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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
Pharmaceutical
The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Roche's Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. 12 August 2022
Generics
USA-based Amneal Pharmaceuticals has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for four generics products. 12 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has granted regular approval to Swiss pharma giant Novartis’ Tabrecta (capmatinib) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. 12 August 2022
Biotechnology
The US Food and Drug Administration is not ready to let French microbiome specialist MaaT Pharma continue work on its acute graft-versus-host disease (aGvHD) candidate. 11 August 2022
Biotechnology
Belgo-Dutch autoimmune diseases specialist argenx has announced that the European Commission (EC) has approved Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 11 August 2022
Biotechnology
Dutch rare diseases biotech firm ProQR Therapeutics today provided an update on its ophthalmology programs following feedback from the European Medicines Agency (EMA) related to sepofarsen and will now focus exclusively on its Axiomer RNA-editing technology platform. 11 August 2022
Generics
Indian drugmaker Strides Pharma Science today announced that its formulation facility at Singapore underwent a US Food and Drug Administration (FDA) inspection that ended on August 8, 2022. 11 August 2022
Biotechnology
Efforts on the part of Swiss pharma giant Roche to take on AstraZeneca in the treatment of paroxysmal nocturnal hemoglobinuria (PNH) advanced a step this week. 10 August 2022
Pharmaceutical
US Health and Human Services (HHS) Secretary Xavier Becerra yesterday took action that will allow the US Food and Drug Administration (FDA) Commissioner to grant emergency use authorizations (EUA) for monkeypox vaccines, following the August 4 declaration of a public health emergency for monkeypox. 10 August 2022
Biotechnology
French drugmaker Sanofi has paused recruitment for its global tolebrutinib Phase III trials following guidance from the independent data monitoring committee (iDMC), resulting in an almost 2% drop in its share price. 9 August 2022
Biotechnology
The outlook for a much-anticipated innovative treatment for Huntington’s disease has been muddied by a surprise serious side effect in a Phase I/II trial. 9 August 2022
Pharmaceutical
US President Joe Biden looks set to secure a major legislative win that would affect drug pricing in the country, as the Inflation Reduction Act narrowly won Senate approval on Sunday. 8 August 2022
Pharmaceutical
Spanish drugmaker PharmaMar has announced that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 8 August 2022
Pharmaceutical
Myovant Sciences and Pfizer have received US Food and Drug Administration (FDA) approval for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months as per the attachment. 8 August 2022
Pharmaceutical
More people with prostate cancer, the second most common type of cancer in men globally, will soon be able to receive treatment with Nubeqa (darolutamide). 8 August 2022
Biotechnology
Among M&A news last week, US biotech Amgen on Thursday announced it is to acquire ChemoCentryx in an all-cash deal of around $3.7 billion. In the regulatory space, US rare diseases specialist Sarepta Therapeutics said it plans to file for accelerated approval from the US Food and Drug Administration (FDA) for its gene therapy SRP-9001 as a treatment for Duchenne muscular dystrophy. As a result of missed efficacy goals of a Phase III study of Innate Pharma’s monalizumab in combination with cetuximab in head and neck cancer, its partner, AstraZeneca, has said the study would be discontinued. On the deal-making front, Rigel Pharmaceuticals entered into an accord to in-license Forma Therapeutics’ myeloid leukemia (AML) candidate olutasidenib. Also, Poseida inked a licensing agreement with Roche, granting the Swiss pharma giant rights to its CAR-T cell therapy that could be worth up to $6 billion. 7 August 2022
Biotechnology
The US Food and Drug Administration (FDA) said on Friday it has approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. 6 August 2022
Pharmaceutical
Shares of Acadia Pharmaceuticals were down 7.8% at $14.40 pre-market today, after the US drugmaker said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). 5 August 2022
Biotechnology
Lynparza (olaparib) has been approved in the European Union (EU) as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer. 4 August 2022
Biosimilars
Yesterday, the US Food and Drug Administration approved Cimerli (ranibizumab-eqrn; FY201) injection, as biosimilar to, and interchangeable with, Lucentis (ranibizumab injection). This is the 37th biosimilar approval in the USA, the agency noted. 3 August 2022
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