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PTC picks up $150 million via voucher sale

PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024

MHRA grants PIM designation for argenx’ SB efgartigimod alfa in CIDP

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

EU shortages monitoring platform goes live

The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024

Applied Thera tanks, as FDA slaps CRL on govorestat NDA

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

FDA investigates bluebird’s Skysona over cancer risk

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

FDA generic drug science and research priorities for 2025

The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024

Ocaliva officially pulled off European market

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

BeOne gains first-line EU nod for checkpoint blocker

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

FDA to hold AdCom on Exelixis’ cabozantinib sBLA

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

EC nod for GSK’s Menveo meningococcal vaccine

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

New EC approval for Novartis’ Kisqali

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

First domestically developed ADC approved in China

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

Biden Medicare plan to drastically expand GLP-1 access

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

PDUFA target action date for Soleno’s DCCR extended by three months

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

Otsuka submits NDA in Japan for bempedoic acid

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

Eckert & Ziegler gains European approval for Theralugand

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

FDA signals progress on the western front for belantamab mafodotin

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

FDA nod for Imkeldi for certain forms of leukemia

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

StemCyte gains FDA nod for cord blood therapy

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

India seeks to set global pharma standards with its Bharat FDA

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

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FDA Focus: Suing the FDA

As many of you will already be aware, the Irish pharmaceutical company Amarin Corp is suing the US Food and Drug Administration, writes Dr Nicola Davies in her exclusive series for The Pharma Letter. 11 September 2015

EC clears acquisition of GSK's meningococcal ACWY vaccines by Pfizer

The European Commission has approved under the EU Merger Regulation the acquisition of the Nimenrix and Mencevax vaccines businesses belonging to UK pharma major GlaxoSmithKline by an Irish subsidiary of US drug giant Pfizer. 10 September 2015

Genentech's alectinib granted priority review by FDA for non-small-cell lung cancer

Genentech, a unit of Swiss pharma major Roche, has been granted priority review by the US Food and Drug Administration for its alectinib for ALK-positive, locally advanced or metastatic non-small-cell lung cancer. 10 September 2015

FDA starts review of oral formulation for Sobi's rare disease drug

Swedish Orphan Biovitrum AB (Sobi) on Thursday said the US Food and Drug Administration (FDA) has started a review of the oral suspension formulation of Orfadin (nitisinone) to treat rare genetic condition. 10 September 2015

Janssen submits MAA to EMA for daratumumab in multiple myeloma

Janssen-Cilag International has submitted a Marketing Authorization Application to the European Medicines Agency for daratumumab. 9 September 2015

EU approval for Santhera's Raxone in LHON

The European Commission has granted marketing authorization for Raxone (idebenone) from Swiss specialty pharma company Santhera Pharmaceuticals. 9 September 2015

Health Canada grants marketing authorization to Recordati's Carbaglu

Health Canada has granted marketing authorization for Carbaglu (carglumic acid) from Italian pharma company Recordati. 9 September 2015

Merck and Samsung Bioepis' Enbrel biosimilar approved in South Korea

US pharma giant Merck & Co and Samsung Bioepis today announced the approval of Brenzys (etanercept), a biosimilar of Amgen and Pfizer’s immunology drug Enbrel, by the Ministry of Food and Drug Safety (MFDS) in South Korea. 8 September 2015

Vernalis and Tris' Tuzistra XR launches in USA with extended relief formulation

UK pharma company Vernalis and specialty pharma company Tris Pharma have launched Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) in the USA. 8 September 2015

Mylan launches generic Yasmin in USA

Netherlands-incorporated Mylan today announced the US launch of drospirenone and ethinyl estradiol tablets USP, 3 mg/0.03 mg, which is the generic version of German pharma major Bayer's Yasmin Tablets 8 September 2015

Scottish Medicines Consortium approves Roche's Avastin for hard-to-treat ovarian cancer

The Scottish Medicines Consortium has approved Avastin (bevacizumab) from Roche for platinum-resistant recurrent ovarian cancer. 8 September 2015

Amgen files for EU approval of etelcalcetide

US biotech major Amgen has submitted a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy. 7 September 2015

Pharma industry pays £209 million for Q2 medicines bill

The UK pharma industry paid £209 million ($317 million) to underwrite growth of the medicines bill for the second quarter of 2015, according to an industry body report, raising concerns patients are not getting access to the right medicines at the right time. 7 September 2015

NICE recommends Merck's Keytruda for treating advanced skin cancer

The UK’s National Institute for Health and Care Excellence has recommended Keytruda (pembrolizumab) from Merck & Co for treating advanced skin cancer. 7 September 2015

EU approval for first-in-class multiple myeloma drug Farydak

The European Commission has approved Swiss pharma giant Novartis’ Farydak (panobinostat, previously known as LBH589) capsules. 6 September 2015

FDA approves new orphan drug to treat very rare autosomal recessive disorder

The US Food and Drug Administration on Friday approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. 5 September 2015

Astellas falls foul of ABPI Code of Practice

The UK subsidiary of Japanese drug major Astellas Pharma breached Clause 2 of the ABPI Code of Practice and is the subject of advertisements in the medical, pharmaceutical and nursing press. 4 September 2015

FDA extends PDUFA date for Alexion's Kanuma

Alexion Pharmaceuticals said today that the US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of the Company’s Biologics License Application (BLA) for Kanuma (sebelipase alfa). 4 September 2015

FDA grants Breakthrough Therapy designation for Roche hemophilia drug

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ACE910 in patients with hemophilia A with factor VIII inhibitors. 4 September 2015

AstraZeneca's heart-condition drug gets US FDA approval for new dosage

Anglo-Swedish drug major AstraZeneca said the US Food and Drug Administration has approved a new dose of its drug to treat patients with a history of heart attack beyond the first year. 4 September 2015

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