Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Plus, regulators are promoting this growth. About the authors.

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Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Another case of same-day (and same-time) FDA approvals! To that end, 35 U.S.C. § 156(c)(4)

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Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI.

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Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. Right) The passage of text from a 2010 review that inspired Mikhail Shapiro to engineer gas vesicles. Voigt, Biotechnology Journal (2010). 31,500x magnification.

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Agency IQ

APRIL 26, 2024

BY RACHEL COE, MSC | APR 24, 2024 10:56 PM CDT Biosimilars and interchangeable products The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act. Yes, the guidance confirms.

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Codon

MARCH 24, 2024

This was the founding ethos of Moderna, the mRNA vaccine developer, when it was launched in 2010 by Noubar Afeyan and Doug Cole at Flagship Pioneering. In response to this hysteria, regulation was aggressively tightened. An alternative approach is to make molecules not in tubes, vials, or cells, but inside the body itself.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 2010; 116(20): 4777–4787. BTK signaling is needed by specific cancer cells to multiply and spread. Accessed May 2021. 4 Shanafelt, et al.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 2010; 116(20): 4777–4787. BTK signaling is needed by specific cancer cells to multiply and spread. Accessed May 2021. 3 Shanafelt, et al.

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Treatment Therapies FDA FDA Approval 52

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. 23, 2010) ( here ), can supersede our list, so far they’ve been thankfully uncommon. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? At the FDA’s suggestion, the manufacturer withdrew that supplement, but kept trying. femur fractures.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. See Prasol v.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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