Regulation
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Biotechnology
The European Medicines Agency’s (EMA) Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. 30 April 2024
Pharmaceutical
A once-weekly insulin product developed by Novo Nordisk will be reviewed by an advisory panel, convened by the US regulator, on 24 May. 30 April 2024
Biotechnology
On April 29, the US Food and Drug Administration granted traditional approval to Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 30 April 2024
Pharmaceutical
More prominent warnings are to be added to the package insert of montelukast (Singulair) in the UK, reminding patients and healthcare professionals that they should be alert to serious behavior and mood-related changes (neuropsychiatric reactions) associated with the treatment, said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 April 2024
Pharmaceutical
Interpharma, the association of research-based pharmaceutical companies in Switzerland, has called on lawmakers to reconsider a cost containment package which it says “is putting patient access at risk.” 29 April 2024
Biosimilars
On April 25, the US Food and Drug Administration (FDA) approved the 50th biosimilar for marketing in the USA. 29 April 2024
Biotechnology
M&A news last week saw US biotech Incyte announce a $750 million offer to acquire Escient Pharmaceuticals and its immunology candidates EP262 and EP547. On the regulatory front, Travere Therapeutics last week gained European conditional approval for its IgA nephropathy drug Filspari. Regeneron signed a collaboration with fellow USA-based biotech Mammoth Biosciences, a developer of CRISPR drugs, worth around $100 million. Also of note, Swiss pharma giant Novartis presented Phase III data at the World Congress of Nephrology on its Fabhalta (iptacopan), the first oral monotherapy for paroxysmal nocturnal hemoglobinuria (PNH). 28 April 2024
Biosimilars
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its April 2024 meeting, as well as two biosimilars. 27 April 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for hemophilia B. 26 April 2024
Biotechnology
The European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use. 26 April 2024
Pharmaceutical
In a recent comment letter to US President Biden’s trade ambassador, Pharmaceutical Research and Manufacturers of America (PhRMA) encourages the Office of the US Trade Representative (USTR) to strengthen medical supply chains by negotiating meaningful trade agreements. 26 April 2024
Biotechnology
The UK’s second-largest drugmaker, GSK, expects to hear by the end of August whether the US regulator will expand the label for Jemperli (dostarlimab). 25 April 2024
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. 25 April 2024
Biosimilars
On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024
Pharmaceutical
San Diego, USA-based Travere Therapeutics and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for Filspari (sparsentan). 24 April 2024
Biotechnology
Day One Biopharmaceuticals closed Tuesday’s trading 8% higher on positive regulatory news. 24 April 2024
Biotechnology
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
Biotechnology
US biopharma Abeona Therapeutics was trading nearly 50% lower in Tuesday morning’s trading after announcing a regulatory update for prademagene zamikeracel (pz-cel). 23 April 2024
Biotechnology
Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG). 23 April 2024
Pharmaceutical
San Diegan cancer company Kura Oncology has picked up Breakthrough Therapy designation for its menin inhibitor ziftomenib. 23 April 2024
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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