Pharma News and Headlines
Pharma News and Headlines
Zinereo Pharma is preparing to launch Otibiome, a clinically evaluated probiotic derived from *Ligilactobacillus salivarius* PS7, aimed at preventing recurrent acute otitis media (AOM) in children. A pilot study of 61 kids showed an 84% drop in AOM episodes over six months and a marked reduction in antibiotic use. The product, already sold in Spain as Elebiotic, can be taken alongside antibiotics with a two‑hour gap. Otibiome will debut at Vitafoods Europe and will be rolled out globally thereafter.
An international team led by the Turku Bioscience Centre discovered that applying sound‑wave vibration to vocal‑fold cancer cells restores cellular movement and markedly reduces tumor aggressiveness. The mechanical stimulation lowered levels of the oncogenic protein YAP, both in cultured cells...
Oncology is moving toward combination regimens, and Merck's Keytruda paired with Pfizer/Astellas' Padcev has emerged as a leading duo. A phase 3 trial in muscle‑invasive bladder cancer showed the combo cut the risk of recurrence, progression and death roughly in half,...
An emulated target trial using the TriNetX database compared tocilizumab and rituximab in 1,194 rheumatoid arthritis‑associated interstitial lung disease (RA‑ILD) patients each over a five‑year follow‑up. The analysis found no statistically significant difference in all‑cause mortality (15.9% vs 17.7%) or...
Capricor Therapeutics announced that the FDA has scheduled an August 22 decision on its investigational Duchenne muscular dystrophy cell therapy, deramiocel, after lifting a prior complete response letter. The biotech resubmitted an enhanced package that includes robust Phase III HOPE‑3 data showing...
ARTHEx Biotech announced that its RNA‑based drug ATX‑01 has received U.S. FDA Fast Track designation for treating Myotonic Dystrophy Type 1 (DM1). The therapy works by inhibiting miR‑23b, thereby increasing free MBNL protein, correcting splicing errors and reducing toxic DMPK mRNA...
UK health agencies and the Wellcome charity have launched a joint initiative to fund high‑quality infectious‑disease clinical trials in Africa, South Asia and Southeast Asia. The program, co‑led by the NIHR, the Foreign Commonwealth Development Office and Wellcome, will prioritize...
RA Capital, Forbion, and Canaan have collectively invested in Solstice Therapeutics, the CTLA-4 antibody partner of Harbour Therapeutics. The funding round, reportedly a multi‑million dollar Series B, will support Solstice's pre‑clinical and early clinical programs. By backing Solstice, the investors...
Researchers have identified the erectile‑dysfunction drug sildenafil as a potential therapy for Leigh syndrome, a fatal mitochondrial disorder affecting roughly one in 40,000 births. In cell models, the compound corrected mitochondrial membrane potential and normalized gene expression, while treated mice...
Early data presented at the San Antonio Breast Cancer Symposium indicate that GLP‑1 receptor agonists, long used for diabetes and obesity, are linked to markedly lower breast cancer recurrence and mortality. Retrospective analyses of thousands of patients showed up to...
Swiss biotech Idorsia has signed an exclusive agreement with UAE‑based Pharmalink Drug Store to distribute its insomnia drug Quviviq (daridorexant) across Kuwait, Oman, Qatar, Bahrain and the United Arab Emirates. Under the deal Idorsia will receive an upfront payment, retain...
NICE has issued final draft guidance recommending fezolinetant 45 mg once daily for moderate to severe menopause‑related vasomotor symptoms when hormone replacement therapy is unsuitable. The recommendation enables the drug to be supplied through the NHS, providing a new non‑hormonal option...
Researchers at Brown University, Rhode Island Hospital, and VA Providence demonstrated that simultaneous electrical stimulation above and below a spinal cord lesion can restore both leg movement and spatial sensory feedback in people with complete spinal cord injuries. In a...
Canada‑based Kainova Therapeutics announced positive top‑line results from its Phase I EPRAD study of DT‑9081, an oral EP4 receptor antagonist, in patients with advanced, recurrent and metastatic solid tumours. The trial, conducted at four sites in Belgium and France, met all...
Osteoarthritis incidence is climbing as populations age and obesity spreads, intensifying health and economic pressures. Conventional treatments merely decelerate disease progression and often entail systemic side effects or surgical risks. Emerging hydrogel microsphere platforms create a biomimetic joint microenvironment, offering...
CorMedix reported Q4 2025 revenue of $128.6 million, propelled by DEFENCATH ($91.2 M) and the first full‑quarter contribution from the Melinta acquisition ($37.4 M). Full‑year pro forma revenue reached $401.3 million, matching prior guidance, with DEFENCATH net sales totaling $258.8 million. Adjusted EBITDA for the...
