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US FDA to consider Dizal’s first-in-class lung cancer drug

Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024

Health Canada approval for Moderna’s RSV vaccine

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

J&J files with EMA and FDA for Darzalex in high-risk smouldering MM

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

FDA Rare Pediatric Disease status for AskBio’s AB-1003

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

Acadia Pharma sells priority review voucher for $150 million

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

GSK’s Arexvy receives expanded approval in Canada

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

Another Dupixent approval in the EU

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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FDA approves REMS, advancing new drug disposal option for opioid analgesics

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

EU sets date for decision on proposed $16.5 billion Catalent buy

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

Photocure’s Hexvix wins Chinese approval

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

FDA accepts Ionis NDA for donidalorsen

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

Disc Medicine leaps as it gets positive FDA feedback

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

FDA sets up Rare Diseases Innovation Hub

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

FDA Rare Pediatric Disease designation for BPGbio

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

The week in pharma: action, reaction and insight – week to November 1

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

FDA panel vote leaves Lexicon’s Zynquista hopes hanging by a thread

Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024

Remove barriers for EU firms trading in other markets, group says

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

Sugemalimab approved to treat adult patients with NSCLC in UK

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

Novartis’ Scemblix gains FDA approval in newly diagnosed CML

Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024

FDA approves Protega’s Roxybond

Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024

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Novel ALS treatment is cleared for further testing in USA

The US regulator has lifted a partial clinical hold affecting research undertaken by New York-based firm ProJenX. 2 April 2024

Additional BLA under review in USA for datopotamab deruxtecan

An additional Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the US Food and Drug Administration. 2 April 2024

Concerns at proposed Danish medicines supply bill

Danish pharma trade group Lif has expressed concerns over a new bill that will make it mandatory for companies to set up safety stocks of critical medicines. 2 April 2024

More work needed on new data governance law, says EFPIA

With new legislation on data protection in the offing, The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on negotiators to take more time to make sure the law is drafted optimally. 2 April 2024

Voydeya approved in the USA for PNH

Marking a second regulatory authorization, Voydeya (danicopan) has now been approved in the USA as add-on therapy for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). 2 April 2024

Biocon first to gain approval for generic of diabetes drug, liraglutide, in UK

India’s Biocon says that it has received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its complex formulation liraglutide (6mg/ml solution for injection in pre-filled pen). 2 April 2024

Guidance needed to ensure EU’s JCA improves access to innovative cancer treatments

Joint Clinical Assessments (JCA) can support getting new innovative cancer medicines to patients faster, if the right balance in evidence generation and assessment to facilitate national decisions on access for these innovations can be found. 2 April 2024

The week in pharma: action, reaction and insight – week to March 29, 2024

M&A news continued last week, with US pharma major AbbVie announcing it was buying Landos Biopharma and its inflammatory diseases candidate NX-13, for up to $212,5 million. On the regulatory front, UK pharm major AstraZeneca scored a US Food and Drug Administration (FDA) approval for a new indication for Ultomiris. Merck & Co won an important FDA approval for its pulmonary arterial hypertension (PAH) candidate Winrevair (sotatercept). 89bio received PRIME designation from the European Medicines Agency (EMA) for its liver disease candidate pegozafermin. Also, Applied Therapeutics announced that the FDA had requested additional time to review the rare disease drug developer’s application for govorestat for the treatment of classic galactosemia. 31 March 2024

FDA delays approval of Applied Therapeutics’ govorestat

The US Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) as a treatment of classic galactosemia by three months. 29 March 2024

Akebia receives FDA approval of Vafseo

The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. 28 March 2024

Takeda granted approval of Adzynma in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Adzynma (apadamtase alfa/cinaxadamtase alfa; code name TAK-755) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older. 28 March 2024

High-stakes bid to ban abortion pill appears unlikely to succeed

An attempt from the conservative Alliance for Hippocratic Medicine to ban mifepristone, a medicine used to induce an abortion, threatens to undermine confidence in the American regulatory regime. 27 March 2024

EMA grants PRIME status for 89bio’s pegozafermin

California, USA-based clinical-stage biopharmaceutical company 89bio saw its shares gain more than 2% to $11.44 today, after it announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with metabolic-associated steatohepatitis (MASH). 27 March 2024

Merck’s PAH drug Winrevair gains FDA approval

In what is seen as an important win for Merck & Co, the US pharma giant late yesterday announced that the US Food and Drug Administration (FDA) has approved sotatercept-csrk injection (which will be marketed in the USA as Winrevair). 27 March 2024

Teva and Daiichi Sankyo named and shamed for UK code breaches

Israel’s Teva Pharmaceutical Industries and Japanese drugmaker Daiichi Sankyo have been called out for breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. 27 March 2024

Study success stokes interest in breakthrough Dravet candidate

Building on positive Phase I/IIa data for its Dravet syndrome candidate, Stoke Therapeutics now hopes to jump towards pivotal research. 27 March 2024

Samsung Bioepis’ Epysqli gains expanded EC approval

The European Commission (EC) has approved an expanded indication for South Korean drugmaker Samsung Bioepis’ Epysqli. 27 March 2024

Long-acting jab may maintain Abilify sales through patent expiry

Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical have secured European approval for a new formulation of Abilify Maintena (aripiprazole). 27 March 2024

Two Japanese approvals for AstraZeneca

UK pharma major AstraZeneca’s shares edged up 1% to 10,550 pence in early trading, as the company announced receipt of two approvals from the Japanese medicines regulator. 27 March 2024

EMA recommendations for 2024/2025 seasonal flu vaccine composition

The European Medicines Agency (EMA) has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. 27 March 2024

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