Know What's Happening in Pharma
Know What's Happening in Pharma
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EMAIL DIGESTS
Daily
Every morning
Weekly
Tuesday recap
Shionogi completes $2.5B acquisition of ALS drug Radicava
Shionogi has finalized a $2.5 billion purchase of global rights to the ALS therapy Radicava from Tanabe Pharma, adding a rare‑disease asset and a U.S. commercial platform that is expected to generate roughly $700 million in revenue starting fiscal 2026.
Also developing:
By the numbers: Lupin Limited acquires VISUfarma in undisclosed deal
Henlius has received IND clearance from China’s NMPA for HLX319, a biosimilar of Roche’s Phesgo that combines pertuzumab, trastuzumab and hyaluronidase for subcutaneous delivery. The product targets neoadjuvant, adjuvant and metastatic HER2‑positive breast cancer, mirroring Phesgo’s five‑to‑eight‑minute injection without weight‑based dosing. HLX319 incorporates Henlius’ own pertuzumab candidate HLX11 and trastuzumab analogue Hanquyou, with the hyaluronidase excipient Henozye enabling the SC formulation. HLX11 is also under review in Canada and the EU, positioning Henlius for a global HER2 portfolio.
Artificial intelligence flagged a long‑neglected breast‑cancer medication as a candidate to block multiple viruses, and subsequent animal studies confirmed it can inhibit coronaviruses, RSV, norovirus, influenza and hepatitis viruses. Model Medicines, a California biotech, is advancing the compound toward a...
Johns Hopkins researchers have created an intranasal DNA vaccine that fuses the relMtb and Mip3α genes to target drug‑tolerant tuberculosis persisters. In mouse models the vaccine accelerated bacterial clearance, lowered lung inflammation and prevented relapse when combined with standard therapy....
Recent comparative studies indicate tirzepatide outperforms semaglutide in accelerating fat loss. Tirzepatide’s dual activation of GLP‑1 and GIP receptors delivers stronger appetite suppression, improved insulin sensitivity, and enhanced lipid metabolism, leading to higher average weight‑loss percentages. Semaglutide remains effective by...
Merck has launched the pivotal Phase IIb/III MALBEC trial to evaluate MK‑8748 (Tiespectus/EYE201) in patients with neovascular age‑related macular degeneration (NVAMD). The study pits two intravitreal dose levels of the bispecific TIE2‑agonist/VEGF‑inhibitor against aflibercept 2 mg, beginning with quarterly injections for three...
Woah. I'm slightly embarrassed that I missed this for a few weeks. Finally there is approval, in a Large Nation, for a stem cell-based REPLACEMENT therapy for an age-related condition. The condition is, no surprise, Parkinson's, which I always highlight...
First Databank (FDB) has released MedProof MCP, the first Model Context Protocol server designed to embed AI agents with its clinical‑grade drug database. The open‑source MCP standard lets large language models query trusted medication intelligence in real time, cutting integration...
Dynamics of blood NAD and glutathione in health, disease, aging and under NAD-booster treatment “In healthy population (n=299;18-70 year-olds) redox metabolites follow normal distribution in blood and remain unchanged during aging. NAD-boosting increased 4-6 fold the blood NAD+ depending on individual,...
Earendil Labs has dosed the first patient in a Phase IIa, randomized, placebo‑controlled trial of its half‑life‑extended anti‑TL1A antibody HXN‑1001 for ulcerative colitis. The company also completed enrollment for the Phase I study in healthy volunteers in Australia, where single doses up...
A new systematic review in BMC Geriatrics finds that levothyroxine offers no measurable benefit for older adults with subclinical hypothyroidism. Patient‑reported quality‑of‑life, cognitive function, physical performance, and major cardiovascular events were unchanged compared with observation or placebo. The analysis also...
Senators Jeanne Shaheen, Raphael Warnock, Susan Collins and John Kennedy introduced the INSULIN Act, which would cap out‑of‑pocket insulin costs at $35 per month for people with private insurance. The proposal also creates a pilot program for uninsured patients in...
BillionToOne, Inc. saw its Nasdaq‑listed shares drop 3.66% to $79.92 following the announcement that Allen Chen will lead medical affairs and clinical development for oncology. The move comes as the company expands its Northstar liquid‑biopsy platform, and investors are weighing...
Most of synthetic biology has been completely transformed in the last decade. DNA manufacturing? Still running on cloning workflows from the 1970s. That's the bottleneck Jodi Barrientos, CEO of @ribbonbiolabs, is tackling head-on — and she's on the @SynBioBeta Main Stage on...
Approved drugs can have a "black box" (aka boxed) warning, the highest safety-related warning that FDA can put on an approved drug Usually applied to multiple drugs in the same class it can hamper revenue potential if alternatives exist Investors should be...
