Jazz Pharmaceuticals presented zanidatamab data from the HERIZON‑GEA‑01 phase 3 trial at the ASCO GI Symposium, targeting HER2‑positive gastric cancer. The company touted the results as practice‑changing, prompting sell‑side analysts to echo the optimism. However, the stock fell 4‑5% as investors questioned the robustness of the findings. The post outlines seven concerns that suggest the data merit deeper scrutiny before reshaping treatment standards.

Lifordi Immunotherapeutics is pursuing an immune‑directed antibody‑drug conjugate (ADC) strategy that uses the VISTA protein to deliver potent steroids directly to immune cells. VISTA’s rapid internalization allows the ADC to release its payload intracellularly, aiming to avoid the systemic toxicities...

Krystal Biotech announced early data showing its mutation‑agnostic platform can deliver functional native CFTR protein to the lungs of cystic fibrosis patients. In pre‑clinical models, the therapy restored up to 45% of normal chloride transport and reduced inflammatory markers. The...

Insmed reported that its newly approved bronchiectasis therapy Brinsupri generated $144.6 million in Q4 2025 sales, nearly three times analyst forecasts. The surge was driven by roughly 9,000 new patients, bringing total users to about 11,500 and pushing the stock up 8%....
“THAT WILL DECIMATE THE COMPETITION” If the FDA is dumb enough to put a 29% delta on the $MLTX label, UCB should simply request a label change to include *their* P2 efficacy data on the label….where their delta was ***36%***. 36>29 for...

Johnson & Johnson has become the latest pharmaceutical company to sign a "most‑favored‑nation" pricing agreement with the White House. The deal commits J&J to lower the list prices of a portfolio of high‑cost drugs for federal programs, including Medicare and...

Roche has agreed to pay $570 million in upfront and near‑term milestone fees to secure exclusive worldwide rights—except mainland China, Hong Kong and Macau—to MediLink’s B7H3‑targeted antibody‑drug conjugate YL201. The ADC, which carries a camptothecin‑derived cytotoxin, is advancing in registrational studies for...

Johnson & Johnson has become the latest pharmaceutical company to sign a Most‑Favoured Nation (MFN) drug‑pricing agreement with the Trump administration, securing an exemption from looming tariffs. The deal, the 15th of its kind, will make J&J medicines available through...

Rampart Bioscience, a stealth startup that raised $85 million in a Series A round to develop a non‑viral DNA‑based therapy platform called HALO, has shut down less than two years after emerging from stealth. The company’s website and LinkedIn page have been...

Researchers analyzed nearly one million genomes and found that short DNA repeats steadily lengthen with age. Inherited genetic variants can accelerate or decelerate this expansion by up to four‑fold, creating substantial individual differences. The study uncovered a previously unknown repeat...

$ASND -2.5% Looks approvable (priority review; class precedent). Combo = upside optionality, not the label. COACH Wk-52 open-label Ph2 (n=21) CNP + hGH >AGV: 8.8 (naïve) / 8.42 cm/yr (prior-CNP), >97th pct vs avg-stature >Z-score: +1.02 / +0.86; proportionality/arm-span up; bone age “consistent” >AEs...

InflaRx announced a restructuring that will eliminate roughly 30% of its workforce and incur about $7 million in one‑time, largely non‑cash, costs. The company is pulling funding from its COVID‑19 antibody Gohibic and redirecting resources toward izicopan, an oral C5a‑receptor inhibitor...

Roche has entered a second licensing agreement with Chinese biotech MediLink, this time to develop an antibody‑drug conjugate (ADC) that targets the B7‑H3 antigen on solid tumours. The deal builds on a prior partnership focused on earlier‑stage oncology assets and...

AirNexis, a Palo Alto biotech, announced a $200 million financing round to launch clinical testing of a chronic obstructive pulmonary disease (COPD) therapy derived from Chinese research. The capital, sourced from a mix of U.S. and Chinese investors, will fund Phase 2/3...

Biotech firm Cellares and cancer research center City of Hope have entered a partnership to evaluate Cellares’ automated Cell Shuttle manufacturing platform and Cell Q quality‑control system for City of Hope’s investigational CARpool IL13RA2‑EGFR CAR‑T therapy targeting glioblastoma multiforme. The...

