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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
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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
Pharmaceutical
The UK’s medicines regulator has given an update on what drugmakers can expect when it comes to registration of clinical trials, in the event of a "no-deal" Brexit. 21 March 2019
Biotechnology
Danish diabetes giant Novo Nordisk has filed for US approval for oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) analogue in a tablet. 20 March 2019
Pharmaceutical
The US Food and Drug Administration yesterday approved Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD). 20 March 2019
Pharmaceutical
The US Food and Drug Administration has announced new final guidance on HIV prevention, following US President Donald Trump’s recently-announced effort to eliminate the HIV epidemic within America. 20 March 2019
Biotechnology
Just a week after a Tecentriq (atezolizumab) combination was the first cancer immunotherapy regimen to be approved for breast cancer in the USA, the Roche drug has achieved another milestone. 19 March 2019
Pharmaceutical
The US Food and Drug Administration has approved Japanese drug major Takeda Pharmaceutical’s (TYO: 4502) second submission for its new plasma manufacturing facility near Covington, Georgia for the production of Flexbumin L25% [albumin (human)], USP, 25% Solution 19 March 2019
Pharmaceutical
Biohaven Pharmaceutical says it has purchased a US Food and Drug Administration priority review voucher (PRV) to use with the New Drug Application (NDA) submission of its migraine treatment candidate rimegepant Zydis ODT in the second quarter of 2019. 19 March 2019
Pharmaceutical
Research funded by the US Food and Drug Administration suggests that people who view drug adverts are more likely to respond to a claim about a product’s popularity than its efficacy. 18 March 2019
Pharmaceutical
Privately-held German firm Boehringer Ingelheim has filed to broaden the label for Ofev (nintedanib), to include patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), also known as scleroderma. 18 March 2019
Biotechnology
Roche majority-owned Chugai has filed a new drug application (NDA) to Japan’s Ministry of Health, Labor and Welfare for entrectinib for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC). 18 March 2019
Biotechnology
Shares of Spectrum Pharmaceuticals dropped 8% in pre-market trading on Friday, after it revealed a further disappointment in the development of its lead product candidate Rolontis (eflapegrastim). 18 March 2019
Biotechnology
The European Commission (EC) has approved a new indication for Praluent (alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors. 18 March 2019
Pharmaceutical
On the research front last week, there was positive clinical trial news for Takeda regarding its Entyvio in ulcerative colitis. Regulatory news of note included Roche winning US Food and Drug Administration approval for its Tecentriq as the first immuno-oncology treatment for breast cancer, and an FDA delay for multiple myeloma drug selinexor which, unusually, was viewed as good news for developer Karyopharm Therapeutics. Elsewhere, the CARB-X incubator got a boost with the German government joining up and providing funding for the development of antibacterials. 17 March 2019
Pharmaceutical
US drugmaker Karyopharm Therapeutics saw its shares soar nearly 30% in pre-market trading on Friday, despite revealing that the US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. 16 March 2019
Pharmaceutical
The European Medicines agency has started a review of medicines containing fluorouracil (also known as 5-fluorouracil or 5-FU) and the related medicines capecitabine, tegafur and flucytosine, which are converted to fluorouracil in the body. The review will examine existing screening methods and their value in identifying patients at increased risk of severe side effects. 15 March 2019
Pharmaceutical
A new procedure for the suspension of the use and sales of drugs in the Russian market has been developed by the Russian Ministry of Health, which used the existing federal law “On the Circulation of Medicinal Products in Russia” during its design, according to an official spokesman of the Ministry, reports The Pharma Letter’s local correspondent. 15 March 2019
Pharmaceutical
The outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has called on other players in the drug development ecosystem to play their part in the modernization of clinical trials. 15 March 2019
Biotechnology
The European Medicines Agency has granted approval for Roche to market MabThera (rituximab) against a rare condition, pemphigus vulgaris (PV). 15 March 2019
Biotechnology
New Jersey, USA-based Merck & Co has picked up another approval in Europe for Keytruda (pembrolizumab), in combination with chemo, for the first-line treatment of squamous non-small cell lung cancer (NSCLC). 14 March 2019
Biotechnology
In combination with chemotherapy, Tecentriq (atezolizumab) can now be used by UK patients with unresectable locally advanced or metastatic triple negative breast cancer whose tumours have PD-L1 expression of at least 1%. 14 March 2019
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