Researchers introduced an integrated machine‑learning framework to predict SARS‑CoV‑2 compound potency. The system combines an IC50 regression model, a binary activity classifier, and a multi‑task neural network that performs both tasks simultaneously. Incorporating ligand efficiency as a classification criterion, the...
Stealth BioTherapeutics secured the FDA's accelerated approval for elamipretide, branded Forzinity, the first drug that directly targets mitochondria. The milestone is igniting a broader push among biotech firms and academic teams to develop mitochondrial‑focused treatments for age‑related diseases.
Three independent research teams reported in Nature Genetics that variants in the non‑coding RNA RNU2‑2 cause both a dominant neurodevelopmental epilepsy syndrome and a prevalent recessive childhood disorder with epilepsy. By analyzing overlapping international cohorts and shared genomic datasets, they...
University College London researchers have created a hydrogel‑based axon model that mimics the ~5 kPa softness and three‑dimensional geometry of real brain axons. The tunable micropillar arrays enable human oligodendrocytes to form compact, multilayered myelin, a first for fully hydrogel systems....
Vedanta Biosciences announced that the independent Data Monitoring Committee has completed the first prespecified interim analysis of its Phase 3 RESTORATiVE303 trial and recommended the study continue unchanged. The interim data showed efficacy surpassing the futility threshold with no new safety...
Biotech breakthroughs have transformed bleeding disorders from fatal diagnoses into manageable chronic conditions, with extended‑half‑life clotting factors, subcutaneous non‑factor drugs, and emerging gene therapies extending dosing intervals to weeks or months. The National Bleeding Disorders Foundation’s Pathway to Cures fund...
Boston University, leading the AI for Alzheimer’s Disease (AI4AD) consortium, is coordinating 11 research institutes to apply machine learning to massive genomic, biomarker and cognitive datasets. The team is building the PreSiBO database, which tags predictor, signature, biomarker and outcome...
President Donald Trump’s proposal to add GLP‑1 obesity drugs to Medicare would impose billions of dollars in costs on private insurers during the first year. The administration claims negotiated drug‑price cuts will offset expenses, but a Vanderbilt‑led analysis estimates only...
A nationwide shortage of estrogen patches is leaving many U.S. women without a key menopause treatment. Prescriptions for hormone replacement therapy have surged 86% since 2021, spurred by the FDA’s removal of a black‑box warning in November. The patch’s popularity...
Pfizer announced it is halting development of its updated COVID‑19 vaccine candidates, ending ongoing Phase 2/3 trials that targeted newer variants. The decision follows mixed efficacy data and waning commercial demand as the pandemic recedes. Pfizer will redirect resources toward...
The U.S. Food and Drug Administration approved Eli Lilly’s oral GLP‑1 obesity medication Foundayo on April 1, 2026. The once‑daily pill can be taken any time of day without food or water restrictions and is priced between $149 and $349 a month,...
A coalition of Democratic and Republican senators has introduced the INSULIN Act, aiming to cap insulin prices at $35 per month for people with private insurance. The bill also proposes a pilot program for uninsured patients in ten states, sparking...
Lipocine Inc.'s stock fell 78% to $2.00 after its Phase 3 placebo‑controlled trial of oral brexanolone (LPCN 1154) missed the primary efficacy endpoint for postpartum depression. The company said it will preserve capital and engage stakeholders to evaluate next steps, underscoring...
The SirPAD trial showed that a sirolimus‑coated drug‑coated balloon (MagicTouch) significantly lowered major adverse limb events (MALE) to 8.8% versus 15% with uncoated balloons in femoropopliteal and below‑the‑knee peripheral artery disease patients. At one year, the composite of unplanned amputation...
Scientists have restored a silenced tumor-suppressor gene in mice with acute myeloid leukemia by blocking KDM4 enzymes, suggesting a potential new therapeutic approach that avoids harming normal blood cells. leukemia
On this week’s pod, we chatted with @docrodwong about the FDA, the next CBER chief and regulatory flexibility for rare diseases https://t.co/f6L7gwcNsr via @statnews
Researchers at Johns Hopkins and the University of Maryland have created first‑in‑class small‑molecule inhibitors that simultaneously block hypoxia‑inducible factors 1 and 2. In mouse models, the dual HIF‑1/2 inhibitors eradicated breast, colorectal, melanoma and prostate tumors when paired with checkpoint antibodies such...
