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United States: Biocon Settles With Bayer And Regeneron, Securing Canada Market Entry Date For Aflibercept Biosimilar - Goodwin Procter LLPOn March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon's proposed biosimilar to EYLEA.Mondaq - Published | |
United States: How Beauty Companies Can Mitigate Risks Associated With AI Technology Use - Duane Morris LLPFrom L'Oreal and Olay to Procter & Gamble and Shiseido, companies across the beauty industry are embracing AI technology with open arms.Mondaq - Published | |
United States: FINRA Proposes To Add 'Knowledgeable Employees' To Category Of Persons Who May Receive Projections And Targeted Returns Under Rule 2210 - Goodwin Procter LLPThis amendment builds on FINRA's recent willingness to relax the prohibition on the use of projections and targeted returns in the marketing materials broker-dealers deliver to institutional...Mondaq - Published | |
United States: Genentech And Partners Voluntarily Dismiss IPR Appeals Related To Genentech's ACTEMRA® (Tocilizumab) - Goodwin Procter LLPOn February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB's Final Written Decisions in IPR2022-00578 and IPR2022-00579.Mondaq - Published | |
United States: Alabama IVF Clinics: Potential Implications Of The LePage Case - Goodwin Procter LLPOn February 16, 2024, the Alabama Supreme Court issued a significant and controversial ruling that gave personhood status to unimplanted human embryos—a decision...Mondaq - Published | |
United States: Antitrust & Competition Life Sciences Year In Review 2023 - Goodwin Procter LLPDespite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as "business as usual" in the antitrust world.Mondaq - Published | |
United States: FDA Approves First Cellular Therapy For Treatment Of Unresectable Or Metastatic Melanoma - Goodwin Procter LLPOn February 16, 2024, the FDA approved Iovance's AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma.Mondaq - Published | |
United States: Debt Download Newsletter - February 29, 2024 - Goodwin Procter LLPWelcome to Goodwin's Debt Download, our monthly newsletter covering what you need to know in the leveraged finance market. Happy Leap Year!Mondaq - Published | |
United States: PTAB Institutes Celltrion And Biocon IPRs On Regeneron Aflibercept Dosing Patent - Goodwin Procter LLPLate last month, a Patent Trial and Appeal Board ("PTAB") panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review ("IPR") of Regeneron's U.S.Mondaq - Published | |
United States: SEC To Ban Exchange Volume-Based Pricing Tiers - Goodwin Procter LLPOn October 18, 2023, the SEC proposed new Exchange Act Rule 6b-1, which, if adopted, would prohibit national securities exchanges like NYSE and Nasdaq from charging members...Mondaq - Published | |
United States: 2023 Year In Review: Major U.S. Supreme Court And Appellate Cases - Goodwin Procter LLPThe Supreme Court continues to take a close look at major administrative law questions, and its answers have the potential to significantly affect the consumer finance industry.Mondaq - Published | |
United States: Pick Up The Indemnification Stick For Your True Lender Bundle - Goodwin Procter LLP"True lender" is one of the biggest risks in a fintech–bank lending partnership. It is a challenge that regulators or plaintiffs' counsel could advance, alleging that the fintech company...Mondaq - Published | |
United States: USPTO Issues New Guidance On Patenting AI-Assisted Inventions - Goodwin Procter LLPPatentability hinges on whether a human made a "significant contribution," even when AI assists in the process of invention.Mondaq - Published | United States: Cash Management In Hotel Financing - Goodwin Procter LLPThe financing of hotels and resorts requires balancing the borrower's need for flexibility to successfully operate the hotel against the lender's desire to prevent cash leakage should conditions...Mondaq - Published |
United States: End Of The Beginning: AIFMD II's Final Text - Goodwin Procter LLPIn our previous alert AIFMD II (Near) Final Text Agreed: What's New? and in our recent update in our Horizon Scan, we noted that the Council of the European Union (EU)...Mondaq - Published | European Union: Shaping The Future: The European Health Data Space - Goodwin Procter LLPThe European Commission published a proposal on 03 May 2022 for a regulation to create a European Health Data Space ("EHDS").Mondaq - Published |
United States: Updates On Aflibercept BPCIA Litigation - Goodwin Procter LLPOn Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. ("Regeneron") filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the..Mondaq - Published | South African all-rounder Mike Procter dies aged 77He was mainly known for his chest-on action and releasing the ball early in his delivery stride. The Proteas have not lost in all the seven Test matches he took part in, winning six gamesMid-Day - Published |
