Regulation
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Biotechnology
New York-based pharma giant Pfizer has secured a European approval for Abrysvo, an innovative vaccine to prevent infection with respiratory syncytial virus (RSV). 25 August 2023
Biosimilars
Switzerland-based Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. 25 August 2023
Pharmaceutical
The trade body for the British pharmaceutical industry has issued a response to a report from the Journal of Royal Society of Medicine, which raised concerns about the Innovative Medicines Fund. 25 August 2023
Biotechnology
The UK Innovative Licensing and Access Pathway Steering Group has awarded an Innovation Passport to vepdegestrant. 24 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment. 24 August 2023
Biotechnology
UK pharma major AstraZeneca today announced extended indication approvals of two major products in Japan. 24 August 2023
Biotechnology
Japanese mid-size drugmaker Kyowa Kirin says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies. 24 August 2023
Biotechnology
Bristol Myers Squibb has been granted a new European approval for Opdivo (nivolumab) as a monotherapy in skin cancer. 23 August 2023
Pharmaceutical
Fulcrum Therapeutics saw its shares gain as much as 48.5% to $5.82 pre-market yesterday following an update from the US Food and Drug Administration (FDA). 23 August 2023
Biotechnology
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting Amgen’s supplemental New Drug Application (sNDA) for the full approval of Lumakras (sotorasib). 23 August 2023
Biotechnology
While Geron had hoped for a Priority Review for its rare blood cancer candidate imetelstat, the US regulator has confirmed a standard review will now take place, with a decision due by mid-June next year. 23 August 2023
Biotechnology
US pharma giant Pfizer’s Abrysvo has won US approval for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age. 22 August 2023
Biotechnology
The European Commission (EC) has granted conditional marketing authorization (CMA) of Talvey (talquetamab), developed by Janssen Pharmaceuticals. 22 August 2023
Pharmaceutical
Medicines for Malaria Venture (MMV) today revealed that Brazil has become the first malaria-endemic country to approve the use of single-dose tafenoquine (Kozenis) for children aged two years and above in combination with chloroquine. 22 August 2023
Biotechnology
Gilead Sciences has been hit with a partial clinical hold by the US Food and Drug Administration (FDA) on the initiation of new patients in US studies evaluating magrolimab to treat acute myeloid leukemia (AML). 21 August 2023
Biotechnology
Neuroscience-focused Neurocrine Biosciences has won US Food and Drug Administration (FDA) approval for Ingrezza (valbenazine) capsules to treat adults with chorea associated with Huntington's disease (HD). 21 August 2023
Biotechnology
The US Food and Drug Administration (FDA) approved Eylea HD (aflibercept) injection 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), said Regeneron Pharmaceuticals. 21 August 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for French privately-held drugmaker Servier’s Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). 21 August 2023
Pharmaceutical
Companies supplying medicines in Australia will be required to provide additional information to the Therapeutic Goods Administration (TGA) if their products go into shortage. 21 August 2023
Biotechnology
Among the important regulatory announcements last week, on Monday US biotech Arcellx said that the Food and Drug Administration (FDA) had lifted the partial clinical hold on the trial of its multiple myeloma candidate CART-ddBCMA, which is being developed with Gilead Sciences’ Kite unit. Also, bluebird bio announced that the FDA has decided it would not be necessary to hold an advisory committee meeting ahead of its approval decision for the firm’s sickle cell disease gene therapy lovotibeglogene autotemcel (lovo-cel). In an interview with The Pharma Letter, US biotech Cytokinetics explained its philosophy on R&D and discussed the FDA complete response letter on its heart candidate omecamtiv mercarbil. Also of note, Seagen released new Phase III data showing positive results for its Tukysa in breast cancer, with the latter an important factor for Pfizer, which is in the process of acquiring the US biotech for $43 billion. 20 August 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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