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FDA nod for Veopoz, first treatment for CHAPLE disease

The US Food and Drug Administration (FDA) on Friday approved Veopoz (pozelimab-bbfg) injection, a complement inhibitor, for the treatment of adult and pediatric patients aged one year and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease. 19 August 2023

EU compulsory pharma licensing reform raises wrath of industry

There has been a substantial backlash from major pharmaceutical trade associations and companies to the European Commission’s (EC) feedback initiative on the introduction of a pan-European compulsory license, which would allow for the invalidation of existing drug patents across the European Union (EU) in emergency situations. 18 August 2023

LEO's hand eczema cream closer to EC approval

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Danish dermatology specialist LEO Pharma’s delgocitinib cream. 18 August 2023

EC approves reduced dosing frequency for Janssen's Tecvayli

US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab). 18 August 2023

Regeneron's lymphoma candidate odronextamab accepted for EMA review

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by US biotech Regeneron Pharmaceuticals for its odronextamab. 18 August 2023

EMA accepts avacincaptad pegol MAA for geographic atrophy

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), Astellas Pharma announced today. 18 August 2023

New approval for AstraZeneca's Forxiga in China

Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF, UK Pharma major AstraZeneca announced this morning. 18 August 2023

AbbVie's Aquipta/Qulipta approved by EC to prevent migraine

US drugmaker AbbVie has won approval from the European Commission (EC) for Aquipta (atogepant) for the prophylaxis of migraine in adults who have four or more migraine days per month. 17 August 2023

FDA to decide on bluebird's lovo-cel without AdCom meeting

The US Food and Drug Administration (FDA) has told bluebird bio that an advisory committee (AdCom) meeting will not be scheduled for lovotibeglogene autotemcel (lovo-cel). 17 August 2023

US Fifth Circuit upholds abortion pill's approval, but backs limits

The USA’s Fifth Circuit Court of Appeals on Wednesday rejected an extraordinary decision blocking the US Food and Drug Administration's (FDA) decades-old approval of the widely used abortion medication mifepristone, but also upheld the decision's reinstatement of restrictions on access to the medication. 17 August 2023

Ipsen follows up Sohonos EC rejection with US approval

French drugmaker Ipsen has won a landmark US approval of Sohonos (palovarotene) for an ultra-rare bone disease, having been rebuffed last month in its efforts to do so in Europe. 17 August 2023

Translational medicine in focus: Key takeaways from the Office of Translational Sciences 2022 annual report

Translational science is intended to bring predictivity and efficacy to the development and dissemination of interventions that improve human health, turning science discoveries into therapeutic applications.1 17 August 2023

Another approval for new Fabry disease medicine Elfabrio

Privately-held drugmaker Chiesi has secured approval from the British medicines regulator for Elfabrio (pegunigalsidase alfa) in Fabry disease (FD). 16 August 2023

FDA delays PDUFA date for Valneva's chikungunya vaccine

The US Food and Drug Administration (FDA) has a revised Prescription Drug User Fee Act (PDUFA) action date from August to November 2023 for French company Valneva’s chikungunya vaccine. 16 August 2023

First domestic innovative weight-loss drug approved in China

According to the official website of the China State Drug Administration the application for marketing authorization of Feisumei (benaglutide) injection for obesity or overweight indications declared by Benemae Pharmaceuticals/Renhui Biotech was approved for weight management of adults. 16 August 2023

Pfizer's Elrexfio enters RRMM market with accelerated approval

The US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm). 15 August 2023

Amicus' Pompe therapy approved in UK

US rare diseases focused biotech Amicus Therapeutics today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for adults living with late-onset Pompe disease (acid α glucosidase [GAA] deficiency). 15 August 2023

FDA lifts hold on Arcellx' iMMagine-1 Phase II clinical program

The US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma (rrMM), under development by US biotech Arcellx. 15 August 2023

The week in pharma: action, reaction and insight – week to August 11, 2023

Among important regulatory news last week, the US Food and Drug Administration approved Sage Therapeutics and Biogen’s Zurzuvae (zuranolone) as the first treatment for post-partum depression (PPD), but declined to clear the drug for the bigger indication of major depressive disorder (MDD). Also, Astellas Pharma gained approval from the FDA for its geographic atrophy treatment Izervay (avacincaptad pegol). On the research front, Swiss ophthalmology focused firm Oculis Holdings reported another Phase III success with candidate OCS-01. M&A activity included Regeneron Pharma announcing it has agreed to acquire long-term partner Decibel Therapeutics and its hearing loss program for an upfront $109 million and $104 million contingent. Also, Novo Nordisk revealed it is acquiring Canadian obesity drug developer Inversago for around $1.1 billion 13 August 2023

FDA approves Akeega for mCRPC

On Friday, the US Food and Drug Administration (FDA) approved Akeega, the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. 12 August 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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