Regulation
Refine Search
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
Pharmaceutical
Xolair (omalizumab) came out unfavorably in a comparison with a new competitor in severe eosinophilic asthma in trial results presented on Monday, but news on Tuesday showed the Novartis (NOVN: VX) drug up in a more positive light. 6 March 2018
Biotechnology
The Ireland-headquartered drugmaker Shire was trading 2% higher on Tuesday after announcing that the US Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for prucalopride as a potential once-daily treatment option for chronic idiopathic constipation (CIC) in adults. 6 March 2018
Biosimilars
The European Medicines Agency has accepted the regulatory resubmission of a proposed biosimilar to Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim). 6 March 2018
Pharmaceutical
Russia can tighten a control on foreign medical laboratories and pharmaceutical companies, operating in the domestic market, according to the press-service of the Russian government and sources in the country’s special services. 6 March 2018
Biotechnology
Canada-based ProMetic Life Sciences could be eligible to receive a rare pediatric disease priority review voucher if and when its inter-alpha-inhibitor-proteins (IaIp) replacement therapy is approved in the USA. 5 March 2018
Pharmaceutical
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorization Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). 5 March 2018
Pharmaceutical
Regulatory news was at the forefront of comment in the past week, notably Celgene getting a major setback on its multiple sclerosis drug candidate ozanimod with a refusal-to-file letter from the US Food and Drug Administration, as well as positive news for Sorrento Therapeutics’ with FDA approval for its non-opioid post-shingles pain drug ZTlido. AstraZeneca attracted interest with its spin out of certain inflammatory and autoimmune products into a new company – Viela Bio, as did Mylan, with the announcement of a deal with Revance Therapeutics to develop a Botox biosimilar. 4 March 2018
Pharmaceutical
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for calaspargase pegol (Cal-PEG; SHP663), a newer formulation of asparaginase. 3 March 2018
Pharmaceutical
USA-based Sorrento Therapeutics and its majority-owned subsidiary, Scilex Pharmaceuticals, received approval from the US Food and Drug Administration for ZTlido (lidocaine topical system) 1.8%. 3 March 2018
Pharmaceutical
UK Prime Minister Theresa May’s “Road to Brexit” speech today in London held some supportive statements for the pharmaceutical industry and its future collaboration with European Union regulatory agencies when Britain leaves the EU in March next year. 2 March 2018
Biotechnology
The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. 2 March 2018
Generics
While likely not the US Food and Drug Administration’s intent, the net effect of the agency’s requirements surrounding importation of active pharmaceutical ingredients (API) is driving manufacturing of investigational finished drug products outside the USA, note David Gibbons and Dara Katcher Levy on Hyman, Phelps & McNamara’s FDA Law Blog. 2 March 2018
Pharmaceutical
Investors in Akorn had a wake-up call yesterday, as Germany-based Fresenius raised doubts about its acquisition of Akorn amid a Food and Drug Administration enquiry into alleged allegations of FDA integrity requirements relating to product developments 28 February 2018
Biotechnology
The European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors. 28 February 2018
Pharmaceutical
UK-headquartered Seqirus today announced its intention to commercialize its cell-based quadrivalent flu vaccine (QIVc) in Europe. 28 February 2018
Pharmaceutical
As Rare Disease Day approaches, the US FDA has released a statement outlining steps the agency is taking to promote the development of therapies in this area. 27 February 2018
Pharmaceutical
Eli Lilly has been granted US FDA approval for Verzenio (abemaciclib) in a new indication, expanding the marketable treatments for the therapy to include initial endocrine-based therapy for certain metastatic breast cancer patients, in combination with an aromatase inhibitor (AI). 27 February 2018
Pharmaceutical
With the USA’s flu epidemic apparently subsiding, the FDA’s Commissioner Scott Gottlieb has provided an update on his agency's efforts to improve the effectiveness of influenza vaccines. 27 February 2018
Pharmaceutical
The Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved the registration of Mavenclad (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. 27 February 2018
Pharmaceutical
The New Drug Application (NDA) for lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, has been accepted for filing and has been granted Priority Review by the US Food and Drug Administration. 27 February 2018
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze