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Pharmaceutical
The US Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians. 17 February 2015
Pharmaceutical
Privately-held US sexual health specialists Sprout Pharmaceuticals has resubmitted its New Drug Application for flibanserin for the second time. 17 February 2015
Pharmaceutical
In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks the continuing impact of the FDA 2014 conference. 17 February 2015
Biotechnology
Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US Food and Drug Administration for Saposin C, the active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme. 17 February 2015
Biotechnology
Finnish biotech and pharma company Biotie has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products, recommending orphan drug designation for BTT1023 in primary sclerosing cholangitis. 17 February 2015
Pharmaceutical
The US Food and Drug Administration on Friday granted approval for Japanese pharma major Eisai’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC). 14 February 2015
Pharmaceutical
The US Food and Drug Administration has granted priority review designation for combination pill LCZ696 (valsartan and sacubitril), an investigational medicine for the treatment of heart failure with reduced ejection fraction (HFrEF), from Swiss pharma giant Novartis. 14 February 2015
Biotechnology
US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for multiple sclerosis, Tecfidera (dimethyl fumarate), from the Drug Controller General of India (DCGI), for people with relapsing-remitting multiple sclerosis (RRMS). 13 February 2015
Pharmaceutical
EMA’s PRAC recommends new measures to minimize known heart risks of hydroxyzine-containing medicines
The European Medicines agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. 13 February 2015
Biotechnology
The England medical costs watchdog the National Institute for Health and Care excellence (NICE) has issued final draft guidance not recommending pomalidomide, marketed by US biotech firm Celgene as Imnovid, for treating multiple myeloma. 13 February 2015
Pharmaceutical
US drugmaker AbbVie has submitted a New Drug Application to the Japanese Ministry of Health, Labor and Welfare for its ombitasvir/paritaprevir/ritonavir combination for genotype 1 chronic hepatitis C infection. 12 February 2015
Generics
Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with the US Food and drug administration, with a Paragraph IV certification for cabazitaxel solution; IV (infusion), a generic version of French pharma major Sanofi’s cancer drug Jevtana. 12 February 2015
Biotechnology
Belgian biotech company ThromboGenics, which is focused on developing and commercializing innovative ophthalmic medicines, today announced that Jetrea (ocriplasmin) has gained approval in Argentina and Israel. 12 February 2015
Pharmaceutical
Trade body Medicines Australia has made a submission to the 2015-2016 Federal Budget, asking the Australian government to recognize the ongoing sustainability of the Pharmaceutical Benefits Scheme resulting from reforms introduced in collaboration with industry. 12 February 2015
Pharmaceutical
The European Medicines Agency has published a detailed response to the European Ombudsman’s questions related to the redaction of certain elements of clinical study reports for the medicine Humira (adalimumab). 11 February 2015
Generics
US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner Onyx Pharmaceuticals (a subsidiary of Amgen), in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for sorafenib. 10 February 2015
Biotechnology
The Scottish Medicines Consortium has decided to recommend Abraxane (paclitaxel) in combination with gemcitabine for the treatment of metastatic adenocarcinoma of the pancreas. 10 February 2015
Pharmaceutical
The US Food and Drug administration has released revised draft guidance for industry, “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.” 9 February 2015
Generics
The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics drugmaker Apotex, regarding its Bangalore-based Apotex Research Private unit, citing serious manufacturing violations. 9 February 2015
Pharmaceutical
Janssen, a UK-based subsidiary of US health care giant Johnson & Johnson is disappointed with the Scottish Medicines Consortium (SMC) decision published today, which does not recommend the use of Zytiga (abiraterone acetate). 9 February 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
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