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Biosimilars
Following warnings from the US Food and Drug Administration last year, and again in February, related to its manufacturing practices, South Korean drugmaker Celltrion has now been handed a Complete Response Letter from the agency related to two of its proposed biosimilars. 6 April 2018
Pharmaceutical
Dacomitinib took a step towards becoming a new treatment option in locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) on Wednesday. 5 April 2018
Biotechnology
The Chinese authority is drafting a system for pharmaceutical patent linkage and drug patent term extension, both are expected to be introduced in 2018, said Song Ruilin, executive president of PhIRDA, a state-backed organization that lobbies for Chinese pharma companies, at the China Healthcare Investment Conference (CHIC) held from March 27 to 29 in Shanghai, reports Wang Fangqing, The Pharma Letter’s local correspondent. 4 April 2018
Pharmaceutical
An absence of comprehensive data did not prevent Italian family-owned drugmaker Chiesi Farmaceutici from receiving Marketing Authorization (MA) for Lamzede (velmanase alfa). 4 April 2018
Pharmaceutical
The European Medicines Agency (EMA) has accepted for review two applications from French drugmaker Sanofi, the firm revealed today. 3 April 2018
Pharmaceutical
Shares in Ireland-headquartered firm Alkermes closed 22% down on Monday at $45.23, a market reaction prompted by the US Food and Drug Administration’s (FDA) Refusal to File letter relating to the New Drug Application (NDA) for a proposed depression treatment. 3 April 2018
Biotechnology
The European Commission has approved an expanded indication for Xgeva (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone. 3 April 2018
Pharmaceutical
The European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for Lynparza (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. 3 April 2018
Pharmaceutical
“Due to strict regulations and legislatory monitoring no falsified or unauthorized medication has entered the legal drug supply chain in Hungary until now, stated the Hungarian Association of Innovative Pharmaceutical Manufacturers (AIPM). 3 April 2018
Pharmaceutical
On March 29, the US Food and Drug Administration announced it has approved use of Leukine (sargramostim) to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome, or H-ARS). 30 March 2018
Biotechnology
The US Food and Drug Administration on Friday granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). 30 March 2018
Pharmaceutical
French pharma major Sanofi is a step closer to the European market with its submission for sotagliflozin, an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus. 29 March 2018
Pharmaceutical
With all eyes in the industry focused on Shire amid confirmed interest from Japanese pharma major Takeda in taking over the Ireland-incorporated drugmaker, Friday was a good time for the company to announce progress on a promising asset. 29 March 2018
Biosimilars
Netherlands-incorporated Mylan and Indian development partner Biocon have been granted European approval for their biosimilar insulin glargine product Semglee. 28 March 2018
Pharmaceutical
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee has voted by 11 members to one to recommend approval of lofexidine for the mitigation of opioid withdrawal symptoms. 28 March 2018
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted SAKIGAKE ’fast-track’ designation for Merck KGaA’s tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. 27 March 2018
Biotechnology
Daiichi Sankyo today announced that DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), has received SAKIGAKE designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labor and Welfare (MHLW). 27 March 2018
Biotechnology
With the rolling submission of the New Drug Application (NDA) now complete, there will be more than a few fingers crossed at both US biotech Loxo Oncology and German pharma major Bayer. 26 March 2018
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI). 26 March 2018
Biotechnology
The associations representing the European and British life science industry (AESGP, ABPI, BIA, BGMA, EBE, EFPIA, EUCOPE, EuropaBio, Medicines for Europe, PAGB, Vaccines Europe) on Friday responded to the European Council approving terms of the transition period agreed between the UK government and European Union with respect to the UK’s departure from the EU (Brexit). 26 March 2018
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
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
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