Regulation
Refine Search
Pharmaceutical
Sanofi Pasteur MSD, a joint venture from the vaccines division of Sanofi and pharma giant Merck & Co, has received marketing authorization from the European Commission for its Gardasil 9. 17 June 2015
Pharmaceutical
Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the US Food and Drug Administration has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. 17 June 2015
Pharmaceutical
The US Food and Drug Administration has told Hungary’s largest drugmaker Gedeon Richter and Allergan that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine. 17 June 2015
Pharmaceutical
Emerging therapeutic categories and a string of breakthrough drug approvals are powering key drug sales across the USA and Europe, fueling a projected 5% increase in global prescription sales over the next five years. 16 June 2015
Generics
In a statement by Ralph Neas, president and chief executive of the US trade group the Generic Pharmaceutical Association (GPhA), he welcomed the opportunity that has been provided to discuss strengthening the Food and Drug Administration’s implementation of the Generic Drug User Fee Act (GDUFA). 16 June 2015
Pharmaceutical
The US Food and Drug Administration has approved US generic drugmaker Impax Laboratories’ Zomig (zolmitriptan) Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. 16 June 2015
Pharmaceutical
The US Food and Drug Administration has entered a research and collaboration agreement with online patient network PatientsLikeMe. 16 June 2015
Pharmaceutical
The US Food and Drug Administration has agreed in written and verbal communications that Aerie Pharmaceuticals may change the primary endpoint range of its second Phase III registration trial of Rhopressa, named Rocket 2. 16 June 2015
Biotechnology
Israeli clinical stage biotech RedHill Biopharma has announced positive top-line results from its Phase III study with RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection. 15 June 2015
Generics
United Therapeutics says it has received a Paragraph IV Certification Notice Letter from Watson Laboratories, advising that it has submitted an Abbreviated New Drug Application to the US Food and Drug Administration requesting approval to market a generic version of Tyvaso (treprostinil) Inhalation Solution. 15 June 2015
Pharmaceutical
The British Medical Journal has published a study showing that pharma companies routinely fail to divulge the reasons their drugs are rejected by the US Food and Drug Administration. 15 June 2015
Pharmaceutical
Japan’s largest drugmaker, Takeda Pharmaceutical says it has received an order to improve business operation from the Japanese Ministry of Health Labor and Welfare (MHLW). 13 June 2015
Pharmaceutical
The US Food and Drug Administration has approved Promacta (eltrombopag) from Swiss drug company Novartis, for the treatment of children aged six years and older with chronic immune thrombocytopenia (ITP) who have insufficient response to corticosteroids, immunoglobins or splenectomy. 12 June 2015
Pharmaceutical
The macroenvironment for the Norwegian pharmaceutical industry is improving. Politically, the centre-left coalition is expected to hold together at least until the general election but the risk of the coalition breaking up has grown, notes a new report from ResearchandMarkets. 12 June 2015
Biotechnology
There was good news for UK pharma major GlaxoSmithKline yesterday, when a US Food and Drug Administration advisory panel came to a favorable conclusion on the company’s Biologics License Application (BLA) for mepolizumab. 12 June 2015
Biotechnology
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted in favor of approving biotech major Amgen’s PCSK9 inhibitor cholesterol lowering drug Repatha (evolocumab). 11 June 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has published draft guidance in which Japanese drug major Astellas Pharma’s Xtandi (enzalutamide) is not recommended as a drug to treat advanced prostate cancer. 11 June 2015
Pharmaceutical
In draft guidance issued today for consultation, the UK Institute for Health can care Excellence (NICE) has asked Danish CNS drug specialist Lundbeck to provide more information about its drug vortioxetine (trade name Brintellix) for treating major depressive episodes in adults. 10 June 2015
Biotechnology
US clinical-stage biotech company bluebird bio says it has completed the National Institutes of Health (NIH) Recombinant DNA Advisory Committee’s (RAC) public review of the HGB-208 pediatric study protocol. 10 June 2015
Pharmaceutical
The US Food and Drug Administration has granted Breakthorugh Therapy designation to Actemra/RoActemra (tocilizumab) from Swiss pharma major Roche for systemic sclerosis (SSc). 10 June 2015
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
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
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