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Successful drug development requires a deep understanding of the disease of interest. In rare diseases, however, much of the information may be
unknown. Patient populations are small and historical data are collected
inconsistently. Patient registries and natural history studies are valuable sources of rare disease information for sponsors seeking to design reliable clinical trials - read our blog to explore their distinctions. .png)
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Today's Big NewsFeb 1, 2023 |
| By Max Bayer More companies laid off staff last month than in January 2022, driven by trims at billion-dollar Big Pharmas and smaller biotechs that had to downsize for the second time in less than a year. |
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By Nick Paul Taylor Novartis has delivered the coup de grâce to its ailing branaplam program, stopping development of the splicing modulator in Huntington’s disease in the wake of a safety signal. The Big Pharma disclosed the update alongside news of the delays and discontinuations that have hit oral factor B inhibitor iptacopan |
By Gabrielle Masson In the pandemic's third year, Pfizer could do whatever it wanted thanks to billions reaped from the COVID-19 shot Comirnaty and antiviral Paxlovid. Instead, executives are signaling a somewhat restrained approach, cutting rare disease assets, seeking external partnerships and bumping up the R&D budget by 8.7% for 2023. |
By James Waldron Once seen as a bright hope for immuno-oncology, the reputation of anti-TIGIT checkpoint inhibitors has yet to recover from the double whammy of trial flops that Roche experienced last year. So you can perhaps forgive fellow Swiss drugmaker Novartis for not putting its own TIGIT ambitions front and center. |
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April 3 - 4, 2023 | San Diego, CA Connect with leading communications professionals and have honest, open discussions about how to develop your career in the industry. Early Bird Rate Ends February 10th. 
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By Annalee Armstrong After cutting 60% of staff in December, Instil Bio is back with another round of layoffs that will see 15 employees in the cell therapy biotech’s U.S. manufacturing operations in California heading out the door. |
By Gabrielle Masson Evelo Biosciences’ lead asset has flunked a phase 2 trial in eczema after an unusually high placebo response rate was reported in at least three of four cohorts. The data drop comes as the biotech manages to hang on to CEO Simba Gill, Ph.D., but initiates layoffs. |
By Nick Paul Taylor GSK’s decadelong involvement with the TG2 pathway has hit a setback. Ten years after helping found Sitari Pharmaceuticals and four years after buying it outright, GSK has dropped plans to develop its drug candidate in celiac disease while leaving the door open to other indications. |
By Angus Liu As Novartis prepares to spin off Sandoz to become a pure-play innovative medicines company, several of the Swiss pharma’s new medicines have started taking diverging launch trajectories. |
By Teresa Carey In this week's episode of "Podnosis," we discuss post-pandemic hospital financing and what leaders will need to focus on this year and beyond. We also talk about the importance of value-based care and how to account for equitable care. |
By Sharon Klahr Coey Roche’s Genentech is back with the latest installment of its "#MSVisibility: Breaking Barriers" campaign, and, this time, the focus is on the Black multiple sclerosis experience. As with many diseases, the Black population is disproportionately affected, yet, at the same time, faces many barriers to proper diagnosis and treatment. |
By Conor Hale Sense acquired a CE Mark approval in Europe last year for its Veros test for COVID-19. |
By Angus Liu In an unusual move, the FDA requested an expanded approval of breast cancer drug Ibrance from Pfizer. And the New York pharma won the go-ahead without additional clinical efficacy data. |
By Heather Landi Top Republican lawmakers are ready to pull the plug on a beleaguered health IT project being deployed at Veterans Affairs hospitals unless significant improvements are made to fix technical glitches. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we hear from Stacie Dusetzina, Ph.D., a professor at Vanderbilt University's Department of Health Policy, about what the IRA means for the pharma industry. We'll also discuss what we can expect from the biotech industry in 2023. |
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May 1 - 3, 2023 | Jersey City, NJ Connect on current challenges and opportunities found within your medical affairs role to become better equipped in developing a unified scientific voice. Take advantage of the Early Bird Rates, Register Today! .png)
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Whitepaper This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
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On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| May 1-3, 2023 | Jersey City, NJ |
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