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Biotechnology
USA-based Bellicum Pharmaceuticals has received orphan drug designations from the European Commission for both its lead T-cell therapy product candidate BPX-501 for hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid for the treatment of Graft versus Host Disease (GvHD). 5 August 2016
Generics
Indian generics firm Natco Pharma says it has received final approval of its Abbreviated New Drug Application filed with the US Food and Drug Administration for oseltamivir phosphate oral capsules. 5 August 2016
Biotechnology
In draft guidance published today, the National Institute for Health and Care Excellence (NICE), the drug cost-effectiveness watchdog for England and Wales, has recommended innovative new drug Cosentyx (secukinumab) from Swiss pharma giant Novartis for treating ankylosing spondylitis. 4 August 2016
Pharmaceutical
A European pilot project which aims to give faster access to promising medicines in areas of unmet medical need has been hailed a success by the European Medicines Agency (EMA). 4 August 2016
Pharmaceutical
Patents are granted to stimulate creativity and innovation among competing drug manufacturers. They are not easy to come by and so innovators who target new areas of health are rewarded with enough time to recoup the typically high costs incurred during the research and development phase, writes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 3 August 2016
Biotechnology
US rare and orphan disease focussed biotech firm Amicus Therapeutics plans to submit a Japanese New Drug Application (J-NDA) to request marketing authorization for migalastat, an oral precision medicine for Fabry disease, in the first half of 2017. 3 August 2016
Biotechnology
The drug cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE), has published draft guidance recommending apremilast, a drug marketed by US biotech firm Celgene as Otezla, for psoriasis patients. 3 August 2016
Pharmaceutical
Swiss pharma giant Novartis has received US Food and Drug Administration Breakthrough Therapy designation for LEE011 (ribociclib), in combination with letrozole, for hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. 3 August 2016
Pharmaceutical
The European Commission has approved US pharma giant Merck & Co’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. 3 August 2016
Pharmaceutical
The High Court in Britain has overturned a decision by NHS England to remove Pre-Exposure Prophylaxix (PrEP) for HIV from its commissioning process. 2 August 2016
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested parties to provide feedback on Clinical Trial Regulation guidance documents. 2 August 2016
Pharmaceutical
The European Medicines Agency has launched a public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB). 2 August 2016
Biotechnology
The European Medicines Agency has accepted for review the Marketing Authorization Application for sarilumab, an investigational human monoclonal antibody directed against the interleukin (IL)-6 receptor that is intended for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA). 1 August 2016
Pharmaceutical
The US Food and Drug Administration has approved French drugmaker Ipsen’s Dysport (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older. 1 August 2016
Pharmaceutical
Drugs that currently exist to treat Alzheimer’s only relieve symptoms temporarily and they don’t work in all patients. Among the 244 Alzheimer’s drugs tested in clinical trials between 2002 and 2012, memantine from Eli Lilly, succeeded. However, last week a little known UK company – TauRx – came up with mixed results on its candidate that could nevertheless provide hope for some Alzheimer’s patients. 31 July 2016
Pharmaceutical
The European Commission has approved US pharma giant Merck & Co’s Zepatier (elbasvir/grazoprevir). 30 July 2016
Pharmaceutical
The US Food and Drug Administration approved Qbrelis (lisinopril) oral solution from Silvergate Pharmaceuticals, the first and only FDA-approved lisinopril oral solution. 30 July 2016
Pharmaceutical
Medicines regulator Health Canada is taking new action to improve the safe use of two prescription opioid drugs, codeine and hydrocodone, to help further address the rare but potentially life-threatening risk of breathing problems in children and adolescents. 29 July 2016
Pharmaceutical
The UK’s revamped Cancer Drugs Fund (CDF) which comes into force today (July 29) will not work for many modern cancer medicines and could leave patients without access to life saving treatment, according to the world’s largest pharmaceutical company. 28 July 2016
Pharmaceutical
The US Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. 28 July 2016
Biotechnology
RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024
Biotechnology
On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024
Pharmaceutical
Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
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