Speculation is mounting that Revolution Medicines, a mid‑stage biotech focused on precision oncology, is in advanced talks with one or more large pharmaceutical companies. Media outlets report that the discussions could lead to a takeover or strategic partnership, though no...

Enliven Therapeutics announced Phase 1 results for its oral leukemia candidate, showing response rates and safety comparable to leading therapies from Novartis and Terns. The data revealed a 45% overall remission rate and manageable adverse events across 30 patients. The...

Viking Therapeutics announced the appointment of Neil Aubuchon as its chief commercial officer, signaling a push to accelerate commercialization of its obesity and MASH drug candidates. The move comes as the company’s shareholders grow impatient for a strategic partner or...

$KYRS +1% Nice science, market not convinced. KB407 shows delivery + CFTR protein in bronchoscopic biopsies, but no sweat chloride/NPD/FEV1. End of day, PD != clinical translation. Also a crowded CF GTx race = priced in. $FDMT 4D-710 (ppFEV1/LCI signals),...
Retro Biosciences has initiated a Phase 1 safety trial of its small‑molecule autophagy promoter RTR242 in healthy volunteers in Australia. The drug is designed to restore lysosomal acidity, thereby enhancing cellular waste‑clearance mechanisms that decline with age. The study is randomized,...

A recent cohort study examined multiple sarcopenia diagnostic criteria to determine which best predicts falls among seniors aged 65 and older. Researchers compared the European Working Group on Sarcopenia in Older People (EWGSOP2) algorithm, the SARC‑F questionnaire, and simple performance...

A new study has produced the first comprehensive map of microbial diversity in amniotic fluid, challenging the long‑held belief that the intrauterine environment is sterile. Researchers analyzed over 500 samples using ultra‑sensitive metagenomic sequencing, identifying a low‑biomass but distinct bacterial...

A team of leading gene‑editing scientists has launched a new startup dedicated to developing custom CRISPR therapies for individual patients. The company builds on a landmark case last spring where researchers engineered a bespoke CRISPR treatment to correct a rare...

A new CRISPR startup, Aurora Therapeutics, aims to secure regulatory approval for a single, modular gene‑editing platform that can be tweaked for multiple mutations. Backed by $16 million from Menlo Ventures and advised by CRISPR co‑inventor Jennifer Doudna, Aurora’s first target...

Financial Times reports MSD is in advanced talks to acquire Revolution Medicines in a deal valued between $28 billion and $32 billion, potentially the largest pharma merger since Pfizer's Seagen purchase. The announcement sent Revolution’s shares up 16% in pre‑market trading, giving...
Researchers at the University of Arkansas evaluated food‑waste compost as a growing substrate for tomato and watermelon seedlings. The study, published in HortTechnology, found that pure food‑waste compost performed worse than standard peat‑based potting mix, while blends containing less than...

Researchers created a single‑cell immune atlas of bone‑marrow cells from 337 newly diagnosed multiple myeloma patients, profiling nearly 1.4 million plasma and immune cells. The study, published in Nature Cancer, links specific immune cell populations and signaling pathways to rapid relapse...

Researchers at the University of Basel introduced Antimicrobial Single‑Cell Testing (ASCT), a high‑throughput live‑cell imaging platform that quantifies antibiotic killing at single‑cell resolution. By dispensing bacteria into 1,536‑well plates and tracking up to one million images per experiment, the team...

Merck KGaA’s corporate venture arm, M Ventures, opened 2026 with Managing Director Hakan Goker outlining its 2025 successes and 2026 priorities. The CVC highlighted marquee investments such as FoRx Therapeutics and Artios, which earned an FDA Fast Track designation, and...
Researchers from Inserm and partner institutions analyzed data from over 100,000 French adults in the NutriNet‑Santé cohort and found that higher consumption of food preservatives—both non‑antioxidant and antioxidant types—was linked to a 40‑49% increased incidence of type 2 diabetes. The study...
Dr. Marty Makary, now FDA commissioner, earned $130,357 from pharma firms before his nomination and serves on the board of an ophthalmic drug company despite pledging never to work for big‑pharma. He appointed former industry executive Dr. George Tidmarsh to...

A new study reveals that R‑loops, three‑strand nucleic‑acid structures, actively reprogram RNA polymerase II (RNAPII) positioning during early embryonic development. Genome‑wide mapping in mouse zygotes shows that 30% of RNAPII peaks coincide with R‑loop sites, directing transcription toward lineage‑specific genes....

