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Biotechnology
The US Food and Drug Administration (FDA) yesterday approved US pharma giant Pfizer’s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). 21 June 2023
Pharmaceutical
An ancient Egyptian medicament, developed by a family-run Slovakian firm, has been approved to help prevent heart attacks and strokes in the USA. 21 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has slapped a clinical hold on US biotech Arcellx’ CART-ddBCMA investigational new drug (IND) for the treatment of patients with relapsed or refractory multiple myeloma (rrMM). 20 June 2023
Generics
The Delhi High Court has sought the Indian government's position regarding a petition that challenges the ban on fixed-dose combination (FDC) drugs, reports The Pharma letter’s local correspondent. 20 June 2023
Pharmaceutical
Hopes for what would be the first new antifungal based on a novel mechanism for decades have been dealt a blow by the US Food and Drug Administration. 20 June 2023
Biotechnology
The World Health Organization (WHO) has granted WHO Emergency Use Listing (EUL) for the COVID-19 vaccine, SKYCovione, from South Korean company SK bioscience. 19 June 2023
Biotechnology
Last week saw the much anticipated Food and Drug Administration (FDA) advisory committee vote in favor of full approval for Eisai and Biogen’s Alzheimer’s disease (AD) treatment Leqembi, which thus far was marketed under an accelerated approval clearance. Also, the FDA granted approval for Japanese drugmaker Daiichi Sankyo’s Injectafer for heart failure patients with iron deficiency. M&A featured, first with Swiss pharma giant Novartis punting up to $3.5 billion to expand its kidney disease portfolio through the acquisition of Chinook Therapeutics and its lead candidates atrasentan and zigakibart. Additionally, Coherus BioSciences last Friday announced it is to acquire fellow USA-based Surface Oncology for around $65 million, with the aim of growing its immuno-oncology assets. 18 June 2023
Biotechnology
A feature on efforts to protect patients from unscrupulous actors in the cell and gene therapy field. 16 June 2023
Pharmaceutical
An allergic conjunctivitis medicine developed by Aldeyra Therapeutics, reproxalap, has generated positive Phase III data in the INVIGORATE-2 trial. 16 June 2023
Pharmaceutical
Texas, USA-based drug developer Reata Pharmaceuticals says that the US Food and Drug Administration (FDA) accepted for filing the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (omaveloxolone). 16 June 2023
Biotechnology
Swiss cancer giant Roche has secured approval for Columvi (glofitamab-gxbm), a treatment for certain people with diffuse large B-cell lymphoma (DLBCL). 16 June 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data, according to a stock exchange filing by UK pharma major GSK. 16 June 2023
Biotechnology
USA-based Mersana Therapeutics has announced that the US Food and Drug Administration (FDA) has issued a partial clinical hold pausing patient enrollment in UP-NEXT and UPGRADE-A, the trials of UpRi in platinum-sensitive ovarian cancer. 16 June 2023
Biotechnology
The European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib. 16 June 2023
Biosimilars
Medicines for Europe has said that it sees the revision of European Union (EU) pharmaceutical legislation as an opportunity to accelerate patient access to safe, effective, and affordable medicines and to improve security of supply. 15 June 2023
Biotechnology
Advanced cellular and tissue-engineered therapies offer ground-breaking opportunities for the treatment of diseases. Recent years have seen an uptick in the development and regulatory approval of revolutionary biological therapies across the globe.1 15 June 2023
Biotechnology
Japanese drugmaker Chugai Pharmaceutical said today it has filed a regulatory application with the Ministry of Health, Labor and Welfare (MHLW) for the anti-C5 antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). 14 June 2023
Pharmaceutical
As a functional, practical and intelligent way to regulate medical products in today’s globalized world—especially with increasing public health needs, limited resources and demand for faster and better treatments—the use of regulatory decisions from other jurisdictions represents a powerful and effective alternative. 14 June 2023
Pharmaceutical
India is to join an international system - the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) - that fosters cooperation between countries and regulatory authorities on good manufacturing practices (GMPs) in order to improve the quality of its medical products. 14 June 2023
Pharmaceutical
Just months after France’s Ipsen bought liver disease specialist Albireo (Nasdaq: ALBO), the company’s main product Bylvay (odevixibat) has won a new US nod. 14 June 2023
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
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
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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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