Barry Richards leads tributes to ‘cricket giant’ Mike ProcterVintcent van der Bijl, who formed a devastating new ball partnership for Natal with Procter, described him as “the most unpretentious great cricketer I knew”Mid-Day - Published | Iconic South African all-rounder, with over 20,000 runs, 1,400 wickets, suffers cardiac arrest, he's now...Former national team coach and South African cricket legend, Mike Procter, has suffered a cardiac incident while already being admitted in the ICU for ill health.DNA - Published |
European Union: Marketing Crypto Assets To EU Investors Under MICA: ESMA's First Take On Reverse Solicitation Alert February 1, 2024 - Goodwin Procter LLPMiCA's provisions governing certain stablecoins will apply from 30 June 2024, and its provisions governing the remaining crypto assets will apply from 30 December 2024.Mondaq - Published | United States: New Jersey Privacy Law Helps Expand US Consumer Privacy System - Goodwin Procter LLPOn Jan. 16, New Jersey Gov. Phil Murphy (D) signed the New Jersey Data Privacy Act into law. Its passage makes New Jersey the 14th state to adopt...Mondaq - Published |
United States: USPTO Publishes Enablement Guidelines In View Of Amgen v. Sanofi - Goodwin Procter LLPOn January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases ("the Guidelines").Mondaq - Published | United States: Ten Considerations For Large-Cap And Upper-Middle-Market Borrowers In Early Stages Of Distress - Goodwin Procter LLPCompanies continue to face economic uncertainty caused by a variety of factors such as high interest rates, changing consumer spending habits, a tight debt and equity environment, ...Mondaq - Published |
United States: PTAB Issues Final Written Decisions Finding Claims Of Aflibercept-Related Patents Invalid - Goodwin Procter LLPOn January 9, 2024, the PTAB issued final written decisions in IPR2022-01225 and IPR2022-01226, filed by Mylan on two Regeneron patents directed to dosing of aflibercept — U.S.Mondaq - Published | United States: Year In Review: Top Legal Developments Of 2023 - Goodwin Procter LLPAs we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market.Mondaq - Published |
Shah Rukh Khan Recommends Tide as the 'Asli SRK - Stain Removal King'*Tide*, the World's No. 1* detergent brand, has announced an iconic new partnership as it continues its history of delighting consumers with superior laundry solutions. The last decade has witnessed..NewsVoir - Published | United States: Goodwin Releases Update To Its Comprehensive Guide To Biosimilars Litigation And Regulation In The U.S. - Goodwin Procter LLPGlobal law firm Goodwin today announced the release of the 2023-2024 annual update to its definitive biosimilars treatise Guide to Biosimilars Litigation and Regulation in the U.S.Mondaq - Published |
United States: Cybersecurity — Cracking The Code On Upcoming Disclosures - Goodwin Procter LLPAs annual reporting season begins, it is important to take a fresh look at the company's governance and incident response processes and develop risk-informed and compliant disclosures.Mondaq - Published | United States: Updates On Patent Challenges By Biosimilar Manufacturers At The PTAB - Goodwin Procter LLPIn the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents.Mondaq - Published |
United States: OCC Report Identifies Key Risks Facing Federal Banking System - Goodwin Procter LLPOn December 7, the OCC's National Risk Committee released its semiannual risk perspective report (the Report), commenting on the condition of the federal banking system...Mondaq - Published | United States: FCC Proposes New, Stricter TCPA Rules That Would Limit Lead Generation To One-Company Consent - Goodwin Procter LLPOn November 22, 2023, the FCC released a Second Report and Order, Further Notice of Proposed Rulemaking, and Waiver Order (Report and Order) outlining new, proposed rules implementing...Mondaq - Published |
United States: FDA Targets April 2024 For Laboratory Developed Test (LDT) Final Rule - Goodwin Procter LLPOn December 6, 2023, the Office of Information and Regulatory Affairs ("OIRA") released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the "Agenda")...Mondaq - Published | United States: Unlocking AI's Power To Multiply Manufacturing Productivity - Goodwin Procter LLPManufacturers have been conducting time and motion studies to increase efficiency and improve productivity for over a century. By doing so, they can often increase production speed...Mondaq - Published |
