Pharma & Biotech Pricing, Policy & Regulation
Biotechnology
A panel of experts convened by the US regulator has given a cautious nod to Johnson & Johnson’s Darzalex Faspro (daratumumab/hyaluronidase-fihj) for some multiple myeloma patients. 21 May 2025
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Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
Pharmaceutical
Health and Human Services Secretary Robert F Kennedy Jr has said he may prohibit researchers at government institutions from submitting their work to major medical journals, raising fresh tensions between the federal agency and the broader scientific community. 29 May 2025
Biotechnology
US biotech Moderna has reported encouraging early-stage results from a trial of its experimental vaccine for avian influenza, just as a significant federal funding agreement was unexpectedly withdrawn. 29 May 2025
Biotechnology
Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025
Biotechnology
In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025
Biotechnology
US late-stage biotech Rocket Pharmaceuticals saw its shares plummet as much as 64% to $2.25 in pre-market activity today, after it announced an update related to a trial of RP-A501, its investigational gene therapy for Danon disease, which resulted in a patient death. 27 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
Japanese drugmaker Eisai today announced that the in-house-discovered and developed orexin receptor antagonist Dayvigo (lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. 27 May 2025
Biotechnology
Japanese drugmaker Otsuka Pharmaceutical today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). 26 May 2025
Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22 to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the USA beginning in the fall of 2025. 26 May 2025
Pharmaceutical
There is good news with the new cancer plan, which focuses on prevention and life with and after cancer. There is reason to be happy that the possibility of individual access to treatment is improving, and that health data must be used more actively to ensure rapid access to treatment for Danish patients, believes the Danish pharma trade group Lif. 26 May 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna announced on Saturday, amidst emerging coronavirus variants. 31 May 2025
Biotechnology
Canadian clinical-stage biotech Zymeworks today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). 30 May 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
A typical advertisement for a prescription drug airs on television. The visuals are lively and upbeat; the people are smiling and confident. But the viewer walks away with no clear understanding of what the drug treats. Within moments, the ad is forgotten. 30 May 2025
Pharmaceutical
Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, calling for more practical detail in a key international framework on good clinical practice. 30 May 2025
Pharmaceutical
Swiss eye care specialist Alcon yesterday revealed the US Food and Drug Administration (FDA) has approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512.The new pushed the firm’s shares up 2.5% to 72.32 francs this morning. 30 May 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has identified a potential path forward for elamipretide for the treatment of Barth syndrome, Stealth BioTherapeutics revealed today. 29 May 2025
Biotechnology
The European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). 29 May 2025
Biotechnology
Japan’s Daiichi Sankyo and partner Merck & Co today revealed that the Biologics License Application (BLA) seeking accelerated approval in the USA for patritumab deruxtecan (HER3-DXd) has been withdrawn. 29 May 2025
Pharmaceutical
Health and Human Services Secretary Robert F Kennedy Jr has said he may prohibit researchers at government institutions from submitting their work to major medical journals, raising fresh tensions between the federal agency and the broader scientific community. 29 May 2025
Biotechnology
US biotech Moderna has reported encouraging early-stage results from a trial of its experimental vaccine for avian influenza, just as a significant federal funding agreement was unexpectedly withdrawn. 29 May 2025
Biotechnology
Texas, USA-based clinical-stage biopharma Savara on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94. 28 May 2025
Biotechnology
In a policy shift that breaks with the previous administration's broad vaccination campaign, US health authorities have removed the COVID-19 vaccine from the routine immunization schedule for healthy children and healthy pregnant women. 28 May 2025
Biotechnology
US late-stage biotech Rocket Pharmaceuticals saw its shares plummet as much as 64% to $2.25 in pre-market activity today, after it announced an update related to a trial of RP-A501, its investigational gene therapy for Danon disease, which resulted in a patient death. 27 May 2025
Biosimilars
Indian biosimilars developer Biocon Biologics, a subsidiary of Biocon Ltd , today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Yesintek, a biosimilar of ustekinumab, which is marketed under the trade name Stelara by us healthcare giant Johnson & Johnson (NYSE: JNJ) . 27 May 2025
Pharmaceutical
Japanese drugmaker Eisai today announced that the in-house-discovered and developed orexin receptor antagonist Dayvigo (lemborexant) has been approved in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Eisai plans to launch this medicine in China in the second quarter of fiscal year 2025. 27 May 2025
Biotechnology
Japanese drugmaker Otsuka Pharmaceutical today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with immunoglobulin A nephropathy (IgAN). 26 May 2025
Biosimilars
The Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. 26 May 2025
Biotechnology
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on May 22 to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the USA beginning in the fall of 2025. 26 May 2025
Pharmaceutical
There is good news with the new cancer plan, which focuses on prevention and life with and after cancer. There is reason to be happy that the possibility of individual access to treatment is improving, and that health data must be used more actively to ensure rapid access to treatment for Danish patients, believes the Danish pharma trade group Lif. 26 May 2025
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