Cutia Therapeutics Ltd. raised HK$465 million (US$65 million) in a Hong Kong IPO on June 12, with almost half of the proceeds going toward furthering its lead product to treat adipose accumulation. Cutia’s shares moved a little higher on the first day of trading, opening at HK$21.80, rising 0.46% and closing at HK$21.95. Founded in 2019, Cutia develops dermatology treatments, including for localized adipose accumulation management, scalp diseases, skin diseases and topical anesthesia. While the company has eight other products in its pipeline, it plans to use 45% of the net proceeds, or HK$185.8 million, for the development of its core asset, CU-20401.

Contra Pfizer, CETP route lives on in LDL-C-lowering via Newamsterdam

Ever since late 2206, when Pfizer Inc. abruptly quit phase III development of its cholesterol drug, torcetrapib, because of safety concerns, investors have been jittery about potential off-target effects with LDL-C-lowering drugs. A cholesteryl ester transfer protein (CETP) inhibitor, torcetrapib was in the works when combined with atorvastatin to prevent cardiovascular (CV) events in people with heart disease. Among those hoping to fill the need for such therapies, especially in patients with high-risk hypercholesterolemia and CV disease, is Newamsterdam Pharma NV. The firm provided phase II hope earlier this month with its CETP inhibitor, obicetrapib, when paired with ezetimibe and tested in an experiment called Rose2. Newamsterdam offered top-line phase IIb data from a monotherapy study, too, with obicetrapib in Japan.

Newco news: Bitterroot Bio raises $145M as it unveils heart disease immunotherapy approach

Seeking to repurpose a validated oncology drug target for atherosclerosis is Bitterroot Bio Inc., a biotech company that introduced itself to the world on the back of a sizable $145 million series A, funds it intends to use to advance its lead monoclonal antibody, BRB-002, toward the clinic. In an interview with BioWorld, CEO Pavan Cheruvu explained why there is a need for new mechanisms of action within the crowded cardiovascular field.

FDA’s temporary import approval of unapproved drug from China could be ‘exception,’ not rule

The U.S. FDA approved the temporary importation of the unapproved chemotherapy drug cisplatin from Qilu Pharmaceutical Co. Ltd. to help address a shortage of drugs used in cancer treatments in the U.S. The decision opened the possibility of more Chinese drugs making their way to the U.S. market, but some warned that this decision would be likely be a one-off.

Blast from the past: Sanders seeks to reinstate ‘reasonable pricing clause’

Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, Sen. Bernie Sanders (I-Vt.) is pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D. To advance the idea, Sanders released a report this week, prepared by the HELP majority staff, that presents two case studies as evidence of the raw deal taxpayers are getting for the public investment in drug development. What’s left unstated in the report is that when the NIH imposed a reasonable pricing clause in 1989, it was a short-lived experiment resulting in dwindling private-sector interest in further developing public-funded research.

Democrats, Republicans spar over FDA drug shortage authority in PAHPA reauthorization

The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties with regard to FDA’s authorities for managing drug shortages. A bill by Rep. Anna Eshoo (D-Calif.) that would authorize the FDA to require manufacturers of finished drugs to disclose their suppliers of active pharmaceutical ingredients on a quarterly basis was not included in the hearing, but while Democrats on the committee blasted the omission, Republicans countered that this type of legislation is unrelated to preparedness and should be considered separately.

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