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Samsung Bioepis' Byooviz approved as interchangeable with Lucentis

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab). 24 October 2023

Patient-friendly infliximab jab set to reach pharmacies in the USA

The US business of South Korea's Celltrion Healthcare has secured approval for Zymfentra (infliximab-dyyb), a subcutaneous reformulation of infliximab. 24 October 2023

New indication for Enhertu approved in the EU

Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). 23 October 2023

FDA green light for Penbraya, first pentavalent vaccine for meningitis

The US Food and Drug Administration (FDA) on Friday approved Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults aged 10 through 25 years. 23 October 2023

WHO issues guidance on safe implementation of AI in medicine

As drugmakers around the world rush to embrace the potential of artificial intelligence (AI) in the design and development of new medications, the World Health Organization has urged caution. 23 October 2023

MHRA backs Tepkinly for diffuse large B-cell lymphoma in adults

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today authorized a new medicine called, Tepkinly (epcoritamab), as a treatment for diffuse large B-cell lymphoma (a type of blood cancer) in adults. 20 October 2023

Green light for clinical testing of NK cell therapy for lupus nephritis

Californian advanced therapy company Nkarta moving forward with plans to leverage the potential of natural killer (NK) cell-based treatments outside of oncology. 19 October 2023

EC approves new indication for Takeda's Adcetris, Stage III Hodgkin lymphoma

The European Commission (EC) has now approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. 19 October 2023

Next idea for BrainStorm is another Phase III trial in ALS

After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics has opted to withdraw its submission. 19 October 2023

Falsified Ozempic pens identified at two wholesalers in the UK

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) late yesterday confirmed that pre-filled pens falsely labeled as the diabetes medicine Ozempic (semaglutide, 1mg, solution for injection) have been identified at two UK wholesalers. 19 October 2023

Tevimbra reacquisition sets stage for BeiGene's bright future in global oncology landscape

Sino-American biotech BeiGene became the first Chinese-origin pharma company to market a programmed cell death protein 1 (PD1) therapy for oncology indications in various global markets, beginning with the European Union. 18 October 2023

At last, US nod for UCB's Bimzelx, and another possible blockbuster too

UCB has won two approvals from the US Food and Drug Administration, one for a new first-in-class rare disease med and another, for Bimzelx (bimekizumab-bkzx), bringing a new option for Americans with plaque psoriasis. 18 October 2023

First-in-class oral kidney disease med to enter US market

A firm in Massachusetts, USA, has won approval for a new kind of medicine, a phosphate absorption blocker, which will be used to treat certain people with chronic kidney disease (CKD). 18 October 2023

New FDA approval for Keytruda

The US Food and Drug Administration (FDA) has approved US pharma giant Merck & Co’s leading checkpoint blocker Keytruda (pembrolizumab) for the treatment of patients with resectable non-small cell lung cancer (NSCLC). 18 October 2023

Geropharm registers generic of Novo Nordisk's Ozempic in Russia

The first generic version of the popular drug for controlling glucose levels, Ozempic (semaglutide), which is produced by the Danish diabetes care giant Novo Nordisk, has been registered in Russia by a local drugmaker, the Pharma Letter’s local correspondent reports. 18 October 2023

Illuminating Rett syndrome: Advances in pharmacological treatments

October marks the annual Rett Syndrome Awareness Month, a time to examine the support and research being afforded to advance pharmacological treatments for this rare condition. 18 October 2023

Aldeyra readies market for bad news as FDA nears decision date

A formal disclosure from Aldeyra Therapeutics, suggesting a potential rejection from the US Food and Drug Administration, has stripped around 70% from the firm’s share price. 17 October 2023

Lung cancer bestseller gains speedy review in USA

Britain’s largest drugmaker, AstraZeneca, has been granted a Priority Review for its bid to broaden the label for Tagrisso (osimertinib) in the USA. 16 October 2023

The week in pharma: action, reaction and insight – week to October 13, 2023

Featuring on the M&A front last week, US pharma major Bristol Myers Squibb revealed that it has reached agreement to acquire KRAS inhibitor company Mirati Therapeutics, and its lung cancer drug Krazati, for $4.8 billion. Among research news, Akero Therapeutics presented new Phase IIb results for its non-alcoholic steatohepatitis candidate, efruxifermin, which failed to impress investors. Regulatory developments included Supernus Pharmaceuticals resubmitting its new drug application (NDA) to the US Food and Drug Administration (FDA) for SPN-830 amomorphine infusion device for CNS diseases. The FDA revised its Manual of Policies and Procedures for generic drug submissions. Also, on Friday, the FDA approved US pharma giant Pfizer’s Velsipity (etrasimod) for the treatment of ulcerative colitis. 15 October 2023

EMA's CHMP backs five novel meds for approval; rejects one

At its October monthly meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval. 14 October 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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