Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL
Eli Lilly announced that its phase‑III BRUIN CLL‑322 trial showed the Jaypirca (pirtobrutinib) + venetoclax + rituximab regimen significantly extended progression‑free survival in relapsed or refractory CLL/SLL compared with venetoclax + rituximab alone. Patients were treated for roughly two years before entering a therapy‑free interval, and the benefit held across key subgroups, including those previously exposed to covalent BTK inhibitors. Overall‑survival data remain immature but trend favorably. Lilly plans to submit the data to regulators later this year for a label expansion.
Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal
Haisco Pharma signed an exclusive licensing agreement with AbbVie to develop, manufacture and commercialize novel pain medicines outside China, Hong Kong and Macau. The deal provides Haisco with a $30 million upfront payment and up to $715 million in development, regulatory and...
Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)
Regeneron and Sanofi announced that the European Commission has approved Dupixent (dupilumab) for moderate‑to‑severe chronic spontaneous urticaria in children aged 2‑11 who remain symptomatic despite antihistamines. The decision follows two Phase‑III studies—LIBERTY‑CUPID and CUPIDKids—that demonstrated significant reductions in UAS7 scores...
Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems
Miracell announced that the U.S. Food and Drug Administration granted 510(k) clearance for its SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including the related kits. The clearance was based on substantial equivalence to the previously cleared SmartPReP...
Oxford BioTherapeutics Partners with BMS to Develop Next-Generation T-Cell Engagers for Solid Tumors
Oxford BioTherapeutics (OBT) announced a multi‑year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next‑generation T‑cell engager therapies for solid tumors. OBT will apply its OGAP‑Verify platform to identify tumor‑selective antigens and design candidate molecules, while BMS...
DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer
DualityBio announced that China’s National Medical Products Administration has accepted its Biologics License Application for trastuzumab pamirtecan (T‑Pam), an investigational antibody‑drug conjugate targeting HER2‑positive metastatic breast cancer. The submission is backed by interim data from the pivotal Phase III DB‑1303‑O‑3001 trial,...
Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
Health Canada has granted approval for Empaveli (pegcetacoplan) to treat patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN). The decision follows the Phase III VALIANT trial, which demonstrated a 68% reduction in proteinuria, stabilization...
Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging
Telix Pharma announced that the U.S. FDA has accepted the resubmitted New Drug Application for TLX101‑Px, marketed as Pixclara, an investigational 18F‑FET PET imaging agent for glioma detection in adults and children. The agency set a PDUFA action date of...
Kymera Therapeutics Reports Gilead’s Option Exercise to License KT-200, a CDK2 Molecular Glue Degrader
Gilead Sciences exercised its option to exclusively license KT‑200, a first‑in‑class oral CDK2 molecular‑glue degrader, from Kymera Therapeutics. The transaction triggers a $45 million milestone payment, with Kymera eligible for up to $750 million in additional milestones and tiered royalties. Gilead will...
Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology
Imagene AI has teamed up with Daiichi Sankyo to use its OI Suite, powered by the CanvOI foundation model, for multimodal biomarker discovery in oncology. The collaboration will integrate H&E and IHC whole‑slide images with molecular and clinical data to...
DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development
DeepCyte, a tech‑bio startup, announced a $1.5 million seed round to launch its AI‑driven toxicology suite for drug development. The company introduced MetaCore, a high‑throughput single‑cell metabolomics platform that uses laser‑based sampling and mass spectrometry to generate AI‑ready data. Its first...
PharmaShots Magazine-April-2026 Edition
The April 2026 edition of PharmaShots spotlights AI’s rapid infiltration into pharmaceutical compliance, turning regulatory oversight into a continuous, data‑driven process. It also details a wave of high‑value deals, with Biogen, Eli Lilly and Merck acquiring AI‑centric assets and forging partnerships...
C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload
C4 Therapeutics and Roche have signed a multi‑billion‑dollar partnership to develop degrader‑antibody conjugates (DACs) for cancer treatment. The deal launches two undisclosed oncology programs, with C4 providing its Torpedo degrader payload platform and Roche handling antibody selection, conjugation, and downstream...
Waters Expands Cervical Cancer Screening Access with At-Home HPV Test Approval
The U.S. FDA has cleared the Onclarity HPV Self‑Collection Kit and approved the BD Onclarity HPV Assay for at‑home cervical cancer screening. The kit detects every high‑risk HPV genotype, delivering both individual and pooled results, and is processed on the...
Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention
Vanda Pharmaceuticals has launched the Phase‑III Thetis trial to test Nereus (tradipitant) against placebo for preventing vomiting in patients on GLP‑1 receptor agonists. The study’s primary endpoint is the proportion of participants who remain vomiting‑free, with topline data slated for...
Astellas Exercises Option to License Dyno’s AAV Capsid for AI-Designed Gene Delivery
Astellas has exercised its option to license an AI‑engineered adeno‑associated virus (AAV) capsid from Dyno Therapeutics for skeletal muscle gene delivery, marking the first licensed asset from their 2021 partnership. The capsid, created using Dyno’s large‑scale in‑vivo data‑driven AI models,...
Garda to Acquire Assertio for ~$125.1M Upfront
Garda Therapeutics has signed a definitive agreement to acquire Assertio for $18 per share in cash, roughly $125.1 million, plus a non‑tradeable contingent value right linked to future Sprix milestones. The transaction also incorporates a $35 million upfront payment from the sale...
Anumana Secures the US FDA 510(k) Clearance for Its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early
Anumana has received FDA 510(k) clearance for its ECG‑AI algorithm, a software‑as‑a‑medical‑device that screens for cardiac amyloidosis using routine 12‑lead electrocardiograms. The AI model, originally developed at the Mayo Clinic, identifies subtle waveform patterns invisible to clinicians, enabling early risk...
Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC
Nuvalent has submitted a New Drug Application to the U.S. FDA for neladalkib, an ALK‑selective inhibitor intended for patients with advanced ALK‑positive non‑small cell lung cancer (NSCLC) who have progressed after prior tyrosine‑kinase inhibitor (TKI) therapy. The filing is backed...
Key Biosimilars Events of March 2026
March 2026 saw a surge of biosimilar activity, highlighted by Celltrion’s launch of Remsima IV in the EU and Avtozma SC in the United States, expanding both IV and sub‑cutaneous options for infliximab and tocilizumab. Samsung Bioepis inked a global...
Biogen Collaborates with Alloy Therapeutics to Advance Antisense Therapeutics
Biogen has signed a collaboration and license agreement with Alloy Therapeutics to use the company’s AntiClastic antisense oligonucleotide (ASO) platform on multiple undisclosed targets. The deal provides Alloy with an upfront cash payment, additional milestone fees and tiered royalties on...
Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC
Akeso presented Phase Ib/II data on its cadonilimab combination with anlotinib and docetaxel in patients whose advanced non‑small cell lung cancer (NSCLC) progressed after PD-(L)1 inhibitor therapy. At a median follow‑up of 21.5 months, the regimen achieved a 6‑month progression‑free...
Organogenesis Reports Trial Results on PuraPly AM for Wound Healing in Diabetic Foot Ulcers
Organogenesis completed a 170‑patient randomized trial of PuraPly AM, an antimicrobial collagen matrix, versus standard of care for non‑healing diabetic foot ulcers. The study met its primary endpoint, showing significantly higher wound‑closure rates at 12 weeks. PuraPly AM integrates cross‑linked...
CuraTeQ Reports P-III Trial Data on BP11 (Biosimilar, Xolair) in Chronic Spontaneous Urticaria
CuraTeQ Biologics announced topline Phase‑III data showing its biosimilar BP11 matches Xolair in treating chronic spontaneous urticaria. The trial involved 608 patients at about 80 sites and met the primary endpoint of ISS7 score change at week 12 within predefined...
Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-Trbw) in Active Thyroid Eye Disease
Amgen announced topline results from a phase‑3 trial of subcutaneous Tepezza (teprotumumab‑trbw) administered every two weeks for 12 doses in patients with moderate to severe active thyroid eye disease. The study met its primary endpoint, showing a 76.7% proptosis response...
Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications
Sanofi announced phase‑IIb results for its subcutaneous antibody lunsekimig across three inflammatory diseases. In the AIRCULES asthma study, the drug reduced exacerbations and improved pre‑bronchodilator FEV1 versus placebo, meeting both primary and key secondary endpoints. The DUET trial in chronic...
When Algorithms Decide Visibility: Ben Beckley, CEO of RevHealth on the Future of Pharma
Ben Beckley, CEO of RevHealth, warns that AI is now the primary gateway to pharmaceutical information, turning search into zero‑click answer delivery. Pharma must move from traditional content publishing to engineering discoverability with machine‑readable, citation‑dense data that AI can surface...
Denali Regains Full Rights to Frontotemporal Dementia Therapy as Takeda Exits DNL593 Pact
Denali Therapeutics has regained full rights to its investigational frontotemporal dementia (FTD) therapy DNL593 after Takeda terminated their co‑development agreement for strategic reasons. DNL593 is a progranulin replacement drug that uses Denali’s Protein Transport Vehicle (PTV) platform to cross the...
Allevion Secures FDA Clearance for Vantage Spinal Decompression System
Allevion Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance to Vantage, a fully disposable, sterile kit for minimally invasive lumbar decompression. The system follows a structured “locate, dilate, decompress” workflow and incorporates built‑in illumination for direct...
Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines has launched the global Phase III RASolute 303 trial to evaluate daraxonrasib, a direct RAS(ON) multi‑selective inhibitor, in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). The study tests the drug as monotherapy and alongside chemotherapy, with progression‑free survival and overall...
Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
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...
Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG
Zeto has secured FDA 510(k) clearance for its New Wave outpatient EEG system, enabling use in clinics and homes. The device features 21 soft‑tip electrodes covering the full 10–20 system and integrates synchronized video and audio capture. It supports recordings...
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
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...
Merck Receives the EC Approval for Keytruda, Plus CT ± Avastin to Treat PD-L1+ Pt-Resistant Ovarian Carcinoma
The European Commission has granted approval for Merck’s Keytruda (pembrolizumab) combined with paclitaxel, with or without Avastin, to treat PD‑L1‑positive, platinum‑resistant ovarian, fallopian‑tube or primary peritoneal carcinoma. The indication covers adults who have received one or two prior systemic regimens...
Biocytogen and Sihuan Pharmaceutical Partner to Discover Novel Therapeutics in Multiple Indications
Biocytogen and China’s Sihuan Pharmaceutical have signed a strategic partnership to co‑develop novel antibody therapeutics across several disease areas, including obesity. The deal merges Biocytogen’s fully human antibody discovery platform—featuring target‑humanized mouse models, in‑vivo efficacy systems, and an AI‑driven sequence...
AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma
AstraZeneca presented interim data from its Phase III EMERALD-3 trial, evaluating a single priming dose of Imjudo (300 mg) plus Imfinzi (1500 mg) followed by quarterly Imfinzi and transarterial chemoembolisation (TACE) with or without lenvatinib in 760 patients with unresectable hepatocellular carcinoma...
Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences announced that the U.S. FDA has received a New Drug Application for bezuclastinib under the Real-Time Oncology Review program, targeting gastrointestinal stromal tumor patients who have progressed after imatinib. The Phase III PEAK trial, comparing bezuclastinib plus sunitinib to...
JenaValve Launches Trilogy Transcatheter Heart Valve System in the US to Treat Symptomatic, Severe Aortic Regurgitation (ssAR)
JenaValve has begun commercializing its Trilogy Transcatheter Heart Valve (THV) system in the United States, becoming the first FDA‑approved transcatheter device for symptomatic, severe aortic regurgitation (ssAR). The valve uses radiopaque locators that attach directly to native leaflets, enabling stable...
Eli Lilly Reports US FDA Approval of Foundayo (Orforglipron) for Weight Loss
The U.S. FDA has approved Foundayo (orforglipron), Lilly’s first oral GLP‑1 pill, for obese or overweight adults with weight‑related health issues, to launch via LillyDirect on April 6, 2026. In the ATTAIN‑1 trial the highest dose produced an average 27.3‑lb (12.4%) weight...
