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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
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Biotechnology
Japanese drugmaker Chugai, which is majority owned by Roche, On Friday revealed that Zenyaku Kogyo has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan (rituximab) intravenous injection 100mg and 500mg, which is co-marketed by both companies, for chronic idiopathic thrombocytopenic purpura (ITP) in children. 23 November 2024
Biotechnology
Zhongshan-based biopharma company Akeso will await the verdict of the Chinese medicines regulator on a penpulimab-based combo therapy. 22 November 2024
Pharmaceutical
The nomination of Robert F Kennedy Jr — known as RFK Jr — for the role of US Secretary of the Department of Health and Human Services (HHS) President-elect Donald Trump sent shares in vaccine companies sharply downwards. 22 November 2024
Biotechnology
Swiss pharma giant Novartis’ Cosentyx is to be made available on the National Health Service (NHS) in England and Wales for another condition affecting a a major patient group. 18 April 2017
Pharmaceutical
China has recently done much work to encourage novel drug development in the country. Among the efforts is a testing program of market authorization holder scheme (MAH), an optimized approval process for novel drugs and the requirement of clinical data validation, reports The Pharma Letter’s local correspondent Wang Fangquing. 18 April 2017
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. 18 April 2017
Biotechnology
Californian biotech firm Rigel Pharmaceuticals is renewing its bid to secure regulatory approval in the USA for fostamatinib, this time for a rare autoimmune disorder. 18 April 2017
Biotechnology
The US Food and Drug Administration has approved Lucentis (ranibizumab injection) for the monthly treatment of all forms of diabetic retinopathy, reported Genentech, a subsidiary of Swiss pharma giant Roche, which markets the drug in the USA. 18 April 2017
Pharmaceutical
In a holiday-shortened week, there were still a bunch of important announcements, among which was the US approval of Neurocrine Sciences’ movement disorder drug Ingrezza, two lots of bad news for OncoMed and Bristol-Myers Squibb offloaded two product candidates as well as entering a research collaboration with Apexigen. 17 April 2017
Biotechnology
The US Food and Drug Administration has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib, a once-daily oral JAK inhibitor for the treatment of moderate-to-severe rheumatoid arthritis (RA). 17 April 2017
Generics
Israel’s Teva Pharmaceutical Industries revealed in a filing with the US Securities and Exchange Commission that, on April 10, it received a Warning Letter from the US Food and Drug Administration. 14 April 2017
Biosimilars
An application for marketing approval of the “trastuzumab (genetical recombinant) preparation” biosimilar monoclonal antibody (CT-P6) has been submitted to Japan’s Ministry of Health, Labor and Welfare. 13 April 2017
Pharmaceutical
A new analysis comparing the performance of the US Food and Drug Administration and the European Medicines Agency has found that the FDA approves drugs three to four months faster than its European counterpart. 13 April 2017
Biotechnology
Ireland’s Health Service Executive (HSE) has announced that its latest round of negotiations with US biotech firm Vertex Pharmaceuticals were a success, bringing access to its drugs closer for cystic fibrosis (CF) patients. 13 April 2017
Pharmaceutical
In its continued effort to ensure the availability of safe and effective drugs that improve health and well-being, the US Food and Drug Administration, more specifically The Center for Drug Evaluation and Research (CDER), has released a series of more than 100 new and updated draft guidance documents this year, says Dr Nicola Davies in her regular exclusive contribution to The Pharma Letter. Below is a brief outline of some of these documents and their importance. 12 April 2017
Generics
The US Food and Drug Administration (FDA) has warned Netherlands incorporated Mylan that unless it addresses manufacturing violations at its facility in Maharashtra, India, then the agency could withhold approval of any new applications or supplements listing the firm as a drug manufacturer. 12 April 2017
Pharmaceutical
About a month ago, the Chinese Food and Drug Administration (CFDA) issued a draft proposal about easing the process for imported drugs to get into China, ie, ‘amended management for imported drugs registration.’ 12 April 2017
Biotechnology
The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). 12 April 2017
Pharmaceutical
New measures introduced by Romania’s Ministry of Health Order 269/2017 are to blame for medicines shortages, as these target all the medicines available in Romania with no time limit. 11 April 2017
Pharmaceutical
The US Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of September 8, 2017 for its decision on the New Drug Application for Zerviate (cetirizine ophthalmic solution) 0.24%. 11 April 2017
Biotechnology
In yet another negative decision of a new cancer drug, the medicines cost-effectiveness watchdog for England and Wales has issued new draft guidance that has also come in for criticism from the Institute for Cancer Research, though the latter sees a role for Pharma to reduce the cost of drug development. 11 April 2017
Pharmaceutical
The European Medicines Agency’s management board has adopted a new policy on how the EMA handles allegations of improprieties received from external parties, it was announced today. 10 April 2017
Pharmaceutical
Shares in US pharma giant Merck & Co slipped in the morning’s trading on news that the US Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the company’s Supplemental New Drug Applications for Januvia (sitagliptin) and its two Janumet (sitagliptin and metformin HCl) formulations. 7 April 2017
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