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Biotechnology
German family-owned pharma major Boehringer Ingelheim has submitted a Biologics License Application (BLA) to the US Food and Drug Administration, requesting an Accelerated Approval pathway, for the use of idarucizumab to reverse the anticoagulant effect of dabigatran, the active ingredient in Pradaxa (dabigatran etexilate mesylate). 2 March 2015
Biotechnology
Ireland-based drugmaker Shire has submitted a New Drug Application with the US Food and Drug Administration for its investigational compound Lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. 2 March 2015
Biotechnology
The European Commission has approved US biotech firm Celgene’s Abraxane (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC). 2 March 2015
Pharmaceutical
Taiho Pharma Europe, a subsidiary of Japanese pharma company Otsuka (TYO: 4768), has submitted a marketing authorization application to the European Medicines Agency for TAS-102 (trifluridine and tipiracil hydrochloride) for refractory metastatic colorectal cancer. 2 March 2015
Pharmaceutical
Leading global pharmaceutical producers operating in the Russian market have criticized a recent decision of the Russian government, which finally approved the provision of state preferences for domestic drugmakers in tenders for the purchase of drugs for state needs. 2 March 2015
Pharmaceutical
News items, as posted by the Korean Research-based Pharmaceutical Industry Association (KRPIA) last month, include the following. 2 March 2015
Pharmaceutical
Swiss drug major Novartis has been ordered to suspend operations in Japan for 15 days as of March 5, the first penalty of its kind for a pharma company in Japan. 2 March 2015
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the use of Swiss pharma giant Roche Avastin (bevacizumab) for cervical cancer. 28 February 2015
Biotechnology
US biotech major Biogen Idec and Nordic drugmaker Swedish Orphan Biovitrum have announced positive top-line results of the Kids B-LONG Phase III clinical study that evaluated the safety, efficacy and pharmacokinetics of Alprolix (coagulation Factor IX [Recombinant], Fc fusion protein) in children under age 12 with severe hemophilia B. 28 February 2015
Pharmaceutical
Three new medicines have been recommended for approval at the February 2015 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 27 February 2015
Pharmaceutical
In a major crackdown, India's drug regulator the National Pharmaceutical Pricing Authority has come down hard against medical device manufacturers, importers and distributors of cardiac stents, drug eluting stents and orthopaedic implants. 27 February 2015
Pharmaceutical
Zambon and its partner, fellow Italy-based Newron Pharmaceuticals, have received approval from the European Commission approved the use of Xadago (safinamide) for the treatment of idiopathic Parkinson’s disease (PD). 27 February 2015
Pharmaceutical
The European Medicines Agency has accepted the Marketing Authorization Application for Kyprolis (carfilzomib) from US biotech company Amgen and its subsidiary Onyx Pharmaceuticals for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. 27 February 2015
Pharmaceutical
Privately-held Italian drugmaker Chiesi Farmaceutici has been publicly reprimanded for providing inaccurate information to the UK’s Prescription Medicines Code Of Practice Authority (PMCPA), breaching the ABPI Code of Practice for the Pharmaceutical Industry. 27 February 2015
Pharmaceutical
The US Food and Drug Administration has approved French pharma major Sanofi’s Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. 26 February 2015
Pharmaceutical
The US Food and Drug Administration has approved antibacterial drug Avycaz (ceftazidime-avibactam) to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole. 26 February 2015
Biosimilars
Although there is widespread optimism around the first biosimilars being launched in the USA, a new report sponsored by Prime Therapeutics warns that pending regulatory decisions and state-level actions could stifle the market and reduce savings for payers and patients. 26 February 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final guidance recommending hepatitis C drugs Sovaldi (sofosbuvir) from US biotech major Gilead Sciences and Olysio (simeprevir) from US health care giant Johnson & Johnson’s Europe-based subsidiary Janssen as treatment options for some people with chronic hepatitis C. 25 February 2015
Pharmaceutical
The UK’s health regulator, the National Institute for Health and Care Excellence (NICE) has recommended three drugs for ulcerative colitis. 25 February 2015
Generics
Ireland-headquartered generics major Actavis yesterday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market budesonide extended-release tablets, 9mg. 25 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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