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Biotechnology
Investors in USA-based AVEO Oncology appear to be fearing the worst after the future of the company’s lead candidate was thrown into doubt. 4 April 2019
Biotechnology
The European Medicines Agency has validated the Marketing Authorization Application (MAA) for pexidartinib. 4 April 2019
Biotechnology
The US Food and Drug Administration has approved ASCENIV, formerly referred to as RI-002, from US bio pharma company ADMA Biologics. 3 April 2019
Pharmaceutical
USA-based Evoke Pharma says it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application (NDA) for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. 3 April 2019
Pharmaceutical
Next week will be the turn of insulin manufacturers to testify about US drug prices in the House of Representatives. 3 April 2019
Pharmaceutical
The immediate response of the pharmaceutical industry to the resignation of US Food and Drug Administration Commissioner Dr Scott Gottlieb on March 5, 2019, was one of shock. 3 April 2019
Biosimilars
Novartis’ USA-based generics division Sandoz has resubmitted a US application for a biosimilar version of pegfilgrastim. 3 April 2019
Biotechnology
China’s state council last August announced reform goals, which included speeding up the approval process for imported drugs, and seeking to include more oncology drugs in the national reimbursement drug list. 2 April 2019
Pharmaceutical
More and more global drugmakers operating in Russia are considering suspension sales of at least part of their new range in the local market in the coming years, due to new rules on price regulation that were recently approved by the Russian Ministry of Health and which will take effect in 2020, according to recent statements of producers. 2 April 2019
Biotechnology
The European Commission has granted the Marketing Authorization for Ajovy (fremanezumab) 225mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. 1 April 2019
Biotechnology
The European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for subcutaneous (SC) Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). 1 April 2019
Pharmaceutical
The Hungarian pharmaceutical industry has urged government to make it easier to access subsidies to promote drug development. 1 April 2019
Pharmaceutical
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submission for cefiderocol from Shionogi. 1 April 2019
Biotechnology
UK biotech firm Circassia Pharmaceuticals was trading 19% higher as London trading neared its close on Monday. 1 April 2019
Pharmaceutical
The US Food and Drug Administration has finally given its approval for Mavenclad (cladribine), in the all important American market, for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS). 1 April 2019
Pharmaceutical
Among regulatory decisions last week, there was good news for Novartis, with US Food and Drug Administration approval for its multiple sclerosis drug Mayzent, and for AbbVie, which gained clearance in Japan for Skyrizi, which was seen as a bonus for the company as Humira competition looms, On the research front, Galapagos and Gilead Sciences presented positive new Phase III data on their filgotinib in rheumatoid arthritis. Deal-making was also in focus, notably with AstraZeneca acquiring rights to Daiichi Sankyo’s cancer drug candidate trastuzumab deruxtecan. 31 March 2019
Pharmaceutical
The March 25-28 2019 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was held for the first time in its new post-Brexit offices in Amsterdam, Netherlands, but came back with only recommendations for one new initial marketing authorization and just three extensions of indication. 29 March 2019
Biotechnology
Belgium’s UCB has won an expansion to the label for Cimzia (certolizumab pegol) in the USA, to include certain adults with active non-radiographic axial spondyloarthritis (nr-axSpA). 29 March 2019
Pharmaceutical
The US Food and Drug Administration on Wednesday approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. 28 March 2019
Pharmaceutical
The UK Supreme Court has handed down a unanimous decision in a case between generics firm Actavis and Eli Lilly subsidiary ICOS, finding that discoveries from routine research can be rewarded with a patent. 27 March 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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