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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
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz). 6 September 2023
Biotechnology
Idorsia is to pay up to $345 million to reacquire rights to aprocitentan, a novel endothelin receptor blocker under development for hypertension. 6 September 2023
Biotechnology
Partners Sage Therapeutics and Biogen secured US approval for Zurzuvae (zuranolone) for adults with postpartum depression (PPD) last month. 5 September 2023
Pharmaceutical
Italy’s privately-held drug developer Italfarmaco Group today revealed that its Marketing Authorization Application (MAA) for Givinostat as a potential treatment for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicine Agency. 5 September 2023
Generics
Indian generic drugmaker Strides Pharma Science announced that its stepdown wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for mycophenolate mofetil for oral suspension USP, 200mg/mL, from the US Food and Drug Administration (FDA). 4 September 2023
Pharmaceutical
AbbVie has announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Aquipta (atogepant) for the prophylaxis of migraine in adults who have at least four migraine days per month. 4 September 2023
Biotechnology
Following its first Chinese approval earlier this year, a next generation BTK blocker, Calquence (acalabrutinib), has picked up another nod in the country. 4 September 2023
Pharmaceutical
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. 4 September 2023
Generics
The US Food and Drug Administration (FDA) on Friday announced a draft guidance for industry, “Post-Warning Letter Meetings Under GDUFA.” 2 September 2023
Biosimilars
Industry analyst GlobalData has released research suggesting that a new Humira (adalimumab) biosimilar can expect to reach over $800 million in sales by the end of the decade. 1 September 2023
Biotechnology
Enhertu (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy designations (BTDs) in the USA. 31 August 2023
Biotechnology
US ophthalmology focused biotech Outlook Therapeutics saw its shares closed down more than 80% at $0.27 yesterday, after it revealed that the US Food and Drug Administration (FDA) has issued a CRL to the company’s biologic license application (BLA) for ONS-5010. 31 August 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorizing a version of BioNTech and Pfizer’s Comirnaty COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant. 30 August 2023
Pharmaceutical
Japanese drugmaker Kyowa Kirin has received approval in its home country for a higher-dose formulation of its oral calcimimetics agent Orkedia (evocalcet). 30 August 2023
Biotechnology
Bristol Myers Squibb has picked up a new approval in the USA for its anemia med Reblozyl (luspatercept-aamt), a first-in-class therapy which promotes late-stage red blood cell maturation. 30 August 2023
Biotechnology
Swiss oncology giant Roche has broken new ground in the UK, with the first ever approval for a subcutaneous version of its checkpoint blocker Tecentriq (atezolizumab). 29 August 2023
Generics
Shares of Indian generic drugmaker Mankind Pharma (edged up 1% today, after it boasted a significant stride with the introduction of 120 DMF (Drug Master File) Quality Medicines in the Indian market. 29 August 2023
Pharmaceutical
The European Commission (EC) has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorization to include infants with a clinical diagnosis of spinal muscular atrophy (SMA) type one, type two or type three or with one to four SMN2 copies from birth to below two months. 29 August 2023
Biotechnology
US pharma giant Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF) earlier this month received US Food and Drug Administration (FDA) authorization for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV. 29 August 2023
Biotechnology
US biotech major Amgen last Monday announced that the US Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the supplementary new drug (sNDA) for full approval of its cancer drug Lumakras. US mRNA focused Moderna last week entered into a collaboration with China’s CARsgen Therapeutics to evaluate a CT041 combination as an mRNA cancer vaccine. US biotech start-up Cellares, which calls itself the first “integrated” development and manufacturing organization (IDMO), has secured $255 million in a series C financing. Also, Denmark’s Novo Nordisk last week presented new data extolling the benefits of its obesity management drug Wegovy (semaglutide) for patients with heart failure. 27 August 2023
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