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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
The FDA announced that the 32 mg intravenous dose of ondansetron (Zofran) will be withdrawn from the market due to its association with QT‑interval prolongation and the risk of Torsades de Pointes. The agency is coordinating a voluntary recall of all pre‑mixed 32 mg products from both brand and generic manufacturers. Clinicians are reminded to limit any single IV ondansetron dose to 16 mg and to follow weight‑based dosing regimens. Oral ondansetron remains an effective alternative for chemotherapy‑induced nausea.
$BMY chief scientist Robert Plenge: says there is “a joke” drug developers often repeat. “It's an overnight sensation a decade in the making. These things can actually be going on for a very long time, and then suddenly the field catches...
Novo Nordisk announced FDA approval of a high-dose formulation of its obesity injectable Wegovy in the United States. The approval was granted through a new FDA priority review voucher program, which Novo earned via a price‑cut deal with the Trump...
India’s wholesale pharmaceutical market is seeing 10‑15% price increases as the Iran‑US war disrupts key raw‑material imports, while Nigeria’s manufacturers caution that prolonged supply‑chain shocks could trigger shortages of essential medicines. Industry bodies in both countries have appealed to governments...
The FDA has issued a safety communication indicating that lamotrigine (Lamictal) may increase the risk of serious arrhythmias in patients with existing heart disease. The agency ordered in‑vitro studies after reports of abnormal ECGs, chest pain, loss of consciousness, and...
Thermal stability assays, especially differential scanning fluorimetry, are gaining traction as early‑stage de‑risking tools in drug discovery. By measuring protein melting temperatures, these assays reveal ligand‑induced stabilization, enabling rapid hit validation and prioritization. The article outlines best‑practice workflows, data‑interpretation guidelines,...
The FDA has introduced the Commissioner’s National Priority Voucher (CNPV) pilot, offering ultra‑fast approval pathways for drugs that align with the current White House policy agenda. The program could slash review times for qualifying products, giving participating companies a market...
The U.S. Food and Drug Administration has granted approval to GSK’s linerixibat (Lynavoy) for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC). The decision rests on the GLISTEN phase‑3 trial, which demonstrated a statistically and clinically significant reduction...
A phase‑3, double‑blind trial of over 500 patients showed the ustekinumab biosimilar CT‑P43 achieved equivalent PASI75 response at week 12 and maintained comparable PASI50/75/90 rates through week 52. Safety, adverse‑event profiles, and antidrug‑antibody incidence mirrored those of reference ustekinumab. Patients who switched...
Sarepta Therapeutics will submit a supplemental NDA to the FDA seeking to convert the accelerated approvals of its Duchenne exon‑skippers Amondys 45 and Vyondys 53 into traditional approvals, despite the confirmatory ESSENCE trial failing to improve motor function. The company bolsters its...
A team at the Hebrew University of Jerusalem has unveiled a high‑resolution melting (HRM) PCR assay that simultaneously identifies sand‑fly species, detects Leishmania parasites, and determines the insect's blood‑meal source from a single specimen. The method was applied to nearly...
Glaukos announced that Epioxa™ HD/Epioxa™ is now commercially available, marking the first FDA‑approved, incision‑free topical drug for keratoconus. The therapy uses a riboflavin solution with the O₂n™ System and Boost Goggles, eliminating the need to remove the corneal epithelium. By...
Pfizer announced that the Phase 3 TALAPRO‑3 trial met its primary endpoint, showing that TALZENNA (talazoparib) combined with XTANDI (enzalutamide) significantly improved radiographic progression‑free survival (rPFS) in patients with HRR gene‑mutated metastatic hormone‑sensitive prostate cancer. The combination achieved a hazard ratio...
Eli Lilly’s late‑stage trial of the injectable retatrutide showed a 1.9% drop in HbA1c and a 15.3% weight loss after 40 weeks, outperforming placebo and matching its blockbuster Mounjaro. The drug targets the roughly 60% of type‑2 diabetics who are also...
Embecta Corp. announced a definitive agreement to purchase UK‑based Owen Mumford Holdings Limited for up to £150 million, with £100 million paid at closing and up to £50 million in performance‑based earn‑out. The deal, slated to close in Embecta’s fiscal Q3 2026, adds...
