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1/14/2022

Morpheus Ventures led a Series A investment round that raised $15 million for VeriSIM Life, a startup founded in 2017 by Jo Varshney, to develop a biosimulation platform that combines machine learning and deep learning methods in physics-based modeling to predict whether drug candidates that succeed in animal testing will also work in humans. "So for example, we want to de-risk the efficacy endpoints, we want to de-risk what the best route of administration would look like, what the dosing could look like," says CEO Varshney, a veterinarian who has a PhD in comparative oncology and genomics.

1/14/2022

Applications are due by Jan. 29 for the L'Oreal USA for Women in Science fellowship program, which has awarded more than $4 million in grants to 90 postdoctoral scientists since 2003. Five scientists will be awarded up to $60,000 to support STEM-related research.

1/14/2022

With the right support, it is possible to return to academia after having children, writes Rachel James, who got a part-time post-doctoral contract after having her second child but did not pursue an extension after being made to feel like she was underachieving. After the birth of her third child, James picked up a freelance editing job followed by an online teaching job, and she was able to return to academia with the help of a fellowship from the Daphne Jackson Trust specifically for researchers resuming a career after a break.

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Nature
1/14/2022

Diagnosing mucopolysaccharidosis disorders can be difficult and requires urine-based tests to identify abnormally high levels of glycosaminoglycan and enzymatic activity assays to confirm decreased levels of lysosomal enzymes associated with high GAG levels. This piece discusses the measurement of GAG levels and the use of urinary GAG concentrations as predictive biomarkers of the efficacy of enzyme replacement therapy as a treatment for MPS I.

1/13/2022

The FDA issued a warning to patients and prescribers about the risk of potential dental problems such as tooth decay, infection and tooth loss from use of opioid addiction treatment buprenorphine, particularly those pills dissolved under the tongue and films put against the inside of the cheek. The agency said it will require a new warning citing the dental risks to be included in the patient medication guide and prescribing information of all orally-dissolving drugs containing buprenorphine.

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Reuters
1/13/2022

The prevalence of virtual meetings is leading Pfizer to reduce its sales staff, although the number of jobs to be cut has not been specified. "We are evolving into a more focused and innovative biopharma company, and evolving the way we engage with health care professionals in an increasingly digital world," Pfizer said in a statement.

1/13/2022

Drug industry groups, drug firms and active pharmaceutical ingredient suppliers are calling on the FDA to implement a phased-in approach or to postpone the manufacturing volume reporting requirement under the Coronavirus Aid, Relief, and Economic Security Act as they need more time to establish necessary systems to comply with the rule. In its comment, Pharmaceutical Research and Manufacturers of America urged the FDA to "undertake an initial two-year phase with only a subset of manufacturing facilities and products, during which time FDA can assess the utility of the information reported with respect to preventing and/or mitigating drug shortages."

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Regulatory Focus
1/13/2022

The FDA sent a warning letter to Chinese firm Hubei Kangzheng for its failure to demonstrate that the manufacturing process for its over-the-counter "pi yen chin" eye drops at its facility in Hubei, China, was "capable of preventing microbial contamination." The violations partly stemmed from the company's incorrect interpretation that the eye drops were not sterile products, which the FDA corrected.

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Regulatory Focus
1/13/2022

Another 600,000 doses of sotrovimab, the COVID-19 antibody therapy developed by GSK and Vir Biotechnology have been ordered by the US for an undisclosed amount. This purchase is to be delivered by the partners in the early months of 2022, with the companies expected to manufacture approximately 2 million doses of sotrovimab within the first six months of this year.

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Reuters
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Vir Biotechnology
1/13/2022

The FDA has given 510(k) clearance to Abbott for its Ensite X EP system with Ensite omnipolar technology, a cardiac mapping platform. The system creates a detailed three-dimensional map of a heart to help physicians conduct ablation procedures to treat abnormal heart rhythms.

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BioWorld MedTech