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Pharmaceutical
US President Donald Trump is reviving a stalled effort to compel drugmakers to list drug prices in direct to consumer (DTC) advertising, after a court struck down the initiative. 22 August 2019
Pharmaceutical
US ophthalmology specialist Clearside Biomedical was 44% down after an hour’s trading on Thursday. 22 August 2019
Pharmaceutical
FibroGen’s Beijing-based subsidiary has won Chinese approval for roxadustat, as a treatment for amemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients. 22 August 2019
Biotechnology
The latest approval for Darzalex (daratumumab), a multiple myeloma drug from Danish biotech Genmab and its big pharma partner Janssen, has come in Japan in the frontline setting. 22 August 2019
Pharmaceutical
Global HIV specialist ViiV Healthcare has announced positive topline data from the Phase III ATLAS-2M study. 22 August 2019
Biotechnology
The US Food and Drug Administration has accepted the New Drug Application (NDA) for zanubrutinib for priority review for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 22 August 2019
Biotechnology
Eiger BioPharmaceuticals says that the US Food and Drug Administration has granted Breakthrough Therapy designation for peginterferon lambda (Lambda) for the treatment of hepatitis delta virus (HDV) infection. 22 August 2019
Pharmaceutical
GlaxoSmithKline has made its first marketing authorization application for its daprodustat with the Japanese regulator the Ministry of Health, Labor and Welfare, seeking approval of oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anemia due to chronic kidney disease (CKD). 21 August 2019
Biotechnology
The US Food and Drug Administration (FDA) has accepted Vertex Pharmaceuticals’ New Drug Application (NDA) for a triple therapy combination in cystic fibrosis (CF), and granted priority review to the submission. 20 August 2019
Biotechnology
The US Food and Drug Administration has seen enough from PharmaMar to accept a filing for an accelerated approval for lurbinectedin monotherapy as a treatment second-line small cell lung cancer. 20 August 2019
Pharmaceutical
The US Food and Drug Administration on Monday approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia, in both oral and intravenous formulations. 20 August 2019
Biotechnology
Sarepta Therapeutics revealed that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the New Drug Application (NDA) for Vyondys 53 (golodirsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. 20 August 2019
Biotechnology
The inclusion and wording of a black box warning for thrombosis and embolism risk in the label for upadacitinib are now likely to be applied across all JAK inhibitors used for autoimmune diseases, according to SVB Leerink Research analyst Pasha Sarraf, referring to last Friday’s approval of AbbVie’s Rinvoq (upadacitinib) by the US Food and Drug Administration. 20 August 2019
Pharmaceutical
Shares in Vanda Pharmaceuticals dropped in pre-market trading on Monday after the US company’s development of a jet lag disorder (JLD) drug suffered a major blow. 19 August 2019
Pharmaceutical
Relations between the US and European governments are generally not at their healthiest at present, but the way that their medicines regulators are spurring each other into improving standards provides a more encouraging picture. 19 August 2019
Pharmaceutical
Shares of Indian drugmaker Glenmark Pharmaceuticals were up 2.3% at 369.50 rupees by close of trading, after it revealed that it has received regulatory approval to market a combination of its novel, patent protected and globally-researched sodium glucose co-transporter-2 (SGLT2) inhibitor remogliflozin etabonate and metformin film coated tablets in India. 19 August 2019
Pharmaceutical
M&A news last week featured Jazz Pharmaceuticals buying US biotech firm Cavion along with its CX-8998, a neurological drug being developed as a treatment for essential tremor. Research news included Deciphera presenting positive results for ripretinib in gastrointestinal stromal tumors and AstraZeneca’s release of new data on Lynparza in the ovarian cancer setting. There were also a bunch of US Food and Drug Administration approvals, including Roche gaining clearance of its Rozlytrek for NSCLC in both adults and adolescents. Also, the agency approved AbbVie’s Rinvoq for rheumatoid arthritis. 18 August 2019
Biotechnology
Discovered and developed by AbbVie Rinvoq (upadacitinib) marks the second US Food and Drug Administration approval of a targeted immunomodulator (TIM) therapy for the company this year. 17 August 2019
Biotechnology
Celgene Corp today announced the US Food and Drug Administration has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. 16 August 2019
Biotechnology
The US Food and Drug Administration has granted accelerated approval for Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). 16 August 2019
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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