Regulation
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Pharmaceutical
The US Food and Drugs Administration is failing to adequately monitor the safety of new drugs approved through its accelerated approval process, a US government report has revealed. 15 January 2016
Pharmaceutical
With a bombshell announcement earlier this week on stage at the JP Morgan Healthcare Conference taking place in San Francisco, the US Centers for Medicare and Medicaid (CMS) is once again taking a major step toward better medical outcomes at a lower cost. 15 January 2016
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter to BioMarin Pharmaceutical’s New Drug Application for Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. 14 January 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) had examined the revised added benefit dossier from US pharma major Bristol-Myers Squibb for Opdivo (nivolumab), which has been approved since June 2015 for adults with advanced melanoma. 14 January 2016
Pharmaceutical
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration has voted 12 to five in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. 14 January 2016
Generics
Netherlands-incorporated Mylan said it has filed an application with the US Food and Drug Administration seeking approval for a generic version of UK pharma major GlaxoSmithKline's best-selling lung drug Advair Diskus (fluticasone/salmeterol). 13 January 2016
Pharmaceutical
The US Senate's Health, Education, Labor and Pensions Committee unanimously voted in favour of approval of Robert Califf as Commissioner of the Food and Drug Administration (FDA). 13 January 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has released its findings with regard to added benefit on two oncology treatments, coming to different conclusions. 13 January 2016
Biotechnology
Biotech firm Galapagos NV and Gilead Sciences on Wednesday said the US Federal Trade Commission has cleared the global partnership agreement on filgotinib and now the deal is expected to close by the end of the month. 13 January 2016
Biotechnology
US biotech major Gilead Sciences has submitted a New Drug Application to the US Food and Drug Administration for tenofovir alafenamide (TAF), an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection. 13 January 2016
Pharmaceutical
The European Medicines Agency has released an overview of its 2015 key recommendations in relation to the marketing authorizations of new medicines and the safety monitoring of authorized medicines. 12 January 2016
Pharmaceutical
Otsuka Pharmaceutical has submitted a New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval for Iclusig (ponatinib). 10 January 2016
Biosimilars
Gedeon Richter says that the European Medicines Agency has accepted Richter's regulatory submission for the proposed biosimilar to teriparatide. 9 January 2016
Pharmaceutical
China’s healthcare system is notorious for “Yi Yao Yang Yi”, a long-time unspoken policy allowing hospitals to gain finical benefits through selling prescriptions. Such a policy is widely criticized as a major cause for briberies and high drug prices, so gradually erasing it is one major goal for China’s ongoing healthcare reform, writes The Pharma Letter’s correspondent Wang Fangqing. 8 January 2016
Biotechnology
Nippon Shinyaku Japanese drugmaker has submitted the New Drug Application for selexipag (development code: NS-304) to the Ministry of Health, Labor and Welfare (MHLW) for the treatment of pulmonary arterial hypertension (PAH). 8 January 2016
Pharmaceutical
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals on Friday said the US Food and Drug Administration has accepted for review the Biologics License Application (BLA) for the drug candidate to treat rheumatoid arthritis. 8 January 2016
Pharmaceutical
Danish diabetes care giant Novo Nordisk today said it has made a submission to the European Medicines Agency of the marketing approval of its long-acting factor IX, nonacog beta pegol. 7 January 2016
Generics
In response to a recent hearing of the US Senate Special Committee on Aging to examine factors contributing to “price spikes in off-patent drugs,” the Generic Pharmaceutical Association (GPhA) and 10 stakeholder groups representing pharmacists, chain drug stores, pharmacy benefit managers, public and private retirement systems, and others, sent a letter to the Committee calling for consideration of the Fair Access to Safe and Timely (FAST) Generics Act (HR 2841) to improve competition in the pharmaceutical marketplace. 7 January 2016
Pharmaceutical
Germany’s Merck has welcomed a decision by the All Wales Medicines Strategy Group (AWMSG) to recommend cetuximab (trade name Erbitux) for some colorectal cancer patients in Wales. 6 January 2016
Pharmaceutical
Healthcare giant Baxter said it has recalled two lots of intravenous solutions that may potentially contain particulate matter. 6 January 2016
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
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