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
Research from industry analyst GlobalData suggests that Pfizer’s newly-approved PARP inhibitor-based combo could achieve sales of around $650 million by the end of the decade. 28 June 2023
Pharmaceutical
US pharma giant Pfizer says the US Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone. 28 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler. 28 June 2023
Pharmaceutical
Mid-size French drugmaker Ipsen is hoping to be lucky third time around in its bid to gain US Food and Drug Administration (FDA) approval for palovarotene for the prevention of heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP). 27 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B, said US pharma giant Pfizer. 27 June 2023
Biotechnology
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023
Pharmaceutical
Bristol Myers Squibb has announced that the European Commission (EC) has approved Camzyos (mavacamten) to treat symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM). 27 June 2023
Pharmaceutical
China’s National Medical Products Administration (NMPA) has approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control, from UK pharma major AstraZeneca. 27 June 2023
Biotechnology
A new antibody from Brussels-based UCB has been approved by the US Food and Drug Administration, for the treatment of certain adults with generalized myasthenia gravis (gMG). 27 June 2023
Pharmaceutical
The newly-elected presidency team of Europe’s leading trade body has met to discuss the industry’s growing concern over the impact of proposed changes to pharmaceutical legislation in the region. 26 June 2023
Biotechnology
M&A news last week saw US pharma major Eli Lilly announce its plan to acquire immunology company DICE Therapeutics for $2.4 billion. On the regulatory front, US biotech Arcellx suffered a setback, as the US Food and Drug Administration (FDA) put a hold on a clinical trial of its multiple myeloma candidate CART-ddBCMA. On a positive note, the FDA approved Belgo-Dutch firm argenx’ Vyvgart Hytrulo, the first subcutaneous injectable for generalized myasthenia gravis (gMG). Also, the US medicines regulator granted accelerated approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug Elevidys, but in a narrower patient population than had been hoped. 25 June 2023
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Litfulo (ritlecitinib), a once-daily oral treatment, for individuals aged 12 years and older with severe alopecia areata. 24 June 2023
article
Nobody can say that US biopharma Intercept Pharmaceuticals has not done all it can to reach market with a long-awaited treatment for non-alcoholic steatohepatitis (NASH). 23 June 2023
Pharmaceutical
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two novel medicines for approval at its June 2023 meeting. 23 June 2023
Biotechnology
Spikevax developer Moderna has submitted data to the US Food and Drug Administration with the aim of securing approval for the latest monovalent version of its jab. 23 June 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday approved Elevidys (delandistrogene moxeparvovec-rokl), the first gene therapy for the treatment of pediatric patients aged four through five years of age with Duchenne muscular dystrophy (DMD). 23 June 2023
Pharmaceutical
A few days after the World Health Organization (WHO) flagged seven India-made syrups during a global investigation into contaminated medicines, India's Health Minister Mansukh Mandaviya has asserted that India follows a zero-tolerance policy on spurious medicines. 23 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review, said the drug’s developer, bluebird bio. 22 June 2023
Biotechnology
Having just last month become the first company to get US approval in the therapy class, UK pharma major GSK revealed that US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of it Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. 22 June 2023
Biotechnology
Belgo-Dutch autoimmune diseases specialist argenx can now boast that it has the first subcutaneous (SC) injectable for generalized myasthenia gravis (gMG) to be approved by the US Food and Drug Administration (FDA). 21 June 2023
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