Regulation
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Pharmaceutical
Shares in Canada-based specialty pharma company Aralez Pharmaceuticals were up more than 9% on Thursday lunchtime after the US Food and Drug Administration approved once-daily Yosprala (aspirin/omeprazole). 15 September 2016
Generics
The European Commission has approved under the EU Merger Regulation the acquisition of Anda Distribution of the USA by Teva Pharmaceutical Industries (NYSE: TEVA) of Israel. 15 September 2016
Pharmaceutical
US pharma giant Pfizer looks set to have the boxed warning removed on its quit smoking product Chantix (varenicline) in the USA. 15 September 2016
Pharmaceutical
Cancer and other patients in Australia could potentially have access to some new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced today by the Turnbull government. 15 September 2016
Pharmaceutical
Japanese pharma major Eisai has received approval from the European Commission for anticancer agent Kisplyx (lenvatinib) in combination with everolimus (Novartis' Afinitor) for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy. 15 September 2016
Pharmaceutical
GlaxoSmithKline edged up 1.48% to 1,620 pence by close of trading on Tuesday, after the company released encouraging results from a Phase III study of its investigational shingles vaccine Shingrix yesterday. 15 September 2016
Pharmaceutical
The US Food and Drug Administration will require additional time to complete its review of the New Drug Application for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome, the drug’s developer Lexicon Pharmaceuticals revealed yesterday. 15 September 2016
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend Swiss pharma giant Roche’s Gazyvaro/Gazyva (obinutuzumab) with bendamustine for treating some people with follicular lymphoma – a type of non-Hodgkin’s lymphoma. 14 September 2016
Biotechnology
The US Food and Drug Administration has granted approval for Ireland-headquartered Shire’s Cuvitru (immune globulin subcutaneous [human], 20% solution) in adult and pediatric patients two years of age and older. 14 September 2016
Pharmaceutical
In our weekly expert view piece, pharmacovigilance team leader at Berlin-based CRO, KCR, examines the increasing benefits of post-authorization studies and the collection of real-world data. 14 September 2016
Biotechnology
French drugmaker Ipsen revealed today that the European Commission has approved Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. 14 September 2016
Pharmaceutical
Australia’s Turnbull government has today introduced important legislation to ensure security and law and order is maintained, as the Coalition leads the way in allowing for the cultivation of a safe, legal and reliable local supply of cannabis for medicinal products. 14 September 2016
Pharmaceutical
Santhera Pharmaceuticals was trading more than 3% higher on Tuesday afternoon after new Phase III data was published on Raxone (idebenone) on inspiratory function in patients with Duchenne muscular dystrophy (DMD), just days after the granting of orphan drug designation for the same treatment in Australia. 13 September 2016
Pharmaceutical
Documents on the smoking cessation product Chantix (varenicline) which will be considered by a US Food and Drug Administration (FDA) advisory committee on Wednesday have questioned the validity of data provided by Pfizer. 13 September 2016
Biosimilars
Samsung Bioepis says that its Brenzys – also known as SB4, a biosimilar to Enbrel (etanercept), has received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. 13 September 2016
Biotechnology
GlaxoSmithKline today announced the regulatory submission of a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 12 September 2016
Pharmaceutical
Scotland-based MGB Biopharma announced today that the US Food and Drug Administration has granted MGB-BP-3, the firm’s lead product, Qualified Infectious Disease Product (QIDP) designation for the Treatment of Clostridium difficile-associated diarrhea (CDAD). 12 September 2016
Biosimilars
Janet Woodcock, director of the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference. 12 September 2016
Pharmaceutical
Shares of Dynavax Technologies were jumping 24.29% to $13.56 on heavy trading volume mid-Tuesday morning as investment bank William Blair said the US Food and Drug Administration’s cancellation of a November 16 Vaccines and Related Biological Products Advisory Committee meeting for the company's hepatitis B vaccine Heplisav is a net positive. 11 September 2016
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will shape an upcoming report on abuse-deterrent opioids. 9 September 2016
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
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
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