| Whitepaper: Early engagement & regulatory considerations for emerging biotechs Despite robust funding and government initiatives for the development of orphan drugs and personalised medicines, small and emerging biotechs are typically very lean on resources, lacking the infrastructure required to bring their innovation to the market. Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner. Learn more. |
Editor’s Note: Fierce Biotech will not publish on Monday in observance of Presidents Day, but we'll be back in your inbox on Tuesday, Feb. 22. Have a great weekend! Featured Story By Nick Paul Taylor GlaxoSmithKline has slammed the brakes on its pivotal maternal respiratory syncytial virus (RSV) vaccine program after a safety assessment, potentially handing an advantage to Pfizer in a close race to market. read more |
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Top Stories By Nick Paul Taylor BioMarin Pharmaceutical faces a long clinical hold on its phenylketonuria (PKU) gene therapy trial. After stopping the trial over tumors in mice, the FDA has asked BioMarin to run additional nonclinical studies that are expected to take “several quarters” to assess the risk of BMN 307. read more By Kyle LaHucik The biotech industry has not caught the ESG bug that has swept across C-suites in recent years as part of the broad push for corporate social responsibility, according to a survey and review from life sciences law firm Fenwick. read more Sponsored by: DeepDyve For researchers unaffiliated with an academic library, finding scientific papers can be time-consuming and expensive—and organizing or sharing them can be even harder. Can a new tool address this gap? read more By Kyle LaHucik Ligand Pharmaceuticals will spin off its Johnson & Johnson-partnered antibody platform business OmniAb and capitalize the company with $70 million. read more By Max Bayer Cellular stress-focused biotech Ribon Therapeutics has hired former Novartis VP and Flagship Pioneering Senior Partner Prakash Raman, Ph.D., as its new CEO. read more By Angus Liu Bayer has spelled out an even more bullish estimate for Nubeqa's blockbuster potential, thanks to a trial win in a new prostate cancer frontier for the androgen receptor inhibitor. But the German drugmaker still faces an uphill fight against two formidable incumbent players. read more By Eric Sagonowsky More than a decade after its founding, Agios Pharmaceuticals has its first FDA green light. With the approval for Pyrukynd to treat hemolytic anemia in adults with pyruvate kinase deficiency, the company is off and running in the commercial arena. read more By Andrea Park So far, no deaths have been reported in connection with the software flaw, but the FDA has received 18 complaints and reports of seven injuries linked to the issue. read more By Robert King The FTC deadlocked on whether to initiate a study into contracting practices of the PBM industry, despite fervent lobbying from pharmacists. read more By Gareth Macdonald Curebase has added real-world data and artificial intelligence experts to its advisory board in a bid to capture a greater share of the decentralized trials market. read more By Anastassia Gliadkovskaya Communications software company PerfectServe wondered whether it could identify evidence of burnout or frustration among clinicians expressed through emoji. But the company discovered just the opposite – emoji were overwhelmingly used to convey politeness and positive intent. Some researchers and physicians have made a case for a comprehensive set of medical emoji. read more By Angus Liu The FDA's negative opinion toward Eli Lilly and Innovent Biologics' PD-1 application has broad implications for Chinese biopharmas eyeing the U.S. market and future PD-1/L1 programs. Novartis India plans to cut 400 jobs after a sales pact with Dr. Reddy's. Moderna will build four new commercial subsidiaries in Asia. And more. read more By Kyle LaHucik Robert Califf, M.D., will once again helm the top spot at the FDA after a narrow confirmation by the Senate. The NIH's Vaccine Research Center Director John Mascola, M.D., will depart at the end of March after nearly 22 years at the center, including eight in the top spot. 2seventy bio poached Steven Bernstein, M.D., from Turnstone Biologics to fill the chief medical officer post. read more Resources Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. Sponsored by: Catalent How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Blue Matter What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. 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