Let's look at how the FDA is treating $SRPT and $QURE differently. The FDA grants accelerated approval to Amondys and Vyondys to treat Duchenne muscular dystrophy. Sarepta conducts a post-marketing confirmatory study that fails to show a benefit for either...
The Financial Times covered recent initiatives at Cancer Research UK (CRUK) including a nice piece on the ongoing Aleta Biotherapeutics clinical trial in CD19-CAR-T treated B cell lymphoma patients. https://t.co/9sDZEItapu
Medable has launched Agent Studio, a no-code/low-code platform that lets pharmaceutical companies configure and deploy AI agents across the clinical trial lifecycle. The platform currently powers two agents—a document‑classification ETMF agent that processes over 80,000 records a year, and a...
The negative oral Ozempic randomized trials (EVOKE, EVOKE+) for Alzheimer's disease have now been published @TheLancet https://t.co/Xx0YknTSC2
GLP-1 drugs have established benefit for Type 2 diabetes. New data suggests that extends to Type 1 diabetes, with heart, vascular, and kidney protection https://t.co/nZDKHoFIRm https://t.co/lTHIgoj4ir
Excalipoint, a biotech focused on cancer T‑cell engagers, announced the close of a $68.7 million seed financing round. The capital, raised from leading venture firms and strategic investors, will fund the development of its bispecific antibody platform targeting solid tumors. The...
Okay here's a game - you're making nanobody therapeutics. AI can help you optimise them, but you need to prioritise order of feature importance. What is your order? Affinity Specificity Expressibility Clinical toxicity In vivo stability Purified stability Patentability Other?
Exclusive: Clarissa Desjardins' newest biotech has put its first drug in the clinic + raised $40M more. Congruence also expects to put 2 more molecules into clinic in early 2027, seeing its platform driving its R&D efficiency: https://t.co/pzxcnmKFBj
The U.S. Food and Drug Administration granted Breakthrough Device Designation to Nia Therapeutics’ Smart Neurostimulation System (SNS) for treating episodic memory loss in adults with moderate to severe traumatic brain injury. The fully implantable, closed‑loop system records neural activity from...
This week’s corporate round‑up highlighted several pivotal moves: Novo Nordisk’s semaglutide patent lapses in India, prompting more than 40 firms to launch over 50 generic weight‑loss brands; BP agreed to sell its Gelsenkirchen refinery, targeting roughly $1 bn of operating‑cost savings;...
Quintessence Biotech introduced DACS, the first "living" artificial cell designed to streamline bio‑separation in cell and gene therapy (CGT) manufacturing. The lipid‑particle platform mimics cell size, deformability and antigen presentation, enabling a gravity‑based flotation method that replaces magnetic‑bead workflows. DACS...
Eli Lilly’s investigational injectable retatrutide achieved a 1.9‑point HbA1c reduction versus 0.8 points for placebo after 40 weeks, while participants on the highest dose shed 15.3% of body weight compared with 2.6% on placebo. The weight loss was still progressing at...
DiaMedica Therapeutics is advancing a recombinant tissue kallikrein (KLK1) to treat ischemic stroke and preeclampsia, leveraging the kallikrein‑kinin pathway to restore microvascular flow. Early trials show maternal blood‑pressure reductions, improved uterine‑artery Doppler indices, and no detectable drug in fetal circulation,...
AL‑S Pharma released Phase II (AP‑101‑02) data evaluating intravenous AP‑101 every three weeks in 73 ALS patients, including 52 with sporadic disease and 21 with SOD1 mutations. The trial met its primary safety and tolerability endpoint and demonstrated disease modification,...
Reviva Pharmaceuticals priced a $10 million public offering of 6.66 million shares and accompanying warrants at $1.50 each, with closing expected around March 20, 2026. The cash will fund the RECOVER‑2 Phase 3 trial of brilaroxazine for schizophrenia. The news sent the stock down more...
Scientists have isolated a gut‑bacterial metabolite, pTOS, that spikes in Burmese python blood after feeding and dramatically reduces appetite in obese mice. When administered to mice, pTOS caused a 9% body‑weight loss over 28 days without affecting energy expenditure. The...
The FDA has approved Icotyde, the first targeted oral peptide therapy for moderate‑to‑severe plaque psoriasis, offering a once‑daily pill that blocks the IL‑23 receptor. In pivotal trials, roughly 70% of patients achieved clear or almost clear skin by week 16,...