Veru Inc. reported a $23.4 million public offering that lifted cash and working capital to $33 million and $29.7 million respectively, while narrowing its quarterly net loss to $5.3 million ($0.26 per share). The company received FDA feedback confirming two regulatory pathways for its...
Vanda Pharmaceuticals reported 2025 revenue of $216.1 million, up 9% year‑over‑year, driven primarily by Fanapt’s 24% sales increase and a successful bipolar launch. The company secured FDA approval for tradipitant (Nirius) to prevent motion‑sickness vomiting, with a commercial rollout slated for...
The FDA granted approval for leucovorin calcium tablets to treat a rare genetic disorder that impairs folate transport to the brain. Unlike typical approvals, the agency relied primarily on a handful of patient case reports rather than a sponsor‑run clinical...
Sen. Ron Johnson (R‑Wis.) announced an investigation into the FDA’s rejections of rare‑disease treatments, requesting the agency’s complete response letters for drugs targeting ataxia, Sanfilippo syndrome and similar conditions. Johnson argues the FDA’s cited deficiencies are often “nitpicky,” suggesting an...
The FDA approved 18 biosimilars in 2025, spanning six therapeutic areas and marking a surge in interchangeable designations to over 20. A wave of denosumab biosimilars and first‑in‑kind interchangeable products such as Poherdy® and Omlyclo® highlighted market diversification. BPCIA litigation...
Public Citizen announced it will encourage compulsory licensing of generic drugs if Pfizer follows through on its January threat to withhold medicines from France unless the country raises drug prices. The consumer group’s stance turns a pricing dispute into a...
Researchers at the University of Toronto have engineered synthetic long non‑coding RNA (lncRNA) molecules that can dampen inflammatory responses. The study, led by PhD student Janice Pang and biologist Omar Khan, demonstrates that these engineered lncRNAs reduce cytokine release in...
Neuland Laboratories announced that the first module of its new commercial peptide manufacturing facility will be operational by summer on its 17‑acre Bonthapally campus in India. The module adds 6,370 L of solid‑phase and liquid‑phase peptide synthesis capacity, ranging from 250 L...
Lundbeck chief executive Charl van Zyl warned that Europe’s fragmented drug‑pricing regime threatens biotech sustainability and patient access. He cited recent remarks by HHS Secretary Robert F. Kennedy Jr. suggesting Europeans already pay higher prices than Americans. Van Zyl called...
The FDA has cleared Pylarify TruVu, a reformulated version of Lantheus’ PSMA‑targeting radiopharmaceutical piflufolastat F‑18. The new formulation improves stability at higher radioactive concentrations, enabling larger batch production and broader distribution. Lantheus plans a Q4 2026 commercial launch with a rolling geographic...
Johnson & Johnson has filed a Type II variation with the European Medicines Agency to add teclistamab, a bispecific T‑cell‑redirecting antibody, as a second‑line monotherapy for relapsed/refractory multiple myeloma. The Phase III MajesTEC‑9 trial, enrolling 614 patients, demonstrated a 71 % reduction in...
Several U.S. universities have launched two‑year medication safety fellowships that rotate participants through academic training, a major pharmaceutical company, and the FDA. Butler University offers two tracks with Regeneron and Eli Lilly, Purdue partners with AbbVie, and Rutgers collaborates with Pfizer....
Peptide therapeutics are booming, with more than 2,000 candidates in discovery and pre‑clinical stages and projected global sales of $91.4 bn by 2025. Companies like Orocidin faced severe synthesis and purification hurdles for their QR‑01 peptide, but Syngene’s custom low‑loading resin...
Johns Hopkins Medicine is heading a five‑year, $24 million NIH‑funded Hepatitis B and HIV Cure Consortium that brings together research teams from the United States, Brazil, India, Senegal and Uganda. The first year will enroll 450 participants co‑infected with HIV and chronic...
A multicenter retrospective study of 17 Chinese patients with juvenile myasthenia gravis found that weekly efgartigimod 10 mg/kg for four weeks produced rapid and substantial clinical improvement. Clinically meaningful improvement was observed in 70.6% of patients by week 1 and 91.7% by...
BioNTech announced it will create an independent biotech company dedicated to next‑generation mRNA technologies. The spin‑out will be led by co‑founders Ugur Sahin and Özlem Türeci, who will assume management by the end of 2026. BioNTech will contribute core mRNA assets in...
