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Even as Indian drug firms continue to reel under plans by the Trump administration in the USA to repeal and replace some parts of The Patient Protection and Affordable Care Act, popularly known as Obamacare, four prominent US lawmakers have outlined a number of concerns, including inadequate intellectual property rights protection, reports The Pharma Letter’s India correspondent. 26 June 2017
Pharmaceutical
The Italian government has passed a law making childhood vaccinations against 12 diseases mandatory. 26 June 2017
Pharmaceutical
The Australian Therapeutic Goods Administration, following the example of US and European regulators, is implementing its own priority review system for novel drugs. 26 June 2017
Pharmaceutical
Japanese pharma major Eisai has applied to the Japanese regulator to broaden the label for its anticancer agent Lenvima for the treatment of hepatocellular carcinoma. 26 June 2017
Pharmaceutical
As talks begin in earnest on the UK’s departure from the European Union, the trade group European Federation of Pharmaceutical Industries and Associations (EFPIA) expresses its concern that the Heads of State on Thursday decided to postpone a resolution on the relocation of the European Medicines Agency until November this year. 26 June 2017
Pharmaceutical
The big news last week came from the USA, when the Senate eventually released Republican proposals for the reform of the Affordable Care Act, or Obamacare, with what is now dubbed the Better Care Reconciliation Act, which has further increased debate on the issue. Also in the news were Portola Pharmaceuticals with its new anticoagulant Bevyxxa (betrixaban), bluebird bio’s LentiGlobin, Aveo Oncology’s Fotivda, Seattle Genetics’ vadastuximab and Clovis’ Rubraca. 25 June 2017
Biotechnology
The US Food and Drug Administration on Friday approved Bevyxxa (betrixaban), sending the shares of the drug’s developer, Portola Pharmaceuticals (Nasdaq: PTLA), rocketing 46.56% to $56.06. 25 June 2017
Pharmaceutical
Anyone unfamiliar with pharma might be puzzled by how often the word ‘innovation’ comes up in dialogue, campaigning and marketing messages. 24 June 2017
Pharmaceutical
Astellas Pharma’s suspension as a member of the Association of the British Pharmaceutical Industry (ABPI) is to be extended for a further 12 months with effect from June 24, 2017 in connection with a number of serious breaches of the ABPI Code. 24 June 2017
Generics
Active ingredients supplier Yamamoto Chemical Industry has been blocked from shipping its products after an inspection revealed the Japanese supplier had been mixing in cheap Chinese paracetamol without clearance from regulators. 23 June 2017
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines, a biosimilar and two generics for approval at its June meeting. 23 June 2017
Pharmaceutical
The US Food and Drug Administration has granted drugmaker Novartis approval to market Tafinlar and Mekinist as a combination therapy for patients with metastatic non-small cell lung cancer with BRAF V600E mutation. 23 June 2017
Biotechnology
Haegarda, a therapy for hereditary angioedema (HAE) from biotech firm CSL Behring, has been approved by the US Food and Drug Administration. 23 June 2017
Pharmaceutical
Shares in Danish CNS specialist Lundbeck have fallen 4% on the news that the company, together with development partner Takeda Pharmaceutical, has not succeeded in adding new data to the label for depression therapy Trintellix. 23 June 2017
Biotechnology
The US Food and Drug Administration yesterday approved Rituxan Hycela, the combination of Genentech’s Rituxan (rituximab) and Halozyme’s hyaluronidase human Enhanze technology for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. 23 June 2017
Biotechnology
The UK's medicines regulator has given a positive scientific opinion to Santhera Pharmaceuticals’ therapy Raxone, through the country’s Early Access to Medicines Scheme (EAMS). 22 June 2017
Biotechnology
The European Medicines Agency has agreed to review London-listed Shire's application for approval to market Veyvondi as a treatment for von Willebrand Disease (VWD), the most common inherited bleeding disorder. 22 June 2017
Pharmaceutical
Anthem is pulling out of health insurance exchanges in Wisconsin and Indiana, a decision cheered by Republicans as another harbinger of doom for Obamacare. 22 June 2017
Generics
Citing the saving of $1.67 trillion that competition from generics has brought to the US health care system in the last decade, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has voiced his support for more of these copycat drugs to reach market sooner. 21 June 2017
Pharmaceutical
Shares in Ireland-headquartered Shire are up more than 2% in London, on news that the rare disease specialist has finally received US Food and Drug Administration approval for its long-acting attention deficit hyperactivity disorder (ADHD) therapy. 21 June 2017
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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