Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Lauren welcome David Robinson, an attorney at Maynard Nexsen, who also serves as the Honorary Consul for Japan in North Carolina and Chairman of the NC...more
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of...more
Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more
On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more
Fuji Pharma and Alvotech announced their agreement to extend the companies’ exclusive partnership for the commercialization of four biosimilar medicines in Japan. We previously posted on that partnership when it was first...more
Key Takeaways - - Foreign Direct Investment (FDI) controls are proliferating around the globe. Since the pandemic, “health” has become a particular focus. - Several countries have adapted their existing FDI rules, or...more
On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
T-Mobile chief and fan-of-magenta John Legere has announced that he’ll be stepping down in April at the end of his current contract. Legere will be succeeded by Mike Sievert, the carrier’s current president and COO....more
Amgen will pay $13.4 billion in cash to buy psoriasis treatment Otezla, a deal that will “pave the way for Bristol-Myers Squibb to complete its acquisition of Celgene” by addressing “regulatory concerns over their union”....more
Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more
To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more
As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical...more
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of...more
Last week, Japan-based Nichi-Iko Pharmaceutical Co. announced the completion of a biologics production facility in Osong, South Korea by its Korean affiliate Aprogen Biologics “[t]o provide a stable supply of premium quality...more
It was a busy Thursday in the big pharma world, with drugmaker Shire rejecting a $60 billion takeover offer from Japan’s Takeda, while US rival Allergan disclosed that it was considering a bid of its own for Shire....more
On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese...more
Last Friday, Japanese company Mochida Pharmaceutical with Korean company LG Chem announced that it has received sales approval from the Japanese Ministry of Health, Labour and Welfare on its etanercept biosimilar (marketed by...more
Aging populations and rising healthcare costs across Asia — particularly in Japan — have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means...more
Dr. Frederick Ch’en, an IP partner in Hogan Lovells’ Tokyo office, explains the political and demographic changes fueling changes in Japan and throughout Asia, and the practical impact on pharmaceutical companies doing...more
The EU and Japan have reached agreement on “the biggest bilateral trade agreement ever negotiated by the European Union”, covering a combined market of over 600m people and 30% of global GDP....more
HSBC’s making good on its plans to shift to a focus on Asia by naming John Flint—who spent his first 14 years at the bank in Asia—as its new CEO. Flint will take over from Stuart Gulliver in February....more
Please see full chart below for approved biosimilar products around the world. ...more