Monday, September 26, 2022 | 11am ET / 8am PT In this webinar Cambrex wil discuss how their facility and the Cambrex network are evolving to enhance capabilities and accelerate API development. Register now. | This Week Sep 16, 2022 Fierce Biotech’s honorees for the 2022 Fierce 15 have scientific roots that run deep—from seeking cures for incurable diseases to tapping the latest AI tech to discover better drugs faster. This year’s class also focuses more than ever before on diversity in management and geography across the biotech world. Read the full special report here. When Bristol Myers Squibb bought Celgene in 2019 for $74 billion, it opted to keep the dermatology and immunology drug deucravacitinib, and it doesn’t regret the move in the slightest. Now dubbed Sotyktu, it’s won FDA approval for plaque psoriasis, and the Big Pharma believes the drug could be a new standard of care. The FDA has found new clusters of specific types of cancer linked to the scar tissue that forms around breast implants, as part of the agency’s yearslong review of the risks that can come with the procedure. Featured | By Ben Adams Welcome to this year's Fierce Biotech's Fierce 15. Join us in celebrating 2022's best of the best biotech startups. This year, we focused more than ever before on diversity in management and geography across the biotech world, highlighting a broader range of teams, leaders and science. |
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| Top Stories By Zoey Becker Back when Bristol Myers Squibb acquired Celgene in 2019 for $74 billion, it opted to keep the dermatology and immunology drug deucravacitinib, as opposed to the already-approved Otezla. And now, BMS doesn’t regret this move in the slightest. Deucravacitinib has won FDA approval for moderate-to-severe plaque psoriasis. By Conor Hale The FDA has found new clusters of specific types of cancer linked to the scar tissue that forms around breast implants, as part of its ongoing, yearslong review of the risks that can come with the procedure. By Fraiser Kansteiner Following years of investor push-and-pull over Bayer's CEO, a hunt for Werner Baumann’s successor has quietly kicked off, Bloomberg News reported Tuesday, citing people close to the matter. The new CEO search may portend an early departure for Baumann, whose contract with Bayer isn’t set to expire until April 2024. By Max Bayer Four months after the latest trial failure for Roche’s tiragolumab, GSK is still pushing ahead with its own anti-TIGIT inhibitor, bullish that plenty of opportunities remain for the next-gen therapy. By Angus Liu In a closely watched competition among KRAS inhibitors, Amgen leads the pack with a randomized trial win in lung cancer. Now, the California drugmaker is giving a first look at the detailed data that could set the bar for all others to come, including Mirati Therapeutics, Roche and Novartis. By Nick Paul Taylor Rubius Therapeutics has torn up its strategy. After reviewing human data on its lead candidates, the cell therapy biotech concluded investment in its two clinical prospects “is no longer justified,” leading it to stop studies and lay off 75% of its workforce. Shares in Rubius fell 25% to $0.80. By Ben Adams Medtronic is turning to a celebrity endorsement in the form of Jennifer Stone, the actress from the Disney Channel’s “Wizards of Waverly Place” series, to promote its reusable smart insulin injectable, InPen. By Gabrielle Masson Investors such as Pfizer have flooded Nimbus Therapeutics with $125 million in private financing, money that will go toward three clinical inflammatory and autoimmune disorder programs, including a phase 3 psoriasis launch. By Angus Liu Riding on fast growth after a temporary pandemic-related slowdown, Takeda’s plasma-derived therapies department is investing heavily to boost its manufacturing capabilities. By Helen Floersh By using a series of analyses to predict how gene protein products interact, researchers from Norway’s University of Oslo have homed in on existing drugs that they believe warrant testing in people with ASD. The results, published Monday in Frontiers of Pharmacology, indicate four possible meds: anti-diarrheal loperamide, dopamine D2 receptor agonist bromocriptine, the female hormone progesterone and the progestin birth control pill drospirenone. Fierce podcasts Don't miss an episode | This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. |
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| Wednesday, September 28, 2022 | 11am ET / 8am PT Learn how scientists can make better decisions faster by unifying vast amounts of data from any source into a single view, how to leverage software to cover most of the common scientific analysis workflows, and more. Register Now. | Resources eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx Whitepaper Advanced research requires advanced tools. The next-generation ELISA takes a fraction of the time to run eight analytes simultaneously while saving your sample volume. Sponsored by: Bio-Techne eBook Improve patient engagement, adherence, and outcomes Sponsored by: Health Catalyst Whitepaper Learn how IT and facility security professionals are collaborating on key initiatives to mitigate digital and physical security risks and build resilience healthcare system-wide. 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Sponsored by: Catalent Biologics Whitepaper How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: ReachBio | The Cell Biology Experts™ Custom Resource Center Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: JLL Whitepaper Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens. Sponsored by: DocuSign Research Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Genpact Executive Summary How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: Cognizant eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent Whitepaper This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences Whitepaper Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation. Sponsored by: Thermo Fisher Scientific Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Research TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Unlearn AI Events Virtual U.S. Healthcare Compliance Certificate Program October 10-13, 2022 European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Universe of Pre-Filled Syringes and Injection Devices Conference October 18-19, 2022 | Palm Springs, CA Promotional Review Committee Compliance and Best Practices Summit West (PRC West) September 20-22, 2022 | San Diego, CA Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 19-20, 2022 | Boston, MA Medical Affairs Strategic Summit West (MASS West) September 20-22, 2022 | San Diego, CA Fierce Health Payer Forum October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Pharma Marketing Awards October 19, 2022 | Philadelphia, PA Clinical Quality Oversight Forum: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia PA | Presented by: Fierce Pharma Decentralized Clinical Trials Summit: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia, PA | Presented by: Fierce Pharma Good Clinical Practice Summit (GCP): Part of the Fierce Clinical Collective October 24-26, 2022 | Philadelphia, PA | Presented by Fierce Pharma Fierce Biotech Cell & Gene Forum November 2, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Diversity, Equity & Inclusion Forum November 15-16, 2022 | Free Virtual Event Drug Development Boot Camp® 2022 November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual Fierce Clinical Trial Billing & Research Compliance Summit February 2023 | Location TBD Fierce BD&L Summit for Life Sciences March 14-15, 2023 | San Francisco, CA |