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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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Casgevy approval unlikely to be followed up by another CRISPR drug in near future, says analyst

Vertex Pharmaceuticals and CRISPR Therapeutics made history last month by gaining approval for the first CRISPR-based drug, Casgevy (exagamglogene autotemcel). 29 December 2023

Amgen set back in bid to upgrade Lumakras approval

Californian biotech Amgen has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib). 28 December 2023

Opdualag licensed for patients with advanced melanoma in UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the advanced melanoma medicine Opdualag (nivolumab-relatlimab) for patients from the age of 12. 28 December 2023

Japan pharma 2023 year in review

Japan’s innovative pharma market has been on an upwards trajectory these last 12 months – despite what you may have seen in IQVIA thought leadership reports, industry advocacy body pronouncements or USD-reported results. 27 December 2023

New approval for UCB's Bimzelx in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Bimzelx (bimekizumab) for the treatment of adults with psoriatic arthritis (PsA), non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not sufficiently responding to existing treatments, said Belgian drugmaker UCB. 27 December 2023

The week in pharma: action, reaction and insight – week to December 22, 2023

US biotech bluebird bio last week announced plans to sell $150 million of common stock, with the proceeds to be used to support commercialization of its approved gene therapies. Japan’s Otsuka signed a licensing deal with the USA’s Ionis Pharmaceuticals for the latter’s donidalorsen, a potential treatment for hereditary angioedema. Israel-based Compugen rocketed on news of a lucrative licensing deal for its COM503 oncology candidate with Gilead Sciences. Also, Ionis and British pharma major AstraZeneca received US Food and Drug Administration (FDA) for their Wainua (eplontersen) for the treatment of the rare neurologic disease ATTRv-PN. On Friday, US pharma major Bristol Myers Squibb announced what is likely the second largest biopharmaceutical M&A deal this year, planning to acquire Karuna Therapeutics and its schizophrenia candidate KarXT for $14 billion. 24 December 2023

Cidara gains European approval of Rezzayo for invasive candidiasis

US drugmaker Cidara Therapeutics’ shares advanced 12.5% to $0.83 on Friday, after it announced that Rezzayo (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults. 23 December 2023

New US govt action to increase naloxone access

In support of US President Biden’s Unity Agenda efforts to beat the overdose epidemic, the US Department of Health and Human Services (HHS) and the General Services Administration (GSA) announced new guidance. 23 December 2023

Unlocking the rich potential of biosimilars

In the two decades since biosimilars emerged on the world stage, their evolution has brought acceptance of the critical role they can play in making life-changing therapies more affordable. 22 December 2023

FDA approves AstraZeneca's Wainua as a treatment for ATTRv-PN

The US Food and Drug Administration has approved AstraZeneca and Ionis Pharmaceuticals’ Wainua (eplontersen). 22 December 2023

Ebglyss approval another step towards Almirall's lofty dermatology ambitions

Last month, the European Commission (EC) approved Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 21 December 2023

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Calliditas gets full approval for Tarpeyo in USA

Swedish drugmaker Calliditas Therapeutics has received full US Food and Drug Administration approval for Tarpeyo (budesonide), upgrading a previous nod under the Accelerated Approval scheme. 21 December 2023

Merck & Co rejected again for novel chronic cough drug

For a second time, the US Food and Drug Administration has rejected a submission from Merck & Co for approval to market a chronic cough medication. 21 December 2023

Shionogi's Fetroja launches in Japan

Japanese drugmaker Shionogi has launched of siderophore cephalosporin antibiotic Fetroja (cefiderocol) intravenous infusion 1g vial in Japan. 21 December 2023

Final FDA guidance on developing MAbs for COVID-19 under EUA

The US Food and Drug Administration (FDA) yesterday issued the final guidance Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization. 21 December 2023

FDA updates list of off-patent, without an approved generic

The US Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). 20 December 2023

Chiesi secures US approval for rare skin disorder med

The rare disease unit of Italian drugmaker Chiesi has secured US approval for Filsuvez (birch triterpenes), a new treatment for people with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB). 20 December 2023

EC revokes centralized authorizations of Tecfidera generics

US biotech major Biogen today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of the company’s multiple sclerosis therapy, Tecfidera (dimethyl fumarate). 19 December 2023

Checkpoint chopped in half by cosibelimab CRL

Shares in US biotech Checkpoint Therapeutics slumped by nearly half on Monday. 19 December 2023

EC expands use of Evkeeza for pediatric patients with HoFH

The European Commission has extended the approval of Evkeeza (evinacumab) as an adjunct to diet and other lipid-lowering therapies to treat children aged five to 11 years with homozygous familial hypercholesterolemia (HoFH). 19 December 2023

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