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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
Biotechnology
Chinese biotech BeiGene has announced that the China National Medical Products Administration (NMPA) has approved its anti-PD-1 antibody tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 6 January 2022
Pharmaceutical
In the UK, a negative reimbursement decision could limit the ability of prostate cancer patients to receive treatment with the PARP blocker Lynparza (olaparib). 5 January 2022
Biotechnology
Shares of PTC Therapeutics were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. 4 January 2022
Pharmaceutical
As another wave of coronavirus infections swamp India, the country has stepped up its efforts to fight the disease and has cleared two new vaccines and one anti-COVID drug for restricted use. 2 January 2022
Biotechnology
Novavax closed down 7.6% at $143.07 on Friday, despite announcing that it has completed submission of the final data package, including the complete chemistry, manufacturing and controls module, to fulfill the prerequisites for emergency use authorization (EUA) application request to the US Food and Drug Administration for NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. 1 January 2022
Pharmaceutical
US specialty pharma company Xeris Biopharma saw its share leap nearly 30% to $3.15 post-market on Thursday, after it announced that the US Food and Drug Administration had approved its Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. 31 December 2021
Pharmaceutical
The UK subsidiary of US pharma giant Pfizer today announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Great Britain for the supply and use of PF-07321332/ritonavir for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe disease. 31 December 2021
Biotechnology
US CNS-focussed biotech Amylyx Pharmaceuticals yesterday revealed that the US Food and Drug Administration has accepted for review its New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). 30 December 2021
Generics
Bangladeshi generics and active ingredients maker Beximco Pharmaceuticals today announced the launch of the world's first generic version of Pfizer’s COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir tablets, co-packaged for oral use), which was granted emergency use authorization (EUA) by the US Food and Drug Administration on December 22, 2021. 30 December 2021
Biotechnology
Privately-held Danish dermatology specialist LEO Pharma yesterday revealed that the US Food and Drug Administration has approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable 29 December 2021
Biotechnology
Daiichi Sankyo’s shares edged up nearly 2% in early trading, after the Japanese pharma major released regulatory updates on two of its investigational products. 29 December 2021
Pharmaceutical
Russia will simplify the procedure for imports of unregistered drugs against serious diseases starting from March of next year, according to recent statements by state authorities and local media reports. 28 December 2021
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the combination of Keytruda (pembrolizumab), Merck Co’s anti-PD-1 therapy, plus Lenvima Ienvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. 28 December 2021
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate (ADC) from Japan’s Daiichi Sankyo. 24 December 2021
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorization to extend the license in Great Britain for Swiss pharma giant Novartis’ Piqray (alpelisib). 24 December 2021
Biotechnology
Hot on the heels of Japanese rejection of a regulatory filing for their controversially US approved Aduhelm (aducanumab), Eisai and Biogen today announced that lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), has been granted Fast Track designation by the US Food and Drug Administration. 24 December 2021
Pharmaceutical
Following an Antimicrobial Drugs Advisory Committee narrow vote of 13-10 last month in favor of the anitviral’s benefits, the US Food and Drug Administration today issued an emergency use authorization (EUA) for Merck & Co’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
Biotechnology
US biotech Biogen and Japanese partner Eisai today announced that the First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council, which advises the Japanese Ministry of Health, Labor and Welfare (MHLW), has decided to continue deliberations on the application for the manufacturing and marketing approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. 23 December 2021
Biotechnology
Wednesday saw Swiss pharma giant Novartis gain approval from the US Food and Drug Administration for Leqvio (inclisiran) and an added indication for Cosentyx (secukinumab). 23 December 2021
Pharmaceutical
On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for pharma giant Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19). 23 December 2021
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