factor receptor (EGFR) mutations. In final draft guidance, NICE said it had rejected regular NHS funding for Tagrisso, because the survival benefits compared with standard treatment such as AZ’s older drug Iressa (gefitinib) are unclear in first-line non-small cell lung cancer. Tagrisso has been the driving force behind AZ’s sales recovery after a steep patent cliff – it generated $630 million in Q1 alone and is the company’s top selling drug after first approval in 2015 in a more advanced form of the disease.
NICE had been considering results from the FLAURA trial, comparing Tagrisso with Roche’s Tarceva (erlotinib) and AZ’s Iressa (gefitinib) in untreated patients. Patients in the trial had either exon 19 deletion (del19) or exon 21 (L858R) mutations, accounting for around 90% of EGFR mutations. NICE said it noted progression-free survival was 18.9 months on Tagrisso compared with 10.2 months on standard care. Overall survival data is not mature but data gathered so far show that Tagrisso will likely extend this too. However NICE is concerned that data so far do not show the size of treatment benefits, and that AZ’s economic model does not fully capture the benefits of subsequent treatments.

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Raman spectroscopy named after Indian physicist Sir C. V. Raman) is a spectroscopictechnique used to observe vibrational, rotational, and other low-frequency modes in a system.[1] Raman spectroscopy is commonly used in chemistry to provide a structural fingerprint by which molecules can be identified.


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Everest Medicines Appoints Rogers Yongqing Luo as Chief Executive Officer to Lead Next Stage of Company Growth

Everest Medicines | September 19, 2022

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors. Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland. "As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business." Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group "I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders." About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

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UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31st EADV Congress

UCB, Inc. | September 02, 2022

UCB, a global biopharmaceutical company, today announced that it will present 20 abstracts across its dermatology portfolio at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. The abstracts, accepted for poster presentation, underscore UCB's commitment to delivering innovative solutions that aim to address the unmet needs of people living with dermatological diseases. "We are proud to present new data from our expanding dermatology portfolio at the 31st EADV Congress. At UCB, our ambition is to transform the lives of people living with severe diseases such as psoriasis and psoriatic arthritis, and the strength of scientific data at this year's congress reaffirms our long-standing commitment to raising standards of care," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. Key data to be presented on UCB's investigational product bimekizumab include new results from the BE BRIGHT open-label extension study evaluating maintenance of response with bimekizumab through three years in patients with moderate to severe plaque psoriasis who responded at week 16 during Phase 3 clinical studies. New analysis of pooled safety data from up to three years of treatment with bimekizumab in the treatment of moderate to severe plaque psoriasis across Phase 2 and 3 clinical trials will also be presented. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S. and it is not approved by the U.S. Food and Drug Administration (FDA). For CIMZIA® (certolizumab pegol), data to be presented include three-year data from three Phase 3 trials evaluating the association of patient-reported outcomes (Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance improvements (Psoriasis Area and Severity Index, PASI) in subgroups of adult patients with moderate to severe plaque psoriasis. About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB).

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Ex-Biocon team Symbio Generrics completes capital raise from Ascent Capital

Symbio Generrics | November 25, 2022

Symbio Generrics India Private Limited a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization, announced that it has completed an equity capital raise from Ascent Capital, a leading growth-capital focused private equity fund. Symbio was founded by pharmaceutical professionals, Salim Shaikh and Abhijit Kale. They were soon joined by the third promoter, Akash Puranik; all of whom possess decades of experience in the global pharmaceutical industry. Symbio's journey from a sales and marketing organization to a full-fledged vertically integrated manufacturer of specialized APIs has been exemplary. Through a well-developed customer ecosystem, the highly experienced & skilled team at Symbio has established a global footprint for its APIs. Ascent Capital's sizeable investment in Symbio will further accelerate the company's expansion plans and sets the company enroute to emerge as a top-10 manufacturer of APIs in India. The funds raised from Ascent will be utilized towards undertaking strategic acquisitions, establishing a best-in-class R&D facility and ramping up manufacturing capacity. The company's R&D Centre is housed in Bengaluru while the manufacturing plant is located at Dobbaspet, Bengaluru. The Company is in the process of acquiring another manufacturing facility in India. The team is focused on building a high-potential generics API portfolio for the global markets and to this effect, will work towards getting US FDA and other SRA approvals for their recently acquired facilities. "We are glad to be associated with Ascent Capital which has a reputation of partnering with entrepreneurs to build leading businesses in India. The sizeable investment from Ascent Capital will add power to our next growth spurt and enable us to emerge as a top-10 API company in India. We are setting ourselves a medium-term goal of growing rapidly into a sizeable company by leveraging the strength of our team and expanding our horizons to actively serve the global API market." Commenting on the fund raise, Salim Shaikh, Executive Chairman & Founder of Symbio Generrics Akash Puranik, Promoter, MD& CEO of Symbio Generrics, says, "The latest feather in our cap is the influx of resources from Ascent Capital. We have carved strategic alliances and relationships spanning over two decades with leading pharmaceutical entities in regulated and semi-regulated markets and are now keen to expand these synergies further in the global arena. With a well-developed infrastructure, both on the manufacturing and R&D front, we are keen to engage with potential partners for CDMO Business." Mr. Raja Kumar, Founder and MD of Ascent Capital, said, "Ascent Capital has been known to support highly qualified professional teams in niche domains. Continuing with this tradition, we are delighted to partner with the first-generation technocrat founders at Symbio. Collectively, the team at Symbio is one of the best multi-disciplinary teams in the Indian pharma space and has shown an exemplary track record of building global relationships. We look forward to working collaboratively with the Company to ensure that we have another category leader from the Ascent stable, akin to BigBasket, Sequent, Skanray, to name a few." IC Universal Legal's Chennai team led by Senior Partner, Sameena Chatrapathy represented Symbio as the legal counsel for the fund raise from Ascent Capital as well as the follow-on acquisitions. About Symbio Symbio Generrics India Private Limited founded in the year 2010 is a specialized Active Pharmaceutical Ingredients & Intermediates manufacturing and marketing organization with headquarters in Bengaluru. The Company was founded by first generation entrepreneurs coming from a leading pharmaceutical organization, with a combined experience of over 40 years. About Ascent Capital Ascent Capital is a leading India-focused Independent Private Equity Fund Manager. The team at Ascent is one of the most experienced investment teams in India with 150+ years of collective experience in Indian PE and capital markets. Thus far, Ascent has helped more than 60 entrepreneurs build leading businesses across diverse sectors such as Technology, Healthcare, Financial Services, Consumer Brands, etc. It typically invests USD 10-30 MM in fast growing businesses, led by outstanding entrepreneurs, that have the potential to emerge as leaders in its segment thereby delivering exceptional exit outcomes. Ascent is backed by marquee investors, who include long term institutional investors like pension funds, foundations, endowments, fund of funds and large corporations - a vote of confidence in the team's ability to excel and deliver results.