A new study published on Bioengineer.org reveals that bioimpedance analysis (BIA) can reliably detect sarcopenia and altered body composition in adolescents. Researchers evaluated over 1,200 youths aged 12‑19, finding a 7.4% prevalence of low muscle mass that exceeds prior estimates...

Researchers identified circular RNA circRNA14781 as a key driver of olaparib resistance in high‑grade ovarian cancer. The non‑coding RNA is markedly overexpressed in tumor samples that fail PARP‑inhibitor therapy and functions by sponging tumor‑suppressive microRNAs, thereby re‑activating DNA‑repair pathways. In...

Researchers have completed a high‑resolution map of eucalyptus genes that control phosphate transport, pinpointing dozens of candidate transporters. Expression profiling shows several genes surge when trees face low‑phosphate soils, suggesting natural efficiency mechanisms. The team demonstrated CRISPR‑mediated edits that boost...

Researchers have engineered chlorella‑derived nanogels that markedly suppress inflammation in experimental lung injury. In murine models, the nanogels lowered pro‑inflammatory cytokines, reduced alveolar edema, and improved survival rates. The delivery platform leverages the natural biocompatibility of chlorella polysaccharides to target...
Under the FDA’s new leadership, 2025 saw the approval of 46 new molecular entities and 10 new biologics, matching the pace of recent years. The agency’s review process remained on schedule, suggesting that the transition in senior management has not...
ANS: I don’t take a dime from Pfizer or any other big pharma company. If and when you decide to visit a library instead of relying on conspiracy sites, you’ll find we develop low cost, patent free vaccines that bypass...
A new report claims that the APOE gene alleles accounts for the vast majority of Alzheimer's cases: "Without strong underlying risks from APOE ε3 and ε4, almost all AD and half of all dementia would not occur." https://t.co/KgRFx36WOn

Researchers evaluated a school‑based albendazole deworming program among 3,200 children aged 5‑12 in Yunnan province. Baseline surveys showed a 42% helminth infection rate, which fell to 13% after a single annual dose. The intervention also correlated with modest gains in...

Genotype-to-phenotype mapping of somatic clonal mosaicism via single-cell co-capture of DNA mutations and mRNA transcripts https://t.co/6Lss1ukbvp https://t.co/bGwnmQEYfI
Did slashing multiple vaccines from the childhood vaccine schedule bring the US in line with other countries? In a word, no. The US now recommends all kids be protected against fewer diseases than South Korea, Israel, Saudi Arabia, Taiwan &...

1/ AI tools are useless if you don't know what you're looking for. I use Perplexity for search. But the AI didn't solve my IGV bug - my domain knowledge did. The AI just helped me find the answer faster. https://t.co/zi2e2FbO5O

$QURE +13% uniQure Announces Type A Meeting Scheduled with FDA 🍿 uniQure Announces Type A Meeting Scheduled with FDA https://t.co/iqZkaNYD7Z https://t.co/lRcR6vgV0D
Fact check: When it comes to vaccine schedules, the U.S. is now the outlier STAT analysis shows top officials have put the country out of step with peer nations By @HelenBranswell https://t.co/t8ZmqatU1U
Remember: Influenza causes myocardial infarction, heart attacks. One of the best ways to protect your heart health is to keep up with your flu vaccine. Link to @nejm article here and attached. https://t.co/yeHUdEClyf
Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines Aurora Therapeutics is one of several efforts vying for space in the growing field Great writing from @Jasonmmast and @ADeAngelis_bio https://t.co/kbDJxY6Sq5
$INSM pre-announces Q4 Brinspuri sales of $144.6M. Consensus $67M, per Visible Alpha. Total '25 revenue $606.4 vs consensus $523M 2026 Arikayce revenue forecast $450-470M vs consensus $488M https://t.co/LhY6SRoTY3
Key scientist from Baby KJ team launches startup to scale personalized CRISPR medicines https://t.co/7RY4SKrx9Y via @Jasonmmast @ADeAngelis_bio

Investors should understand the #FDA regulatory process well. Here is a quick summary At each step investors should ask themselves if the company is developing things in a way that will satisfy the FDA Until a drug is approved the FDA is...