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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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FDA accepts Keytruda/Padcev sBLA for priority review

The US Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Merck& Co’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). 1 December 2023

Karuna's schizophrenia drug NDA accepted by FDA

Boston, USA-based biopharma Karuna Therapeutics has announced the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) to treat schizophrenia in adults. 30 November 2023

Daiichi Sankyo's COVID-19 booster vaccine approved in Japan

Tokyo-based Daiichi Sankyo (TYO: 4568) has announced that its booster vaccine Daichirona for Intramuscular Injection (DS-5670) has been approved as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19. 29 November 2023

FDA investigating risk of malignancy linked with CAR-T cell therapies

The US Food and Drug Administration (FDA) yesterday said it has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous chimeric antigen receptor (CAR)-T cell immunotherapies. 29 November 2023

Novavax's updated COVID-19 jab granted EUL by WHO

US biopharma Novavax has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for its updated COVID-19 jab for active immunization to prevent COVID-19 in people aged 12 and older. 28 November 2023

SpringWorks' Ogsiveo nabs first FDA approval for desmoid tumors

US biopharma SpringWorks Therapeutics has won a landmark approval from the US Food and Drug Administration (FDA). 28 November 2023

As expected, US regulator rejects Aldeyra's novel dry eye drug

Citing a failure to show required efficacy, the US Food and Drug Administration has rejected a submission from Aldeyra Therapeutics for its dry eye candidate reproxalap. 28 November 2023

Abeona leaps, as FDA accepts its pz-cel BLA for priority review

The US Food and Drug Administration (FDA) has accepted and granted priority review for the Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), submitted by Abeona Therapeutics. 28 November 2023

The FDA seeks stakeholder input into AI/ML regulatory standards

Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023

The week in pharma: action, reaction and insight – week to November 24, 2023

After lengthy and tense negotiations, last week saw the UK government and trade group the Association of the British Pharmaceutical Industry (ABPI) and its members reach agreement on a new pricing framework for medicines. Across the Atlantic, the US Food and Drug Administration (FDA) said it would be holding an advisory committee meeting to review the supplemental Biological License Application (sBLA) for Bristol Myers Squibb and 2seventy bio’s multiple myeloma candidate Abecma, so delaying the final decision date. US Pharma giant Merck & Co agreed to acquire Caraway Therapeutics for up to $610 million, aiming to expand its neurodegenerative disease portfolio. Also of note, Germany’s Bayer saw its biggest share drop in a decade, after it said it is discontinuing development of blood thinning drug candidate asundexian, adding to other woes. 26 November 2023

EMA to review Vertex MAA change request

The European Medicines Agency (EMA) has validated Vertex Pharmaceuticals Type II variation application to the Marketing Authorization for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. 24 November 2023

Nefecon approved in China for IgAN

Chinese biopharma Everest Medicines has won approval from China's National Medical Products Administration (NMPA) for Nefecon (budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. 24 November 2023

Pfizer's RSV jab Abrysvo secures approval in the UK

New York-based pharma major Pfizer has announced the UK approval of its respiratory syncytial virus (RSV) vaccine Abrysvo (respiratory syncytial virus vaccine). 23 November 2023

EC expands indication for Vertex' Kaftrio

The European Commission has granted approval for the label expansion of Kaftrio (ivacaftor/tezacaftor/elexacaftor; marketed in the USA as Trikaftra) in a combination regimen with ivacaftor for the treatment of children with cystic fibrosis (CF) ages two through five years old who have at least one F508del mutation in the cystic fibrosis (CF) transmembrane conductance regulator (CFTR) gene, US biopharma Vertex Pharmaceuticals announced today. 23 November 2023

Janssen files for EMA approval of Rybrevant

Janssen says it has submitted a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of Rybrevant (amivantamab). 23 November 2023

FDA issues final guidance on developing drugs for COVID-19 treatment and prevention

The US Food and Drug Administration (FDA) yesterday issued the final guidance COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. 23 November 2023

First-in-class blood cancer med could soon face regulatory test

It has been a challenging week for Germany's MorphoSys, with the firm’s share price falling as much as 40% in the last five days. 22 November 2023

Sumitomo's Xenleta approved in China

Japanese drugmaker Sumitomo Pharma has received approval from China’s National Medical Products Administration (NMPA) for the use of Xenleta (lefamulin acetate) to treat adults with community-acquired pneumonia in injection and tablet formulation. 22 November 2023

Best practices for Orange Book listings

In 1984, Congress passed and the President signed into law the Drug Price Competition and Patent Term Restoration Act, better known as the Hatch-Waxman Act. 21 November 2023

FDA delays review of sBLA for Abecma for earlier use

Shares of US pharma major Bristol Myers Squibb fell more than 4% pre-market and partner 2seventy bio was down 17.6% at $1.76 on Monday, after the companies said the US Food and Drug Administration would miss its target date for potential approval of earlier use of a cancer therapy Abecma (idecabtagene vicleucel). 21 November 2023

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