BMS’ Opdivo disappoints in late-stage trial

pharmatimes | June 26, 2019

Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical significance for its primary endpoint of overall survival. The news isn’t all negative, however, as a clear trend was demonstrated towards improvement in overall survival for patients treated with Opdivo compared Nexavar. The drug is currently being studied by the company across multiple settings and lines of therapy for HCC, including as monotherapy in the adjuvant setting and in combination with Yervoy (ipilimumab) for previously treated patients. The company say that they are still “encouraged by the promising efficacy and safety trends seen with Opdivo in CheckMate -459, especially as HCC is a devastating and difficult-to-treat cancer, for which there have been no significant advances over sorafenib, a standard treatment, in more than a decade,” said Bruno Sangro, head of the Liver Unit, Clínica Universidad de Navarra. Ian Waxman, development lead, Gastrointestinal Cancers BMS also commented that the company will “remain confident in the important role of Opdivo for the treatment of patients with HCC and look forward to evaluating insights garnered from this trial with the goal of ensuring patients with liver cancer have the opportunity to achieve the best possible outcomes.”

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The Drug Quality and Security Act, a United States bill passed in 2013, calls for manufacturers to make prescription drugs traceable on a per-unit basis. Manufacturers will need to mark each package with a serial number or machine-readable code in order to comply, a process better known as serialization.


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BD Completes Acquisition of Parata Systems

BD | July 19, 2022

BD announced it has completed the acquisition of Parata Systems. Parata advances BD's transformative solutions strategy by providing a portfolio of innovative pharmacy automation solutions that power a growing network of pharmacies to reduce costs, enhance patient safety and improve the patient experience for retail, hospital and long-term care pharmacies. As a combined company, BD is positioned to offer a comprehensive set of technologies to the $600 million pharmacy automation market segment that is expected to grow approximately 10% annually to $1.5 billion in the U.S. alone over 10 years. "Completing this acquisition represents an important step towards advancing our 2025 growth strategy around smart, connected care and enabling new care settings. I'd like to officially welcome the Parata team to BD as we join together to uniquely provide a more comprehensive set of smart, connected care technologies to support our customers as they expand care to new settings and centralize their pharmacy operations." Tom Polen, chairman, chief executive officer and president of BD The acquisition builds on BD's legacy and experience of seamlessly integrating teams to drive future growth and innovation. The Parata portfolio will become part of the solutions offered by BD's Medication Management Solutions business within the BD Medical segment. Together, the combined BD and Parata team will help pharmacy leaders address critical trends, such as clinician shortages, wage inflation, centralization of pharmacy services and increased clinical demands on pharmacy staff. About BD BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

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Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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Element Materials Technology Announces Completion of its Acquisition by Temasek

Element and Temasek | July 08, 2022

Element Materials Technology a global leader in testing, inspection, and certification services, has completed its acquisition by Temasek, a global investor headquartered in Singapore. Temasek has been a minority shareholder in Element since 2019. Temasek has acquired Element from Bridgepoint, whose successful ownership has been an important part of a more than ten-fold increase in Element’s turnover over the past decade. The acquisition, which was subject to regulatory approvals, was previously announced on 25th January 2022. As a highly differentiated TIC leader with a track record of technical expertise, Element is a trusted partner to customers, supporting them from early R&D, through complex government approvals, and into production, with a focus on laboratory-based testing. Its 7,000+ scientists, engineers, and technologists, based across a global network of more than 200 laboratories in 30 countries, serve technically demanding and highly regulated sectors, ensuring products are safe and sustainable. Element works with customers across a wide spectrum, from developing the next generation of aircraft, spacecraft, and autonomous vehicles, to vaccine component testing in its US pharmaceutical laboratories; and from the certification of smartphones and wearable technologies, to providing 5G carrier approvals and developing connected robots. The Group generates annual revenues of more than $1 billion and has grown at over 20% a year over the last ten years. It is well-positioned to accelerate this growth as it builds deeper leadership positions in critical end-markets including life sciences and connected technologies. Element also benefits from strong global ESG tailwinds - with over 60% of its work directly supporting customers on their sustainability journeys, it will continue to play a critical role in the decarbonization of the global economy. “We are delighted to complete this landmark transaction with Temasek, and to begin work on the next chapter of Element’s story. Their partnership over the last three years has been hugely beneficial to our growth. Today, Element is the partner of choice to companies at the forefront of innovation, from advanced medical science to autonomous cars, and has one of the most talented and highly qualified teams in the TIC space. Jo Wetz, CEO of Element We are excited to build upon that legacy of success and drive Element forward by scaling our business further through strategic investments and acquisitions, with a focus on high growth end-markets such as life sciences and connected technologies. Element will continue to play a crucial role in supporting our customers on their sustainability journeys, and in making tomorrow safer than today.” Allan Leighton, Non-Executive Chairman of Element, said: “Element is a true success story – a talented management team leading an exceptional group of experts across offices and laboratories in more than 30 countries around the world. We’re now entering another exciting chapter of purpose-driven growth, together with our customers and our new owners”. Chris Busby, partner at Bridgepoint, said: “Element has been bold in its ambition, delivered impressive organic growth, and implemented a targeted acquisition strategy. As a result, it has significantly expanded its expertise for over 50,000 customers worldwide and become an undisputed heavyweight in TIC. We are proud of what Element has achieved and wish them continued success in the future.” Element was advised by Bank of America Securities, Goldman Sachs and Rothschild & Co A&O EY BCG DLA, Jamieson and PwC. About Element The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.7,000 scientists, engineers, and technologists, working in our global network of over 200+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable, and achieve market access. In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data. About Temasek Temasek is a global investment company with a net portfolio value of S$381 billion as at 31 March 2021. Headquartered in Singapore, it has 13 offices in nine countries around the world. The Temasek Charter defines Temasek’s three roles as an Investor, Institution, and Steward, which shape its ethos to do well, do right, and do good. As a provider of catalytic capital, it seeks to enable solutions to key global challenges. With sustainability at the core of all Temasek does, it actively seeks sustainable solutions to address present and future challenges, as it captures investible opportunities to bring about a sustainable future for all.

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AustinPx Names Elizabeth Hickman Chief Business Officer

AustinPx | September 28, 2022

AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers. Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University. "Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her." As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth. "I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world." Elizabeth Hickman About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

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Spotlight

The Drug Quality and Security Act, a United States bill passed in 2013, calls for manufacturers to make prescription drugs traceable on a per-unit basis. Manufacturers will need to mark each package with a serial number or machine-readable code in order to comply, a process better known as serialization.

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