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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
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
Biotechnology
In calendar year 2015, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approved 45 novel new drugs, approved as new molecular entities (NMEs) under New Drug Applications or as new therapeutic biologics under Biologics License Applications. 5 January 2016
Biotechnology
Gilead Sciences says that the US Food and Drug Administration has granted priority review to the company’s New Drug Application for an investigational, once-daily fixed-dose combination of its already approved Sovaldi (sofosbuvir; SOF) and velpatasvir (VEL). 5 January 2016
Pharmaceutical
Sunesis Pharmaceuticals has announced that the European Medicines Agency has validated the Marketing Authorization Application for vosaroxin. 4 January 2016
Biotechnology
Addex Therapeutics says that the US Food and Drug Administration has granted orphan drug designation to dipraglurant for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). 4 January 2016
Biotechnology
Chinese vaccine maker Sinovac Biotech today announced that the China Food and Drug Administration (CFDA) issued the new drug certificate and production license for its Enterovirus 71. 4 January 2016
Generics
Hikma Pharmaceuticals revealed this morning that its Abbreviated New Drug Application for neostigmine methylsulfate injection USP, multiple-dose vials has been approved by the US Food and Drug Administration. 4 January 2016
Biotechnology
The US Food and Drug Administration has granted Israel-based cell therapy products developer Pluristem Therapeutics’ PLX-PAD cells Orphan Drug designation in the treatment of severe preeclampsia. 31 December 2015
Generics
Shares in India-based Cadila Healthcare 17% on the Bombay Stock Exchange Thursday following the announcement the company has received a warning letter from the US Food and Drug Administration (FDA) regarding irregularities at its manufacturing facilities. 31 December 2015
Biotechnology
KemPharm plans to initiate development of KP746, a recently identified oral prodrug of oxymorphone. 30 December 2015
Pharmaceutical
Sanofi Pasteur, the vaccines division of French drug major Sanofi, said its dengue vaccine Dengvaxia has granted regulatory approval in Brazil. 29 December 2015
Pharmaceutical
pSivida has said that it plans to file for European Union marketing approval of its injectable micro-insert Medidur for chronic non-infectious uveitis of the posterior segment of the eye (posterior uveitis). 29 December 2015
Pharmaceutical
Danish allergy specialist ALK-Abello says that its partner for Japan, Torii Pharmaceutical, has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare (MHLW), for the Japanese cedar pollen sublingual allergy immunotherapy tablet (SLIT-tablet; TO-206). 28 December 2015
Pharmaceutical
German family-owned drugmaker Merz Pharma Group says its US subsidiary has received approval from the Food and Drug Administration for Xeomin (incobotulinumtoxinA) for the treatment of upper limb spasticity (ULS) in adult patients. 24 December 2015
Biotechnology
Israeli cell therapy specialist Pluristem Therapeutics says it has reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI). 24 December 2015
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has recommended pharma giant Merck & Co’s ezetimibe (Ezetrol) to treat hypercholesterolemia. 24 December 2015
Pharmaceutical
Adamas Pharmaceuticals has released positive top-line Phase III results of ADS-5102 for patients with Parkinson's disease. 23 December 2015
Biotechnology
Biotech firm Zealand Pharma on Wednesday said it is set to receive a $20 million milestone payment from the French drug major Sanofi following the submission of a New Drug Application for LixiLan to the US Food and Drug Administration. 23 December 2015
Biotechnology
CSL Behring has submitted its Marketing Authorization Application to the European Medicines Agency for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. 23 December 2015
Pharmaceutical
AstraZeneca says that the US Food and Drug Administration has approved Zurampic (lesinurad) in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone. 23 December 2015
Biotechnology
Shares of US biotech major Celgene rose 9% to $121.03 in after-hours trading on Tuesday, after it reported a patent settlement – or pay-for-delay deal - for its best-selling drug Revlimid (lenalidomide). 23 December 2015
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