PFIZER INC.

The ZEST trial failed to enroll enough ctDNA-positive patients for niraparib to prevent breast cancer recurrence. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Only 40 patients were enrolled, with niraparib showing a median recurrence-free interval of 11.4 months vs. 5.4 for placebo.

EMA’s CHMP recommended approval of eight new medicines, including BridgeBio’s TTR stabilizer and Geron’s telomerase inhibitor. BridgeBio’s Beyonttra acoramidis, following U.S. approval, seeks EU approval to compete with Pfizer’s Vyndaqel. Alnylam submitted an EMA application for Amvuttra vutrisiran.

Moderna, a biotech company specializing in mRNA technology, developed one of the first COVID-19 vaccines and researches treatments for infectious diseases, cancer, and rare genetic disorders. Founded in 2010, it became publicly traded in 2018 and has since expanded its mRNA-based vaccine research to include RSV, HIV, and Zika fever, among others.

64% of hemophilia A patients given giroctocogene fitelparvovec were bleed-free for nearly 3 years post-infusion, with significant reductions in bleed rates and FVIII replacement use, showing potential to lessen disease and treatment burden.

FDA approved Orlynvah, the first oral penem antibiotic for uncomplicated UTIs in women, effective against resistant bacteria like ESBL-producing E. coli. It combines sulopenem etzadroxil and probenecid, extending sulopenem's half-life. Orlynvah could also treat other UTI-related infections, offering an oral alternative to IV treatment, though concerns exist about potential overuse and resistance.

PROTAC technology enables targeted protein degradation, offering a novel approach to cancer therapeutics. With about 90 candidates in development, PROTACs can tackle 'undruggable' targets, potentially improving efficacy and overcoming resistance. The first PROTAC drug approval is expected by 2027, marking a significant milestone. Collaboration and proprietary platforms are accelerating advancements in this field.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention, was terminated early due to low ctDNA detection post-treatment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients for future trials.

FDA experts call for more data on RSV vaccine safety in infants after Moderna trial pause. Panel seeks additional information before moving forward, emphasizing need for better understanding of immune response in different age groups.

The global medical writing market is projected to grow from US$3.44 billion in 2021 to US$9.09 billion by 2031, at a CAGR of 10.2%. This growth is driven by the expansion of pharmaceutical, biotechnology, and medical device industries, increased clinical trials, and stricter regulatory requirements. Key players include Cactus Communications, Certara, Covance, and others.

The Breakthrough Therapies Market was valued at USD 150.6B in 2024, projected to reach USD 287.5B by 2029, growing at a CAGR of 13.80%. The report analyzes BTD's risks, benefits, fast-track drug development, therapy areas, leading companies, and market dynamics.