As investors await an MAA submission to the EMA for U.S.-approved Mycapssa (octreotide) in acromegaly, Chiasma Inc. disclosed its plan to merge with Amryt plc in an all-stock deal, thereby gaining a global commercial presence. Terms call for the exchange of each Chiasma share for 0.396 American depositary share of Amryt. The latter closed May 4 at $12.95, so the deal values Chiasma at $5.13 per share, an 81% premium over the previous day’s ending price, noted Piper Sandler analyst Edward Tenthoff. The stock (NASDAQ:CHMA) rose $1.14, or 40%, to finish at $3.98. Read More
Eikon Therapeutics Inc., a startup leveraging advanced optics and machine learning to track protein dynamics for drug discovery, has closed a $148 million series A financing. Led by a high-profile CEO, former Merck & Co. Inc. R&D chief Roger Perlmutter, and with the counsel of two Nobel prize winners, its team is working to "expand the druggable proteome by targeting protein dynamics directly." Read More
The rocky first quarter for public biopharmaceutical companies continued into April as the BioWorld Biopharmaceutical index remained flat for the period in contrast to the general market, with the Dow Jones Industrial Average growing by more than 2%. Weighing on the sector has been softer than expected earnings in the period among the top tier companies. Read More
Since joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2017, China has approved clinical trials and marketing of drugs a lot faster with simultaneous clinical development at home and abroad, according to China’s National Medical Products Administration officials in a webinar on April 29. Read More
Once again, the World Trade Organization (WTO) postponed a decision on a temporary intellectual property (IP) waiver for COVID-19 vaccines and other related medical products. Read More
An international collaborative study led by scientists at Sweden’s Lund University has classified Alzheimer’s disease into four distinct subtypes, which has important implications for the management of the progressive neurodegenerative disease, the authors reported in the April 29, 2021, edition of Nature Medicine. Read More
The 2021 Special 301 Report recently released by the U.S. Trade Representative is mostly déjà vu for the 32 countries included on the Priority Watch and Watch Lists, as all of them have appeared before on the lists that call out U.S. trading partners for unfair intellectual property practices that disadvantage foreign companies. Read More
The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes. Read More
Biopharmas raising money in public or private financings, including: Bridgene, Cocrystal, Corvus, Day One, Esker, Hepalink, Nervgen, Resverlogix, Summit Healthcare, Vaccitech, Valneva. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adagio, Ascletis, Catalyst, Cerecor, Genascence, Genprex, Neoleukin, Oncopeptides, Tilt, Vivace. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, GC Pharma, Replimune, Roche, Servier, Tarsus. Read More
