Regulation
Refine Search
Pharmaceutical
Swiss drug major Roche says the European Commission has approved Avastin (bevacizumab) in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic cervical carcinoma. 8 April 2015
Pharmaceutical
US biotech major Gilead Sciences, the world’s leading independent biotech firm, has submitted a New Drug Application to the US Food and Drug Administration for a new HIV treatment. 8 April 2015
Pharmaceutical
Indian drug major Dr Reddy's Laboratories and its subsidiary, Promius Pharma, have filed three 505(b)(2) New Drug Applications with the US Food and Drug Administration. 8 April 2015
Biosimilars
The Canadian Generic Pharmaceutical Association (CGPA) has established a new CGPA Biosimilars board and has elected Michel Robidoux, president and general manager of Sandoz Canada, as its inaugural chairman. 8 April 2015
Pharmaceutical
The US Food and Drug Administration has announcing the availability of a guidance for industry, titled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions.” 8 April 2015
Pharmaceutical
The US Food and Drug Administration) has accepted for review Danish diabetes care giant Novo Nordisk’s Class II Resubmissions for its ultra long-acting insulins Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), 8 April 2015
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for US personalized cancer therapy specialist Clovis Oncology’s investigational agent rucaparib. 7 April 2015
Biosimilars
The Netherlands’ Medicines Evaluation Board (MEB) has updated its position about biosimilar medicinal products, saying that biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned. 7 April 2015
Generics
Actavis confirms that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market ambrisentan tablets, a generic version of Gilead Sciences' Letairis. 7 April 2015
Pharmaceutical
Pharma regulator Health Canada has approved the use of US drugmaker Ariad Pharmaceuticals’ Iclusig (as ponatinib hydrochloride) in Canada. 7 April 2015
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world’s leading independent biotech firm, said today it has received approval from the European Commission for a new use of Vectibix (panitumumab). 6 April 2015
Pharmaceutical
As a result of the non-renewal of the license for its pneumococcal vaccine Prevenar by the Chinese authorities, US pharma giant Pfizer has said it will cease marketing the product in that country. 2 April 2015
Pharmaceutical
The Russian government plans to approve a new plan of import substitution in the national pharmaceutical industry shortly, according to Sergey Tsyb, Russia’s Deputy Minister of Industry and Trade, reports The Pharma Letter’s local correspondent. 1 April 2015
Pharmaceutical
The US Food and Drug Administration has approved Jadenu (deferasirox), manufactured by Swiss drug major Novartis. 1 April 2015
Pharmaceutical
In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at the role CROs play in pharma R&D. 1 April 2015
Pharmaceutical
A draft common strategy to 2020 for the European medicines agencies network has been opened for a three-month public consultation by the European Medicines Agency and the Heads of Medicines Agencies. 31 March 2015
Pharmaceutical
The US Food and Drug Administration is strengthening the existing warning on Feraheme (ferumoxytol), manufactured by AMAG Pharmaceuticals. 31 March 2015
Pharmaceutical
The recently implemented GAIN Act is expected to lure companies back into R&D as well as attract new participants, a new report finds. 31 March 2015
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Cerdelga (eliglustat), the only oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. 31 March 2015
Pharmaceutical
The Medicines Company (Nasdaq: MDCO) said yesterday that the European Commission has granted marketing authorization for three of its hospital acute care products, and the firm is looking for partners. 31 March 2015
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
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
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