Regulation
Refine Search
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 today published draft guidance as part of its highly specialized technologies program that does not recommend US drugmaker Alexion’s Strensiq (asfotase alfa) for treating pediatric-onset hypophosphatasia. 3 December 2015
Biotechnology
US biotech major Gilead Sciences priced its hepatitis C treatment Sovaldi (sofosbuvir) at $1,000 per pill or $84 000 for a course of treatment, with the sole purpose of maximizing revenue, according to a US Senate investigation report into pricing of dugs released Tuesday. 2 December 2015
Generics
Mylan says that it expects to be the first to launch, upon regulatory approval and for developing country markets funded by international donors, TLE400 (tenofovir disoproxyl fumarate 300mg + lamivudine 300mg + efavirenz 400mg) for $99 per patient, per year. 2 December 2015
Biotechnology
Cellceutix Corp revealed that the US Food and Drug Administration has granted Rare Pediatric Disease designation for its Kevetrin (thioureidobutyronitrile) for the treatment of retinoblastoma. 2 December 2015
Pharmaceutical
Basilea Pharmaceutica said the European Commission in October approved the antifungal Isavuconazole (Cresemba) to treat invasive aspergillosis and mucormycosis. 2 December 2015
Pharmaceutical
Japanese drug major Astellas Pharma and the USA’s Ironwood Pharmaceuticals say that the Phase III clinical trial of linaclotide conducted in Japan in adults with irritable bowel syndrome with constipation (IBS-C) met its primary endpoints. 1 December 2015
Biosimilars
Australia’s Generic and Biosimilar Medicines Association (GBMA) on Tuesday welcomed the inclusion of Inflectra (infliximab), the first monoclonal antibody biosimilar, on the Pharmaceutical Benefits Scheme (PBS) saying the move will deliver immediate savings to the federal government. 1 December 2015
Pharmaceutical
Janssen Biotech and Janssen-Cilag International NV have submitted applications to the US Food and Drug Administratio and the European Medicines Agency seeking approval of Stelara (ustekinumab) to treat adult patients with moderately to severely active Crohn’s disease. 1 December 2015
Pharmaceutical
Horizon Pharma announced yesterday that the European Commission has adopted a binding decision to approve Ravicti (glycerol phenylbutyrate) oral liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients. 1 December 2015
Generics
Shares in India’s Jubilant Life Sciences jumped 10% Tuesday as the company announced the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for antidepressant tablets. 1 December 2015
Biotechnology
The US Food and Drug Administration granted approval today for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. 30 November 2015
Pharmaceutical
At the 26th China-US Joint Commission on Commerce and Trade (JCCT) held in Guangzhou, China, earlier this month, China and the United States agreed to further enhance cooperation in the field of food safety, joint actions against online sales of counterfeit drugs, drug and medical device registration approval and clinical trial, as well as dialogue on cosmetics supervision, in order to protect the health of the public. 30 November 2015
Pharmaceutical
The US Food and Drug Administration on Friday declined to approve expanded use of Pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) based on current data. 28 November 2015
Pharmaceutical
The European Commission has granted marketing authorization for Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding. 27 November 2015
Generics
Indian drugmaker Dr Reddy’s Laboratories said the US Food and Drug Administration have extended the timeline for replying to the warning letter issued to the company to December 7. 27 November 2015
Pharmaceutical
Swiss drug company Roche has said the European Union has given its nod of approval for the company’s Cotellic (cobimetinib) for use in combination with the drug Zelboraf (vemurafenib) to treat advanced melanoma. 26 November 2015
Pharmaceutical
Amidst growing drug development and manufacturing costs, setting up globalized drug making sites has become more common among pharma companies in the last decade or so, comments Dr Nicola Davies in her monthly exclusive for The Pharma Letter. According to the Food and Drug Administration, the amount of drug imports they regulate has doubled since 2004. 26 November 2015
Pharmaceutical
Danish allergy specialist ALK-Abello on Thursday said its sublingual allergy immunotherapy product Miticure to treat house dust mite allergic rhinitis, will now be available for prescription in Japan. 26 November 2015
Biosimilars
US biotech giant Amgen yesterday announced the submission of a Biologics License Application (BLA) with the US Food and Drug Administration for ABP 501, a biosimilar candidate to Humira. 26 November 2015
Pharmaceutical
Under its accelerated approval regulatory pathway, the US Food and Drug Administration has cleared Fluad, the first seasonal influenza vaccine containing an adjuvant, from Seqiris. 26 November 2015
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze