4 April 2025 A planned autumn review of the UK’s 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) will be brought forward to report back in June, it has been announced.
Neurodevelopmental disorders company GRIN Therapeutics, an affiliate of the Blackstone Life Sciences portfolio company Neurvati Neurosciences, has announced a major milestone. 26 February 2025
Chicago, USA-based Emalex Biosciences announced positive top-line data from its Phase III registrational study of ecopipam, a novel dopamine-1 receptor antagonist, in subjects with Tourette syndrome. 26 February 2025
Cardiovascular diseases specialist Kiniksa Pharmaceuticals International has announced updates to its pipeline alongside fourth quarter and full year 2024 financial results. 26 February 2025
Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically-significant and clinically-meaningful improvement in the primary endpoint of progression-free survival (PFS). 26 February 2025
Privately-held BridGene Biosciences has announced a strategic collaboration and licensing agreement with Japan’s Takeda (TYO: 4502). The new deal expands on their initial 2021 partnership, valued at around $500 million, centered on chemoproteomics-based approaches to address "undruggable" targets. 26 February 2025
Israel-headquartered Teva Pharmaceutical Industries’ US subsidiary and France’s Medincell announced that the supplemental New Drug Application (sNDA) for Uzedy (risperidone) extended-release injectable suspension for the maintenance treatment of bipolar-I (BP-I) in adults has been accepted for filing by the US Food and Drug Administration (FDA). 26 February 2025
US pharma major Eli Lilly has announced a deal with San Diego-based Organovo Holdings, a biotech focused on developing novel treatment approaches in inflammatory bowel disease (IBD). 25 February 2025
Ryvu Therapeutics saw its shares tumble nearly 13% to 22.70 zloty by close of trading today, as the Polish oncology-focused biotech company announced a strategic reorganization that will extend Ryvu’s cash runway to second-half 2026 to focus on driving the RVU120 clinical program and the early pipeline to key data inflection points. 25 February 2025
The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) for a new indication. 25 February 2025
The US Food and Drug Administration (FDA) has lifted the clinical hold on ENTR-601-44 and provided authorization to initiate ELEVATE-44-102, a Phase Ib multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in adult patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping. 25 February 2025
Danish pharma major Novo Nordisk has announced the appointment of Sebnem Avsar Tuna as the new general manager (GM) of its UK affiliate. 25 February 2025
Boston, USA-based biotech Nimbus Therapeutics today revealed that, along with partner Eli Lilly, it has achieved a significant pre-clinical milestone in their research collaboration targeting AMP-activated protein kinase (AMPK) for the treatment of cardiometabolic diseases. 25 February 2025
UK-based Swarm Oncology, a biotech developing T-cell therapies to achieve long-term remission in advanced solid cancers, has announced a strategic partnership with cell and gene therapy-focused contract development and manufacturing organization Cellex Cell Professionals. 25 February 2025
US biotech Regeneron Pharmaceuticals says that its investigational gene therapy DB-OTO showed clinically-meaningful hearing improvements in nearly all children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene. 25 February 2025
Florida, USA-based Summit Therapeutics saw its share rise 6.2% to $23.50 pre-market on the news of a clinical trial collaboration with Pfizer to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of the US pharma giant’s antibody drug conjugates (ADCs) across multiple solid tumor settings. 25 February 2025
The US Food and Drug Administration (FDA) has approved label changes for Sublocade (buprenorphine extended-release), including a rapid initiation protocol and alternative injection sites. 25 February 2025
The Japanese Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Sarclisa (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. 25 February 2025
al rule on April 4, that modernizes and improves Medicare Advantage (MA), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) programs.
New Medicare proposals will not cover obesity drugs
April 4, 2025 5 April 2025
A planned autumn review of the UK’s 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) will be brought forward to report back in June, it has been announced. 4 April 2025
US private equity firm Vance Street Capital has expanded its life sciences manufacturing platform with the acquisition of Irish contract manufacturer Zenith Adhesive Components, adding further technical capabilities and boosting regional reach. 4 April 2025
Swedish biotech OncoZenge has expanded its regulatory team as it prepares for a Phase III trial of BupiZenge (bupivacaine), a non-opioid treatment for oral pain caused by cancer therapies. 4 April 2025
US neuroscience-focused biopharma Neurocrine Biosciences today announced the appointment of Sanjay Keswani to the company's executive management team as chief medical officer (CMO) effective June 2, 2025. 4 April 2025
Dark Blue Therapeutics, a UK discovery and development biotech developing precision oncology medicines, has announced the appointment of Edwin Moses as chairman. 4 April 2025
The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), the drug’s developer, Amgen announced yesterday. 4 April 2025
US biotech MoonLake Immunotherapeutics has entered into an agreement with Hercules Capital for up to $500 million in non-dilutive capital, of which $75 million drawn down at close and additional tranches will become available upon achievement of certain pre-specified milestones that are aligned with MoonLake’s strategy and funding needs. 4 April 2025
Struggling US genomic medicines company Sangamo Therapeutics has been offered a lifeline via a licensing deal with pharma major Eli Lilly, sending its share up 24% to $0.77. 4 April 2025
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Wainzua (eplontersen) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which is a rare progressive condition that runs in families caused by a protein called transthyretin (TTR). 4 April 2025
US biotech Aldeyra Therapeutics has received a Complete Response Letter from the US Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of its dry eye disease candidate reproxalap. 4 April 2025
Swiss pharma giant Roche’s Genentech subsidiary has presented new data at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria. 4 April 2025
UK pharma major AstraZeneca today reported extended approvals in Europe for two of its cancer drugs: Imfinzi (durvalumab) and Enhertu (trastuzumab deruxtecan). 4 April 2025
US biotech Novavax is still waiting on a decision from the Food and Drug Administration over full approval of its protein-based COVID-19 vaccine, despite the agency having set an April 1 target date to complete its review. 4 April 2025
US regenerative cell therapy specialist Neurona Therapeutics has announced the successful completion of an upsized and oversubscribed $102 million financing. 4 April 2025
US pharma major Eli Lilly’s brand value has surged by 108% since entering the weight loss market in 2023, according to a new report from Brand Finance. 3 April 2025
US biotech BioMarin Pharmaceutical yesterday revealed that the Phase III PEGASUS trial evaluating Palynziq (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically-significant lowering in blood phenylalanine( Phe) levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone. 3 April 2025
Sino-American biotech BeiGene today revealed it intends to discontinue its clinical development program for ociperlimab (BGB-A1217), an anti-TIGIT antibody, as a potential treatment for lung cancer. 3 April 2025
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Company Spotlight
A clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors.