Regulation
Refine Search
Biotechnology
AusBiotech, the representative body for Australia’s biotechnology industry, has made a draft submission to the country’s federal government on the future of its taxation system. 26 May 2015
Pharmaceutical
Japanese drug major Chugai Pharmaceutical has submitted a New Drug Application to Japan’s Ministry of Health, Labor and Welfare for a combination topical drug preparation of maxacalcitol and betamethasone butyrate propionate (Development Code: M8010). 26 May 2015
Pharmaceutical
Eight new medicines have been recommended for approval at the May 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 22 May 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed documents subsequently submitted by US biotech giant Gilead Sciences in the commenting procedure on the dossier assessment of the firm’s new blockbuster hepatitis C drug Harvoni (ledipasvir and sofosbuvir). 22 May 2015
Biotechnology
UK-based stem cell therapy company ReNeuron has been granted Fast Track designation by the US Food and Drug Administration for its human Retinal Progenitor Cell therapy candidate for retinitis pigmentosa. 22 May 2015
Biotechnology
The benefit assessment by Germany's Federal Joint Committee (G-BA) indicated that US biotech firm PTC Therapeutics’ Translarna (ataluren) provided a benefit for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD). 22 May 2015
Biotechnology
UK pharma major GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for mepolizumab. 22 May 2015
Pharmaceutical
US health care product company Baxter International has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20% concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies. 22 May 2015
Biotechnology
The European Medicines Agency has released draft guidelines to help facilitate the development of gene therapies for a three-month public consultation. 21 May 2015
Biotechnology
Since early last year, Australia’s Therapeutic Goods Administration (TGA) has been monitoring reports of melanoma in patients being treated with natalizumab and encouraged consumers and health professionals to report all such cases. 21 May 2015
Pharmaceutical
The US Food and Drug Administration is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling. 21 May 2015
Pharmaceutical
At a meeting today with industry analysts, senior leaders from Johnson & Johnson’s Janssen Pharmaceutical companies announced plans to file for regulatory approval of more than 10 new products between 2015 and 2019. 20 May 2015
Pharmaceutical
The US Food and Drug Administration has approved the New Drug Application for atypical antipsychotic Invega Trinza (paliperidone palmitate) from Johnson & Johnson subsidiary Janssen Pharmaceuticals under priority review for schizophrenia. 20 May 2015
Pharmaceutical
Suggested ways to improve patient safety, including tackling growing resistance to human and veterinary antibiotics, using today’s treatments more responsibly and promoting innovation, are set out in a resolution voted on Tuesday in the European Parliament. 19 May 2015
Biotechnology
US clinical-stage biotech firm bluebird bio says that it has met with regulatory authorities in Europe and the USA to discuss potential approval pathways for its LentiGlobin BB305 product candidate for the treatment of beta-thalassemia major. 19 May 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined two dossier relating to US biotech firm Celgene’s Otezla (apremilast) as to whether this drug offers an added benefit over the respective appropriate comparator therapy. 19 May 2015
Biotechnology
The US Food and Drug Administration has granted Fast Track designations to US biopharma companies Celgene Corp and Acceleron Pharma’s luspatercept for two separate indications. 19 May 2015
Pharmaceutical
There is a growing trend of health care professionals and medical practice administrators buying prescription drugs from outside of the legitimate supply chain, according to Ilisa Bernstein. 18 May 2015
Pharmaceutical
The US Food and Drug Administration is warning that several type 2 diabetes drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. 16 May 2015
Pharmaceutical
The US Food and Drug Administration has approved Pernix Therapeutics’ Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. 16 May 2015
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