While the signing of the Food and Drug Administration Reauthorization Act of 2017 (FDARA) was not the the action of US President Donald Trump that garnered most headlines last week, it has undoubted importance for the drug development industry. 22 August 2017
A total of 32 biosimilar products, based on 12 biologics, have been approved for use in the European Union. This compares with just ten in the USA, referencing nine biologics. 22 August 2017
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine Designation to OTL-101 for the treatment of adenosine deaminase severe combined immunodeficiency, commonly known as ADA-SCID, or ‘bubble baby’ disease. 22 August 2017
US Food and Drug Administration Commissioner Scott Gottlieb says there’s perhaps no more important mandate that the FDA has than safeguarding the health and safety of children. 22 August 2017
The European Commission today approved the extension of the indication for USA-based Alexion Pharmaceuticals’ Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. 21 August 2017
Eliciting considerable comment last week was news of UK pharma major GlaxoSmithKline pulling out of its deal with Ionis Pharmaceuticals on inotersen; Mylan reaching a settlement with the US Justice Department over classification of its EpiPen; another setback for Ophthotech’s eye drug Fovista; expanded indications for AstraZeneca and Merck & Co’s cancer drug Lynparza; and US approval for Pfizer’s leukemia treatment Besponsa. 20 August 2017
Nigeria’s Minister of Health, Isaac Adewole, has said the federal government is determined to stop the sale of drugs in open markets in the country at the end of 2018. 19 August 2017
The US Food and Drug Administration has issued a statement requesting input on a possible change to the rules governing the way statements about drug safety are presented in pharmaceuticals advertising. 18 August 2017
Japanese drugmaker Ono Pharmaceuticals has been granted approval from the Taiwan Food and Drug Administration to market Opdivo in a fourth indication, head and neck cancer. 18 August 2017
Hours after US pharma giant Pfizer announced the news of regulatory approval for its drug Besponsa (inotuzumab ozogamicin) in the USA, the company suffered a setback with its attempts to sell the drug in the UK. 18 August 2017
In timely fashion, US pharma giant Pfizer has received US Food and Drug Administration (FDA) approval for Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 18 August 2017
US biotech Amicus Therapeutics says the Australian Therapeutic Goods Administration (TGA) has approved its Galafold (migalastat) for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. 18 August 2017
On the morning of August 16,2017, Wu Zhen, vice minister of the China Food and Drug Administration (CFDA), met with visiting Dr Ian Hudson, the chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and his delegation. 18 August 2017
The genomics-based drug discovery company Exelixis has submitted for regulatory approval to market Cabometyx in a new indication in the USA. 17 August 2017
Canada’s Valeant Pharmaceuticals International says the US Food and Drug Administration confirmed it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Tampa, Florida, as part of a forthcoming Establishment Inspection Record for the facility. 17 August 2017
A new coagulation reversal agen, Praxbind (idarucizumab) from German family-owned pharmaceutical company Boehringer Ingelheim, is now being used in Brazil, following marketing clearance earlier this year. 17 August 2017
Biocon, an Indian drugmaker that together with Netherlands-headquartered Mylan is a frontrunner in the race to take big-selling biosimilars to major markets, has suffered a damaging blow affecting two of its oncology submissions in Europe. 16 August 2017
Privately-held USA-headquartered generics manufacturer Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate, USP 2mg/mL, to the consumer level due to a defect in the dropper markings, the US Food and Drug Administration announced today. 16 August 2017
The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) have published an updated Code of Practice for drugmakers. 23 September 2024
Shares of California, USA-based precision medicines IDEAYA Biosciences were down 6.3% at $32.5 mid-morning after it revealed what is described as “positive” developments for its darovasertib. 23 September 2024
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Hetronifly (serplulimab). 23 September 2024
The US Food and Drug Administration (FDA) has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). 23 September 2024
Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize Zerviate (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. 23 September 2024
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM). 23 September 2024
The European Commission has conditionally approved the marketing application submitted by Ipsen for Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) 21 September 2024
On Friday, the US Food and Drug Administration approved UK pharma major AstraZeneca’s (LSE: AZN) FluMist for self- or caregiver-administration by a parent/caregiver to individuals 2-17 years of age. 21 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Applied Therapeutics saw its stock price climb by over two-thirds after an encouraging update on the US Food and Drug Administration review of govorestat. 19 September 2024
Pharma giant Merck & Co has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). 18 September 2024
AstraZeneca’s Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today. 18 September 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice” 18 September 2024