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Spirulina’s role in shaping the future of preventative biologics

Drug Target Review

Finrow highlights the economic challenges within the sector, particularly the reluctance of doctors to use new antibiotics when cheaper generic options are available. “Doctors face incentives to prioritise generic antibiotic use first because they are cheaper, leaving novel antibiotics as a last resort.

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Operation Warp Speed’s top doctor says coronavirus vaccine likely won’t be approved until after November

The Pharma Data

Dr Moncef Slaoui, the leading doctor involved with Operation Warp Speed, has said it is unlikely a vaccine for the US will be ready by November. . It is hoping to accelerate the production of a vaccine to be made widely available across the country by the end of the year. Air Force photo/Senior Airman Areca T. Conor Kavanagh.

Doctors 52
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

This product was developed by uniQure prior to being licensed to CSL Behring. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

Therapies 119
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Allecra Therapeutics and Shanghai Haini Pharmaceutical Announce Exclusive Licensing Agreement for Cefepime/enmetazobactam for Greater China

The Pharma Data

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. Unlike hospital reprocessing facilities, many clinical laboratories are overseen by laboratory directors who themselves are medical doctors.

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Healthcare, HIPAA, Sitecore and BAAs

Perficient: Drug Development

Not only has this been communicated from a general Sitecore perspective, but we have clients who have signed agreements with Sitecore to have them enact a BAA for these products within these timelines. The relationship between XM Cloud and Sitecore CDP and Personalize make the timing of this support really interesting.

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NEW STORAGE OPTION FOR PFIZER-BIONTECH VACCINE, EASING DISTRIBUTION AND STORAGE OF DOSES ACROSS EUROPEAN UNION

The Pharma Data

It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Vaccine 52