Regulation
Refine Search
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 US Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) for the treatment of COVID-19, to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. 7 July 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained almost 6% to 6,167 yen after, along with partner Biogen, it announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (BAN2401). 6 July 2022
Pharmaceutical
Excited by the prospect of renewed regulatory support for amyotrophic lateral sclerosis (ALS) candidate AMX0035, investors bought up shares in Amylyx Pharmaceuticals before the opening bell on Tuesday. 6 July 2022
Biotechnology
Trials of a potentially curative remedy for type 1 diabetes (T1D) will continue, after the US Food and Drug Administration lifted a clinical hold on the candidate. 6 July 2022
Biotechnology
Shares of Swiss pharma giant Roche edged up 2% to 325.35 francs this morning, after it announced that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio (mosunetuzumab). 6 July 2022
Pharmaceutical
Japanese drugmaker Shionogi has begun its submission of a new drug application in China for its COVID-19 antiviral S-217622. 4 July 2022
Pharmaceutical
US clinical-stage biopharma NRx Pharmaceuticals on Friday announced that the US Food and Drug Administration (FDA) has declined to issue an Emergency Use Authorization (EUA) for Zyesami (aviptadil) for a sub-group of patients that in addition to Zyesami, also received remdesivir and continued to progress. 4 July 2022
Biotechnology
Last Monday, French drugmaker Ipsen said it has agreed to acquire US epigenetic therapies specialist Epizyme and its lead candidate Tazverik, for around $247 million. Blueprint Medicines entered a deal with Sixth Street and Royalty Pharma selling them royalties to Ayvakit and Gavreto for about $1.25 billion. Switzerland’s Roivant Sciences has set up another ‘vant’ – Priovant Therapeutics - with US pharma giant Pfizer taking a 25% stake, that will develop the autoimmune disease candidate brepocitinib. Also, Denmark’s Lundbeck and Japan’s Otsuka announced encouraging Phase III results of their brexpiprazole for the treatment of agitation in Alzheimer’s disease. Finally, the US Food and Drug Administration adapted new rules for COVID-19 booster jabs. 3 July 2022
Pharmaceutical
Regulators have discussed emerging evidence to support the adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve. 1 July 2022
Biosimilars
Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines 1 July 2022
Biotechnology
Danish biotech company Genmab has announced its intent to submit a biologics license application (BLA) to the US Food and Drug Administration (FDA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL), in the second half of 2022. 1 July 2022
Biotechnology
The US Food and Drug Administration (FDA) yesterday issued a warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. 1 July 2022
Generics
This week Kelly Del Dotto, principal at USA-based patent firm Fish & Richardson P.C., provides context on the all-important Orange Book. 30 June 2022
Biotechnology
The US Food and Drug Administration (FDA) has placed Phase III studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis on partial clinical hold, said French pharma major Sanofi. 30 June 2022
Pharmaceutical
India's drug regulator seems to be taking into account the views of the domestic drug industry, which urged the Central Drugs Standards Control Organization (CDSCO) to consider extending the fast-track approval process adopted during COVID-19 to non-Covid drugs as well. Apart from domestic majors, multinational pharma companies, with their vaccines and drugs, also stand to benefit, reports The Pharma Letter’s India correspondent. 30 June 2022
Biotechnology
Coronavirus vaccine developers have been busy updating their jabs in time for cold weather booster campaigns, but a panel of US Food and Drug Administration scientists has just thrown a wrench into the works. 29 June 2022
Pharmaceutical
Specialty pharmaceutical company Santhera Pharmaceuticals has announced a delay to the finalization of its New Drug Application (NDA) for vamorolone. 29 June 2022
Pharmaceutical
German pharma major Bayer says that its Kerendia (finerenone) was recognized by the American Diabetes Association (ADA) Standards of Medical Care in Diabetes - 2022 with a new grade A recommendation for improving cardiovascular (CV) outcomes and reducing the risk of chronic kidney disease (CKD) progression in patients with CKD associated with type 2 diabetes (T2D). 29 June 2022
Pharmaceutical
Bavarian Nordic has announced that its respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV in older adults has been granted PRIME eligibility by the European Medicines Agency (EMA). 28 June 2022
Pharmaceutical
In a filing with the US Securities and Exchange Commission (SEC), central nervous system specialist Axsome Therapeutics reveals proposed labeling has been received for its depression candidate AXS-05 (bupropion/dextromethorphan). 28 June 2022
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