UCB Bags First EU Approval for Rare Genetic Disease TK2d
UCB’s Kygevi (doxecitine and doxribtimine) received a CHMP recommendation for EU approval, targeting thymidine kinase 2 deficiency (TK2d) in patients whose disease began before age 12. The drug already secured FDA approval last November and is slated for launch in the United States later this quarter. Retrospective data showed a 95 % reduction in mortality and 84 % of patients regained motor milestones, with many reducing ventilatory support. TK2d is an ultra‑rare mitochondrial myopathy affecting fewer than 150 individuals worldwide.
EMA Looks Into 'Data Integrity' Issue with Amgen's Tavneos
The European Medicines Agency has opened a review into the data integrity of the pivotal ADVOCATE trial that underpinned the EU approval of Amgen’s oral complement C5 inhibitor Tavneos. The regulator’s concerns focus on how the study data were handled...
Three More Biotechs Price Their Nasdaq IPOs
AgomAb Therapeutics, SpyGlass Pharma, and Veradermics have filed Nasdaq IPO pricing, each seeking $150‑200 million. AgomAb plans to sell 2.5 million shares at $15‑$17, targeting a post‑money valuation near $875 million. SpyGlass will issue 9.4 million shares at the same price range, aiming for...
Digital Musculoskeletal Care Firm Sword Buys Rival Kaia
US digital physical‑therapy specialist Sword Health announced a $285 million acquisition of German rival Kaia Health. The deal will migrate Kaia’s millions of U.S. users onto Sword’s platform, instantly expanding its American footprint. Combined, the companies will serve over 100 million patients,...
Otsuka Preps for July Decision on Centanafadine for ADHD
The FDA has placed Otsuka Pharma’s centanafidine under priority review, with a decision expected by July 24. The drug is the first norepinephrine‑dopamine‑serotonin reuptake inhibitor (NDSRI) aimed at children, adolescents, and adults with ADHD, and is backed by four phase 3 trials...
Halozyme Diversifies in Drug Delivery with Surf Bio Buy
Halozyme Therapeutics has bolstered its drug‑delivery portfolio by acquiring Surf Bio for a $300 million upfront payment, adding the ultrahigh‑concentration Snapshot platform. The deal follows a recent $750 million purchase of Elektrofi, giving Halozyme three complementary technologies for subcutaneous administration. Snapshot enables...
Eikon Prices Its IPO, Seeking to Raise $318m
Eikon Therapeutics priced its Nasdaq IPO at $16‑$18 per share, aiming to raise up to $318 million and valuing the company at more than $900 million. The offering includes 17.6 million shares after the biotech raised roughly $1 billion in private funding, including a...
Boehringer Drug Scores in Rare Kidney Disease FSGS
Boehringer Ingelheim’s TRPC6 inhibitor apecotrep, originally a COVID‑19 candidate, achieved a 40% reduction in proteinuria versus placebo in a phase 2 trial for primary focal segmental glomerulosclerosis (FSGS). The study, published in The Lancet, provides the first efficacy signal for a...
CMS's Medicare Price Negotiations Start Round Three
The Centers for Medicare & Medicaid Services released the third round of Medicare drug price negotiations, naming 15 drugs that will face mandatory discounts starting in 2028. The list, which adds Eli Lilly’s GLP‑1 therapy Trulicity and several physician‑administered products such...
China Clears Its First Drug for Chronic Hepatitis D
Huahui Health’s libevitug has secured conditional approval from China’s NMPA, marking the nation’s first domestically approved drug for chronic hepatitis D. The antibody blocks the PreS1 domain of HBV and HDV, preventing viral entry into liver cells. Previously, only Gilead’s Hepcludex...
Boehringer Signs €1bn+ Deal for Simcere IBD Candidate
Boehringer Ingelheim has licensed SIM0709, a bispecific antibody targeting IL‑23p19 and TL1A, from China’s Simcere in a deal valued at up to €1.05 billion. The agreement includes a €42 million upfront payment and milestone‑based payouts. SIM0709 is in pre‑clinical development and aims...
Roche Claims Midstage Win for Obesity Injectable
Roche announced phase‑2 results for its dual GIP/GLP‑1 obesity drug CT‑388, showing a placebo‑adjusted 22.5% weight loss at the 24 mg dose after 48 weeks. More than half of participants fell below the obesity BMI threshold, and 96% lost at least...
