Amgen Inc. said as part of its quarterly results that the company has turned down a request from the U.S. FDA that Tavneos (avacopan) be taken off the market. The complement 5a receptor antagonist was approved by the agency in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy including glucocorticoids. Tavneos was developed by Chemocentryx Inc., which Amgen acquired in 2022, and the FDA is questioning the process followed by the originator to re-adjudicate primary endpoint results for nine of the 331 patients in the pivotal trial. Hepatotoxicity, which is a known but infrequent risk with Tavneos, was also raised in the context of the benefit-risk profile of the drug. Thousand Oaks, Calif.-based Amgen said the company is “not aware of any issue with the underlying patient data” from the trial done by Chemocentryx, of San Carlos, Calif. Shares of Amgen (NASDAQ:AMGN) were trading at $357.94, up $19.36.

Hair loss drugmaker Veradermics floats upsized $256M US IPO

Veradermics Inc. is raising $256.3 million from an IPO on the New York Stock Exchange, with proceeds funding three ongoing phase II/III clinical trials of VDPHL-01, its novel oral formulation of Rogaine (minoxidil) to treat pattern hair loss in men and women. Shares of the New Haven, Conn.-based dermatology and aesthetics company are expected to begin trading Feb. 4 under the ticker symbol MANE, with 15.07 million shares offered at $17 each.

New push to increase investor interest in UK life sciences research

The U.K.’s main research funding agency is looking to put more public money into proof-of-concept and pre-seed funding of putative university spinouts to make them more investible and help foster relationships between academics and investors. The move by UK Research and Innovation (UKRI), which this year will allocate £9.22 billion (US$12.58 billion), is in response to a government edict that it prioritizes outputs over inputs and channels more resources toward helping companies based on publicly-funded research to start up, scale and remain in the U.K.

Rare pediatric PRV extended to 2029

Reauthorization of the rare pediatric disease priority review voucher (PRV) was included in the spending package signed into law Feb. 3 by U.S. President Donald Trump, removing at least one aspect of uncertainty facing rare disease companies, many of which have relied on the PRV’s transferrable option as a lucrative source of funding.

Boston Sci sees shares tumble despite strong Q4 results

Despite reporting strong fourth-quarter organic sales growth of $5.29 billion, up 12.7% year-on-year, Boston Scientific Corp. saw its shares plunge more than 17% in early trading. Investors appeared disappointed by weaker U.S. sales in the Electrophysiology and Watchman businesses, two of the company’s growth engines, and concern over the 2026 organic growth guidance provided by management of 10% to 11%, down from the 15.8% seen in 2025.

China amends drug rules to enforce lifecycle accountability

China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework. Rather than focusing narrowly on approval mechanics, the revision formalizes a lifecycle-based accountability model that places the Marketing Authorization Holder (MAH) at the center of regulatory responsibility, while expanding exclusivity incentives, increasing manufacturing flexibility, and strengthening post-market enforcement. Overall, the government is encouraging innovation and faster market entry while tightening expectations around quality, supply reliability, and post-approval stewardship.

BARDA offers $100M in prize money for antiviral development

Looking to fill a treatment gap, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is launching the first stage of a $100 million prize competition to support development of broad-spectrum, small-molecule antiviral therapies targeting viruses in the Togaviridae and Flaviviridae families. “Currently, no FDA-approved broad-spectrum antivirals exist for any viruses within these families, which include dengue, [Z]ika, West Nile and chikungunya,” said John Knox, principal deputy assistant secretary of the Administration for Strategic Preparedness and Response, which includes BARDA.

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