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The week in pharma: action, reaction and insight – week to August 19

Major research news last week was mixed, with the USA’s Gilead Sciences last Monday releasing positive Phase III data for its Trodelvy in HR+/HER2 metastatic cancer, while France’s Sanofi released disappointing Phase III trial results with its SERD candidate amcenestrant and saying it would discontinue the development program. On the deal-making front, US pharma Merck & Co entered into a collaboration with biotech Orna Therapeutics on the development of multiple vaccines and therapies, paying an upfront $150 million plus pledging milestone and royalties of up to $3.5 billion. Also of note, the US Food and Drug Administration (FDA) last week approved bluebird bio’s beta thalassemia drug Zynteglo, making it the first cell-based gene therapy for this condition. 21 August 2022

Kyowa Kirin gains EC approval of Crysvita for TIO

Japanese drugmaker Kyowa Kirin said on Friday that the European Commission (EC) has approved Crysvita (burosumab) for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults. 20 August 2022

EMA advises on intradermal use of Imvanex/Jynneos against monkeypox

The European Medicines Agency’s (EMA) Emergency Task Force (EFT) has reviewed data on the monkeypox vaccine Imvanex used as an intradermal injection. 20 August 2022

European nod helps clarify future for Oncopeptides therapy

Swedish blood disease specialist Oncopeptides has won European approval for its multiple myeloma therapy Pepaxti (melphalan flufenamide). 19 August 2022

FDA partially lifts hold on development of novel kinase inhibitor

Shares in oncology company Curis rose by around 15% on Thursday, after the US Food and Drug Administration lifted a partial clinical hold on the Phase I/II TakeAim Lymphoma trial. 19 August 2022

EMA validates Menarini's application for breast cancer SERD elacestrant

Today, privately-held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for elacestrant, an investigational oral selective estrogen receptor degrader (SERD) for patients with ER+/HER2- advanced or metastatic breast cancer. 19 August 2022

EC approves Celltrion's Vegzelma, a biosimilar bevacizumab

South Korea-based Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing Roche’s European Union-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer. 19 August 2022

EMA starts review of Skycovion COVID-19 vaccine application

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has started a review of a conditional marketing authorization application for Skycovion, a vaccine for protecting against COVID-19. 19 August 2022

Menopause product with a lot riding on it reaches FDA review

A significant new product candidate with great potential in the treatment of symptoms associated with the menopause will now be considered by the US regulator for approval. 18 August 2022

FDA accepts NDA for GSK's momelotinib

UK pharma major GSK announced today that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients. 17 August 2022

FDA nod for citrate-free Humira biosimilar Hadlima

The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 17 August 2022

BrainStorm to press on with NurOwn BLA

USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022

FDA inspections back up to speed, except those now deemed unnecessary

During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals. 16 August 2022

Chugai's Edirol Tablet approved in Japan as osteoporosis therapy

Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022

Lynparza combo accepted by FDA for priority review

UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022

First global nod for Moderna's Omicron-containing bivalent Covid-19 vaccine

US mRNA biotech Moderna edged up less than 1% pre-market this morning, despite announcing the first-ever approval worldwide for its next-generation bivalent COVID-19 vaccine. 15 August 2022

The week in pharma: action, reaction and insight – week to August 12

Confirming earlier rumors, last Monday UK pharma giant Pfizer revealed it has entered into a $5.4 billion deal to acquire Global Blood Therapeutics, along with its sickle cell disease gene therapy Oxbryta. The US Food and Drug Administration (FDA) last week granted approval for Myovant and Pfizer’s Myfembree for the treatment of severe pain associated with endometriosis. Last Tuesday Mersana Therapeutics entered into a licensing agreement with GSK, with the UK pharma major taking an option on its Immunosynthen ADC, XMT-2056 that could earn Mersana as much as $1.36 billion. Also last week, fears of Zantac side-effect financial liability lawsuits impacted several pharma majors, including GSK and Sanofi, wiping billions off their marker capitalization. 14 August 2022

New Enhertu approval a milestone in lung cancer

AstraZeneca and Daiichi Sankyo’s drug Enhertu (trastuzumab deruxtecan) has become the first HER2-directed therapy to be approved in the USA for patients with previously-treated HER2-mutant metastatic non-small cell lung cancer. 12 August 2022

Menarini's elacestrant accepted for priority review by the US FDA

Privately held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, yesterday announced that the US Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. 12 August 2022

Affimed to focus AFM28 efforts outside USA

German biopharma company Affimed Therapeutics closed Thursday’s New York trading 9% lower. 12 August 2022

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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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