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October 18-20, 2022 | Philadelphia, PA Explore how life science companies can augment their marketing and commercialization efforts and deliver improved value to customers by leveraging digital channels and technologies. Register Now! |
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Biogen-Eisai go for another biomarker approval in Alzheimer's with lecanemab—and snag priority review BeiGene's R&D chief knows PD-1 is crowded. But TIGIT, combos and a Novartis partnership put asset in play Nordic Nanovector pulls the plug on troubled Paradigm trial, moves for restructuring Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management OBI Pharma culls early cancer asset as it focuses on later-stage bets Doubling down on mRNA, BeiGene taps rising Hong Kong star to create targeted therapies High times: Anebulo drug reduces cannabinoid intoxication in phase 2 study Codiak gets $2.5M from CEPI to forge way out of pandemic, prep for disease X Joining the resistance: Boehringer rounds up allies to build €40M anti-superbug startup ClinChoice raises $150M in series E round as CRO outlines growth plan and potential IPO How Pfizer CEO Bourla's evening call brought Biohaven back into the M&A fold Seagen touts new Tukysa colorectal cancer data, setting up FDA filing and a potential $500M opportunity Labcorp launches monkeypox PCR tests through CDC initiative Featured Story | By Annalee Armstrong Biogen and Eisai’s follow-up to the Alzheimer’s disease treatment Aduhelm scored priority review under the FDA's accelerated review pathway, with a decision slated for Jan. 6. read more |
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Top Stories By Angus Liu With an FDA target decision date set for next week, BeiGene and Novartis’ tislelizumab has a real chance of becoming the first China-developed PD-1 cancer immunotherapy to reach the U.S. And BeiGene is already lining up potential combination approaches, including TIGIT. read more By Max Bayer Signs that Nordic Nanovector’s Paradigm trial was on its last legs were clear last month when the company initiated a comprehensive review after enrollment ground to a halt. Now, the trial has been taken off life support. read more Sponsored By: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By James Waldron OBI Pharma is dropping its cancer antibody over cost concerns after a glimpsing preliminary phase 1/ 2 data and will focus on its late-stage oncology programs. read more By Nick Paul Taylor BeiGene is getting deeper into mRNA drug discovery. Having teamed up with Strand Therapeutics last year, the cancer biotech has now partnered with InnoRNA to jointly research targeted mRNA programs. read more By James Waldron Cannabis has long been used as a form of self-medication, but what happens when use of that drug requires medication itself? Anebulo Pharmaceuticals hopes to be the first to answer that, as the biotech unveils positive phase 2 data for its treatment of acute cannabinoid intoxication. read more By Gabrielle Masson The Coalition for Epidemic Preparedness Innovations is dishing out up to $2.5 million to Codiak BioSciences to develop vaccines for COVID-19 and the mystery disease X that could strike next. read more By Nick Paul Taylor Boehringer Ingelheim is pumping 30 million euros ($31 million) into the fight against drug-resistant bacteria. Working with Evotec and bioMérieux, the German drugmaker has set up Aurobac Therapeutics, a biotech that will take a precision medicine approach to diagnosing and treating infections. read more By Gareth Macdonald Eli Lilly-backed CRO ClinChoice says its new $150 million investment will fund growth through acquisitions and internal expansion. read more By Angus Liu After a call from Pfizer CEO Albert Bourla to Biohaven's chief exec Vlad Coric, Pfizer and Biohaven quickly came to terms on the buyout, reviving a plan Biohaven had explored years ago. read more By Zoey Becker Seagen unveiled full results from a pivotal trial that could expand Tukysa’s use into colorectal cancer. The new tumor progression and patient survival data make the Seagen med look stronger than Novartis' Tykerb. read more By Andrea Park Labcorp was tapped by the U.S. Centers for Disease Control and Prevention last month to help make monkeypox testing widely available through its broad network of diagnostic labs. read more | | New Product Planning Summit September 19-20, 2022 | Boston, MA Join us for the ONLY conference for defining how the new product planning role and related functions make informed, value-based, data-driven decisions about products in the pipeline. Register now! |
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Resources Sponsored by: Catalent Pharmaceutical drug developers continue to realize the strong therapeutic potential of highly potent active pharmaceutical ingredients (HPAPIs). This is particularly true for therapeutic areas such as oncology, where highly potent drugs are becoming more commonplace. Sponsored by: Lumanity Check out our 22 on-demand panels, featuring 100+ speakers. Tap into discussions of scientific progress in oncology around development, regulatory, clinical, commercial and investment perspectives. Sponsored by: Catalent Pharmaceutical development companies face several challenges when developing orally bioavailable formulations of active pharmaceutical ingredients. Up to 70% of new drug molecules are poorly soluble in gastrointestinal fluids and can exhibit poor absorption across the gut wall. Sponsored by: Cognizant Explore how Cognizant SIP helped Roche streamline its global feasibility process. Sponsored by: Blue Matter Consulting For an emerging biopharma company, Europe can be very attractive. But it can also be complex and confusing. This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent 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 Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | 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 Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual | 