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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
Pharmaceutical
USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese pharma major Sumitomo Dainippon Pharma, has received approval from the US Food and Drug Administration for the supplemental New Drug Application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures. 30 August 2015
Generics
Indian drugmaker Aurobindo Pharma has received the final approval from the US Food and Drug Administration to manufacture and market entecavir tablets, 0.5mg and 1mg. 28 August 2015
Biotechnology
The US Food and Drug Administration late on Thursday approved biotech major Amgen’s Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options. 28 August 2015
Biosimilars
The US Food and Drug Administration (FDA) has released draft guidance on biosimilar medicines naming conventions. 28 August 2015
Pharmaceutical
The US Food and Drug Administration has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from German family-owned pharma major Boehringer Ingelheim and Eli Lilly, for the treatment of adults with type 2 diabetes. 28 August 2015
Biotechnology
US drugmaker Exelixis says that Swissmedic, the Swiss licensing and supervisory body, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma. 27 August 2015
Pharmaceutical
The UK’s National Institute for health and Care Excellence (NICE) has recommended Entyvio (vedolizumab) from Takeda for adults with moderate to severe Crohn’s disease who have either failed or were intolerant to an anti-TNF. 26 August 2015
Pharmaceutical
The US Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. 26 August 2015
Pharmaceutical
Japanese drugmaker Daiichi Sankyo on Wednesday said the UK's National Institute for Health and Care Excellence (NICE) has recommended its Lixiana (edoxaban) for the treatment of blood clots in legs and lungs. 26 August 2015
Biotechnology
Amgen has submitted a New Drug Application with the US Food and Drug Administration for etelcalcetide (formerly AMG 416). 25 August 2015
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation to cabozantinib, US pharma company Exelixis’ lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. 25 August 2015
Pharmaceutical
The US Food and Drug Administration late on August 24 approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients (aged one year and older) with a rare blood disorder - chronic immune thrombocytopenic purpura (ITP). 25 August 2015
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical suffered a major setback, when US District of Delaware Judge Gregory Sleet ruled against the company on the validity of a patent on its best-selling drug Velcade (bortezomib), according to a report by Bloomberg. 25 August 2015
Pharmaceutical
Japan-based Chugai Pharmaceutical said it has made a regulatory filing for its drugs to treat kidney inflammation. 25 August 2015
Generics
The US Federal Trade Commission has terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to US pharma giant Pfizer’s pending acquisition of Hospira 24 August 2015
Pharmaceutical
The UK’s Health Secretary Jeremy Hunt is to bring in a new rule from 2016 which will affect any member of senior medical staff who receives gifts and hospitality from drug companies. 24 August 2015
Pharmaceutical
NHS England has published a new Clinical Commissioning Policy making Sirturo (bedaquiline) routinely available on the National Health Service. 24 August 2015
Biotechnology
US RNA-based drug developer Sarepta Therapeutics says that the US Food and Drug Administration has granted Rare Pediatric Disease Designation for eteplirsen, a potential treatment for patients with Duchenne muscular dystrophy (DMD) who are amenable to skipping exon 51. 22 August 2015
Pharmaceutical
The US Food and Drug Administration has issued a warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate), which is used to treat actinic keratosis. 22 August 2015
Pharmaceutical
Swedish Orphan Biovitrum together with its Australian partner, the local subsidiary of Italy’s Menarini, received marketing authorization in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA). 21 August 2015
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