The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook – at least for now. After hours Friday, Oct. 13, Pfizer Inc. reduced its 2023 revenue guidance for its COVID-19 therapy, Paxlovid (nirmatrelvir/ritonavir), by about $7 billion, including a $4.2 billion noncash revenue reversal for the U.S. government’s return of about 7.9 million treatment courses labeled for emergency use authorization. The company also reduced its revenue guidance for its Comirnaty COVID-19 vaccine by about $2 billion and recorded a $5.5 billion noncash charge in the third quarter primarily due to inventory write-offs with demand not meeting expectations. While all that may seem like bad news, some analysts are looking at the positives as COVID-19 vaccines and therapies transition to the commercial market, and higher prices, in the U.S.

Still a no for Amylyx’s ALS drug Ambrioza as European regulator upholds negative vote

The EMA is standing firm on its refusal to recommend approval of the amyotrophic lateral sclerosis (ALS) treatment Albrioza in Europe after re-examining Amylyx Pharmaceuticals Inc.’s marketing authorization application and remaining unconvinced that the main study demonstrated the drug effectively slows disease progression. The EMA’s Committee for Medicinal Products for Human Use adopted its initial negative opinion on the Cambridge, Mass.-based firm’s drug in June, when it also cited concerns of the lack of reliability of survival data, “given the way the data were collected and analyzed” in the phase II Centaur trial. 

Omeros clipped on phase III data from IgAN study 

Shares of Omeros Corp. (NASDAQ:OMER) were trading midday at $1.20, down $1.07, or 47%, after the company offered an update regarding the interim analysis outcome in its phase III trial evaluating narsoplimab for the treatment of immunoglobulin A nephropathy (IgAN). Called Artemis-IgAN, the study did not reach statistical significance on the primary endpoint of reduction in proteinuria from baseline compared to placebo. Proteinuria reduction in the placebo group was substantially greater than reported in other IgAN trials, the firm noted. Narsoplimab is a fully human monoclonal antibody that binds to and inhibits mannan-binding lectin-associated serine protease-2, the effector enzyme of the lectin pathway and an activator of the coagulation cascade.

Aldeyra tanks on FDA doubts ahead of PDUFA date for reproxalap in DED

Shares of Aldeyra Therapeutics Inc. (NASDAQ:ALDX) were trading down 67% at midday, after the company disclosed in a U.S. SEC filing that the FDA indicated an additional clinical trial might be needed, potentially delaying approval of reproxalap, its RASP modulator, in dry eye disease. The PDUFA date for the NDA had been set for Nov. 23, 2023. It’s a disappointment to investors, who had been awaiting news of a partnership and a possible supplemental NDA filing for the drug in allergic conjunctivitis.

China tries to woo foreign investors to biotech industry amidst crackdown on anti-corruption 

China is pushing to increase biopharma investment to woo foreign investors, and the State Council laid out policy areas to further incentivize foreign companies to expand their operations in the country. Among those policies are guaranteeing equal treatment of foreign-invested enterprises and domestic enterprises, particularly in government procurement activities. China has some additional pricing issues that are becoming problematic for multinational pharma companies, because even if they get a product approved and launched, it doesn’t mean the product will be successful. This is due in a large part to volume-based procurement policies that bring down drug and device prices for public hospitals with volume, Helen Chen, greater China managing partner at L.E.K. Consulting, told BioWorld.

KSC 2023: DTx for individualized obesity treatment at doorstep

“Digital therapeutics (DTx) for obesity may seem light years away,” Rhee Sang-youl, from Kyung Hee University Medical Center said to the Korea Society of Cardiology (KSC) 2023 audience members on Oct. 13, “but the reality is that it’s right in front of us.” As Korean medical experts mulled the “correct” way to treat obesity for a heterogenous population during the KSC 2023 session held at the Grand Walkerhill in Seoul, South Korea, the answers seemed to progressively converge at prescribing individualized therapy, including digital therapeutics.

AACR-NCI-EORTC 2023: Understanding ecDNA to stop running in circles in cancer

Cancer treatments for targeting tumor amplifications lag behind those targeting point mutations – and part of the reason may be that amplifications often reside on extrachromosomal DNA (ecDNA). Since ecDNA was first described back in 1965 as minute chromatin bodies in brain cancer cells, the use of large-scale DNA sequencing techniques has revealed the presence of ecDNA across a wide range of cancer types. “The circular structure of ecDNA is associated with increased proto-oncogenic capacity in comparison to linear amplifications. Another key feature is that ecDNA does not contain centromeres,” Roel Verhaak from Yale School of Medicine told the audience at the 2023 AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston.

IDWeek 2023: Next pandemic preparedness – how to forecast and prevent

The COVID-19 pandemic was one of the biggest challenges humanity has confronted recently, and still is. But lessons from the past and signs from the present all indicate that this pandemic will not be the last. In a study published in Nature on Oct. 11, coinciding with the beginning of IDWeek 2023 in Boston, researchers from Harvard Medical School described EVEscape, a method for anticipating the movements of SARS‑CoV‑2 by predicting potential mutations likely to escape current vaccines and treatments.

Also in the news

Allogene, Antiverse, Atom, Bicara, Chromocell, Cimeio, Concentra, Crispr, DBV, Eyepoint, Fortress, Globalbio, Glycotope, KBP, Legochem, Longeveron, Modifi, Novo Nordisk, Rain, Scisparc, Shaperon, Sotio, Summit