Regulation

Refine Search

The week in pharma: action, reaction and insight – week to November 10, 2023

Among dealmaking news last week, US biotechs Halozyme Therapeutics and Acumen Pharmaceuticals signed a license collaboration for the use of Enhanze drug delivery for Acumen’s Alzheimer’s disease candidate ACU193. On the regulatory front, the US Food and Drug Administration (FDA) last Wednesday approved Eli Lilly’s tirzepatide, under the trade name Zepbound, as a treatment for chronic weight management, opening competition for Novo Nordisk’s already authorized Wegovy. Anglo-Swedish pharma major AstraZeneca last week reported financial result that beat expectations, a change from some other European drugmakers. Additionally, India’s Zydus Lifesciences entered into a co-promotion for its non-alcoholic steatohepatitis (NASH) drug Lipaglyn with fellow Indian firm Lupin. 12 November 2023

November 2023 batch of EMA/CHMP recommendations

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines and two biosimilars for approval at its November 2023 meeting. 11 November 2023

FDA approves first drug for rare inherited blood clotting disorder

The US Food and Drug Administration yesterday approved Japanese pharma major Takeda’s Adzynma (ADAMTS13, recombinant-krhn; TAK-755), adding to the approval a day earlier of the firm’s bowel cancer drug Fruzaqla (fruquintinib). 10 November 2023

FDA approves Valneva's Ixchiq

The US Food and Drug Administration (FDA) has approved Ixchiq, French specialty vaccines developer Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus. 10 November 2023

Lilly's obesity drug gets US and UK approval, all in one day

The US Food and Drug Administration late yesterday approved US pharma major Eli Lilly’s Zepbound (tirzepatide) injection for chronic weight management in adults with obesity. 9 November 2023

New targeted therapy for bowel cancer receives approval in the USA

Japanese drug major Takeda has received US approval for Fruzaqla (fruquintinib), an oral targeted therapy for bowel cancer. 9 November 2023

Menarini sub-licenses Orserdu in China

Privately-held Italian drugmaker Menarini and USA/China-based SciClone Pharmaceuticals have entered into an exclusive sub-licensing agreement to develop and commercialize Orserdu (elacestrant) in China. 8 November 2023

Compliance services firm makes Inflation Reduction Act update

Life science compliance specialist Model N has announced product enhancements relating to the Inflation Reduction Act. 8 November 2023

Europe's R&D lag to grow under pharma proposals, EFPIA warns

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is not happy. 7 November 2023

Calliditas presents positive Tarpeyo data at ASN Kidney Week 2023

Swedish nephrology company Calliditas Therapeutics has highlighted new analyses from the Phase III NefIgArd study. 7 November 2023

UK's MHRA approves 'repurposed' anastrozole to prevent breast cancer

Anastrozole, which has been used for many years as a breast cancer treatment, has today been licensed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a preventive option – which it is hoped could help prevent around 2,000 cases of breast cancer in England. 7 November 2023

UK rare disease companies call for leadership in supporting access to new treatments

Working together through their trade body, the BioIndustry Association (BIA), a group of British rare disease drug developers is calling for the UK to lead greater collaboration between stakeholders, and uptake of best practice both in the UK and internationally, to improve access to new treatments for patients. 6 November 2023

The week in pharma: action, reaction and insight – week to November 3, 2023

Research news last week included US biotech Sarepta Therapeutics releasing mixed top-line result for its gene therapy Elevidys in Duchenne Muscular dystrophy (DMD). On the licensing front, Eli Lilly entered into a collaboration with US biotech Beam Therapeutics to acquire the latter’s opt-in right to Verve Therapeutics’ editing program for cardiovascular diseases. Additionally, US ophthalmic drug specialist Aldeyra Therapeutics signed an option agreement with AbbVie for its dry eye disease candidate reproxalap. Also of note, the US Food and Drug Administration (FDA) granted approval for Pfizer’s Penbraya, the first pentavalent vaccine for meningococcal disease in adolescents. 5 November 2023

EMA validates Pierre Fabre lung cancer combo MA

The European Medicines Agency (EMA) has validated the submission for Braftovi (encorafenib) with Mektovi (binimetinib), submitted by privately-held French drugmaker Pierre Fabre, for the treatment of adult patients with BRAFV600-mutant advanced non-small cell lung cancer (NSCLC). 2 November 2023

More antibiotics on the way as US regulator approves reformulation

Phathom Pharmaceuticals has received approval from the US regulator for a reformulation of its oral vonoprazan products. 2 November 2023

FDA AdCom largely supports safety of Vertex/CRISPR's exa-cel

The US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Committee concluded that Vertex Pharmaceutical and Swiss gene editing specialist CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel) is generally safe for clinical use. 1 November 2023

Sixth nod in GI cancer for world's leading checkpoint blocker

Merck & Co has secured another approval from the US Food and Drug Administration for its blockbuster immuno-oncology product, Keytruda (pembrolizumab). 1 November 2023

MHRA authorizes Litfulo as a treatment for severe alopecia

Adding to recent regulatory approvals in the USA and European Union, pharma giant Pfizer can now add the UK to the geographies where its alopecia treatment can be marketed. 1 November 2023

FDA approves Wezlana, interchangeable biosimilar of Stelara

The US Food and Drug Administration (FDA) yesterday announced it has approved US biotech major Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. 1 November 2023

Novavax pulling out all the stops to ensure successful season with updated protein-based COVID-19 vaccine

On Tuesday, US biotech company Novavax, which is advancing protein-based vaccines with its Matrix-M adjuvant, announced a timely update with its Nuvaxovid XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted). 1 November 2023

Previous page 37 38 39 404142 43 44 45 46 Next page

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

article

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

12 3 4 5 6 7 8 9 10 Next page

Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze