Regulation
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Pharmaceutical
The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on an additional schedule of administration for Hexyon, (DTaP-IPV-Hep B-Hib). 9 February 2015
Biotechnology
The US Food and Drug Administration on Friday approved Swiss pharma giant Roche subsidiary Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). 8 February 2015
Pharmaceutical
The USA’s Drug Enforcement Administration (DEA) has de-scheduled UK pharma major AstraZeneca’s Movantik (naloxegol) as a controlled substance. 7 February 2015
Pharmaceutical
UK pharma major GlaxoSmithKline has filed a submission with the European Medicines Agency for a variation to the Marketing Authorization for Revolade (eltrombopag), seeking an additional indication for the treatment of pediatric patients. 6 February 2015
Biotechnology
US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV (Janssen) has received approval from the European Commission for a variation to the terms of the marketing authorization of Velcade (bortezomib). 6 February 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination of Latuda (lurasidone) as to whether this new drug offers an added benefit over the appropriate comparator therapy. 6 February 2015
Pharmaceutical
After a day of rumor and speculation, late yesterday US Food and Drug Administration Commissioner Margaret Hamburg confirmed that she would be resigning from the post. 6 February 2015
Pharmaceutical
Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) has announced its latest findings regarding added benefit of Triumeq (dolutegravir/abacavir/lamivudine), a treatment for HIV from ViiV Healthcare, and GlaxoSmithKline's diabetes drug Eperzan (albiglutide), coming to mostly favorable conclusions. 5 February 2015
Pharmaceutical
The US Food and Drug Administration yesterday granted accelerated approval for pharma giant Pfizer’s Ibrance (palbociclib) to treat advanced (metastatic) breast cancer, making this the first-ever marketing clearance for the drug. 4 February 2015
Pharmaceutical
The Japanese unit of Swiss drug major Novartis is facing suspension following allegations of data manipulation in the results of Diovan (valsartan) clinical trials. 4 February 2015
Pharmaceutical
US biopharma company Arena Pharmaceuticals has received marketing authorization in South Korea for Belviq (lorcaserin HCl) via its marketing and distribution partner, Ildong. 3 February 2015
Pharmaceutical
The US Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a 9% increase over the enacted budget for FY 2015. 3 February 2015
Pharmaceutical
The US Food and Drug Administration has approved Glyxambi (empagliflozin/linagliptin) tablets from German family-owned drug major Boehringer Ingelheim and Eli Lilly to improve glycemic control in adults with type 2 diabetes. 2 February 2015
Pharmaceutical
Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Commission to market Xiapex (collagenase clostridium histolyticum) for the treatment of adult men with Peyronie’s disease. 2 February 2015
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy Designation for MPDL3280A (anti-PDL1) in non-small cell lung cancer, developed by Swiss drug major Roche. 2 February 2015
Pharmaceutical
US drug major Bristol-Myers Squibb has received approval from the US Food and Drug Administration for Evotaz (atazanavir 300mg and cobicistat 150mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. 2 February 2015
Pharmaceutical
A single state body for the control of pricing and the turnover of drugs will soon be established in Ukraine, as part of the ongoing reforms of the country’s pharmaceutical market, reports The Pharma Letter’s local correspondent. 2 February 2015
Pharmaceutical
The US Food and Drug Administration on Friday approved UK drugmaker Shire’s Vyvanse (lisdexamfetamine dimesylate) capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. 31 January 2015
Pharmaceutical
The US Food and Drug Administration has approved Prezcobix (darunavir 800mg/cobicistat 150mg) tablets, manufactured by Janssen, a subsidiary of Johnson & Johnson for the treatment of HIV. 30 January 2015
Pharmaceutical
The US Food and Drug Administration has expanded approval of Johnson & Johnson and Pharmacyclics’ Imbruvica (ibrutinib) to include the treatment of Waldenstrom’s . 30 January 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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