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The European Commission yesterday granted marketing authorization for US biotech antiviral specialists Gilead Sciences’ Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. 19 November 2014
Pharmaceutical
Chinese authorities will hand out harsher punishment for the production and sale of fake and substandard drugs as the country combats increasingly severe drug scandals, judicial authorities have said, according to a report by the state news agency Xinhua today. 18 November 2014
Biotechnology
German pharma major Bayer’s Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME). 18 November 2014
Pharmaceutical
The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug importers for their compliance of products with Good Manufacturing Practices (GMP) standards, which became mandatory in Russia since the beginning of the current year, according to an official representative of the Russian Ministry of Industry and Trade. 18 November 2014
Pharmaceutical
Former AstraZeneca serialization expert, Ian Haynes asks whether the fact that many pharma companies are dangerously behind in their implementation strategies to achieve compliance with the forthcoming European Union Safety Features regulations in the EU’s Falsified Medicines Directive (EU-FMD) will lead to a significant shake out in pharma manufacturing akin to a mass extinction event? 18 November 2014
Pharmaceutical
The Ukraine government has officially imposed state control on the prices of drugs in the domestic market, according to press service of the Ministry of Health. 18 November 2014
Pharmaceutical
Internationally health economic evaluations (HEEs) form a legally regulated fixed component in health-care decisions. This applies particularly to the drug sector, notes a new German reoport. 17 November 2014
Biotechnology
The US Food and Drug Administration on Friday approved Avastin (bevacizumab) solution for intravenous infusion in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. 16 November 2014
Biotechnology
The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). 15 November 2014
Pharmaceutical
The Association of the British Pharmaceutical Industry has spoken out against imminent changes to how NHS England will re-evaluate the medicines currently offered under the Cancer Drugs Fund in the UK. 14 November 2014
Pharmaceutical
Ethical business practices promoted by industry representative Medicines Australia in Asia Pacific are to be commended by the 2014 Asia-Pacific Economic Co-Operation Leaders’ Declaration. 14 November 2014
Pharmaceutical
The European Medicines Agency says it has taken note of the European Ombudsman’s recent remarks on the Agency’s redaction of certain documents submitted by a pharmaceutical company. 13 November 2014
Generics
US drugmaker Mallinckrodt says it has been informed by the Food and Drug Administration that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release tablets, USP may not be therapeutically equivalent to the category reference drug, Johnson & Jonson’s Concerta. 13 November 2014
Pharmaceutical
The UK’s National Health Service has updated its procedure for evaluating drugs in the Cancer Drugs Fund, which it says means more effective and promising drugs will be prioritized and made available to patients. 13 November 2014
Pharmaceutical
The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from US health care giant Johnson & Johnson’s subsidiary Janssen for Invega Sustenna (paliperidone palmitate) for monotherapy or adjunctive therapy in schizoaffective disorder. 13 November 2014
Pharmaceutical
Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris (asenapine) for the acute treatment of manic or mixed episodes in bipolar I disorder in pediatric patients, aged 10-17 accepted by the US Food and Drug Administration. 13 November 2014
Pharmaceutical
Generic and branded specialty pharma company Par Pharmaceuticals has received approval for its New Drug Application for Vasostrict (vasopressin injection, USP) from the US Food and Drug Administration. 13 November 2014
Pharmaceutical
The Scottish Medicines Consortium (SMC) has accepted German drugmaker Bayer’s Eylea (aflibercept solution for injection) for restricted use within NHS Scotland for the treatment of visual impairment due to diabetic macular oedema. 13 November 2014
Pharmaceutical
UK pharma major GlaxoSmithKline has filed an application with the European Medicines Agency for a variation to the marketing authorization for Revolade (eltrombopag), seeking an additional indication. 12 November 2014
Pharmaceutical
Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated POL7080, its lead antibiotic product, as a Qualified Infectious Disease Product (QIDP) for the treatment of ventilator-associated bacterial pneumonia (VABP) caused by Pseudomonas aeruginosa. 12 November 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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