Any one know which pharma companies have yet to strike a deal with the US? (I don't ... my sense is that most have but haven't kept a tally) 1/2 https://t.co/bYYde5ZaIm
New: Small pharma companies are in talks with the White House to sign drug pricing deals of their own. Small companies will have to cut a deal in the next 180 days to fully avoid tariffs on branded drugs. https://t.co/XFalvi3i3D
Dr. Jason Aldred of Selkirk Neurology highlights the safety profile of Vyalev (foscarbidopa/foslevodopa), a subcutaneous therapy for Parkinson's disease. He notes that injection‑site reactions such as erythema, swelling, tenderness, bruising, and induration are the most common adverse events. Aldred advises...
Cell line development (CLD) remains a hidden bottleneck that dictates speed to clinic, manufacturability, and long‑term product performance. Traditional random‑integration and lengthy clone screening are giving way to engineered platforms, especially glutamine synthetase (GS) knockout systems, which reduce heterogeneity and...
The U.S. Department of Justice filed a brief backing pharmaceutical manufacturers in the ongoing 340B drug‑discount litigation. The brief argues that discounts should be calculated using the average manufacturer price rather than the lowest price, a stance that could curb...
What if the biggest unlock in biotech is simply access? Douglas Crawford built MBC BioLabs to lower barriers and enable 500+ startups. Excited to have him at SynBioBeta 2026. Visit the @SynBioBeta website to read the full article. https://t.co/HEfhvmwZ8i
Health‑tech firms are pivoting toward peptide therapeutics as the next growth engine after the blockbuster GLP‑1 weight‑loss drugs. Peptides, which include insulin and GLP‑1, are being explored for obesity, metabolic and chronic disease treatments. Industry analysts project the global peptide...
A team from the Weizmann Institute of Science has genetically modified a tobacco plant to produce five distinct psychedelic compounds in a single host. The breakthrough could streamline drug research and reduce ecological pressure on natural sources, while raising biosecurity...
GENFIT reported 2025 results with cash €101.1 million (~$109 million) and revenue €65.4 million (~$70.6 million), the bulk coming from Ipsen milestones and royalties. Iqirvo® generated $208 million in full‑year sales, triggering a $20 million commercial milestone and activating an additional €30 million (~$32 million) royalty‑financing tranche. The...
Cocrystal Pharma (COCP) saw its shares climb 50.98% to $1.54 after the FDA granted Fast Track designation to its oral antiviral candidate CDI-988 for norovirus. The designation could accelerate development and bring the first oral therapy for the virus closer...
The United Kingdom and the United States have finalized the legal text of a landmark pharmaceutical partnership that eliminates import tariffs on U.S. medicines and certain medical technologies for at least three years. The agreement arrives amid heightened diplomatic tension,...
Alpha Cognition reported $2.8 million in Q4 2025 revenue, with ZUNVEYL sales up 62% quarter‑over‑quarter. COO Lauren D’Angelo highlighted a rapid go‑to‑market expansion across long‑term‑care facilities, while the company balances rising operating costs against a $66 million cash cushion.
Senators Jeanne Shaheen, Raphael Warnock, Susan Collins and John Kennedy introduced the INSULIN Act, capping private‑insurance insulin costs at $35 per month and launching a pilot for uninsured patients in ten states. The move could affect roughly 8.1 million insulin users...
Vancouver‑based Aspect Biosystems secured $79 million CAD (≈$58 million USD) from Canada’s Strategic Response Fund for a $280 million CAD (≈$204 million USD) project to scale its 3D‑printed tissue platform. The company will fund the remaining $201 million CAD (≈$147 million USD) and aims to enhance...
Whoa, @grok 4.1 beats many newer models in BVP. Btw. it is surprising that Grok does such a good job (not SOTA but better than frontier foundation models) in many drug discovery tasks https://t.co/UWaQZucawU
Biodexa Pharmaceuticals saw its Nasdaq‑listed shares climb 69% after revealing a partnership with Syngene International to manufacture the active pharmaceutical ingredient and dosage form of its MTX240 candidate. The deal paves the way for an IND filing and a Phase...
The pharmaceutical sector is reshaping its workforce as AI, precision medicine, tighter regulations, and global manufacturing scale become central to drug development. Companies are seeking talent that can harness data‑driven discovery, navigate complex clinical trials, and ensure compliance across jurisdictions....
BASF Pharma Solutions announced a 12% price increase on its active pharmaceutical ingredients (APIs) as soaring energy costs, driven by the ongoing Middle East conflict, strain its supply chain. The hike affects generic manufacturers and could push drug prices higher...
Lipocine reported top‑line Phase 3 data for its postpartum depression candidate LPCN‑1154, revealing no statistically significant improvement over placebo and prompting a 77% plunge in its shares. The Utah‑based biotech’s safety profile was acceptable, but efficacy shortfalls undermine its commercial prospects....