Future Biotech Expo 2026 | June 02-03 | Hilton Houston North, TX, USA
The Future Biotech Expo 2026 will take place June 2‑3 at the Hilton Houston North in Texas. It is an international red biotechnology exhibition and conference aimed at accelerating breakthroughs in healthcare. Over 3,500 industry pioneers will attend, with exhibitions,...
PharmaShots Quarterly Outlook: The Forces Reshaping Biopharma in Q1 2026
Q1 2026 biopharma saw a wave of mega‑size M&A, with deals like Boston Scientific’s $14.5 billion purchase of Penumbra and Eli Lilly’s $7.8 billion acquisition of Centessa, underscoring a strategic push for precision platforms. The quarter also delivered a string of rare‑disease approvals—Zycubo,...
Axsome Therapeutics Acquires Global Rights to Balipodect From Takeda
Axsome Therapeutics has signed an asset purchase agreement with Takeda to acquire worldwide rights to the PDE10A inhibitor TAK‑063, branded as balipodect. The deal provides Axsome with the ability to develop, manufacture and commercialize the drug for schizophrenia and Tourette...
GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma
GlaxoSmithKline’s biologic Exdensur (depemokimab) received approval from China’s National Medical Products Administration as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval is based on Phase III SWIFT‑1 (382 participants) and SWIFT‑2 (380 participants)...
Frontier Medicines Grants Ex-China Rights of FMC-220 to LG Chem
Frontier Medicines has granted LG Chem an exclusive global license to develop and commercialize its covalent p53 Y220C activator FMC-220 outside Greater China, while retaining full rights within that region. LG Chem will manage regulatory filings, global clinical development, and...
Elidah Reports US FDA Clearance of Elitone for Men to Treat Post-Prostatectomy Urinary Incontinence
Elidah announced that the U.S. Food and Drug Administration has cleared its at‑home device, Elitone for Men, to treat urinary incontinence after prostate surgery. The non‑invasive system delivers neuromuscular stimulation to the pelvic floor for a 20‑minute daily session, eliminating...
Blackstone Closes $6.3B BXLS VI Fund, Making It the Largest Life Sciences Vehicle
Blackstone announced the final close of its Life Sciences VI fund at a hard cap of $6.3 billion, roughly 40% larger than the prior vehicle. The BXLS platform, launched in 2018, now manages about $15 billion and invests across the entire drug...
Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia
Merck presented Phase III CORALreef AddOn trial results for enlicitide decanoate, an oral PCSK9 inhibitor, in hypercholesterolemic adults on statins. At eight weeks, the drug lowered LDL‑C by 64.6%, outperforming bempedoic acid, ezetimibe and their combination. It also achieved 54.6%...
Teva Advances Biosimilars Portfolio with Ponlimsi (Denosumab) FDA Approval and Dual Omalizumab Filing Acceptance
Teva Pharmaceutical received U.S. FDA approval for Ponlimsi, a biosimilar to Amgen’s Prolia (denosumab), covering all approved indications. The approval was granted after extensive analytical and clinical studies demonstrated comparable efficacy, safety, and immunogenicity to the reference product. In parallel,...
Triple Therapy Momentum: Caterina Brindicci of AstraZeneca on Breztri in Asthma
AstraZeneca is testing its COPD triple‑inhaler Breztri Aerosphere in uncontrolled asthma. Phase III KALOS and LOGOS trials showed 76‑90 mL improvements in FEV₁ and a 14% reduction in severe exacerbations versus standard ICS/LABA therapy. The studies enrolled about 4,300 patients across 20...
UK Biotech Day 2026 | May 27-28 | London, UK
UK Biotech Day 2026 will take place on May 27‑28 at the Radisson Hotel & Conference Centre London Heathrow. The two‑day conference convenes executives, R&D scientists, investors, legal and finance professionals from pharma, biotech, medtech, and tech‑bio sectors. Positioned as...