Vaccination Fall Costs UK Its Measles Elimination Status
WHO has stripped the United Kingdom of its measles elimination status after England recorded 2,911 laboratory‑confirmed cases in 2024, the highest in over a decade. The loss follows a decline in MMR vaccination rates, which fell below the 95 % herd‑immunity...
Bausch Health Hit as Xifaxan Successor Flunks Trials
Bausch Health’s SSD rifaximin program, aimed at primary prevention of hepatic encephalopathy, failed both phase‑3 RED‑C trials, missing the primary efficacy endpoint. The setback caused the company’s shares to tumble about 11 % and raises concerns as Xifaxan, its top‑selling drug,...
COPD Patients Will Get Access to Dupixent via NHS
The UK’s health technology assessment agency NICE has recommended Sanofi‑Regeneron’s Dupixent for adults with eosinophilic, uncontrolled COPD, making it the first targeted biologic for the disease. Approved in September 2024, the IL‑4/IL‑13 inhibitor is prescribed alongside standard LABA/LAMA ±ICS therapy...
Introducing the Sunday Times Tech 100: Life Sciences Part 1
The Sunday Times Tech 100 list shows that 23 of the 100 fastest‑growing UK private tech firms operate in life sciences, underscoring the sector’s momentum. The list aggregates £3.7 billion in revenue and 23,100 jobs, with a focus this week on five...
Nature: "Sidewinder" Tech a Leap Forward in DNA Synthesis
Nature has published a breakthrough DNA‑synthesis method called Sidewinder, which employs three‑way junctions instead of the traditional two‑way structures. This design lets researchers write DNA sequences from scratch, as demonstrated by assembling the full coding region of apolipoprotein E. Sidewinder promises...
Digital Osteoarthritis, Bulimia Tools Backed for NHS Use
The UK’s National Institute for Health and Care Excellence (NICE) has issued early value assessment (EVA) guidance allowing the NHS to temporarily adopt digital health technologies for hip and knee osteoarthritis and for bulimia. Eight osteoarthritis apps—including GetUBetter, Hinge Health...
Sanofi Plans Amlitelimab Dermatitis Filing After New Readout
Sanofi announced it will move forward with regulatory filings for its atopic dermatitis candidate amlitelimab after positive readouts from the SHORE and COAST 2 phase 3 trials. SHORE showed robust improvements on vIGA‑AD and EASI‑75, while COAST 2 met only the vIGA‑AD endpoint...
NICE Backs Roche Lupus Drug that Supports Kidney Function
NICE has issued a draft recommendation approving Roche’s anti‑CD20 antibody Gazyvaro for lupus nephritis patients in England and Wales, making the therapy available to roughly 12,000 people with kidney‑damaging systemic lupus erythematosus. The drug is administered intravenously twice yearly alongside...
EU Approves Otsuka's Long-Acting HAE Drug Dawnzera
European Commission approved Otsuka’s Dawnzera, a first‑in‑class antisense RNA therapy, for prophylaxis of hereditary angioedema in patients 12 and older. Clinical data showed an 81% attack‑rate reduction with four‑weekly dosing and up to 94% reduction after one year. Otsuka secured...
Hopstem Maps Course to Bring Stem Cell Stroke Therapy to US
Hopstem Biotech received FDA clearance to begin US clinical trials of its iPSC‑derived stroke therapy, hNPC01, under an accelerated development pathway. The company completed a Phase 1 study in China showing sustained motor improvements over 18 months without safety concerns. The...
ImmunityBio Rises as Route Opens to Broader Anktiva Label
ImmunityBio announced an FDA pathway to refile for Anktiva in papillary‑only NMIBC after an initial rejection. The IL‑15 agonist, already approved for BCG‑refractory CIS, generated $113 million in sales last year. Data from the QUILT‑3.032 trial show a 58.2% 12‑month disease‑free...
Call Goes Out for Type 1 Diabetes Screening in UK
Researchers from the University of Birmingham reported that the ELSA feasibility trial screened roughly 17,000 UK children aged three to 13 using a finger‑prick autoantibody test, identifying early‑stage type 1 diabetes before symptoms appear. The study found 75 children with...