Europe’s pharmaceutical sector is losing its historic lead in R&D, with its share of global private research dropping from roughly half in 1990 to a third in 2025, while the United States now commands 55% and China is rapidly closing...
The 2025 review examines tocotrienols, a subset of vitamin E, as chemosensitizers that boost the effectiveness of conventional cancer drugs. Pre‑clinical studies show that combining tocotrienols with antiparasitic agents such as fenbendazole or mebendazole markedly increases tumor cell death. The analysis...
BioCina has launched a comprehensive Chemistry, Manufacturing and Controls (CMC) program for Patrys Ltd’s injectable formulation RLS-2201, a proprietary quetiapine product aimed at treating acute delirium in intensive‑care patients. The manufacturing effort is based in BioCina’s sterile facility in Perth...
A large pragmatic trial involving 1,565 overweight or obese youths with bipolar spectrum disorders found that adding metformin to a brief lifestyle program significantly blunted weight gain associated with second‑generation antipsychotics. Over six months, the metformin group’s BMI rose only...
After eight years of denying pharmaceutical preliminary injunctions, Australia’s Federal Court granted two rare orders in 2025‑26, favoring originators Janssen and AstraZeneca. The court applied the traditional two‑factor test—prima facie infringement and balance of convenience—but placed greater weight on the...
India’s Directorate General of Trade Remedies has launched an anti‑dumping investigation into ethyl chloroformate imports from China following a complaint by domestic producer Paushak. The probe, covering Oct 2024‑Sept 2025, could lead to duties that raise costs for drugmakers and agrochemical firms...
Merck Animal Health announced that the FDA has approved an expanded label for its once‑yearly injectable parasite control, Bravecto Quantum, adding treatment and control of Asian longhorned tick (Haemaphysalis longicornis) and Gulf Coast tick (Amblyomma maculatum) for 12 months. The product...
Questioning the benefit of an implant to close the left atrial appendage vs medical therapy in a randomized trial @NEJM https://t.co/N0hpdIfmLe https://t.co/8bkk8FzLuY
The FDA issued draft guidance to help drug developers validate new approach methodologies (NAMs) as alternatives to animal testing. The guidance outlines four validation principles—context of use, human biological relevance, technical characterization, and fit‑for‑purpose—to ensure NAM data are reliable for...
Matthew Turner, President of Patient Affordability at Paysign, says next‑generation copay assistance relies on ecosystem partnerships rather than a single‑vendor model, combining best‑in‑class services such as messaging, hub operations, and nursing education. He highlights financial threats like accumulator and maximizer...
MilliporeSigma, the life‑science arm of Merck KGaA, completed its €104 million acquisition of HUB Organoids and has since integrated the business into its Discovery Solutions unit. The company launched a partnership with Promega to develop real‑time reporter assays for organoids, while...
A new finding after stopping GLP-1 drugs in a large cohort with Type 2 diabetes: rapid erosion of CV benefit/protection New @bmj_latest by @zalaly @Biostayan https://t.co/JG6yB8wTJJ See thread: https://t.co/6JvfIIjVBw https://t.co/wUgWhvs9Yy
The U.S. Food and Drug Administration has opened an investigation after a patient died following self‑injection of Laennec, an allogeneic placental extract imported from Japan. A similar fatality occurred in Russia involving health influencer Anna Kolyada, whose companion fell seriously...
CBER changes its standard operating procedures to open the door to RMAT designations for therapies on clinical hold - https://t.co/bZmhga8xxC
A Maryland bill would force pharmaceutical companies and patient advocacy groups to disclose any financial ties when they run disease‑awareness advertisements. The legislation requires drugmakers to state whether they sell or are developing a treatment for the condition featured, and...
What if we could engineer T cells in the body, making CAR T vs cancer, autoimmune diseases, and other applications far more practical, much less expensive? A step forward today via genome editing T cells https://t.co/FjgQA8NUlu https://t.co/XXk43WL1ac https://t.co/rpC7eCAlJH
Repeated head impacts in contact sports have been linked to lasting damage of the blood‑brain barrier (BBB), a finding that may underlie chronic traumatic encephalopathy (CTE). Researchers scanned 47 retired athletes using an MRI contrast agent that only enters brain...
We're about to see an explosion of AI models for Science like Andre's LigandForge and I'm here for it!
