US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
The National Institute for Health and Care Excellence (NICE) has recommended privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals’ Firmagon (degarelix) for a group of men with advanced hormone-dependent prostate cancer – those with spinal metastases. 1 July 2016
US pharma major AbbVie says that the US Food and Drug Administration has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. 1 July 2016
Ampio Pharmaceuticals today announced disappointing results of the Ampion PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the Food and Drug Administration. 30 June 2016
Medicines regulator Health Canada published final regulations in the Canada Gazette, Part II requiring mandatory reporting by industry of drug shortages and discontinuances of sales. Health Canada is on track to implement these regulations, which will be supported by a new third party reporting website, by spring 2017. 30 June 2016
Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets. 30 June 2016
Stronger warnings are needed on drugs that can cause patients to lose control of their behavior, leading to pathological gambling, hypersexuality, and compulsive shopping or eating, Public Citizen said in a petition to the US Food and Drug Administration. 29 June 2016
US pharma company AbbVie said today that the US Food and Drug Administration has granted a fourth Breakthrough Therapy designation (BTD) for Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. 29 June 2016
The US Food and Drug Administration has placed a clinical hold on studies of the Regulus Therapeutics drug RG-101 for the treatment of chronic hepatitis C virus (HCV). 29 June 2016
A US Food and Drug Administration advisory committee yesterday voted 12-11 that substantial evidence exists to establish that Jardiance (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease. 29 June 2016
A group of four pharma industry associations have signed a memorandum of understanding in China to adopt pro-medicine and patient-centered principles, build public consensus on the value of medical representatives and establish a national system to manage them, and promote proper and orderly development of the sector. 29 June 2016
There was good news today for US biotech giant Gilead Sciences, when the US Food and Drug Administration gave its approval for the company’s Epclusa (sofosbuvir/velpatasvir), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. 28 June 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced a decision to fund nivolumab (trade name Opdivo), from US pharma major Bristol-Myers Squibb, for patients with unresectable or metastatic (stage III or IV) melanoma (advanced melanoma) from July 1, 2016. 28 June 2016
The marketing application submitted by Swiss pharma giant Roche or Ocrevus (ocrelizumab) to treat two forms of multiple sclerosis has been accepted for review by both the European and US regulators. 28 June 2016
The European Medicines Agency has granted marketing approval to the mylife YpsoPump for use with the prefilled pump cartridge NovoRapid PumpCart. 28 June 2016
The European Commission has granted marketing authorization for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalization. 28 June 2016
The boss of one of Europe’s leading biotech companies tells The Pharma Letter that it cannot now consider teaming up with UK researchers because of fears that such partnerships will lose European Union (EU) funding. 27 June 2016
USA-based Puma Biotechnology said today that it has submitted its Marketing Authorization Application to the European Medicines Agency for neratinib. 27 June 2016
USA-based Cytori Therapeutics today announced that the use of Cytori Cell Therapy was approved for clinical use on June 24, to treat knee osteoarthritis. 27 June 2016
Swedish Orphan Biovitrum has announced that it has received approval in Switzerland for the use of hemophilia A treatment Elocta (rFVIIIFc), which it is co-developing with US biotech major Biogen. 27 June 2016
While the exit of the UK from the European Union undoubtedly creates significant issues for the UK pharmaceutical and medical device industries in ensuring highly regulated European markets remain open to business, opportunities remain for these sectors to thrive. 27 June 2016
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon. 10 October 2024
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
The UK has launched a new Regulatory Innovation Office (RIO), with the goal of accelerating new technologies, particularly in sectors like biotech and healthcare, by reducing regulatory barriers. 9 October 2024
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024
UK-based ViiV Healthcare, the specialist HIV company majority-owned by GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has announced a milestone in its efforts to achieve widespread international access to its therapies. 7 October 2024
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024