Regulation
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Pharmaceutical
German family-owned drug major Boehringer Ingelheim has been accused of withholding ‘important analyses’ from regulators regarding its anticoagulant Pradaxa (dabigatran). 24 July 2014
Biotechnology
The US Food and Drug Administration late yesterday approved Zydelig (idelalisib), a new drug from US biotech major Gilead Sciences to treat patients with three types of blood cancers. 24 July 2014
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the UK’s health care guidance body, has reviewed and updated its guidance on Efient (prasugrel), produced by Eli Lilly. 23 July 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Amitiza (lubiprostone) from US biopharma firm Sucampo Pharmaceuticals (Nasdaq: SCMP) as a treatment option for chronic idiopathic constipation in adults. 23 July 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued guidance recommending new prostate cancer drug Xtandi (enzalutamide) and extending the use of Yervoy (ipilimumab) for skin cancer for use on the Natiional Health Service. 23 July 2014
Pharmaceutical
US-based pharmaceutical company Halozyme Therapeutics has said it is once again enrolling and dosing patients in its ongoing Phase II trial to evaluate PEGPH20 in patients with pancreatic cancer under the revised clinical protocol agreed with the US Food and Drug Administration last month. 22 July 2014
Pharmaceutical
French active ngredients company Novasep has successfully completed US Food and Drug Administration pre-approval inspections carried out at two of its sites in France. 22 July 2014
Pharmaceutical
In the latest in an ongoing takeover attempt of Allergan by Valeant, Valeant has contacted financial authorities in both Quebec and the USA regarding Allergan’s apparent attempt to mislead investors and manipulate the market. 22 July 2014
Pharmaceutical
USA-based Arena Pharmaceuticals has entered into an exclusive marketing and supply agreement for its obesity drug Belviq (lorcaserin) with Teva Pharmaceutical Industries’ subsidiary, Abic Marketing. 21 July 2014
Biotechnology
US biotech firm Cell Therapeutics has received approval from the Israeli Ministry of Health (MOH) for Pixuvri (pixantrone). 21 July 2014
Pharmaceutical
The organization that reviews oncology medicines in Canada may unnecessarily delay approvals while cancer patients suffer, according to the findings of a new study released by the Fraser Institute, an independent, non-partisan Canadian public policy think-tank. 21 July 2014
Biosimilars
The Association of the British Pharmaceutical Industry (ABPI) and the Bioindustry Association (BIA) have teamed up to develop material on biological medicines including biosimilars to improve prescriber and stakeholder understanding and perceptions. 21 July 2014
Pharmaceutical
All Australian Health Ministers have committed to working towards the virtual elimination of new Australian HIV transmissions by the end of 2020, said the Department of Health and Ageing over the weekend. 21 July 2014
Biotechnology
US biotech firm InterMune’s Esbriet (pirfenidone) has been granted Breakthrough Therapy designation from the US Food and Drug Administration. The announcement of Friday caused a 2.7% rise to $41.70 in InterMune’s shares. 21 July 2014
Pharmaceutical
Last week, Ireland’s Health Products Regulatory Authority (HPRA) published a list of 12 active substances (or combinations of substances) contained in medicinal products (medicines) currently classified as prescription-only medicines (POM) for which it considers the method of sale and supply (MoSS) classification could be safely switched from POM to over the counter (OTC) (pharmacy sale not subject to medical prescription). 20 July 2014
Pharmaceutical
The recent decision by the heads of National Medicine Regulatory Authorities (NMRA) and West African Economic Monetary Union (WAEMU) to hasten the harmonization of drugs standards in West Africa is laudable against the backdrop of the region's quest for unity and a common destiny, meaning that what affects one country affects the others. 18 July 2014
Biotechnology
Netherlands-based Pharming Group and Salix Pharmaceuticals have received approval from the US Food and Drug Administration for Ruconest (C1 esterase inhibitor [recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). 17 July 2014
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation for German family-owned pharma major Boehringer Ingelheim’s nintedanib, a treatment in idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease. 17 July 2014
Biotechnology
Quebec-based Pendopharm, a division of privately-held Canadian drugmaker Pharmascience, says the regulator Health Canada has approved its Ibavyr (ribavirin tablets), the first stand-alone oral ribavirin for the treatment of chronic hepatitis C virus (HCV) infections in Canada. 16 July 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has today published the results of a literature search for evidence-based clinical practice guidelines on the treatment of people with breast cancer. 16 July 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
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