Shelby Walker

In our latest issue of Blockbuster Biologics Review, we cover the status and developments of post-grant challenges and patent litigations implicating blockbuster #biologics and legislative proposals related to #biosimilars in Q2 2024. #WeAreMorganLewis

9

Latest updates on #biosecure...

6

#FDA has released its long-awaited draft Platform Technology Designation Program for Drug Development: Guidance for Industry, which could represent a potentially significant shift in the regulatory and commercial strategies for novel drug and biologics products. Our alert looks at the key details. #DrugDevelopment #PlatformTechnology #FDCA

5

BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

11

My latest article.

3

I pose this question to people in the know, including Shannon Bennett, Karin A. Hughes, Ph.D., Lisa Charter, Joshua D. Levin, Tom Soriano, and Brendan O'Leary. I was on the FDA call with the media regarding LDT regulations. While most people were interested in Grandfathering and NYC review allowance, one question was raised by the media regarding how the FDA viewed the reclassification plan and how many PMAs the FDA expects to review under the final rule. Dr. Shuren answered that they expect reclassification to happen concurrently and that the number of PMAs submitted may be small by the time LDT must start submissions. Reclassification petitions take years. Is there some framework where an entire class of Companions can be down-classified in one swoop? I assume most will be regulated under unique product codes and/or regulations. My regulatory brain says no, but the ex-FDA folks tagged on this message may have some thoughts. Brendan O'Leary, is there an easy way to determine the average time it takes for the FDA to down-classify one IVD (Class)?

2

Attention all manufacturers of laboratory developed tests: #FDA recently issued a final rule significantly modifying its approach to oversight of LDTs, with the phased implementation taking place over the next four years. My colleagues provide an overview of the final rule in the blog post below. #lifesciences #healthcare

2

Give your key patents a check-up! When biopharma conducts due diligence on your company, important patents will be scrutinized. Have a patent attorney review your portfolio ahead of time to ensure everything is in good order and corrections are made. Learn more in this post: https://lnkd.in/g4MqTJ8a

7

Due to the #FDA's recent draft guidance on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies, companies conducting these studies should be diligent in ensuring the integrity of the data that is generated and submitted to the FDA. For a complete overview of the FDA's draft guidance, check out the blog post below. #lifesciences #data

1

1 Comment

FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Public Health Service Act (PHS Act), and biosimilar products and interchangeable biosimilar products approved under 351(k) of the PHS Act—with respect to meeting FDA’s general accuracy and truthful and non-misleading standards that are applied to advertising and promotion of prescription drug products generally. Check out this informative blog post by my colleague Maarika Kimbrell. #mllifesci #wearemorganlewis

21

Munger, Tolles & Olson partner Rohit Singla was quoted in Pharmaceutical Technology’s article titled “How Sham Patents Are Hurting the Pharma Industry.” The article discusses the Federal Trade Commission’s crackdown on pharmaceutical companies filing sham patents in the Orange Book, which hinders or delays generics competition and does not protect genuine innovations. #MTO #PharmaceuticalToday #patentlitigation #shampatents #orangebook

19

While I've attended several fantastic ACI conferences in the past, this is my first time going to the Biologics one! Very excited to connect with my colleagues in the industry. If you're heading there and would like to schedule a coffee or meal, DM me! #bpcialitigation #andalitigation #biologics #iplitigation #pharmaceuticals #pharmalitigation #patents #patentlaw #iplaw

4

The increasing shift to “biologic” drugs may encourage anticompetitive moves by pharmaceutical companies. #Antitrust litigation will be key to employers and union health funds recovering prescription overcharges that result, writes Aaron Marks: ➡ https://lnkd.in/eT4YNATx #shareholderadvocate #cohenmilstein #employeebenefits #genericdrugs

8

Kelly Gordon, Ph.D., MB (ASCP) is on point as always! As you and I discussed previously, we knew #FDA oversight was coming and #LDT developers have to be mindful in designing their studies accordingly, but there is a lot of opportunity in the oncology space for #CDx and #LDTs with all of the accelerated review channels being provided under the various cancer-related drug, device, and diagnostic development programs. Exciting times in our space! #Boudicca #LDTs #FDA

5

2 Comments

https://lnkd.in/ea86SkAc See attached released today via various news outlets. The information here is consistent with what you will find at www.subsema.com. There are right and wrong ways to provide compounded drug products - including GLP-1 RA medications. Additionally, even if a compound is done the right way, one must never imply or confuse a patient or other party that the compound has been reviewed by FDA. Further, and certainly not embraced by all, I think the manufacturer has strong molecular patents surrounding Tirzepatide so a pharmacy obtaining the active-pharmaceutical-ingredient as a bulk chemical, at least to me, is in a very precarious position - at best. #subsema #semaglutide #tirzepatide #compoundingpharmacy

2

Due to the #FDA's recent draft guidance on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies, companies conducting these studies should be diligent in ensuring the integrity of the data that is generated and submitted to the FDA. For a complete overview of the FDA's draft guidance, check out the blog post below. #lifesciences #data

2