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The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Generics
The European Medicines Agency has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, a contract research organization (CRO) with an analytical and a clinical site located in Bangalore, India. 24 July 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Lonsurf (trifluridine–tipiracil hydrochloride) for the treatment of patients with metastatic colorectal cancer who have received previous treatment. 23 July 2016
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its July meeting. 23 July 2016
Pharmaceutical
Brexit has sent shockwaves through the pharmaceutical and life science industries and although the exact extent of the fallout is not yet known, the impact is sure to be felt for many years to come. Exactly a month on from one of the most significant votes in British history, the Pharma Letter takes a look at the immediate aftermath of the decision and some of the potential long term implications. 23 July 2016
Biotechnology
The European Medicines Agency has recommended granting marketing authorizations in the European Union for two medicines for the treatment of advanced renal cell carcinoma (kidney cancer). 22 July 2016
Biotechnology
Puma Biotechnogy has released encouraging interim five-year invasive disease free survival results from the company's Phase III trial of PB272 (neratinib) and announced a regulatory filing. 22 July 2016
Biotechnology
US biotech Spark Therapeutics and pharma giant Pfizer have been granted Breakthrough Therapy designation from the US Food and Drug Administration for their hemophilia B treatment SPK-9001. 22 July 2016
Biotechnology
US pharma giant Merck & Co says that the US Food and Drug Administration has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab. 22 July 2016
Biotechnology
Belgium’s UCB and biotech major Amgen have submitted a Biologics License Application (BLA) to the US Food and Drug Administration for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. 22 July 2016
Pharmaceutical
The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union, is proposing changes to current guidance on first-in-human clinical trials to further improve strategies to identify and mitigate risks to trial participants. 21 July 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has recommended Translarna (ataluren), from US pharma company PTC Therapeutics, for children with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation, after reaching a ‘managed access agreement’. 20 July 2016
Pharmaceutical
The Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. 20 July 2016
Pharmaceutical
Shares in Canadian drugmaker Valeant took an upturn on Wednesday with the news that a US Food and Drug Administration advisory committee had voted unanimously in favor of approving Siliq (brodalumab) for adult patients with moderate-to-severe plaque psoriasis. 20 July 2016
Pharmaceutical
The pharmaceutical market in Vietnam will expand in value from $3.5 billion in 2015 to an estimated $6.6 billion by 2020, registering a compound annual growth rate of 13.8%, a new report shows. 20 July 2016
Pharmaceutical
In our weekly expert view piece, Darren Cooper, director of industry solutions at Stibo Systems examines the implications and potential benefits of the Indentification and Medicinal Products (IDMP) standards. 19 July 2016
Pharmaceutical
AstraZeneca today announced that the European Commission has approved its Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 European Union member countries plus Iceland, Liechtenstein and Norway. 19 July 2016
Pharmaceutical
UK pharma major GlaxoSmithKline has received approval for its cervical cancer vaccine Cervarix from the Chinese Food and Drug Administration. 19 July 2016
Pharmaceutical
Eisai and US partner Arena Pharmaceuticals have received US Food and Drug Administration approval of the New Drug Application for obesity drug Belviq XR (lorcaserin HCl) CIV extended-release 20mg tablets. 19 July 2016
Pharmaceutical
The US Food and Drug Administration has approved the use of Berinert (esterase inhibitor [human]), CSL Behring’s therapy for treating hereditary angioedema (HAE) attacks, for use in pediatric patients. 19 July 2016
Biotechnology
Bristol-Myers Squibb today announced that both the US Food and Drug Administration and European Medicines Agency have accepted marketing applications to expand the use of Opdivo (nivolumab) for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). 18 July 2016
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