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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
In order to increase the nation’s access to new drugs, the Taiwan Food and Drug Administration (TFDA) has sped up the review procedure for new drugs. 22 February 2016
Pharmaceutical
Even though the latest settlement number is large, $784.6 million, it is less than the more than $2 billion that the US Justice Department had previously estimated, the Wall Street Journal pointed out, commenting on last week’s settlement by US pharma giant Pfizer relating to the calculation of Medicaid rebates for Protonix. 21 February 2016
Pharmaceutical
The US Food and Drug Administration has approved a new indication for pharma giant Pfizer, expanding the use of Ibrance (palbociclib) 125mg capsules, the firm’s metastatic breast cancer therapy. 21 February 2016
Generics
The US Federal Trade Commission was seen to flex its muscles on Friday, as it imposed conditions on two proposed M&A deals. 21 February 2016
Pharmaceutical
Swiss pharma major Novartis revealed on Friday that the US Food and Drug Administration has granted Breakthrough Therapy designation to its PKC412 (midostaurin). 20 February 2016
Pharmaceutical
The US Food and Drug Administration yesterday approved Briviact (brivaracetam), from Belgium’s UCB, as an add-on treatment to other medications to treat partial onset seizures in patients aged 16 years and older with epilepsy. 20 February 2016
Pharmaceutical
The European Commission has granted the marketing authorization for Sanofi Pasteur MSD’s Vaxelis, a new fully-liquid hexavalent vaccine. 19 February 2016
Pharmaceutical
The European Commission (EC) has granted marketing authorization for Zurampic (lesinurad). 19 February 2016
Biotechnology
Boehringer Ingelheim will soon produce a monoclonal antibody (MAb) BGBA317 in its Shanghai facility for the Beijing-based biotech company BeiGene through a contract manufacturing deal. 18 February 2016
Pharmaceutical
At the request of the Federal Joint Committee (G-BA), the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined French pharma major Sanofi’s Praluent (alirocumab). 18 February 2016
Pharmaceutical
Boehringer Ingelheim says that its Praxbind (idarucizumab) is now available to be used commercially in England, Ireland and Wales after the Health Technology Appraisal bodies in these countries agreed that it is eligible for full reimbursement without the need for a full appraisal. 18 February 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today published draft guidance as part of its highly specialized technologies program that recommends further clinical trials are carried out to demonstrate the benefits of Kanuma (sebelipase alfa), from Alexion Pharma (Nasdaq: ALXN), for treating lysosomal acid lipase (LAL) deficiency, a rare inherited genetic disorder. 18 February 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for durvalumab (MEDI4736), a system which is designed to expedite the development of new drugs. 17 February 2016
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy Designation for Roche’s investigational medicine Ocrevus (ocrelizumab) in primary progressive multiple sclerosis (PPMS). 17 February 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined the added benefit of the drug Eklira/Bretaris (aclidinium bromide) under the Act on the Reform of the Market for Medicinal Products (AMNOG). 17 February 2016
Biotechnology
The US Food and Drug Administration has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease, said the blockbuster drug’s marketer, Gilead Sciences. 16 February 2016
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding pharma giant Merck & Co's supplemental New Drug Applications for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). 16 February 2016
Pharmaceutical
Following emerging concerns about increased reported cases of rare but serious allergic reactions with fusafungine by independent French drugmaker Servier and other sources, the European Medicines Agency initiated in September 2015 a review process. 15 February 2016
Generics
India’s Biocon, a leading biosimilars and generics drugmaker, saw its shares gain 4.8% to 464.30 rupees by midday today, after it announced its first generic formulation approval to make rosuvastatin calcium tablets in the European Union. 15 February 2016
Generics
The Netherlands Medicines Evaluation Board (MEB) wants to continue publishing the complete SmPC (Summary of Product Characteristics) and package leaflet of generic medicinal products on the MEB website, even if a patent still rests on an indication. 15 February 2016
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