A prolific builder of biopharma and health technology companies, Roivant Sciences Ltd. is poised to join Nasdaq through a newly proposed merger with a special purpose acquisition company (SPAC) sponsored by Patient Square Capital LLC. The deal, which values Roivant at $5 billion, includes $611 million of new money, composed of $411 million held in trust by the SPAC, Montes Archimedes Acquisition Corp., plus $200 million from a committed PIPE financing. The transaction, expected to peg Roivant's initial market cap at $7.3 billion, follows a September 2019 deal in which Roivant sold interests in five biopharmas to Sumitomo Dainippon Pharma Co. Ltd. (SDP) for $3 billion cash. Read More
Astrazeneca plc followed up its win a year ago in heart failure (HF) with yet another approval for its oral SGLT2 inhibitor, Farxiga (dapagliflozin), now cleared by the FDA to reduce the odds of kidney function decline, failure, cardiovascular death and hospitalization for HF in adults with chronic kidney disease (CKD) at risk of disease progression. Read More
LONDON – In what is claimed as the largest series A for a Danish biotech, Adcendo ApS has raised €51 million (US$61.3 million) to take forward antibody-drug conjugate (ADC) drugs aimed at proprietary targets that are involved in cellular recycling processes. Read More
LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K. Read More
To honor its part for phase one of the U.S.-China trade deal, China has revised its patent law to establish a drug patent linkage system and provide compensation for lost patent terms, similar to procedures under the U.S. Hatch-Waxman Act. Effective June 1, the new patent law is expected to drive biotech innovation and welcome more foreign drugs to the China market. Read More
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product. Read More
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actuate, Biovaxys, Cocrystal, Enteris, Esteve, Gain, Gemini, Gensight, Hoth, Immunicum, J&J, Kowa, Lantern, Moderna, Moonlake, Merck KGaA, New Life, Ocugen, Revive, Samsung Bioepis, Sonnet, Tryp, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advicenne, Amicus, Avrobio, Astrazeneca, Camurus, Chiesi, Clearside, Galmed, Intra-Cellular, Jacobio, Moderna. Read More
