The US Food and Drug Administration (FDA) has granted Priority Review designation for the Biologics License Application (BLA) for the COVID-19 vaccine from Pfizer and BioNTech. 19 July 2021
The European Medicines agency announced today that it has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly). 19 July 2021
Imfinzi (durvalumab) has been approved in China for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin). 19 July 2021
The US Food and Drug Administration (FDA) approved Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. 19 July 2021
Licensing agreements featured heavily in last week’s news, starting with US biotech Biogen entering into an agreement that could cost it $1 billion to get rights to a BTK inhibitor – orelabrutinib for multiple sclerosis – from China’s InnoCare Pharma. Denmark’s Novo Nordisk in-licensed rights to Prothena’s ATTR amyloidosis program, and PRX004, in a deal worth up to $1.2 billion. Also, Ionis Pharmaceuticals last Tuesday exercised an option on fellow USA-based Bicycle Therapeutics’ oligonucleotide targeting the transferrin receptor 1. On the M&A front, Eli Lilly revealed on Wednesday it was acquiring privately-held US company Protomer Technologies for what could be a $1 billion transaction, getting rights to its glucose-sensing insulin project. Additionally, the US Food and Drug Administration took issue with Amgen’s promotion of its cancer drug Neulasta, which the agency said could undermine confidence in biosimilars. 18 July 2021
Shares of USA-based Kadmon Holdings shot up more than 20% to $4.28 on Friday, after the company revealed its pharma unit had received its first regulatory approval, for Rezurock (belumosudil). 17 July 2021
The US Food and Drug Administration on Friday approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. 17 July 2021
The European Medicines Agency has validated and accepted the marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs), submitted by China’s Hutchmed. 16 July 2021
USA-based FibroGen's shares have dropped by more than a third after a scientific panel of the US Food and Drug Administration voted against approval of roxadustat. 16 July 2021
Looking to overturn a regulatory rebuff, New Jersey, USA’s Merck & Co has announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase III study KEYNOTE-522. 16 July 2021
Following investigations from the UK’s Competition and Markets Authority (CMA), a fine of around £260 million ($360 million) has been imposed on several pharmaceutical firms, due to competition law breaches. 15 July 2021
The Food and Drug Administration (FDA) has issued an untitled letter to US biotech giant Amgen for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. 15 July 2021
The US Food and Drug Administration has lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the USA, Poland largest biotech Ryvu Therapeutics (WSE: RVU) announced today. 14 July 2021
The US Food and Drug Administration (FDA) has announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson COVID-19 jab. 14 July 2021
British pharma major and coronavirus vaccine developer AstraZeneca has cleared the final regulatory hurdle in its acquisition of Alexion Pharmaceuticals. 14 July 2021
The Russian government is considering allowing foreign vaccines against COVID-19 to enter the domestic market, according to recent statements by some senior state officials and some local media reports, reports The Pharma Letter’s local correspondent. 13 July 2021
The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. 13 July 2021
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ASP3772 for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in ASP3772 in adults aged 50 years and older. 13 July 2021
French vaccines developer Valneva has been awarded Breakthrough Therapy designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA). 12 July 2021
The US Food and Drug Administration has approved under priority review Kerendia (finerenone), the first and only non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), German pharma major Bayer announced late Friday. 12 July 2021
Important regulatory news last week included French pharma major Sanofi gaining approval from the US Food and Drug Administration (FDA) and the Chinese medicines authority for its blockbuster drug Dupixent as the first biologic for chronic obstructive pulmonary disease (COPD). Spanish epigenetics firm Oryzon Genomics announced that, with FDA feedback, it is preparing for a Phase III trial of its CNS drug candidate vafidemstat. Also, the FDA authorized Bristol Myers Squibb’s blockbuster drug Opdivo in a new lung cancer indication for patients with specific mutations such as EGFR or ALK. On the deal-making front, US biotech Arcus Biosciences has entered a collaboration with AstraZeneca to evaluate its casdatifan with the UK pharma major’s volrustomig in renal cell cancer. 6 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 3 October 2024
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
As stakeholders in the pharmaceutical industry, we all have a responsibility to ensure life-saving treatments promptly and safely reach patients regardless of where they live. To this end, by integrating early access programs and other less conventional strategies into a company’s business model for drug distribution, patients who are suffering from life-threatening conditions can gain access to needed treatments in regions where there is a lack of drug accessibility, while at the same time offering benefits to pharmaceutical companies. 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
Following a positive a positive European Medicines Agency recommendation in July, the European Commission (EC) has now approved Yuvanci (macitentan 10mg and tadalafil 40mg single tablet combination therapy [M/T STCT]). 1 October 2024
Johnson & Johnson has halted its plan to implement a 340B rebate model after pressure from the Health Resources and Services Administration (HRSA). 1 October 2024
The Danish government is to remove the rules that currently prohibit the purchase of medicines from countries outside the European Union (EU) in a move that has not been welcomed by pharma. 30 September 2024
The National Medical Products Administration (NMPA), China's top drug regulator, says it will redouble efforts to facilitate research and market registration of homegrown innovative drugs, while speeding up the introduction of novel foreign drugs to the domestic market to meet public demand. 30 September 2024
The US Food and Drug Administration (FDA) granted traditional approval for US pharma major Eli Lilly’s Retevmo (selpercatinib) for adult and pediatric patients two years and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation. 30 September 2024
Significant regulatory news last week included the US Food and Drug Administration (FDA) granting approval for Zevra Therapeutics’ Miplyffa, making it the first treatment for Niemann-Pick disease type C, although this was quickly followed by an FDA nod for Aqneursa, developed by privately-held rare disease specialist IntraBio, for the same condition. Additionally, Bristol Myers Squibb last week announced that the FDA has approved its schizophrenia treatment Cobenfy, previously called KarXT. On the research front, US drug developer IDEAYA Biosciences released new Phase II data on its investigational uveal melanoma drug darovasertib. And US biotech Wave Life Sciences announced positive Phase II data on its Duchenne muscular dystrophy candidate WVE-N531. Also of note, due to safety concerns, US pharma giant Pfizer announced it is withdrawing its sickle cell disease drug Oxbryta from the market. 29 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024