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High percentage of unapproved antibiotic formulations raises questions on regulatory effectiveness in India

Even as India's drug pricing authority, the National Pharmaceutical Pricing Authority (NPPA) last week brought 33 fixed-dose combination (FDC) drugs under its price regulation, in an initiative to make these drugs more cost-effective, a recent comprehensive analysis reveals a concerning trend, that the Indian government's efforts to eliminate centrally unapproved and banned antibiotic FDC drugs have experienced limited success, reports The Pharma Letter’s India correspondent. 20 November 2023

EC approval for Santen's Catiolanze

Japanese ophthalmology firm Santen Pharmaceutical has received marketing authorization from the European Commission for Catiolanze (cationic emulsion of latanoprost 50μg/mL, STN1013001). 20 November 2023

Acrotech urged to hurry up with confirmatory trial

Aurobindo Pharma subsidiary Acrotech Biopharma has been urged to work with the US Food and Drug Administration (FDA) to swiftly advance a confirmatory trial of the cancer drugs Folotyn (pralatrexate) and Beleodaq (belinostat). 20 November 2023

CStone's Cejemly approved in China for ENKTL

China-based CStone Pharmaceuticals’ Cejemly (sugemalimab) has been approved by the China National Medical Products Administration (NMPA) for the treatment of relapsed or refractory extranodal natural killer/T-cell lymphoma (r/r ENKTL). 20 November 2023

The week in pharma: action, reaction and insight – week to November 17, 2023

Important research news last week included Denmark’s Novo Nordisk presenting strong new data for its weight management drug Wegovy, showing that it improves cardiovascular outcomes in at-risk patients with BMI of 27 and above with established CVD, without diabetes. On the deal-making front, Switzerland’s Basilea Pharmaceutica entered into an asset purchase deal with US pharma giant Pfizer subsidiary Amplyx for fosmanogepix, an antifungal candidate. Additionally, Gilead Science’s Kite subsidiary expanded its ACLX-001 multiple myeloma collaboration with Arcellx. Also of note, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made history last week, becoming the first anywhere to approve Vertex Pharmaceuticals and CRISPR Therapeutics’ gene therapy exagamglogene autotemcel (exa-cel), now trade named Casgevy, for sickle cell disease and beta thalassemia. 19 November 2023

First-line gastric cancer nod for Keytruda plus chemo

Leading checkpoint blocker Keytruda (pembrolizumab) has picked up a new American approval, in combination with chemotherapy, for the first-line treatment of certain people with gastric cancer. 17 November 2023

Xtandi wins US approval earlier in prostate cancer

Astellas and Pfizer’s Xtandi (enzalutamide) has won a new approval in prostate cancer from the US Food and Drug Administration (FDA). 17 November 2023

EC approval for Ebglyss in eczema

Almirall has won European Commission (EC) approval for Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. 17 November 2023

BeiGene notches up fourth EC approval for Brukinsa

The European Commission (EC) has granted marketing authorization for China-headquartered biotech BeiGene’s Brukinsa (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma. 17 November 2023

Teva nabs FDA approval for generic version of Forteo

The US unit of Israeli generics giant Teva Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval of a generic version of Forteo (teriparatide). 17 November 2023

FDA approves AstraZeneca's Truqap with fulvestrant for breast cancer

The Food and Drug Administration yesterday granted approval for UK pharm major AstraZeneca’s (LSE: AZN) Truqap (capivasertib) with Faslodex (fulvestrant). 17 November 2023

Combination therapies: CMA prioritization statement

The UK’s Competition and Markets Authority (CMA) has clarified the circumstances under which it will not prioritize enforcement action against pharmaceutical companies when they implement a specific ‘negotiation framework’ to make more combination therapies available on the National Health Service (NHS). 17 November 2023

BMS bet looking good as Augtyro approved in ROS1-positive NSCLC

Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has approved Augtyro (repotrectinib) to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). 16 November 2023

Prospects for Valneva single-dose chikungunya vaccine Ixchiq

French specialty vaccines developer Valneva’s last week received approval of Ixchiq from the US Food and Drug Administration (FDA), marking the approval of the world’s first chikungunya virus (CHIKV) vaccine. 16 November 2023

MHRA first to back Vertex and CRISPR's gene therapy Casgevy

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today granted conditional marketing authorization for Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), developed by USA-based Vertex Pharmaceuticals and Swiss firm CRISPR Therapeutics. 16 November 2023

CorMedix gains FDA approval for DefenCath

Shares of US biopharma CorMedix rose as much as 18% ad closed up 6.4% at $3.33 yesterday, after it revealed that the US Food and Drug Administration (FDA) has approved its DefenCath (taurolidine and heparin). 16 November 2023

MHRA licenses cystic fibrosis drugs Kaftrio and Kalydeco for infants

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today extended the license of the cystic fibrosis medicines Kaftrio (ivacaftor, tezacaftor and elexacaftor) and Kalydeco (ivacaftor) for children aged two to five years old. 15 November 2023

Hemogenyx lentivirus re-manufacturing completed

London-listed blood disease specialist Hemogenyx Pharmaceuticals has announced the successful completion of the re-manufacturing of an improved lentivirus (LVV) devoid of splice variants. 15 November 2023

Imfinzi approved in China for biliary tract cancer; trial miss

UK pharma major AstraZeneca today announced two developments for its best-selling cancer drug Imfinzi (durvalumab). 14 November 2023

Vanflyta scores a first with EU approval

Following US approval in the same indication earlier this year, Japanese drugmaker Daiichi Sankyo’s Vanflyta (quizartinib) has now also been approved in the European Union (EU). 13 November 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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