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Europe targets more joined-up health technology assessments

Significant changes to the way European health technology assessments (HTA) take place is underway, with a transitional period set to be in force for several years. 18 September 2023

Biosimilars gaining traction in the USA

A feature on recent market activity in the biosimilar sector. 18 September 2023

FDA's new draft guidance on biosimilars labeling

While the US medicines regulator has been granting approvals for biosimilar version of branded medicine for some time, it is only in the last year or so that they have been coming onto the market due to originators’ strong patent positions. 18 September 2023

The week in pharma: action, reaction and insight – week to September 15, 2023

Among last week’s notable news, US drug developer Crinetics Pharmaceuticals released surprisingly good Phase III clinical trial results for its paltusotine in acromegaly. Germany’s Immatics has entered into a collaboration with the USA’s Moderna to develop mRNA-based cancer therapies. US cell and gene based immune-oncology drug developer 2seventry bio last week announced it is cutting its work force by 40% as part of a cost-cutting restructuring, and that chief executive Nick Leschly is stepping down. Also of note, Alnylam received a positive US Food and Drug Administration (FDA) advisory committee vote for its ATTR-cardiomyopathy candidate Onpattro (patisiran). 17 September 2023

FDA's Project Renewal leads to updated labeling for Temodar

The US Food and Drug Administration has approved updated labeling for Temodar (temozolomide), a legacy oncology drug developed by Merck & Co. 16 September 2023

September batch of EMA/CHMP novel drug approval recommendations

Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023

Positive outcome of FDA AdCom on Alnylam's Onpattro

A US Food and Drug Administration advisory panel on Wednesday backed the expanded use of Alnylam Pharmaceuticals' gene silencing drug to treat a type of heart disease associated with a rare organ-damaging disorder. 14 September 2023

Positive FDA discussion lifts Rocket amid $175 million funding round

Stock in New Jersey, USA-based Rocket Pharmaceuticals shot up around 40% on Wednesday, following good news on the financing and regulatory fronts. 14 September 2023

Hemogenyx' clinical hold lift plan is accepted by FDA

Shares of London-listed blood disease specialist Hemogenyx Pharmaceuticals were up more than 9% at 1.80 pence, after it revealed in a stock exchange filing a positive development for its investigational product. 14 September 2023

FDA panel says cold meds don't work, just in time for winter

Oral phenylephrine has for years generated major revenues as an over-the-counter decongestant, but a meeting of the US Food and Drug Administration’s scientific experts has thrown a wrench in the works. 13 September 2023

EMA validates Type II variation for Astellas' Xtandi

The European Medicines Agency (EMA) has validated Japanese pharma major Astellas Pharma’s Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC). 13 September 2023

Sanofi seeks to strengthen Altuviiio case based on trial results

The US Food and Drug Administration (FDA) has accepted a supplemental biologics license application (sBLA) for Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]. 13 September 2023

Questions raised over UK's International Recognition Procedure

With the European Commission Decision Reliance Procedure (ECDRP) due to come to an end on December 31, 2023 - subject to consultation - the UK’s Medicines and Healthcare Regulatory Agency (MHRA) will launch a new International Recognition Procedure (IRP) from January 1, 2024. 12 September 2023

FDA approves two COVID-19 vaccines for 2023-2024

The US Food and Drug Administration (FDA) has now approved the supplemental Biologics License Application (Comirnaty 2023-2024 Formulation) from US pharma major Pfizer and partner BioNTech. 12 September 2023

Belgian medicine shortages 'complex issue,' say drugmakers

The Belgian pharmaceutical industry has responded to reports of medicine shortages, with local media attributing the blame in some cases to the actions of pharmaceutical companies. 11 September 2023

GSK's momelotinib submission accepted for review by Japanese regulator

Japan’s Ministry of Health, Labor and Welfare (MHLW) has accepted for review a new drug application (NDA) for momelotinib, filed by UK pharma major GSK. 11 September 2023

EFPIA et al discuss opt-out requirements in EHDS

Multi-stakeholder group consisting of 32 European patient organizations, medical associations, research organizations, data collaborations and industry associations consider EHDA opt-out. 11 September 2023

The week in pharma: action, reaction and insight – week to September 8, 2023

Last week, the USA’s Seagen and Danish partner Genmab released positive new Phase III data on their Tivdak in the treatment of cervical cancer. Also, US clinical-stage biotech CymaBay Therapeutics released positive Phase II results for its seladelpar in biliary cholangitis. On the regulatory front, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) on UK pharma major AstraZeneca’s supplemental biologic license application (sBLA) for its rare disease drug Ultomiris. Meantime, US clinical-stage biopharma Nurix Therapeutics revealed a collaboration with Seagen to develop degrader-antibody conjugates for cancer 10 September 2023

Daiichi Sankyo says mRNA COVID-19 Vaccine DS-5670 meets goal; files sNDA

Japanese pharma major Daiichi Sankyo today announced that the primary endpoint was achieved in a Phase III trial of a booster vaccination with DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19) being developed in Japan (in a booster vaccination trial). 7 September 2023

UK gives green light to kidney disease indication for Jardiance

Cardiometabolic med Jardiance (empagliflozin), a blockbuster product developed by Boehringer Ingelheim and Eli Lilly, has picked up a new approval in the UK. 7 September 2023

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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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