Tagged with MPA

USA Since founding the HIV advocacy group Prevention Access Campaign (PAC) and launching its Undetectable=Untransmittable (U=U) campaign in 2016, Bruce Richman has been focused on raising awareness around a revolutionary but widely unknown fact: people living with HIV who are on treatment and have an undetectable viral load cannot sexually transmit…

China Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the…

Global Having been quietly working away on its mRNA platform for years, Moderna stepped into the limelight during the COVID-19 pandemic and became a commercial-stage outfit almost overnight with its vaccine. After generating sales of USD 18.4 billion in 2022, demand for the company’s Spikevax shot, still its only commercialized product…

China In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the…

USA Johnson & Johnson has been building its medtech arm and creating a differentiated pipeline through strategic M&A, an approach that generated USD 30.4 billion in medical device sales last year, representing growth of 12.4 percent. The company has now acquired Shockwave Medical, bringing its IVL technology on board for USD…

China No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2…

Belgium Janssen has the lofty aim of reaching USD 60bn dollars in sales by 2025, an 8bn increase on the 2021 figure, despite some high-profile losses of exclusivity and the spin-off of its consumer healthcare branch. This massive growth plan involves both existing products as well as new CAR-T and autoimmune…

China Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.  …

France French mid-cap Servier has launched a new visual identity and logo and announced an ambitious 2030 growth plan with an increased focus on hard-to-treat cancers.   Servier, which is governed by a foundation, brought in EUR 4.7 billion in the 2020/21 period according to the firm’s latest annual report, and…

Italy Historically, SIFI has been a modest local player focused on ophthalmic products, but in recent years the company has set some ambitious goals for itself—becoming a leading force in European ophthalmic markets, breaking into orphan drugs and adding value in the glaucoma field—and is now seeing its ambitions become a…

Korea Two decades ago, South Korean company Celltrion embarked on a quest to find the necessary resources to produce biopharmaceuticals. It took five years for their manufacturing plant to receive GMP certification from the US FDA in 2007 and another one to launch an initial public offering; an ascent that, while…

Global In June 2021, as part of a broader restructuring, Merck (MSD globally) spun off its women’s health, legacy products, and biosimilars businesses. The new company formed, Organon, is positioning itself as “the only player of its size (USD 6.3 billion in revenues for 2021, 9,000 employees) focused on women’s health…