FDA: Drug firms must follow CDC guidance for workers with COVID-19

FDA: Drug firms must follow CDC guidance for workers with COVID-19 | Experts warn of potential shortages of dexamethasone | Pandemic changes SOP at hospitals

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June 23, 2020

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FDA: Drug firms must follow CDC guidance for workers with COVID-19

The FDA released new guidance on how drug and biologic product manufacturers should address COVID-19 cases among their workers, including those with asymptomatic infections. According to the guidance, employees who have symptoms or test positive for COVID-19 should be excluded from drug manufacturing areas and should not be allowed to return until they have complied with CDC's home isolation criteria.

Full Story: Regulatory Focus (6/19)

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Health Care & Policy

Experts warn of potential shortages of dexamethasone

After a study reported last week found the corticosteroid dexamethasone reduced mortality rates among severely ill COVID-19 patients by up to one-third, "hoarding and speculative procurement appear to have already started," said Emer Cooke of the World Health Organization. The drug can be administered orally or intravenously, and the shortages could be more focused on the injectable version, which is preferred in many cases.

Full Story: Science (tiered subscription model) (6/21)

Pandemic changes SOP at hospitals

Hospital-based physicians usually wait until medical societies issue guidance or studies have undergone peer review before trying drugs for unapproved uses, but the urgency of the COVID-19 pandemic has changed standard operating procedures at many hospitals. Some with surging COVID-19 cases have begun using dexamethasone to treat severely ill patients based on preliminary data, and remdesivir is also being used prior to full FDA approval.

Full Story: Reuters (6/19)

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Company & Financial News

Gilead plans trials for inhaled version of remdesivir

Gilead Sciences announced plans to launch clinical trials in August to assess the efficacy of an inhaled version of remdesivir to treat COVID-19 patients. The company intends to explore earlier use of the drug, treatment in combination with other therapies and its use in additional patient groups, Chairman and CEO Daniel O'Day said.

Full Story: HealthDay News (6/22)

4 late-stage studies launched for Pfizer vaccines

Pfizer has begun four late-stage trials for vaccine candidates to prevent pneumonia, meningitis and respiratory syncytial virus. Two studies will test a 20-valent pneumococcal vaccine in infants as a four-dose series, while an RSV vaccine will be studied in infants whose mothers have been immunized, and a pentavalent meningococcal vaccine will be studied in a cohort of adolescents and young adults to determine their non-inferiority to licensed vaccines.

Full Story: Seeking Alpha (free registration) (6/22)

Orgenesis, Leidos collaborate on potential SARS-CoV-2 treatment

Orgenesis and Leidos have partnered through a preliminary, nonbinding term sheet for the development and commercialization of Orgenesis' ranpirnase as a treatment for SARS-CoV-2. The companies will be seeking the FDA's approval to market the broad spectrum antiviral agent that Orgenesis acquired from Tamir Biotech recently.

Full Story: Seeking Alpha (free registration) (6/22)

Cancer drug startup Shattuck Labs raises $118M

Shattuck Labs, a cancer immunotherapy startup, raised $118 million in its Series B funding round. With the new capital it plans to begin human testing of some of its cancer treatment drugs.

Full Story: Xconomy (6/19)

Global Developments

UK researchers gain $2.7M to identify 2nd wave of COVID-19 drugs

The British research group AGILE received a $2.7 million grant from the nongovernmental organization Unitaid to identify other drugs aside from the ones already being tested that could treat COVID-19 in light of the possibility that the first wave of treatments does not prove to be beneficial to this patient population.

Full Story: PharmaPhorum (UK) (6/19)

Genexine of S. Korea initiates coronavirus vaccine trial in humans

South Korean biotech firm Genexine is one of the companies developing a COVID-19 vaccine and has seen its company shares increase 14% last weekend on the news. The company announced it has enrolled the first of about 40 participants for its early-stage human trial to test its COVID-19 vaccine candidate.

Full Story: Reuters (6/19)

Ag & Environment

UK environment secretary endorses gene editing for plant breeding

George Eustice, the UK's Secretary of State for Environment, Food and Rural Affairs, voiced his support regarding the use of gene editing technology for agricultural purposes. His comments indicated that the British government disagreed with the stance of the European Union on this topic and that "gene editing techniques like CRISPR are really a more targeted form of conventional plant breeding, allowing to move or modify a particular gene within a certain species," Eustice said.

Full Story: EurActiv (6/19)

IDTechEx: Advanced recycling an opportunity to curb waste

Innovations in pyrolysis and other advanced recycling technologies have the potential to drive down costs and help create a circular economy for polymers, says IDTechEx. "New, biodegradable plastics and better recycling strategies are two promising approaches to help the world cut down on plastics waste," it says.

Full Story: PlasticsToday (6/19)

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