Regulation
Refine Search
Pharmaceutical
UK-based Clinigen Group has published a new International Society for Pharmaceutical Engineering (ISPE) white paper covering regulatory-compliant mechanisms that enable access to medicines for patients who have exhausted all other treatment options. 8 August 2014
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether Danish diabetes care giant Novo Nordisk’s Tresiba (insulin degludec), alone or in combination with other blood-glucose lowering drugs, offers an added benefit over the appropriate comparator therapy. 8 August 2014
Biotechnology
In its early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether US biotech firm Biogen Idec’s new drug Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 8 August 2014
Generics
The European Union’s decentralized procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators Pilot (IGDRP), the European Medicines agency has announced. 8 August 2014
Pharmaceutical
Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that the US Food and Drug Administration has verbally confirmed it has modified the full clinical hold placed on its TKM-Ebola Investigational New Drug application to a partial clinical hold. 8 August 2014
Pharmaceutical
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) said this morning that it is very disappointed that Swiss drug pharma major Roche, the manufacturer of Kadcyla (trastuzumab emtansine), has decided not to offer its new treatment at a price that would enable it to be available for routine use in the National Health Service. 8 August 2014
Biotechnology
The European Commission has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). 7 August 2014
Pharmaceutical
Canada’s Minister of Health, Rona Ambrose, says that the government has launched a pilot project targeting patient input from Canadians with rare diseases to help inform future reviews of orphan drugs. 7 August 2014
Biotechnology
AusBiotech, a body representing the biotechnology industry in Australia, has called for a greater culture of innovation in its submission to the Australian senate standing committee on economics calling for tax reform, support for commercialization, incentives for commercial thinking and clinical trial reform. 7 August 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) is consulting again on its review of existing guidance on the use of Swiss drug major Roche’s Tarceva (erlotinib) and Anglo-Swedish pharma firm AstraZeneca’s Iressa (gefitinib) for treating non-small-cell lung cancer (NSCLC) that has progressed after prior chemotherapy. 7 August 2014
Pharmaceutical
The Food and Drug Administration has approved The Medicines Company’s Orbactiv (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). 7 August 2014
Pharmaceutical
Health Canada has approved US biotech company Celgene’s Abraxane, and gemcitabine, marketed by US drug major Eli Lilly, for first-line treatment of adults with metastatic pancreatic cancer. 6 August 2014
Biotechnology
American biopharmaceutical company Cubist has issued a voluntary recall of certain lots of Cubicin (daptomycin injection) to the user level due to the presence of glass particulate matter in vials produced by a contract manufacturer. 6 August 2014
Biosimilars
US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in calling on the Obama administration to release guidance documents on biosimilar drug approvals. 6 August 2014
Pharmaceutical
US pharma giant Pfizer has been granted a license extension by the European Commission for Enbrel (etanercept) in the treatment of adult patients with severe non-radiographic axial spondyloarthritis, a chronic, lifelong inflammatory disease. 6 August 2014
Pharmaceutical
The European Commission has approved the use of Swiss pharma major Roche’s blockbuster cancer drug Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy. 6 August 2014
Pharmaceutical
Newly-approved drugs have a one in three chance of acquiring a black box warning, or being withdrawn for safety reasons within 25 years of being approved, according to a new study conducted by several East Coast academic institutions and Public Citizen. 5 August 2014
Generics
The US Federal Trade Commission revealed yesterday that US generics drugmaker Akorn has agreed to sell its rights to develop, manufacture, and market the generic injectable tuberculosis drug, rifampin, in order to settle FTC charges that Akorn’s proposed acquisition of VersaPharm and its parent company, VPI Holdings, would likely be anticompetitive. 5 August 2014
Pharmaceutical
US drugmaker Raptor Pharmaceutical says that the European Commission has approved its application for orphan drug designation of cysteamine bitartrate, the active ingredient in RP103, for the treatment of Huntington's disease. 5 August 2014
Pharmaceutical
Patients in the UK with one of the most common forms of blood cancer can now benefit from a new injection. MabThera (rituximab) subcutaneous (SC), which is given to patients just beneath the skin, can be administered in around five minutes, compared to the current two and a half hour intravenous (IV) infusion. 5 August 2014
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