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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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EC grants conditional marketing authorization for Taiho's Lytgobi

The European Commission has granted conditional marketing authorization for Lytgobi (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA). 6 July 2023

ICRMA seeks to combat 'devastating impact' of false information on COVID-19 vaccines

The European Medicines Agency (EMA) is among the regulators to have endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA). 5 July 2023

UK approves first and only med to treat non-segmental vitiligo

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. 5 July 2023

FDA slaps CRL on Amneal's IPX203

Shares of Amneal Pharmaceuticals fell 13.1% to $2.70 in choppy post-market trading, after the US drugmaker revealed that the US drugmaker revealed that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease. 5 July 2023

China's NMPA approves RareStone's Wakix for narcolepsy

Chinese rare disease drug developer RareStone Group has received approval from the National Medical Products Administration (NMPA) for Wakix (pitolisant) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. 5 July 2023

EC approves Orkambi for infants with cystic fibrosis

The European Commission has granted approval for the label extension of Orkambi (lumacaftor/ivacaftor), from US biopharma firm Vertex Pharmaceuticals, for the treatment of children with cystic fibrosis (CF) ages 1 to 5 July 2023

Rare disease focus finds success in China for AstraZeneca

For many years, Britain’s pharma largest company AstraZeneca has maintained a strong presence in China, and this approach looks set to pay off. 4 July 2023

India's Lupin gets two generics approvals from FDA

Mumbai, India-based generic drugmaker Lupin Limited saw US regulatory approval for two of its copy medicines in the space of two days. 4 July 2023

Moderna submits EMA filing for updated COVID-19 jab

US biotech Moderna’s original Spikevax COVID-19 vaccine made the company a household name across the western world during the pandemic. 3 July 2023

Guidance aims to further strengthen consensus on bioequivalence

The general assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new topic focused on the harmonization of bioequivalence for modified-release products. 3 July 2023

Roche and Blueprint withdraw Gavreto from US market in MTC

Genentech, the US biotech subsidiary of Swiss pharma giant Roche, plans to withdraw Gavreto (pralsetinib) from use in the USA for the treatment of a type of RET+ medullary thyroid cancer (MTC) as it was not feasible to pursue the drug for full approval, its partner Blueprint Medicines said on Friday. 3 July 2023

Negative Investor reaction as BioXcel own goal threatens AD progress

Industry analyst GlobalData has provided a downbeat analysis of prospects for BioXcel following claims of “bad clinical practice” related to the TRANQUILITY II study. 3 July 2023

The week in pharma: action, reaction and insight – week to June 30, 2023

Research news last included Germany’s Boehringer Ingelheim and Danish partner Zealand Pharma releasing weight loss results for their candidate survodutide (BI 456906) and US pharma giant Pfizer announcing it would drop development of lotiglipron as a potential treatment for obesity and type 2 diabetes, instead focussing on danuglipron. Also of note, US biopharma Intercept Pharmaceuticals announced another setback for its obeticholic acid (OCA) in pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH), causing the company to give up on the drug in this indication. Eli Lilly revealed plans to acquire Sigilon Therapeutics, and its diabetes candidate SIG-002, for around $310 million, with a modest $34.6 million upfront. On the regulatory front, US biotech BioMarin gained US Food and Drug Administration (FDA) approval for Roctavian, its gene therapy for severe hemophilia A. 2 July 2023

Medicines for Europe calls on lawmakers not to increase fees

Medicines for Europe, the trade body for generics and biosimilars companies in the region, has called for “a fair, cost-based approach” to regulatory fees. 30 June 2023

BioMarin gets go-ahead for Roctavian in the USA

US biotech BioMarin Pharmaceutical has won US approval for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of severe hemophilia A without antibodies to adeno-associated virus serotype 5. 30 June 2023

New blow for Alvotech and Teva's Humira biosimilar

Deficiencies identified by the US Food and Drug Administration (FDA) at Icelandic biosimilar firm Alvotech’s Reykjavik facility have resulted in a second complete response letter (CRL) for AVT02, its copy of Humira (adalimumab). 30 June 2023

Opdivo continues strong showing in lung cancer with new EU nod

Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023

FDA nod for first cellular therapy for type 1 diabetes

The US Food and Drug Administration yesterday approved Lantidra (donislecel), the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. 30 June 2023

Italfarmaco completes givinostat NDA with FDA

Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD). 29 June 2023

Favorable FDA AdCom vote for Ipsen

The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). 29 June 2023

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