Pharma News and Headlines
Pharma News and Headlines
Pharma Pulse
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Every morning
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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 cardiac arrest linked to the drug. Lamotrigine, used for seizures and bipolar disorder for over 25 years, now carries a warning that patients and clinicians must weigh cardiac risks, especially when combined with other sodium‑channel blockers. Patients are advised not to stop the medication without medical guidance.
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...
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...
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...
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...
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,...
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...
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...
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...
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...
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 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...
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...
The FDA released a draft guidance that details how biopharma firms can validate non‑animal approaches for early‑phase toxicology and safety studies. The document encourages the use of in‑vitro assays, computational modeling, and other modern methods to replace traditional animal testing....
Regeneron scientists have integrated hydrogen‑deuterium exchange mass spectrometry (HDX‑MS) with AI‑driven computational analysis to pinpoint binding sites, geometry, and stoichiometry in sandwich ELISA assays. The approach rapidly distinguishes protected versus exposed regions of antibodies, boosting assay specificity and sensitivity. By...
Azalea Therapeutics, a spinout from Jennifer Doudna’s lab, reported in Nature that its in vivo CAR‑T approach can generate functional CAR‑T cells directly within mice and eradicate both solid and hematologic tumors. The technique uses infused gene‑editing particles that precisely...
UniQure’s experimental gene‑therapy for Huntington’s disease, which previously reported a 75% slowdown in disease progression, has received a third consecutive rejection from the FDA. The trial’s lead investigator, Ed Wild of University College London, praised the early data but warned...
Basecamp Research, an AI‑focused biotech startup backed by Microsoft and Nvidia, announced a trillion‑gene sequencing initiative. The company aims to collect genetic sequences for over a trillion proteins within the next two years. Leveraging high‑performance cloud computing and advanced generative‑AI...
Ionis Therapeutics announced that the primary completion date for its Phase 1/2a prion disease trial has been pushed to February 2027, extending the study timeline by more than two years. In parallel, Arvinas reported new biomarker data from its Parkinson’s disease program,...
Structure Therapeutics reported a 16.3% weight loss after 44 weeks in a Phase 2 trial of its oral GLP‑1 pill, positioning it as a competitive alternative to Eli Lilly’s and Novo Nordisk’s candidates. Rhythm Pharmaceuticals disclosed that its obesity drug Imcivree failed in...
Crossbow Therapeutics, founded by biotech veteran Briggs Morrison, announced a $77 million Series B round to accelerate its off‑the‑shelf T‑cell engager platform. The funding, led by a mix of venture capital and strategic investors, will support the advancement of three preclinical candidates...
Aspen Neuroscience reported encouraging early data from a small autologous cell therapy trial for Parkinson's disease. The treatment, derived from each patient's own skin cells and reprogrammed into dopaminergic neurons, was safely implanted in twelve participants, showing graft survival and...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will begin delivering aligned guidance in June, enabling simultaneous licensing and reimbursement decisions for new medicines. Twenty‑seven companies have signed up...
Sanofi’s oral glucosylceramide synthase inhibitor venglustat has earned U.S. FDA breakthrough therapy designation for treating the neurological aspects of type 3 Gaucher disease. The designation follows the Phase III LEAP2MONO trial, which showed significant improvements in motor and cognitive scores compared with...
Excalipoint Therapeutics, a Shanghai‑based biotech, closed a $68.7 million seed round, including a $41 million founding raise and a $27.7 million extension led by MPCi, Centurium Capital, Lilly Asia Ventures, and Eisai Innovation. The capital will fund six tri‑specific T‑cell engager candidates, notably...
Johnson & Johnson received FDA clearance for Icotyde, the first oral daily pill for moderate‑to‑severe plaque psoriasis. The drug, originally called icotrokinra, is approved for patients aged 12 and older and is designed to replicate the efficacy of injectable biologics...
Myriad Genetics announced FDA approval of its MyChoice CDx test as a companion diagnostic for GSK’s Zejula (niraparib) in advanced ovarian cancer. The clearance follows the PRIMA trial, which showed that patients identified as HRD‑positive derived significant benefit from Zejula...
Biotech startups face the notorious "valley of death" as they move from proof‑of‑concept to commercialization, but investors remain active, with a 70.9% jump in venture‑financing deal value between Q2 and Q3 2025. A GlobalData survey shows 39% of respondents are...
A phase 2 trial of the Na‑GST1/Al–CpG vaccine demonstrated near‑complete protection against hookworm infection in healthy adults, with vaccinated participants shedding a median of zero eggs per gram versus 67 in the placebo group. The study, conducted in Washington, DC,...
