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Biotechnology
The European Medicines Agency’s (EMA) human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy. 25 July 2022
Biosimilars
Sandoz announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics. 25 July 2022
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) has provisionally approved the Biocelect - on behalf of US biotech Novavax - COVID-19 vaccine, Nuvaxovid, for use in individuals aged 12-17 years 25 July 2022
Biotechnology
Last week’s news featured two M&A deals. First, last Tuesday Ultragenyx Pharmaceutical exercised its option to acquire development partner GeneTx for an upfront $75 million. Later, Silverback Therapeutics entered into a merger agreement with ARS Pharmaceuticals, that would see ARS equity holders owning 63% of the combined company. On the regulatory front, late Monday, the US Food and Drug Administration grated approval for Incyte’s vitiligo treatment Opzelura. US biotech VistaGen Therapeutics saw nearly 86% of its market capitalization wiped out last Friday, when it revealed that a Phase III study of its social anxiety disorder candidate PH94B had missed its primary endpoint. 24 July 2022
Pharmaceutical
The European Medicines Agency’s ’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex, developed by Denmark’s Bavarian Nordic, to include protecting adults from monkeypox disease. 22 July 2022
Biotechnology
The European Medicines Agency’s human medicines committee (CHMP) recommended 10 novel medicines for approval at its July 2022 meeting. 22 July 2022
Pharmaceutical
An upcoming meeting of the US regulator’s Oncologic Drugs Advisory Committee (ODAC) will discuss the benefit/risk profile of Oncopeptides’ Pepaxto (melphalan flufenamide). 22 July 2022
Biotechnology
French clinical-stage drug developer Acticor Biotech announced late Thursday that it has received "PRIority Medicines" status from the European Medicines Agency (EMA) for its drug candidate, glenzocimab, for the treatment of patients with stroke. 22 July 2022
Pharmaceutical
Karyopharm Therapeutics’ shares were trading up 9% at $5.22 pre-market, as it announced that the European Commission (EC) has granted Marketing Authorization for Nexpovio (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. 21 July 2022
Biosimilars
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, today announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz). 21 July 2022
Biotechnology
New Jersey, USA-based rare disease drug developer PTC Therapeutics today announced that Upstaza (eladocagene exuparvovec) was granted marketing authorization by the European Commission. 20 July 2022
Biotechnology
Comirnaty developers Pfizer and BioNTech have submitted to the European Medicines Agency for their Omicron-adapted variant. 20 July 2022
Biosimilars
The Pharmaceutical Research and Manufacturers of America (PhRMA) is to oppose what it calls “flawed price-setting proposals,” arguing instead for changes to the way Medicare covers and pays for medicines, including biosimilars. 20 July 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, the drug’s developer, Incyte, announced late Monday, when the firms share closed up 3.2% at $81.36. 20 July 2022
Biotechnology
US biopharma firm Apellis Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA). 19 July 2022
Biotechnology
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. 19 July 2022
Pharmaceutical
Qulipta (atogepant) has taken another step on its way to becoming a significant force in the world of calcitonin gene-related peptide (CGRP) receptor blocking migraine drugs. 18 July 2022
Pharmaceutical
Swiss biopharma company Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs), has resubmitted its New Drug Application (NDA) for ACER-001 to the US Food and Drug Administration (FDA). 18 July 2022
Pharmaceutical
Life science companies look to technology solution to increase efficiencies and reduce errors, whether these are related to data entry or other reasons. 18 July 2022
Pharmaceutical
The European Commission (EC) has granted conditional marketing authorization for Kinpeygo (budesonide) for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 16 July 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
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