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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
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Novartis’ Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of skin cancer 29 April 2016
Pharmaceutical
The outgoing chief executive of troubled Canadian drugmaker Valeant Pharmaceuticals has admitted to a US Senate committee that he made mistakes in leading the company’s "aggressive" strategy on buying old drugs and increasing their prices. 28 April 2016
Pharmaceutical
Novartis has received Breakthrough designations from the US Food and Drug Administration for its drug Ilaris (canakinumab) to treat three rare types of periodic fever syndromes. 28 April 2016
Biotechnology
US RNA-based drug developer Sarepta Therapeutics saw its shares plunge by a further 40% with the news that a Food and Drug Administration panel had voted against its Duchenne muscular dystrophy (DMD) drug eteplirsen. 27 April 2016
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter (CRL) for Otsuka Pharmaceutical and Proteus Digital Health “Digital Medicine,” a drug/device combination product, which combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic. 27 April 2016
Biotechnology
Sweden’s Oasmia Pharmaceutical has released positive overall survival results for Paclical/Apealea (paclitaxel) in the Phase III study that included a total of 789 patients with epithelial ovarian cancer. 27 April 2016
Pharmaceutical
In guidance published today, drug cost-effectiveness watchdog for England and Wales, the National Institute for Health and Clinical Excellence (NICE), has recommended that Swiss pharma giant Novartis’ new heart failure drug Entresto (sacubitril valsartan), the first drug of its kind, as an option for some people with heart failure. 27 April 2016
Biotechnology
US pharma major Eli Lilly announced on Tuesday that the European Commission has granted marketing authorization for Taltz (ixekizumab) for plaque psoriasis. 26 April 2016
Biotechnology
Swedish Orphan Biovitrium AB (Sobi) has gained approval from the US Food and Drug Administration for Orfadin (nitisinone) oral suspension to treat hereditary tyrosinaemia type-1 (HT-1), in combination with dietary restriction of tyrosine and phenylanine. 26 April 2016
Pharmaceutical
Pharma giant Pfizer is remaining tight-lipped about the prospect of new data on its smoking cessation med Champix (varenicline) potentially leading to the removal of black triangle warnings on the drug’s side effects. 26 April 2016
Biotechnology
Exelixis has received approval from the US Food and Drug Administration for Cabometyx (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. 26 April 2016
Biotechnology
US biotech Gilead Sciences has received marketing authorization for two doses of Descovy (emtricitabine and tenofovir alafenamide), a fixed-dose combination for the treatment of HIV-1 infection. 25 April 2016
Pharmaceutical
Swiss firm Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for Veltassa (patiromer) for oral suspension. 25 April 2016
Pharmaceutical
Aralez Pharmaceuticals reports Health Canada approval of Blexten (bilastine) for the treatment of the symptoms of seasonal allergic rhinitis (SAR) and chronic spontaneous urticaria (CSU) (such as itchiness and hives). 25 April 2016
Pharmaceutical
The Ukraine Association of Pharmaceutical Research and Development (APRaD), uniting the largest world leading pharmaceutical companies active in the research and development of new medicines with a presence in Ukraine, will disclose the information on transfers of value to healthcare professionals and organizations. 25 April 2016
Pharmaceutical
Cannabis has had a long, difficult and often contradictory relationship with the pharmaceutical world but it is making something of a resurgence and the companies that specialize in it are full of confidence for the future. 24 April 2016
Biotechnology
Gilead Sciences stock has risen sharply in the last 10 weeks, as a result of analysts upgrading the company. There was one up revision during the last seven days and five earnings per share up revisions during the last thirty days. 24 April 2016
Pharmaceutical
Lundbeck said on Friday that the US Food and Drug Administration has accepted for review the resubmission of the New Drug Application (NDA) for intravenous carbamazepine, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. 23 April 2016
Pharmaceutical
A new fast-track system to get the most innovative and transformative drugs to patients more quickly could be introduced in England and Wales, a conference has heard. 22 April 2016
Biotechnology
Sarepta Therapeutics has suffered a further share-busting setback over its attempts to gain accelerated US Food and Drug Administration approval for eteplirsen as a treatment for certain patients with Duchenne muscular dystrophy (DMD). 22 April 2016
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