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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
US pharma company Bristol-Myers Squibb on Thursday said Medicines Healthcare Products and Regulatory Agency (MHRA) has granted UK lung cancer patients access to treatment with potentially life-extending medicine nivolumab, through the Early Access to Medicines Scheme (EAMS), prior to the pending marketing authorization decision. 5 February 2016
Pharmaceutical
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for single-dose Emend (fosaprepitant dimeglumine) for injection. 4 February 2016
Biotechnology
US biotech firm Seattle Genetics says it will receive a one-time $20 million milestone payment under its Adcetris (brentuximab vedotin) collaboration with Takeda Pharmaceutical. 4 February 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued its final guidance recommending German pharma major Bayer’s Xofigo (radium-223 dichloride) to treat castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, who have received previous docetaxel therapy. 4 February 2016
Pharmaceutical
The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). 4 February 2016
Pharmaceutical
Danish CNS specialist Lundbeck and Otsuka Pharmaceutical Europe on Wednesday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a label update of Abilify Maintena (aripiprazole) to describe new clinical data for the treatment of acutely relapsed adults with schizophrenia. 3 February 2016
Pharmaceutical
Anglo-Swedish drug major AstraZeneca on Wednesday said the European Commission (EC) has granted conditional marketing authorization for Tagrisso (osimertinib) to treat non-small cell lung cancer (NSCLC). 3 February 2016
Pharmaceutical
Following a consultation last December, New Zealand’s Pharmaceutical Management Agency PHARMAC is today announced the approval of agreements with the local subsidiaries of Germany’s Boehringer Ingelheim and the UK’s GlaxoSmithKline involving a number of respiratory products. 3 February 2016
Generics
Indian drugmaker Sun Pharma launched of the generic version of Swiss drug firm Novartis' cancer drug Gleevec (imatinib) in the USA. 2 February 2016
Pharmaceutical
Biopharma company Stallergenes Greer, which specializes in treatments for respiratory allergies, yesterday announced that the manufacturing and distribution of immunotherapies Oralair, Actair and Alyostal venom is starting after a temporary suspension at its Stallergenes SAS plant in Antony, France. 2 February 2016
Biotechnology
US biotech firm Exelixis has announced positive overall survival (OS) results from METEOR, the Phase III pivotal trial comparing cabozantinib to everolimus in 658 patients with advanced renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). 2 February 2016
Pharmaceutical
Capitalizing on export opportunities in regulated and semi-regulated markets has been the way forward for the Indian pharmaceutical sector, with exports set to cross $55 billion by 2020 versus current exports of $18 billion. 1 February 2016
Biotechnology
Luxembourg-headquartered Steba Biotech, a privately-owned biotechnology company has announced positive top-line results from PCM304, its Latin American Phase III clinical trial of Tookad (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. 1 February 2016
Pharmaceutical
Allergan said its anti-depression drug candidate has received Breakthrough Therapy status from the US Food and Drug Administration. 1 February 2016
Pharmaceutical
The past week saw a bundle of fourth-quarter and full year financials from the biotech and pharma sector this week, with one factor paramount, especially US companies. Changes in currency year over year are wreaking havoc on the absolute numbers. That fact is that businesses with a lot of international business are hurting from the stronger dollar. 30 January 2016
Biotechnology
The European Medicines Agency has recommended granting a marketing authorization for Empliciti (elotuzumab) for the treatment of multiple myeloma. 30 January 2016
Biotechnology
The European Medicines Agency ‘s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Coagadex (human coagulation factor X) to treat factor X deficiency, a rare inherited bleeding disorder. 30 January 2016
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorization at its January 2016 meeting, two of which – for Empliciti and Coagadex – will becovered in separate stories. 30 January 2016
Pharmaceutical
US pharma giant Merck & Co on Friday said the US Food and Drug Administration has approved its Zepatier (elbasvir and grazoprevir) to treat chronic hepatitis C virus (HCV) following priority review. 29 January 2016
Pharmaceutical
Japanese drug major Eisai on Friday said the US Food and Drug Administration has approved its anticancer agent Halaven (eribulin mesylate) to treat liposarcoma, a specific type of soft tissue sarcoma. 29 January 2016
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