Regulation
Refine Search
Biotechnology
Advaxis today revealed that the Food and Drug Administration has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates. 16 December 2015
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has recommended Vimizim (elosulfase alfa) for the treatment of a very rare life-limiting genetic disorder, it has been announced. 16 December 2015
Pharmaceutical
A ‘promising’ new treatment for lung cancer cannot be recommended for use in the NHS because it is not cost effective, the UK's National Institute for Health and Care Excellence (NICE) has said. 16 December 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved US pharma giant Merck & Co’s Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. 16 December 2015
Pharmaceutical
USA-based Pacira Pharmaceuticals has announced a US Food and Drug Administration U-turn, allowing the company to market its post-surgical analgesia treatment as not being limited to a specific surgery. 16 December 2015
Pharmaceutical
The Russian government will start inspections of foreign drug manufacturers supplying their products to Russia starting from next year, in accordance with a recent decree signed by Russia’s Prime Minister Dmitry Medvedev. 16 December 2015
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the medicines cost watchdog for England and Wales, this morning issued two sets of final guidance, one negative and one positive. 16 December 2015
Biotechnology
Egalet has filed a New Drug Application for Arymo ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. 15 December 2015
Pharmaceutical
Israel-based Kitov Pharmaceuticals said today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the US Food and Drug Administration. 15 December 2015
Pharmaceutical
Helsinn today announced today that Swissmedic, Switzerland’s Agency for Therapeutic Products, has approved Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults. 15 December 2015
Pharmaceutical
The US Food and Drug Administration has granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori (crizotinib). 14 December 2015
Pharmaceutical
UK-based specialist health care company BTG says that the US Food and Drug Administration has approved privately-held US firm Wellstat Therapeutics’ Vistogard (uridine triacetate). 14 December 2015
Generics
Teligent has reported the Food and Drug Administration has approved supplemental New Drug Application for the antibiotic Cefotan (cefotetan) for injection. 11 December 2015
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency, PHARMAC, has announce the approval of an agreement with the local subsidiary of US drugmaker Baxter International to fund Asacol (mesalazine) 800mg tablets. 11 December 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending enzalutamide to treat metastatic castration-resistant prostate cancer (mCRPC) 11 December 2015
Pharmaceutical
In final draft guidance published today, England and Wales medicines watchdog the National Institute for Health and Clinical Excellence (NICE) says it intends to recommend the drug Anglo-Swedish pharma major AstraZeneca’s Lynparza (olaparib) for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer. 11 December 2015
Pharmaceutical
In draft guidance published today for consultation, the UK National Institute for Health and Clinical Excellence (NICE) has provisionally recommended novel heart failure drug sacubitril valsartan, trade name Entresto from Swiss pharma giant Novartis, as an option for some people with heart failure. 11 December 2015
Pharmaceutical
Janssen says is extremely disappointed with the UK National Institute for Health and Care Excellence (NICE) draft guidance published today which does not recommend the use of Zytiga (abiraterone acetate) for the treatment of metastatic hormone-relapsed prostate cancer (mCRPC), before chemotherapy. 11 December 2015
Biosimilars
Leading Russian biopharmaceutical company Biocad has obtained a marketing authorization from the Russian Ministry of Health for its bevacizumab, a biosimilar of Swiss pharma giant Roche’s Avastin. 10 December 2015
Pharmaceutical
The new executive director of the European Medicines Agency has outlined his vision for the next five years saying he is ‘ready to address the challenges ahead.’ 10 December 2015
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 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
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