Samsung Bioepis and Sandoz have signed a global license, development and commercialization agreement covering up to five biosimilar candidates, including the preclinical SB36 biosimilar to Entyvio (vedolizumab). Samsung Bioepis will manage development, manufacturing and regulatory submissions, while Sandoz will handle...
The U.S. Ninth Circuit Court of Appeals denied dismissal motions by AbbVie, AstraZeneca, Novartis and Sanofi, allowing a whistleblower False Claims Act suit over alleged 340B program overcharges to proceed. The lawsuit, filed by Adventist Health System/West, claims the manufacturers...
Xaira, the biotech AI startup with the deepest funding round, launched its first model, X‑Cell, on Tuesday. The platform uses deep learning to generate virtual cell representations from multi‑omics data, enabling researchers to simulate cellular responses without physical experiments. Early...
R1 Therapeutics announced a $77.5 million oversubscribed Series A round to advance AP306, a first‑in‑class pan phosphate transporter inhibitor for hyperphosphatemia in chronic kidney disease patients. The funding, led by Abingworth, F‑Prime and DaVita Venture Group, also secured an exclusive global licence...
Researchers at the Medical University of Graz conducted one of the largest genome‑wide association studies on tick‑borne encephalitis (TBE), analyzing about 1,600 patients from multiple European nations. The study pinpointed variants in the cholesterol‑transport gene ABCG1 as a genetic risk...
START Center for Cancer Research has partnered with Trialing to broaden access to early‑phase oncology clinical trials throughout Europe. The exclusive agreement lets START distribute curated trial information and real‑time enrollment updates via Trialing’s platform, directly notifying oncologists when slots...
Maryland’s life‑science cluster, home to over 2,700 institutions, is projected to generate a $16.7 billion R&D market by 2026. Six home‑grown biotech firms—SciNeuro, Gain Therapeutics, Theriva Biologics, Supernus Pharmaceuticals, Elixirgen Therapeutics and Altimmune—have secured sizable financing and strategic partnerships in the...
Clarity Pharmaceuticals presented Phase II Co‑PSMA data at the EAU Congress, showing its 64Cu‑SAR‑bisPSMA PET tracer outperforms the standard 68Ga‑PSMA‑11 in detecting prostate cancer recurrence at low PSA levels. In 50 men post‑radical prostatectomy, 64Cu‑SAR‑bisPSMA identified 63 lesions versus 24...
Cogent Biosciences announced that the U.S. FDA has accepted its new‑drug application for bezuclastinib in non‑advanced systemic mastocytosis (NonAdvSM), with a PDUFA target date of December 30 2026 and no advisory committee required. The filing is supported by the SUMMIT trial, which...
Ascendis Pharma released topline results from its Phase‑II New InsiGHTS trial evaluating TransCon hGH (lonapegsomatropin) administered once‑weekly versus daily somatropin in 49 prepubertal children with Turner syndrome. At week 52, the weekly formulation achieved an LS mean annualized height velocity...
Voro Therapeutics has signed a research collaboration with Daiichi Sankyo’s San Diego research institute to create tumor‑activated antibody‑drug conjugates (ADCs) using Voro’s PrimeBody platform. The partnership will focus on masked ADCs that employ proprietary masking domains and protease‑cleavable linkers to achieve...
Chinese researchers at Shandong University have engineered the probiotic strain Escherichia coli Nissle 1917 to synthesize and deliver the anticancer drug Romidepsin directly within breast‑tumor tissue in mice. The bacteria colonized the tumors, releasing the drug locally and achieving tumor‑inhibiting...
President Trump’s TrumpRx website claims to offer the world’s lowest prescription‑drug prices, but a New York Times analysis finds the opposite. The site lists only a few dozen negotiated U.S. prices, omitting widely used drugs such as statins and many high‑cost cancer...
Researchers have engineered lipid nanoparticles tethered with a prodrug that releases an IDO‑1 inhibitor while simultaneously delivering mRNA encoding interleukin‑12. The dual‑action formulation, administered intratumorally, generated robust CD8⁺ T‑cell responses, mitigated T‑cell exhaustion, and produced complete tumor regressions in several...
The U.S. Federal Trade Commission announced it is closely monitoring how pharmaceutical companies respond to the upcoming patent cliff affecting numerous blockbuster drugs. FTC antitrust director Dan Guarnera said the agency’s “laser focus” on healthcare will target any anticompetitive conduct...