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SmartSkin Partners With PDA to Bring New Technology to Aseptic Processing

SmartSkin Technologies and PDA | October 06, 2022

SmartSkin Technologies and Parenteral Drug Association, Inc. announced a partnership to integrate SmartSkin’s data collection technologies with PDA’s aseptic processing and visual inspection training. SmartSkin is recognized by leading pharmaceutical brands as an innovator. Its technology helps the industry adapt faster and improve production quality by providing timely data from the container’s perspective inside the production process — from the washer to warehousing. This previously unavailable information enables data-driven decisions, improving efficiency, lowering costs, and reducing waste. Built on a reputation of scientifically reliable and compliant industry best practices, PDA's hands-on aseptic processing and visual inspection training courses provide new and experienced pharmaceutical professionals with practical information and implementable solutions related to these critical manufacturing operations. “PDA’s training curriculum is widely acknowledged as the gold standard for the pharmaceutical industry. We have been working closely with them for the past several months and are thrilled to have our technology included as part of their training. We have been working hard to understand all aspects of sterile products, aseptic processing, and how to improve quality in pharmaceutical manufacturing. PDA training will ensure industry professionals understand what is now possible.” SmartSkin CEO, Evan Justason “We are always looking to integrate new technologies into our training courses to provide meaningful hands-on experience to our attendees. Smartskin’s technology to protect the integrity of containers across the fill-finish process will enhance the aseptic processing and visual inspection training courses, making them even more unique and valuable,” said PDA VP of Education, David Talmage. SmartSkin discussed manufacturing and quality assurance issues at the 2022 PDA/FDA Joint Regulatory Conference in Washington earlier this month and showcased its latest product innovations to PDA and FDA members. SmartSkin will also be attending the upcoming PDA Universe of Pre-Filled Syringes and Injection Devices show in Palm Springs, CA, October 18-19. About PDA The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information. The PDA creates awareness and understanding of important issues facing the pharmaceutical and biopharmaceutical community and delivers high-quality, relevant education to the industry. Since its founding in 1946 as a nonprofit organization, PDA has been committed to developing scientifically sound, practical technical information and expertise to advance pharmaceutical/biopharmaceutical manufacturing science and regulation, so members can better serve patients. About SmartSkin Technologies SmartSkin Technologies, Inc. is based in Fredericton, New Brunswick, Canada. The company’s patented Quantifeel™ solutions fuse innovative sensors, deep analytics and artificial intelligence to provide global manufacturers with actionable data on the forces their containers experience during the filling and packaging process. By identifying previously undetectable adverse or abnormal operating conditions, workers are able to better control the process, preventing product defects and costly downtime. SmartSkin’s technology is in use around the world and has earned a reputation as a world leader in IIoT productivity solutions across multiple industries. SmartSkin was honored with the “Best Manufacturing Innovation” at the 2020 PharmaPack Awards in Paris.

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Raman spectroscopy named after Indian physicist Sir C. V. Raman) is a spectroscopictechnique used to observe vibrational, rotational, and other low-frequency modes in a system.[1] Raman spectroscopy is commonly used in chemistry to provide a structural fingerprint by which molecules can be identified.

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