Drugmakers would have until 2032 to cut ties with WuXi AppTec and other Chinese life sciences companies, according to an updated draft of the closely watched Biosecure Act circulating ahead of the planned markup Wednesday. The draft, introduced by Rep. Brad Wenstrup (R-OH), would still effectively ban companies from working closely with certain Chinese biotechs, but it now includes a clause allowing existing contracts with “companies of concern” to be grandfathered in until 2032, as Endpoints News previously reported. A Senate version of the bill would grandfather in all existing contracts wit ..read more

Sens. Elizabeth Warren (D-MA), Bernie Sanders (I-VT) and Jeff Merkley (D-OR) accused a new US Chamber of Commerce coalition of attempting to “stymie the White House’s drug pricing initiatives.” The Business Alliance to Stop Innovation Confiscation (BASIC) Coalition launched in March to “counter emerging policy threats to U.S. innovation from excessive government overreach.” One of its targets is a White House proposal around the use of “march-in rights” on high-priced drugs. The Bayh-Dole Act of 1980 allows the government to, in limited circumstances, require new licenses for certain patents b ..read more

Lawmakers in the House Energy and Commerce Committee criticized the management of the national stockpile in a letter to the federal government’s Administration for Strategic Preparedness and Response (ASPR) on Thursday. In the six-page letter, the Republican leaders of the committee question actions taken over the last few years by ASPR, an agency in the Department of Health and Human Services, to manage the Strategic National Stockpile (SNS), an initiative to stockpile medicines for emergencies. The letter says ASPR is stockpiling expired medicines as well as failing to budget and manage SNS ..read more

BALTIMORE — HIV patients who received a CRISPR-based gene editing treatment developed by Excision BioTherapeutics saw the virus rebound, and now the company is going back to the lab to develop the experimental treatment with a new vector. In Excision’s Phase 1 study, five patients received a gene editing therapy for HIV. Three patients were taken off their standard antiretroviral therapy, but then had to return to standard treatments, according to clinical trial results shared Friday at the American Society of Gene & Cell Therapy’s annual meeting in Baltimore. Two of the three patients saw ..read more

Several secretive and well-funded biotechs are sharing the first glimpses of data from a new suite of gene editing tools that promise to overcome one of the field’s grand challenges: precisely inserting large sequences of DNA, or even whole genes, into the genome. So far, most work with CRISPR gene editing has used the tool to turn off problematic genes. Newer versions of the technology, like base editing and prime editing, can make small changes to one or a few letters of genetic code, respectively. But replacing large swathes of errant code, or uploading brand new ones, has remained a challe ..read more

Plus, news about AnaptysBio, Alzamend, AEON Biopharma and argenx: iTeos Therapeutics’ $120M offering: The immuno-oncology company is selling about 1.1 million shares for $17.50 apiece. RA Capital Management and Boxer Capital — both existing investors — are leading the financing. iTeos added that its Phase 2 test of belrestotug plus dostarlimab in metastatic PD-L1 high non-small cell lung cancer “exceeded pre-defined efficacy criteria” at an interim assessment. Its stock $ITOS was up about 40% on Friday morning. — Jaimy Lee & Ayisha Sharma Xbrane, STADA out-license US ranibizumab ..read more

Ginkgo Bioworks is looking to cut expenses and personnel in an effort to return to profitability and break even by the end of 2026. The company said it is planning to reduce operating expenses — including a 25% reduction in labor spending across both research and development, and general and administrative departments, according to a Thursday afternoon press release. Jason Kelly During an investor call on Thursday, CEO and co-founder of Ginkgo Jason Kelly said that the company is working on exact numbers for the layoffs. According to SEC filings, Ginkgo had 1,218 employees at the end of last y ..read more

Tessera Therapeutics, a well-funded startup based outside of Boston, announced Friday that it developed a lipid nanoparticle that shuttles a gene editing therapy directly to the bone marrow of mice. One or two infusions of the treatment corrected enough of their broken hemoglobin genes to be potentially curative. If the treatment works in people, it could provide a simpler and potentially more affordable alternative to two recently approved therapies for sickle cell disease: Casgevy from CRISPR Therapeutics and Vertex Pharmaceuticals, and Lyfgenia from bluebird bio. Those treatments are medica ..read more

The FDA has delayed the PDUFA date for Moderna’s RSV vaccine, the company announced Friday morning. The delay likely won’t push the decision past the end of May, according to Moderna’s press release, and regulators have not raised any concerns about “vaccine safety, efficacy or quality” preventing the shot’s approval. Rather, the FDA cited “administrative constraints” for the delay, and the shot is still on track to be reviewed at the CDC’s June ACIP meeting, when the agency will make its recommendations for the upcoming RSV vaccine season. Moderna shares $MRNA were down about 1% to 2% in Frid ..read more

MacroGenics reported on Thursday afternoon that three patients died in a mid-stage trial of its antibody-drug conjugate for prostate cancer. Two participants died due to pneumonitis and the third died from a pleural effusion. The biotech’s shares $MGNX plummeted 66% to $4.91 premarket on Friday. A total of five patients died in the trial, although two of the deaths were deemed unrelated to vobramitamab duocarmazine, also dubbed vobra duo. All but one patient in the trial had a treatment-emergent adverse event and 33.5% experienced a grade 3 or higher event. The Phase 2 TAMARACK trial tested tw ..read more