It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rise 39% to close Feb. 2 at $4.10 on news the U.S. FDA has declined – for now – to approve the NDA for Anaphylm (dibutepinephrine), delaying the commercial entry of what could be the first oral alternative to Epipen.

Liver fibrosis in the course of metabolic dysfunction-associated steatohepatitis could be significantly reduced using CAR T-cells generated in vivo. Scientists at the Icahn School of Medicine at Mount Sinai have developed an experimental cell therapy that eliminates only one type of liver cell, the stellate cells that express fibroblast activation protein alpha. This strategy not only reduced fibrosis but also reversed liver damage.

The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022.

Quince Therapeutics Inc. is scrapping work with dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) for patients with ataxia-telangiectasia (A-T), and Boral analyst Jason Kolbert said “the core value driver has been effectively removed, and the equity appears fully impaired at this stage.”

Astrazeneca plc is investing $15 billion in China through 2030 to expand R&D and manufacturing, marking one of the largest long-term investments by a multinational pharma company in the country. The U.K.-based company also struck a deal worth up to $3.5 billion with China’s CSPC Pharmaceuticals Group Ltd. to accelerate the development of next-generation therapies for obesity and type 2 diabetes.

In its fourth major biopharma deal since its 2019 founding, Repertoire Immune Medicines signed a partnership with Eli Lilly and Co. to develop tolerizing therapies for several autoimmune diseases, gaining an up-front payment of $85 million, with a potential $1.84 billion in development and commercial milestone payments coming later, along with tiered royalties.

Boehringer Ingelheim International GmbH signed a €1.058 billion (US$1.26 billion) deal with Simcere Pharmaceutical Group Ltd. to license select rights to SIM-0709, a preclinical TL1A/IL-23p19-directed bispecific antibody targeting inflammatory bowel disease (IBD).

Heeding the recommendation of an independent data monitoring committee, Calcimedica Inc. said it is discontinuing the phase II study testing calcium release-activated calcium channel inhibitor Auxora in patients with acute kidney injury with associated acute hypoxemic respiratory failure.

The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.

The prevalence of asthma differs between men and women, and furthermore, the difference changes over the lifespan. “Asthma is more common in boys than girls, but more common in women than men,” Clare Lloyd told BioWorld. Females are particularly susceptible to asthma during developmental periods of hormonal changes, also known as puberty, pregnancy and menopause.