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Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
Takeda Pharmaceutical says it has completed the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study for pioglitazone containing medicines. 31 July 2015
Pharmaceutical
The European Commission has approved the use of Perjeta (pertuzumab) from Swiss drug major Roche in combination with Herceptin (trastuzumab) and chemotherapy. 31 July 2015
Biotechnology
Japanese drug major Eisai on Friday said it has partnered with Halozyme Therapeutics for early stage combination drug trial to treat advanced breast cancer. 31 July 2015
Pharmaceutical
The US Food and Drug Administration is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix (vortioxetine) and anti-blood clotting medication Brilinta (ticagrelor) have resulted in the wrong medication being prescribed or dispensed. 31 July 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines cost:benefit watchdog for England and Wales, has issued draft guidance restricting the use of Daklinza (daclatasvir) for the treatment of adult patients with chronic hepatitis C infection. 29 July 2015
Pharmaceutical
Rostec, a Russian state corporation which specializes in development, production and export of hi-tech industrial products for civil and defense sectors, plans to become the sole supplier of drugs for the treatment of HIV, tuberculosis and hepatitis for state needs this year, according to the company, reports The Pharma Letter’s local correspondent. 28 July 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment to Japan’s largest drugmaker Takeda Pharmaceutical’s ixazomib. 28 July 2015
Pharmaceutical
KYTHERA Biopharmaceuticals has received authorization from drug regulator Health Canada to market Belkyra (deoxycholic acid) “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults.” 27 July 2015
Biotechnology
There was a second piece of good news on Friday for Regeneron Pharmaceuticals and its partner France’s Sanofi, when the US Food and Drug Administration approved Praluent (alirocumab) Injection. 26 July 2015
Pharmaceutical
US pharma major Bristol-Myers Squibb’s Daklinza (daclatasvir), an NS5A replication complex inhibitor, has been approved by the US Food and Drug Administration. 26 July 2015
Pharmaceutical
The US Food and Drug Administration approved Swiss pharma giant Novartis’ Odomzo (sonidegib, formerly LDE225) 200mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC). 26 July 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Ireland-headquartered Shire’s (LSE: SHP) Intuniv (guanfacine). 26 July 2015
Biotechnology
The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. 24 July 2015
Pharmaceutical
There was good news on Friday for Swiss pharma giant Novartis, with positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), one for a melanoma treatment and other for a blood disorder drug. 24 July 2015
Pharmaceutical
Janssen Therapeutics, a subsidiary of US health care giant Johnson & Johnson, has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration to update the label for once-daily, all-oral Olysio (simeprevir) for hepatitis C. 24 July 2015
Pharmaceutical
France-based biopharmaceutical company Nicox on Friday noted Bausch + Lomb confirming the submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Vesneo. 24 July 2015
Pharmaceutical
Doctors without Borders/Médecins Sans Frontières (MSF) on Friday called for the removal of access to medicines provisions in the Trans-Pacific Partnership (TPP) trade deal, saying if not checked it could lock out a major chunk of the global population from receiving affordable medicines. 24 July 2015
Pharmaceutical
The European Medicines Agency’s Pediatric Committee (PDCO) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan (PIP). 23 July 2015
Pharmaceutical
The European Commission has approved US pharma giant Merck & Co’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. 23 July 2015
Biotechnology
Danish biotech company Genmab has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Arzerra (ofatumumab) as a maintenance therapy of patients with relapsed chronic lymphocytic leukemia. 23 July 2015
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