CSL‑Behring broke ground on a $1.5 billion expansion of its Kankakee, Illinois manufacturing complex, slated to be operational by 2031. The project will add at least 300 pharmaceutical positions and roughly 800 construction jobs, with the state offering more than $200 million...
Researchers at Johns Hopkins found a single dose of psilocybin dramatically increased smoking cessation rates compared with nicotine patches. In a randomized trial of 82 smokers, 17 of 41 participants who received psilocybin remained abstinent after six months versus four...
Scientists announced ETVAX, the first oral vaccine that targets enterotoxigenic *E. coli* (ETEC) in children, after a large‑scale trial in The Gambia. The study involved 4,936 infants aged six to 18 months and demonstrated a 48% reduction in moderate‑to‑severe ETEC...
Novo Nordisk received an FDA warning letter on March 5, 2026 for failing to report suspected side effects of its GLP‑1 medicines. The violations were uncovered during a 2025 inspection of the company’s facilities and were described as “serious.” The agency warned...
The Trump administration, led by Health Secretary Robert F. Kennedy Jr., plans to eliminate over a third of the CDC childhood vaccine schedule, targeting seven of eleven vaccines. The United States, which produces roughly 36% of global vaccine output, could...
Dubai is positioning itself as a long‑term hub for healthcare and life sciences through two complementary free‑zone clusters – Dubai Healthcare City (DHCC) and Dubai Science Park (DSP). DHCC is undergoing a $1.3 bn expansion that will create six tightly linked...
The FDA has defined the scope of pre‑submission facility meetings to curb manufacturing‑related complete response letters that delay drug approvals. It agreed to cover prior production‑site inspections, novel process elements and supply‑chain node strategies, while rejecting topics such as alternative...
Arizona's biotech sector is booming, with $3.7 billion invested over the past seven years and a growing pipeline of innovative companies. Nectero Therapeutics secured a $96 million Series D to develop a fast‑track, breakthrough‑designated endovascular treatment for abdominal aortic aneurysms, while Humabiologics obtained...
BioNTech co‑founders Ugur Sahin and Özlem Türeci will leave the company by year‑end to launch an unnamed mRNA‑focused venture, with BioNTech retaining a minority stake and licensing key technology. The split allows BioNTech to concentrate on its late‑stage cancer pipeline...
China is actively targeting ultra‑expensive gene therapies, challenging the notion that these treatments are immune to price competition. Recent regulatory approvals and centralized procurement initiatives have forced manufacturers to negotiate steep discounts on therapies that once commanded multi‑million‑dollar price tags....
The U.S. Food and Drug Administration has approved the generic form of leucovorin, also known as folinic acid, for treating cerebral folate deficiency (CFD). The decision widens the drug’s label despite the absence of new clinical trial data, relying on...
Credence Research forecasts the global cell and gene therapy manufacturing market to surge from $19.3 billion in 2024 to $146.2 billion by 2032. The compound annual growth rate is estimated at 28.8%, propelled by rising demand for advanced therapies, expanding commercialization, and...
BIOTECanada welcomes the launch of the National Research Council of Canada’s Biomedical Countermeasures Initiative, a key component of the federal Defence Industrial Strategy. The program is designed to strengthen Canada’s domestic capacity to develop and manufacture diagnostics, vaccines, and therapeutics...
Stylus Medicine entered the cell‑therapy arena in May 2025 with an in‑vivo CAR‑T platform that delivers a lipid nanoparticle‑encapsulated recombinase to engineer T cells inside patients. The move comes after major pharma acquisitions—BMS buying Orbital Therapeutics for $1.5 billion and Gilead...
Drug pricing is increasingly viewed as a reputation issue, not just a financial decision. Carreen Winters of MikeWorldWide argues that pricing choices shape public perception of a company's values, as illustrated by Novo Nordisk’s 50% cut to GLP‑1 drug prices....
India’s active pharmaceutical ingredient (API) market posted a landmark trade balance in FY25, with exports climbing to roughly Rs 41.5 billion while imports lagged at Rs 39.2 billion. The surplus marks the first time the sector has out‑exported its imports, signaling a maturing domestic...
Samsung Biologics and U.S. pharma leader Eli Lilly have signed an agreement to launch a biotech incubator in Incheon’s Songdo district. The facility will host Lilly’s Gateway Labs platform, offering lab space, equipment, funding and R&D collaboration to emerging biotech firms....
Dyne Therapeutics reported that its exon‑skipping candidate z‑rostudirsen sustained respiratory and cardiac benefits through 24 months in the Phase 1/2 DELIVER study for Duchenne muscular dystrophy. The therapy maintained forced vital capacity, circumferential strain and left‑ventricular ejection fraction improvements compared with...
