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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.
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Pharmaceutical
A final report for KarXT (xanomeline tartrate/trospium chloride) has been published by influential US pricing watchdog The Institute for Clinical and Economic Review (ICER). 12 March 2024
Pharmaceutical
India's Department of Pharmaceuticals introduced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme aimed at enhancing the technological prowess of the country's pharmaceutical sector to meet global standards. 12 March 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. 12 March 2024
Biotechnology
US immunology specialist Acelyrin came up with positive trial results for izokibep, which last year failed to meet a study endpoint for the treatment of moderate-to-severe hidradenitis suppurativa (HS). 12 March 2024
Pharmaceutical
On Monday, the US Food and Drug Administration (FDA) issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. 12 March 2024
Biotechnology
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
Biotechnology
Eli Lilly has announced results from a Phase III study of lebrikizumab, an investigational therapy designed to treat atopic dermatitis in people with skin of color. 11 March 2024
Biosimilars
German biosimilars company Formycon and Jordan-based MS Pharma have announced that FYB201, a biosimilar to Lucentis (ranibizumab), has received marketing authorization from the Saudi Food and Drug Authority. 11 March 2024
Pharmaceutical
Israel-based RedHill Biopharma has announced the issuance of a new US patent related to Talicia (omeprazole/amoxicillin/rifabutin). 11 March 2024
Pharmaceutical
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024
Pharmaceutical
In a new report, The World Health Organization (WHO) has warned of growing resistance to certain HIV medications, while the overall picture on combating the disease remains positive. 11 March 2024
Biotechnology
French pharma major Sanofi has touted amlitelimab as one of 12 potential blockbusters in its immunology pipeline. 11 March 2024
Biotechnology
US retinal disease specialist Apellis Pharmaceuticals today announced that Dr Philip Ferrone will join the company as chief medical retina advisor, effective March 18. 11 March 2024
Pharmaceutical
Privately-held German firm Boehringer Ingelheim and Japan’s Sosei Group Corporation have entered into a global collaboration and exclusive option-to-license agreement. 11 March 2024
Biotechnology
Shares of Switzerland-based MoonLake Immunotherapeutics were up 10.5% at $50.38 in pre-market activity today, after its Sunday R&D update on its Nanobody sonelokimab. 11 March 2024
Biotechnology
Polish cell therapy company PolTREG has received a Current Good Manufacturing Practice (cGMP) certificate, allowing it to produce advanced therapies at its own facility. 11 March 2024
Pharmaceutical
Data protection is in the spotlight in Europe, as lawmakers gather to decide on an important set of rules on intellectual property, the Regulatory Data Protection (RDP) law. 11 March 2024
Generics
Brazil’s Institute of Drug Technology (Farmanguinhos/Fiocruz) has announced a partnership agreement with the Brazilian unit of the German family-owned pharma major Boehringer Ingelheim. 11 March 2024
Generics
India has finalized a trade pact with the European Free Trade Association (EFTA), comprising Iceland, Liechtenstein, Norway and Switzerland, marking a significant milestone in international commerce. 11 March 2024
Biotechnology
Belgium’s largest drugmaker UCB on Friday announced the first presentations of Bimzelx (bimekizumab-bkzx) four-year efficacy and safety data in the treatment of adults with moderate-to-severe plaque psoriasis. 11 March 2024
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Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 4 April 2025
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
A new report from GlobalData has raised concerns over the effectiveness of mpox vaccines for people living with HIV. 4 April 2025
Biotechnology
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
Biotechnology
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
Biotechnology
US regenerative cell therapy specialist Neurona Therapeutics has announced the successful completion of an upsized and oversubscribed $102 million financing. 4 April 2025
Pharmaceutical
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
Biotechnology
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
Biotechnology
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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