Regulation
Refine Search
Biotechnology
The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, UK pharma major GSK announced today. 20 January 2025
Biotechnology
Germany’s Formycon and its licensing partner Klinge Biopharma have announced that the European Commission (EC) has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama. 20 January 2025
Pharmaceutical
Germany’s pharmaceutical sector is taking steps to combat worsening drug supply shortages, which have been driven by production bottlenecks, global dependencies, and increasing demand. 20 January 2025
Pharmaceutical
Australia’s Therapeutic Goods Administration (TGA) has called for more prominent safety warnings about the neuropsychiatric effects of montelukast. 20 January 2025
Biotechnology
UK pharma major AstraZeneca on Friday revealed that Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the USA. 18 January 2025
Biotechnology
The US Food and Drug Administration approved sotorasib (trade name Lumakras) with panitumumab Vectibix), from US biotech major Amgen, for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 17 January 2025
Biotechnology
T-cell immunotherapy company Atara Biotherapeutics closed 41% lower on Friday. 17 January 2025
Pharmaceutical
China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), from Innovent Biologics and Aosaikang Pharmaceuticals (ASK Pharm). 17 January 2025
Pharmaceutical
The US Food and Drug Administration has granted AstraZeneca’s Calquence (acalabrutinib) full approval as part of a combination therapy for mantle cell lymphoma (MCL). 17 January 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today, approved Livdelzi (seladelpar), developed by CymaBay Therapeutics, in adults for the treatment of a liver illness called primary biliary cholangitis (PBC), including pruritus. It works by controlling liver problems in the body and making the liver less inflamed 16 January 2025
Pharmaceutical
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in the European Union (EU) before. 16 January 2025
Pharmaceutical
Johnson & Johnson has started the submission of an original New Drug Application with the US Food and Drug Administration (FDA) for TAR-200. 16 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz), from US pharma major Eli Lilly, for the treatment of moderately to severely active Crohn's disease in adults. 16 January 2025
Biotechnology
Swedish immuno-oncology firm Alligator Bioscience saw its shares jump more than 13% to 0.26 kronor this morning, as it announced the positive outcome of regulatory interactions with the Paul Ehrlich Institute (PEI) of Germany and the US Food and Drug Administration (FDA) regarding the CMC development of mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. 16 January 2025
Biosimilars
Formycon and its commercialization partner, fellow German firm Fresenius Kabi, have received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Otulfi (ustekinumab). 15 January 2025
Pharmaceutical
In the USA, the National Institutes of Health (NIH) has announced a new policy aimed at ensuring affordable access to medical products developed using government-owned technology. 14 January 2025
Pharmaceutical
Chinese biopharma Hutchmed today announced that the supplemental New Drug Application for Orpathys (savolitinib) has been granted approval by the China National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration. 14 January 2025
Pharmaceutical
China's top drug regulator has recently approved the nation's first stem cell therapy to treat a type of complication associated with bone marrow transplant, as well as a novel HIV drug that only requires two shots yearly. 13 January 2025
Biosimilars
Teva Pharmaceuticals has partnered with Klinge Biopharma and Formycon to commercialize FYB203, a biosimilar to Eylea (aflibercept), in Europe and Israel. 13 January 2025
Pharmaceutical
Among significant news last week, the US Food and Drug Administration (FDA) required Agios Pharmaceuticals to amend the label for its hemolytic anemia drug Pyrukynd to reflect the risk of liver injury. Swiss ophthalmic drugs developer Oculis Holdings released positive Phase II results for its OCS-05. US drug developer Climb Bio entered into a licensing deal with China-based Mabworks Biotech on the latter’s monoclonal antibody CLYM116/MIL116. Also of note, US CRISPR gene editing company Intellia Therapeutics announced strategic plans which included cuts in programs and workforce. 12 January 2025
Biotechnology
Akeso has announced that its new drug application for gumokimab, an IL-17-targeting monoclonal antibody, has been accepted in China. 27 January 2025
Biotechnology
Eisai and Biogen have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab). 27 January 2025
Pharmaceutical
Lif, Denmark’s life sciences association, has published an opinion piece urging the government to adopt a stronger political vision for advanced therapies. 27 January 2025
Pharmaceutical
The Food and Drug Administration (FDA) last week granted the first approval for UK pharma major AstraZeneca’s Datroway (Dato-DXd) in the USA for the treatment of breast cancer. On his first day back in the White House as President of the USA, last Monday Donald Trump announced he was pulling the country out of the World Health Organization (WHO). US giant Johnson & Johnson kicked off the fourth-quarter financial results reporting season by big pharma last week, with better-than-expected figures.US mRNA vaccines specialist Moderna announced another supply contract for its COVID-19 vaccine with the European Union (EU). 26 January 2025
Pharmaceutical
US clinical-stage drug developer Stealth BioTherapeutics announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for elamipretide, a first-in-class mitochondria-targeted therapeutic in development for individuals with Barth syndrome. 24 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to NS-051/NCNP-04, which is being developed for the treatment of Duchenne muscular dystrophy (DMD) by Japanese drugmaker Nippon Shinyaku. 24 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen, marketed as Spinraza, for spinal muscular atrophy (SMA). 23 January 2025
Biotechnology
China-based Kelun-Biotech Biopharmaceutical has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody (MAb) tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). 23 January 2025
Pharmaceutical
Regulatory authorities, particularly the US Food and Drug Administration (FDA), have played a crucial role in accelerating and incentivizing the development of innovative treatments through review designations. 23 January 2025
Pharmaceutical
The new US President has repealed an executive order from October 2023, signed by the Biden administration, that sought to establish rigorous safeguards for artificial intelligence (AI) development. 22 January 2025
Pharmaceutical
The US Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (marketed under trade names including Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). 22 January 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. 22 January 2025
Biotechnology
T-cell immunotherapy company Atara Biotherapeutics closed 8% lower on Tuesd
ay, having lost 41% of its stock market value on Friday. 22 January 2025
Pharmaceutical
The US Food and Drug Administration has issued a warning letter to French drugmaker Sanofi following an inspection of its Massachusetts manufacturing site. 22 January 2025
Biotechnology
French pharma giant Sanofi has secured European Union approval for Sarclisa (isatuximab) for certain people with newly diagnosed multiple myeloma. 22 January 2025
Generics
This article explores the latest conversations around generic topical and transdermal drug delivery systems (TDS) in the US Food and Drug Administration’s (FDA dermal pharmacology space, delving into recent guidance updates and examining the challenges facing the development of generic TDS. 21 January 2025
Pharmaceutical
US healthcare giant Johnson & Johnson announced the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Spravato (esketamine) CIII nasal spray as the first and only monotherapy for adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. 21 January 2025
Biotechnology
The European Commission (EC) has approved a Marketing Authorization (MA) for Lazcluze (lazertinib), in combination with Rybrevant amivantamab), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations. 21 January 2025
Pharmaceutical
French pharma major Sanofi’s consumer healthcare business, Opella, has announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil), for erectile dysfunction (ED), from a prescription to an over-the-counter medicine. 21 January 2025
Pharmaceutical
Swiss pharma giant Novartis has filed a lawsuit against the US Department of Health and Human Services (HHS) over a proposed cash rebate model. 20 January 2025
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