J&J Bets on Isomorphic for AI-Powered Drug Hunt
Johnson & Johnson’s Janssen Biotech unit has entered a cross‑modality, multi‑target research collaboration with Isomorphic Labs, the Alphabet‑backed AI drug‑discovery start‑up. The partnership combines Isomorphic’s planet‑scale computing and AI‑driven design engine with J&J’s experimental and development capabilities, covering both small‑molecule...
ViiV Ownership Shifts as Pfizer Sells Its Stake
Pfizer is selling its ViiV Healthcare stake for $1.875 billion, reducing its involvement in the HIV joint venture. Shionogi’s ownership more than doubles to 21.7% while GSK retains a 78.3% majority and aims to push ViiV sales beyond £7 billion this year....
AstraZeneca Pays $630m to Get Full Control of AbelZeta CAR-T
AstraZeneca paid $630 million to acquire full rights to C‑CAR031 (AZD7003) from AbelZeta for China. The armored CAR‑T targets GPC3 in solid tumours and showed a 56.5% overall response in advanced hepatocellular carcinoma, rising to 75% at the top dose, with...
GSK Reaches $2.2bn Deal to Buy Food Allergy Biotech RAPT
GlaxoSmithKline announced a $2.2 billion acquisition of U.S. biotech RAPT Therapeutics, securing global rights to its anti‑IgE antibody ozureprubart, currently in Phase 2b trials. The deal, the first major transaction under new CEO Luke Miels, aims to strengthen GSK’s immunology pipeline and...
Sun Pharma Says Talk of $10bn Organon Bid Is 'Speculative'
Sun Pharmaceutical Industries denied rumors of a $10 billion bid for women's‑health specialist Organon, calling the Economic Times report speculative and stating no material event has occurred. The proposed price would make the deal Sun's largest acquisition since the 2015 Ranbaxy...
EU Starts Review of First-Line Enhertu for Breast Cancer
The European Medicines Agency has opened its review of Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) combined with pertuzumab as a first‑line treatment for HER2‑positive metastatic breast cancer. The DESTINY‑Breast09 trial demonstrated a 44% reduction in disease recurrence or death versus...
Could Alzheimer's Be Predicted with a Finger-Prick Test?
An international trial, Bio‑Hermes‑002, is testing a finger‑prick blood test to predict Alzheimer’s risk in people over 60. The study measures three biomarkers—pTau217, GFAP, and NfL—and compares results with PET/MRI scans, lumbar punctures and digital assessments. With 1,000 volunteers across...
NICE Relents, Ending Postcode Access to Prostate Cancer Drug
NICE has issued new guidance allowing abiraterone, both the Zytiga brand and generics, for men in England with high‑risk localized or locally advanced prostate cancer, aligning England with Wales and Scotland. The decision follows a patient‑led campaign and recent phase‑3...
'Skinny' Generic Vascepa Label Case Reaches US Supreme Court
The U.S. Supreme Court agreed to hear Amarin’s appeal against Hikma over the use of a “skinny label” for a generic version of Vascepa, the omega‑3 drug that accounts for roughly $215 million of Amarin’s annual revenue. Hikma’s generic entered the...
Wegovy Pill Shows Strong Early Uptake, as Rival Looms
Novo Nordisk's oral Wegovy pill recorded 3,071 prescriptions within its first four days on the U.S. market, a figure that excludes sales through its NovoCare direct‑to‑consumer channel. The launch arrives as Eli Lilly awaits an FDA decision on its own oral...
Sanofi Linked to Takeover Bid for Ocular Therapeutix
Sanofi is reportedly preparing a renewed takeover bid for US‑based Ocular Therapeutix after its initial $16‑per‑share offer was rejected last summer. Ocular, valued at roughly $2.4 billion with shares trading around $11.28, is poised to file for approval of Axpaxli, a...
Ocugen Shares Fall, Despite Positive Eye Disorder Trial
Ocugen reported that its phase‑2 ArMaDa trial of the gene therapy OCU410 achieved a 46% reduction in geographic atrophy lesion growth for medium and high doses, with the medium dose showing a 54% reduction. The data also revealed a 60%...
