Merck and AZ pile on more positive Lynparza data in bid to break into prostate cancer

FiercePharma | August 07, 2019

Two months back, AstraZeneca and Merck made a strong case at the American Society of Clinical Oncology ASCO annual meeting that Lynparza should be the first PARP inhibitor approved to treat prostate cancer, with data showing the drug significantly delayed disease progression when added to Johnson and Johnsons Zytiga. Now the Lynparza partners have a fresh set of data to back up their case, and this time its for use of the drug as a solo therapy. Merck and AstraZeneca said they have seen positive results from a phase 3 trial of Lynparza in men with metastatic castration-resistant prostate cancer and a mutation in a homologous recombination repair (HHR) gene. The men in the trial had progressed after receiving either Zytiga or Astellas’ and Pfizer’s Xtandi. The companies said there was a “statistically significant and clinically meaningful improvement” in progression-free survival among trial participants taking Lynparza over those on either Zytiga or Xtandi. They plan to present the full data at an upcoming medical meeting.

Spotlight

Have you ever wondered what happens to a painkiller, like ibuprofen, after you swallow it? Medicine that slides down your throat can help treat a headache, a sore back, or a throbbing sprained ankle. But how does it get where it needs to go in the first place? Céline Valéry explains how your body processes medicine.

Spotlight

Have you ever wondered what happens to a painkiller, like ibuprofen, after you swallow it? Medicine that slides down your throat can help treat a headache, a sore back, or a throbbing sprained ankle. But how does it get where it needs to go in the first place? Céline Valéry explains how your body processes medicine.

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PHARMA TECH

Medable and CVS Health Announce Collaboration to Expand Clinical Trial Access

Medable Inc. and CVS Health | February 08, 2022

Medable Inc. and CVS Health announced a collaboration to expand clinical trial access and engagement for patients at select MinuteClinic™ locations via Medable’s clinical trials software platform. CVS Health Clinical Trial Services™ will manage the relationship. The collaboration combines Medable’s software platform with CVS Health’s community reach and experienced MinuteClinic providers to effectively deliver clinical trials in a way that improves patient access, engagement and retention to advance research effectiveness. Despite the importance of clinical trials, less than four percent of Americans participate in clinical studies. Additionally, 30 percent of participants drop out before study completion, and 80 percent of studies do not meet enrollment deadlines. While industry efforts are making progress in closing the gap in African-American clinical trial participation, Asian, Hispanic and Latino groups also continue to be significantly and consistently underrepresented. “Our mission is to bring effective therapies to all patients, regardless of where they live, their social status or race. This collaboration intends to bridge research and science into communities with local access and experience that builds greater trust in health and medicine. Practical applications of Medable technology with the reach and experience of CVS Health gives us an opportunity to harness this time of change and respond differently to unmet needs in local communities.” Sans Thakur, chief growth officer at Medable “This dynamic collaboration with Medable will help us intensify our efforts to drive meaningful awareness and access to a broader population, in particular those with mounting chronic illnesses and the vulnerable populations who today are underrepresented in clinical research. Those populations often have limited access to health care, and therefore a greater chance of poor health and lower life expectancy. Over 40% of the vulnerable population in the U.S. lives within five miles of a CVS Pharmacy location, so we have a chance to engage them,” said Tony Clapsis, General Manager and Senior Vice President of CVS Health Clinical Trial Services. “Coupling Medable’s software platform and experience with CVS Health’s national reach, analytics, and established clinical trial and care delivery teams and services will further enrich and accelerate our ability to make a difference in the lives of patients and support an improved clinical research process.” CVS Health’s unwavering commitment to diversity and inclusion fits well in this partnership. A diverse CVS Health workforce can also contribute to improving culturally inclusive care delivery and clinical trial services. Since May 2021, CVS Health Clinical Trial Services (CTS) has been working with key stakeholders in the biopharmaceutical industry and across the clinical trial ecosystem to design and deliver innovative approaches to research and real-world evidence generation. CTS was instrumental to help engage patients and facilitate trials for investigational COVID-19 vaccines and treatments. As part of this collaboration, CVS Health will continue to offer: Precision patient recruitment: Study population readiness that leverages advanced analytics, national reach and local community connections to drive awareness and engagement in clinical research for faster and more comprehensive trial recruitment, especially in hard-to-reach populations. Clinical trial delivery: Innovative, decentralized options for the delivery of Phase III/IV clinical trials and real-world evidence studies at designated MinuteClinic locations, in home through its Coram home health services team, and virtually. Real-world evidence generation: Retrospective and prospective studies that measure the impact of novel devices and therapeutics in real-world settings. Where applicable, CVS Health will employ Medable’s clinical trial software platform to enhance patient access, engagement and retention while capturing required endpoint data and other information both onsite and remotely. Medable is a leader in the evolving digital and hybrid clinical trial landscape. Technology has played a vital role in extending trial engagement beyond the clinic, allowing patients and clinicians to communicate regularly and enroll participants online, review documentation, sign consent forms and report health status remotely via mobile applications and medical devices. Medable has deployed its software-as-a-service platform via more than 150 decentralized and hybrid clinical trials in 60 countries, serving 1M+ patients and research participants globally. Medable customers have achieved impressive results with decentralized and hybrid trials – including 200% faster enrollment, 90% retention rates and 50% cost reductions. About CVS Health CVS Health is the leading health solutions company, delivering care like no one else can. We reach more people and improve the health of communities across America through our local presence, digital channels and approximately 300,000 dedicated colleagues – including more than 40,000 physicians, pharmacists, nurses and nurse practitioners. Wherever and whenever people need us, we help them with their health – whether that's managing chronic diseases, staying compliant with their medications, or accessing affordable health and wellness services in the most convenient ways. We help people navigate the health care system – and their personal health care – by improving access, lowering costs, and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day. About Medable Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company’s digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution. Medable connects patients, sites and clinical trial teams to improve patient access, experience and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California.

