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Pharmaceutical
KYTHERA Biopharmaceuticals has submitted a Marketing Authorization Application (MAA) in the European Union, seeking approval for ATX-101 (deoxycholic acid) injection. 18 August 2015
Generics
Mylan has confirmed that it has been sued by BTG and Johnson & Johnson subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for abiraterone acetate tablets, 250mg. 18 August 2015
Pharmaceutical
Insys Therapeutic has filed a Citizen Petition with the US Drug Enforcement Administration to request the agency reschedule its synthetic pharmaceutical cannabidiol (CBD) from Schedule I to Schedule IV. 18 August 2015
Biotechnology
The US Food and Drug Administration has approved Seattle Genetics’ Adcetris (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. 18 August 2015
Pharmaceutical
The protection of the people of South Africa against dangerous medicines and related substances depends largely on the existence of an effective and a strong health regulatory authority, said the chairperson of the Portfolio Committee on Health Mary-Ann Lindelwa Dunjwa reported by AllAfrica. 18 August 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has published guidance to help doctors, nurses and pharmacists promote and monitor the sensible use of antimicrobials - a group of medicines that kill or stop the growth of microorganisms and include antibiotics, antivirals, antiparasitics and antifungals. 18 August 2015
Pharmaceutical
Medicines regulatory agency Health Canada has approved US drugmaker Alexion Pharmaceuticals’ Strensiq (asfotase alfa) as enzyme replacement therapy for patients with confirmed diagnosis of pediatric-onset hypophosphatasia (HPP). 17 August 2015
Biotechnology
The European Commission has granted marketing authorization for US biotech firm United Therapeutics’ Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years. 17 August 2015
Biotechnology
Roche and its subsidiary Genentech today announced that, in the large pivotal Phase II study, BIRCH, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PD-L1) met its primary endpoint 17 August 2015
Pharmaceutical
Australia’s regulator the Therapeutic Goods Administration (TGA) is advising consumers and health professionals that serious cases of diabetic ketoacidosis (DKA) have been reported in patients taking prescription medicines that are inhibitors of sodium glucose co-transporter 2 (SGLT2). 14 August 2015
Pharmaceutical
Basilea Pharmaceutica has received US Food and Drug Administration designation for its investigational drug ceftobiprole as a Qualified Infectious Disease Product (QIDP). 14 August 2015
Biosimilars
US generics and biosimilars developer Hospira says it applauds the UK's National Institute for Health and Clinical Excellence (NICE) for developing and issuing a new adoption resource to further support the introduction of biosimilar infliximab. 13 August 2015
Pharmaceutical
The New Drug Application for SD-809 (deutetrabenazine) has been accepted by the US Food and Drug Administration, according to the drug’s developer, Israel-based generics giant Teva Pharmaceutical Industries. 13 August 2015
Pharmaceutical
Bristol-Myers Squibb said that the FDA has extended the action date for its application for expanded approval of Opdivo (nivolumab) to include patients with previously-untreated advanced melanoma. 13 August 2015
Biotechnology
Roche today released positive results from the Phase II M13-982 study of venetoclax, an investigational drug being developed in partnership with the USA’s AbbVie and Roche subsidiary Genentech. 12 August 2015
Generics
Allergan has confirmed it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for Posaconazole delayed-release tablets, a generic of Merck’s Noxafil. 12 August 2015
Pharmaceutical
Following an assessment of a dossier from Danish CNS specialist Lundbeck for its drug Brintellix (vortioxetine), the German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that no added benefit for the product in the treatment of depression can be derived based on the evaluable data. 12 August 2015
Pharmaceutical
The US Food and Drug Administration has approved Swedish drug developer Orexo’s Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. 12 August 2015
Pharmaceutical
Midatech Pharma (on Wednesday said its acquisition of Dara Biosciences is on track and the company has filed its form F-4 registration statement with the US Securities and Exchange Commission. 12 August 2015
Pharmaceutical
The US Food and Drug Administration has approved Taro Pharmaceutical Industries’ Keveyis (dichlorphenamide) 5mg Tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis. 11 August 2015
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
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
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