Autonomous AI Can Spot Cognitive Decline in Medical Notes
Researchers at Mass General Brigham unveiled an autonomous, agentic AI system that scans routine clinical notes to flag early cognitive impairment. The platform, built from five specialized LLM agents, demonstrated 98% specificity and 91% sensitivity in balanced testing, though real‑world...
J&J Builds Case for Earlier Tecvayli Use in Multiple Myeloma
Johnson & Johnson reported that Tecvayli (teclistamab) monotherapy cut overall survival risk by 40% in the MajesTEC‑9 trial for patients who had received one to three prior lines of therapy. The same study showed a 71% reduction in progression‑free survival...
Novartis Issues a Life Sciences Warning in a 'G-Zero' World
Novartis has sent an open letter to governments in the EU, Canada and Japan warning that fragmented regulation, unpredictable pricing and blunt cost‑control tools are causing Europe to lose life‑science ground to the United States and China. The company, together...
Oxford BioMedica Confirms Private Equity Takeover Talks
Oxford BioMedica, a UK contract development and manufacturing organisation specialising in cell and gene therapies, disclosed an unsolicited cash approach from Stockholm‑listed private‑equity group EQT. The news sent the shares up 15% intraday and over a third higher year‑to‑date, reflecting...
FDA Seeks Changes to GLP-1, Flu Shot Labels
The FDA has asked manufacturers of GLP‑1 weight‑loss drugs, including Wegovy, Saxenda and Zepbound, to drop the suicide‑ideation warning after a comprehensive safety review found no elevated risk. The agency’s meta‑analysis of 91 trials involving more than 100,000 participants confirmed...
Hippocratic AI Builds in Life Sciences with Grove AI Buy
Hippocratic AI announced the acquisition of Grove AI, a pharma‑R&D specialist, and launched a dedicated life‑sciences division headed by Dr Ahad Wahid. The move adds the Grace agent, which automates clinical‑trial tasks, to Hippocratic's safety‑first generative AI portfolio. The company,...
JPM: Illumina Launches 'Unprecedented' Disease Biology Atlas
Illumina unveiled the Billion Cell Atlas, a genome‑wide perturbation database that profiles 20,000 genes across 250 disease‑relevant human cell types using CRISPR. The initial release contains data from 150 million cells and aims to expand to five billion cells within three years,...
UK Names Health Data Chief, as BIA Finds Its New CEO
Former Moderna executive Dr Melanie Ivarsson has been named chief executive of the UK Health Data Research Service, a £600 million government‑backed unit that will create a secure, single gateway to NHS health data. The HDRS, based at the Wellcome Genome...
AbbVie Turbocharges Its US Investment Promise to $100bn
AbbVie has signed a most‑favoured‑nation pricing deal with the Trump administration, committing $100 billion to U.S. research, development and manufacturing over the next ten years. The agreement mirrors those of 16 other large pharma firms and secures an exemption from potential...
JPM: Is the UK's Clinical Trials Sector Turning a Corner?
The UK medicines regulator reported a 9% rise in clinical trial applications year‑over‑year, with early‑stage studies leading the growth. Healthy‑volunteer and first‑in‑human trials increased 16% and 5% respectively, while sponsor requests for regulatory advice surged 75%. The MHRA announced a...
JPM: AbbVie Pays $650m Upfront for RemeGen Cancer Drug
AbbVie has signed a $5.6 billion licensing agreement with China’s RemeGen, paying $650 million upfront for exclusive rights to the PD‑1×VEGF bispecific antibody RC148 outside Greater China. The deal includes up to $4.95 billion in milestone payments and gives AbbVie access to a...
Abivax Climbs on Lilly Takeover Speculation
Shares of French biotech Abivax jumped about 32% after La Lettre reported that Eli Lilly may be considering a €15 billion takeover. The speculation follows Abivax's positive phase 3 data for obefazimod, an oral miR‑124 enhancer, in ulcerative colitis. The deal would add...
Madrigal Eyes Combination MASH Therapy with Pfizer Deal
Madrigal Pharma has licensed Pfizer’s oral DGAT‑2 inhibitor ervogastat for a $50 million upfront payment, planning to pair it with its approved MASH drug Rezdiffra. The combination targets complementary pathways in triglyceride synthesis and inflammation, aiming to enhance therapeutic outcomes for...
J&J Jumps on the MFN Pricing Train
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...
