Regulation
Refine Search
Biotechnology
India's Central Drugs Standard Control Organization's (CDSCO) oncology/hematology Subject Expert Committee, which advises the drug regulator, has asked the local subsidiary of Swiss pharma giant Roche to submit the efficacy results of its Phase III trial on Tecentriq (atezolizumab), an anti-cancer drug. 16 June 2022
Pharmaceutical
US pharma giant Pfizer has provided an update on the latest data on its COVID-19 treatment Paxlovid (nirmatrelvir and ritonavir tablets). 15 June 2022
Biotechnology
A key scientific panel of the US Food and Drug Administration has unanimously voted to recommend approval for Moderna’s COVID-19 vaccine in the age group six to 17. 15 June 2022
Biotechnology
Eli Lilly has achieved a first by gaining an approval in alopecia areata from the US Food and Drug Administration (FDA). 14 June 2022
Biotechnology
Biotech BeiGene has announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to January 20, 2023 for the supplementary new drug application (sNDA) submitted for Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 June 2022
Biotechnology
RNAi therapeutics company Alnylam Pharmaceuticals today announced that the US Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 14 June 2022
Biotechnology
Shares of Valneva on Monday dropped by as much as 28%, after the specialty vaccine maker warned over prospects for its COVID-19 vaccine, VLA2001. 14 June 2022
Pharmaceutical
Amylyx Pharmaceuticals’ shares closed down 3.9% at $13.00 on Monday, despite announcing it has received the first regulatory approval for its Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), from Health Canada, for the treatment of amyotrophic lateral sclerosis (ALS). 14 June 2022
Biotechnology
Vertex Pharmaceuticals and CRISPR Therapeutics have presented new data on exa-cel at the European Hematology Association (EHA) annual meeting. 13 June 2022
Biotechnology
Last week’s news saw a lot of coverage of the American Society of Clinical Oncology (ASCO) meeting, among which the presentation of Phase III data on Enhertu by AstraZeneca and Daiichi Sankyo was viewed as especially important. Almirall and partner Eli Lilly on Tuesday released impressive new data on their lebrikizumab in the treatment of dermatitis. US Food and Drug Administration advisory committee meetings also attracted a good deal of attention. First, an AdCom voted overwhelmingly for the grant of emergency use authorization of Novavax’ COVID-19 vaccine Nuvaxovid. Thursday and Friday saw consecutive positive outcomes for bluebird bio’s gene therapies, first for its elivaldogene autotemcel (eli-cel) and then for beta-thalassemia candidate betibeglogene autotemcel (beti-cel). 12 June 2022
Biotechnology
US biotech firm bluebird bio on Friday received another booster to its prospects as it announced the positive outcome of the US Food and Drug Administration’s (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) discussion of betibeglogene autotemcel (beti-cel) for the treatment of people with beta-thalassemia who require regular red blood cell (RBC) transfusions. 11 June 2022
Pharmaceutical
As part of its advice on safety-related aspects to European Medicines Agency committees stemming from its June 7-10 meetings, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed direct healthcare professional communications (DHPCs) containing important information for Neofordex (dexamethasone) and Xalkori (crizotinib). 11 June 2022
Biotechnology
Chinese biotech BeiGene today announced that the China National Medical Products Administration (NMPA) has approved the firm’s anti-PD-1 antibody, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). 10 June 2022
Biotechnology
In a surprise unanimous vote, the US Food and Drug Administration’s scientific advisors have endorsed a rare disease therapy from bluebird bio, despite a perceived cancer risk. 10 June 2022
Pharmaceutical
Pharma trade group Medicines Australia has moved quickly to ensure that major reform of Australia’s health technology assessment (HTA) system is high on the new government’s agenda. 10 June 2022
Pharmaceutical
Chinese vaccine developer Sinovac Biotech yesterday announced that it received the World Health Organization (WHO) prequalification for its poliomyelitis vaccine (Vero Cell) inactivated Sabin strain (sIPV) on June 2, 2022. 9 June 2022
Biotechnology
US RNAi therapeutics company Alnylam Pharmaceuticals today announced that zilebesiran (formerly ALN-AGT), an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), has been awarded an Innovation Passport for the treatment of hypertension by the UK Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Therapeutics and Toxicology Centre (AWTTC). 8 June 2022
Biotechnology
The European Commission has granted conditional marketing authorization for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab), developed by Swiss pharma giant Roche. 8 June 2022
Biotechnology
The Lancet has published detailed results from the Phase III TACKLE study, showing the prophylactic benefits of Evusheld (tixagevimab/cilgavimab) in COVID-19. 8 June 2022
Biotechnology
The US Food and Drug Administration has approved Dupixent (dupilumab) for certain children, aged six months to five years, with moderate-to-severe atopic dermatitis (AD). 8 June 2022
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze