Featured Story | By Annalee Armstrong The pharma world is eagerly watching as Amgen moves its KRAS inhibitor toward a regulatory decision, and they now have a name for the much-anticipated new drug: Lumakras. Amgen listed off a laundry list of clinical trials and regulatory milestones for Lumakras while reporting first-quarter earnings April 27. read more |
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Top Stories By Ben Adams GlaxoSmithKline is calling time on two phase 1 assets in oncology and a rare, fatal disease in young children because of “portfolio prioritisation.” read more By Nick Paul Taylor Pfizer has bought infectious disease biotech Amplyx Pharmaceuticals for an undisclosed sum. The deal gives Pfizer control of a pipeline led by phase 2 antifungal candidate fosmanogepix. read more Sponsored By: Parexel Biotech A well-thought-out strategic development plan that brings together nonclinical, clinical, regulatory and commercial experts can improve efficiencies, cut costs, shorten timelines, and increase the chances of success for a new drug program. read more By Annalee Armstrong Trillium Therapeutics is up against some stiff competition to become a leader in the new class of drugs called CD47, which turn off the “don’t eat me” signal transmitted by cancer cells, but CEO Jan Skvarka believes his biotech’s data will stand for themselves. read more By Nick Paul Taylor Sanofi is planning to restart dosing and recruitment in its pediatric fitusiran clinical trial later this year. The study has been on hold since the identification of vascular thrombotic events in the wider hemophilia program late last year. read more By Amirah Al Idrus With two partnered drugs in the clinic, Exscientia is reeling in up to $525 million to push its own pipeline into clinical testing and continue developing an artificial intelligence-based technology toward autonomous drug design. read more By Amirah Al Idrus Having moved its anti-CD47 antibody into a phase 1/2 study, Arch Oncology collected $105 million from new and old backers to fuel the drug’s journey through the clinic and into new trials. Arch is testing the drug alone in patients with multiple myeloma and alone and in combination with the chemotherapy drug paclitaxel in patients with “select solid tumors.” read more By Eric Sagonowsky With a half-dozen COVID-19 vaccines on the market or close to it, one of the world's top vaccine players called it quits after R&D delays and setbacks. But not Sanofi. The company still thinks its shot can help meet global demand. read more By Angus Liu Scientists have proposed a possible explanation for the disappointing clinical trial results from Biogen's anti-amyloid Alzheimer's drug aducanumab. The team pointed to the brain’s newly discovered drainage system, suggesting drugs could be developed to enhance its function, in turn improving the efficacy of drugs like aducanumab. read more By Conor Hale Versiti’s blood tests screen for antibodies that may make typical clot treatments harmful to help healthcare providers choose alternative therapies. read more By Ben Adams Major CRO and soon-to-be Thermo Fisher unit PPD saw a major boost in sales in its financials this week as it continued to break free of the pandemic chaos that engulfed the CRO sector in 2020. read more Resources Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: PerkinElmer Informatics Discover the benefits of a cloud-native ELN that delivers better performance, security, connectivity, total cost of ownership PLUS sub-second search results through even the largest data volumes. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Culture Biosciences Find out how upstream bioprocess scientists can use Culture Biosciences’ bioreactor system and real-time data visualizations to get faster insights and get their product to market more quickly. Sponsored By: BC Platforms Those wishing to unlock RWD’s true value must have access to a variety of data sources/types and the technological capabilities to use the data to uncover meaningful insights. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 
