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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
Important research news last week included US liver disease biotech Mirum Pharmaceuticals reporting positive Phase IIb data on its volixibat in cholangitis. UK pharma major AstraZeneca released disappointing Phase III trial data on its breast cancer drug Truqap (capivasertib). Also, Denmark’s Zealand Pharma presented new data on its weight loss candidate petrelintide, an amylin agonist that could pitch itself against current blockbuster obesity treatments. On the regulatory front, the USA’s Sarepta Therapeutics received a welcome expanded indication from the US Food and Drug Administration (FDA) for its Duchenne muscular dystrophy drug Elevidys to cover older patient age groups. 23 June 2024
Pharmaceutical
US pharma major Bristol Myers Squibb saw its shares close up 2.2% at $41.93 on news of an additional indication approval for its Krazati (adagrasib) on Friday. 22 June 2024
Biotechnology
Johnson & Johnson has submitted for an additional approval for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn's disease. 21 June 2024
Biosimilars
In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars developers to gain interchangeable status for their products. 21 June 2024
Biotechnology
US precision genetic medicines firm Sarepta Therapeutic saw its close up 5% and soar a further 36.5% to $168.55 in after-hours activity, as it revealed a welcome indication extension for its Duchenne muscular dystrophy (DMD) drug. 21 June 2024
Pharmaceutical
New data analysis by University of Bath, UK, and Lund University, Sweden, academics reveals that public health in the UK could be undermined by a failing system of drug company self-regulation. 21 June 2024
Biotechnology
The US Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics, replacing the June 2022 draft guidance on this topic. 21 June 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Sofdra (sofpironium) topical gel, 12.45%. 20 June 2024
Biotechnology
Shanghai-based Dizal Pharmaceutical announced that the National Medical Products Administration of China has approved golidocitinib. 20 June 2024
Pharmaceutical
As anticipated following a positive scientific opinion, British pharma major AstraZeneca's Truqap (capivasertib) has been approved by the European Union. 20 June 2024
Biotechnology
The European Commission has granted marketing authorization for Altuvoct (efanesoctocog alfa), for the treatment and prevention of bleeds and perioperative prophylaxis in hemophilia A. 19 June 2024
Biotechnology
Chicago, USA-based biopharma giant AbbVie has picked up a new nod for Skyrizi (risankizumab-rzaa), for adults with moderately to severely active ulcerative colitis. 19 June 2024
Pharmaceutical
In the USA, the Federal Trade Commission (FTC) has expressed support for a proposed rule to require the disclosure of all pre-institution patent settlement agreements. 19 June 2024
Pharmaceutical
In Europe, revised rules for the Clinical Trials Information System (CTIS) are now applicable, offering faster access to clinical trial information. 18 June 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Capvaxive (pneumococcal 21-valent conjugate vaccine), submitted by US pharma giant Merck & Co. 18 June 2024
Biotechnology
German biotech BioNTech today announced that it has been informed by its partner, China’s MediLink Therapeutics (Suzhou), that the US Food and Drug Administration (FDA) has placed a partial clinical hold on a trial of their antibody-drug conjugate (ADC). 17 June 2024
Biotechnology
British pharma major AstraZeneca has announced that the US Food and Drug Administration has provided a new approval for Imfinzi (durvalumab). 17 June 2024
Biotechnology
Last week Swiss ophthalmic disease drug developer Oculis Holdings announced positive top-line results from a Phase IIb study of its licaminlimab for the treatment of dry eye disease. On the regulatory front, Genfit and fellow French drugmaker Ipsen received US Food and Drug Administration (FDA) approval for their liver disease treatment Iqirvo (elafibranor). Additionally, the FDA granted approval of a new indication for Bristol Myers Squibb’s Augtyro in an aggressive blood cancer. Also of note last week, US pharma Pfizer had another setback for its Duchenne muscular dystrophy candidate fordadistrogene movaparvovec, as it missed Phase III endpoints. 16 June 2024
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