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PHARMA TECH

Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

Pfizer | December 21, 2020

Since the time Pfizer was fixed to partake in the U.S. government's Warp Speed exertion to get COVID-19 antibodies to showcase, the organization has made it very clear it didn't have to take any bureaucratic cash to build up the immunization. In any case, did that refusal of R&D subsidizing add to Pfizer's failure to produce more dosages of its mRNA antibody for the U.S. market? Pfizer could give more than the 100 million portions it guaranteed in its unique agreement with the U.S. government in the main portion of one year from now—however just if Trump organization authorities request that providers of crude materials rapidly satisfy the organization's requests. Furthermore, CEO Albert Bourla, Ph.D., is approaching the public authority to utilize the Defense Production Act to do precisely that. The Trump organization hasn't done as such yet on the grounds that they've zeroed in on giving those materials to antibody producers that took government R&D subsidizing, as Moderna, as indicated by anonymous sources who addressed The New York Times. A representative for Pfizer declined to remark, refering to the privacy of conversations with the U.S. government. Yet, Bourla said during a CNBC meet that the organization is in exchanges to sell an extra 100 million dosages of Pfizer's COVID-19 immunization to the U.S. government. "We can give a ton of that in the second from last quarter. The U.S. government needs it in the subsequent quarter," Bourla said in the Monday meet. "We are working cooperatively to attempt to discover an answer and have the option to apportion those 100 million [doses] in the subsequent quarter if conceivable, or a ton of them." Pfizer mentioned almost immediately that the public authority grant it "supported status" with providers of crude materials, however authorities were anxious about the possibility that that would harm contending immunization programs that took government R&D cash, as per the Times report. Among those organizations is Moderna, which is required to win crisis use approval from the FDA for its mRNA immunization this week—and last Friday, inked an arrangement to add 100 million additional portions to its underlying U.S. request.

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RESEARCH

Nanoform Releases Next-Generation AI-based Drug selection Tool

Nanoform | March 23, 2021

Nanoform innovative nanoparticle medicine enabling company next generation of its STARMAP® AI artificial intelligence platform nanoparticle bioavailability excipient microns nm CESS technology silico pharma drugs lifecycle managementNanoform, an innovative nanoparticle medicine enabling company, has today dispatched the next generation of its STARMAP® AI (artificial intelligence) platform, v2.0. The technology uses scanty information AI to expand trial results from its CESS® nanoparticle designing process with detailed master information, permitting dependable expectations to be made in regards to accomplices' likely success of nanoforming their medication atoms. CESS® is a nanoparticle platform technology which produces unadulterated homogeneous medication particles from arrangement in a without excipient process. By diminishing the molecule size e.g., from 10 microns to 50 nm, the particular surface territory can be expanded by as much as 1000-crease, subsequently improving disintegration rate, solvency, and bioavailability. Subsequently, Nanoform can help pharma accomplices progress atoms into advancement that in any case might not have been conceivable. It additionally opens up energizing opportunities for a wide scope of novel medication conveyance applications. STARMAP® is a computerized form of the CESS® technology that empowers in silico tries in enormous amounts, making quick forecasts of which atoms ought to be nanoformed. This is significant since there are more potential medication atoms than particles in the known universe. STARMAP® can be a useful asset for pharma accomplices to pick appropriate medication contender for additional improvement from their huge libraries. The benefits may incorporate quicker way to advertise and additional opportunities for widening and extending drug pipelines while at the same time expanding the likelihood of medication improvement success. The STARMAP® platform can have wide materialness in drug disclosure and advancement just as in lifecycle management for existing promoted drugs and 505b2-like item improvement methodologies. "AI algorithms developed for big data have so far struggled to live up to expectations in pharma because the data, especially for early assets (drug discovery, drug screening), that is available to pharma is typically insufficient for generating reliable predictions. We believe sparse-data AI will work much better - in practice, this means augmenting experimental results with detailed expert knowledge, which can be used to prevent the AI from predicting outcomes that are nonsensical based on prior understanding. There is a lot of untapped potential in sparse-data AI for the pharma industry and the field continues to undergo rapid development in both academia and the industry in general," said Prof. Jukka Corander, Head of AI at Nanoform. "By determining which drug candidates are ideal for our CESS® process, the next-gen STARMAP® platform can potentially create new opportunities for our pharma partners. These can include both revisiting drug candidates unnecessarily discarded by AIs trained on old particle engineering techniques, and rapidly picking winners among new drug candidates. Ultimately, the benefit of more advanced AI will be felt by patients as new therapies are accelerated to market," commented Christian Jones, Chief Commercial Officer at Nanoform

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