Articles

  • 5 days ago | cen.acs.org | Rowan Walrath

    The US Food and Drug Administration has greenlit a next-generation COVID-19 vaccine from Moderna that's engineered to be given in a smaller dose than the current one and targets certain portions of the SARS-CoV-2 spike protein. But only certain groups are approved to get the new vaccine. The FDA approved mRNA-1283, marketed under the name mNEXSPIKE, for all adults 65 and older and 12- to 64-year-olds with at least one condition that puts them at risk for severe outcomes of COVID-19.

  • 2 weeks ago | cen.acs.org | Rowan Walrath

    US residents' ability to get COVID-19 vaccines this fall is about to change as US Food and Drug Administration leaders shift away from a one-size-fits-all approach, raising concerns among vaccine researchers. Under new guidance this week from the FDA's top brass, annual COVID-19 boosters will be authorized only for people 65 years old and older, as well as people with certain health risks, including asthma and diabetes (N. Engl. J. Med. 2025, DOI: 10.1056/NEJMsb2506929).

  • 2 weeks ago | cen.acs.org | Rowan Walrath

    Since President Donald J. Trump took office a second time on Jan. 20, leaders across the biotechnology and pharmaceutical industry have by and large tried to play it safe with the new administration. There's plenty at stake: drug-pricing policy, manufacturing, tariffs and other trade agreements, and how the US Food and Drug Administration is likely to approach new drug approvals, among other things.

  • 1 month ago | cen.acs.org | Rowan Walrath

    A start-up targeting regulatory RNA is one step closer to getting a drug candidate into human trials with the help of $65 million in series A financing. Haya Therapeutics announced the new fundraising round on Thursday. CEO Samir Ounzain says he and his team will use the money to advance their lead candidate, called HTX-001, into clinical studies. HTX-001 is an antisense oligonucleotide that targets a long noncoding RNA, or lncRNA, that regulates fibroblast activity in the heart.

  • 1 month ago | cen.acs.org | Rowan Walrath

    The last few weeks have been busy for Jim Corbett. Corbett, the CEO of organ-chip developer Emulate, has been fielding requests from potential clients, as well as from early investors who say they want to put more money into the start-up. The impetus: an announcement from the US Food and Drug Administration in early April indicating that the agency plans to phase out animal tests -a longtime cornerstone of preclinical drug testing-in favor of other technologies.

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Rowan Walrath 😷
Rowan Walrath 😷 @rowanwalrath
14 May 25

RT @davidkmyang: Global pharmaceutical market could split into two, US pharma owning US and Chinese pharma taking over the rest. Most-fav…

Rowan Walrath 😷
Rowan Walrath 😷 @rowanwalrath
13 May 25

RT @ADeAngelis_bio: Biotech investment firm RA Capital has laid off staff at its internal startup incubator, @statnews has learned, highlig…

Rowan Walrath 😷
Rowan Walrath 😷 @rowanwalrath
13 May 25

RT @jrkelly: Seems like this is a great opening to raise prices on therapeutics around the world. US has been subsidizing everyone else. N…