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While relying solely on your nonclinical laboratory can be tempting when conducting IND-enabling studies, it’s important to provide significant input and oversight to ensure regulatory compliance. Watch our on-demand webinar to learn how to prepare so that your studies meet FDA guidelines. Premier Consulting. Built for Biotech℠. _updated+(1).png)
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Today's Big NewsJun 14, 2023 |
| By Nick Paul Taylor Investigators have paused an early-phase trial of 2seventy bio’s CD33-targeted CAR-T cell therapy after a patient died. The acute myeloid leukemia (AML) patient was the first person treated in the second dose cohort of the phase 1 clinical trial. |
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By Max Bayer Merck says its GLP-1/glucagon receptor co-agonist has the upper hand against Ozempic in patients with NASH, according to abstract data from a phase 2a trial. The New Jersey Big Pharma plans to present a fuller look at the data at the European Association for the Study of the Liver annual congress. |
By Max Bayer Encoded Therapeutics has laid off almost 10% of its staff, nearly three years after raising a $135 million series D backed by GV, formerly Google Ventures. The company's lead asset is a gene therapy aimed at treating Dravet syndrome. |
Sponsored by YPrime Michael Hughes, Chief Product Officer at YPrime discusses the benefits and challenges of eConsent implementation and how to circumvent the biggest barriers to adoption. |
By James Waldron Fresh from Qalsody’s success, Biogen is keeping its eye on whether a candidate from NeuroSense Therapeutics could also prove to be a hit against the same biomarker—and maybe become the next addition to the Big Pharma’s amyotrophic lateral sclerosis portfolio. |
Sponsored by Sanyou Biopharmaceuticals Co., Ltd. On June 12th, 2023 local time, Sanyou Biopharmaceuticals Co., Ltd. officially announced the launch of "Sanyou Super Trillion Common Light Chain Antibody Discovery Platform" (the "platform"). As one of the nine trillion antibody discovery platforms of Sanyou, the platform features a library capacity of up to 1.12E+12 CFU. For a single target, the platform can generate hundreds of lead antibodies with diverse sequences, which can be further designed into bispecific antibodies with good drug developability, providing a feasible solution for obtaining bispecific antibodies with structures similar to the natural monoclonal antibodies |
By Nick Paul Taylor Inventiva finally has data from a midphase clinical trial of lanifibranor in patients with Type 2 diabetes and nonalcoholic fatty liver disease. Almost four years behind schedule, the investigator-initiated study has linked the candidate to reductions in liver fat—and triggered a 25% jump in the biotech’s share price. |
Sponsored by The Janssen Pharmaceutical Companies of Johnson & Johnson The creation of collaborative partnerships continues to be essential to delivering transformational therapies to address critical healthcare needs. |
By James Waldron PepGen has bowed to the inevitable and paused plans to get its second oligonucleotide therapy into the clinic in any country while it continues to wait for the post to deliver an FDA clinical hold letter. |
By Zoey Becker As supply chain issues sweep across the industry, Pfizer is warning about expected supply shortfalls of its penicillin offerings. |
By Phil Taylor Inspire Medical Systems has won an expanded label from the FDA for its eponymous medical device for obstructive sleep apnea (OSA) that should expand the number of people it can be used to treat. |
By Kevin Dunleavy An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout of Horizon Therapeutics has raised concerns that the United States’ antitrust watchdog is tightening the screws on major M&A moves in the biopharma industry. A month later, according to an SEC filing, Pfizer has withdrawn its notification for its proposed $43 billion acquisition of cancer drug specialist Seagen and will submit another later in the day. |
By Frank Diamond Ozempic, estimated to cost about $10,000 a year per person, and other GLP-1 drugs could put significant financial strain on payers as demand grows. |
Fierce podcasts Don't miss an episode |
| 'Podnosis': Are canines the secret to anti-aging meds and the benefits and challenges of direct contracting and purchase alliances. |
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July 18-19, 2023 | Jersey City, NJ This is the only communications event for peer learning and networking exclusively for the life science community. Save $300 when you Register Today! .png)
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Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| July 18-19, 2023 | Jersey City, NJ |
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