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Pharmaceutical
In a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at how the FDA is responsible for recalling dangerous drugs. 8 January 2015
Pharmaceutical
Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which had already assessed a dossier on dolutegravir in spring 2014, has now examined in another dossier of the fixed-dose combination of dolutegravir/abacavir/lamivudine, marketed by ViiV Healthcare as Triumeq, to assess whether the drug combination also offers an added benefit over the appropriate comparator therapy. 8 January 2015
Biosimilars
The US trade group the Biotechnology Industry Organization (BIO) has called on the Food and Drug Administration to release final guidance on processes and scientific criteria for the approval of biosimilars. 8 January 2015
Biosimilars
The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended approval of Swiss pharma giant Novartis’ generics subsidiary Sandoz’ investigational biosimilar filgrastim chemotherapy in the USA. 8 January 2015
Pharmaceutical
Late-stage biopharma company Soligenix has said that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the US Food and Drug Administration. 7 January 2015
Pharmaceutical
Independent UK pharma company Shield Therapeutics has received acceptance for review of the Marketing Authorization Application for Ferracru (ST10, ferric maltol) by the European Medicines Agency. 7 January 2015
Pharmaceutical
Italy-based Newron Pharmaceuticals and its partner Zambon have received a recommendation from the Euroean Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) that the European Commission approve Xadago (safinamide). 7 January 2015
Generics
At Health Canada's request, Canadian importers have agreed to quarantine health products made with active pharmaceutical ingredients (APIs) from Indian drugmaker Sri Krishna Pharmaceuticals, due to data integrity concerns. 7 January 2015
Biosimilars
In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration are recommending clearance of a biosimilar version of Neupogen (filgrastim), manufactured by Swiss drug major Novartis. 6 January 2015
Pharmaceutical
Independent Danish dermatology specialist Leo Pharma has submitted a New Drug Application to the US Food and Drug Administration for calcipotriene/betamethasone dipropionate aerosol foam 0,005%/0,064% for the treatment of psoriasis vulgaris. 6 January 2015
Biosimilars
Secretary general and chief operating officer of Turkey’s Association of Research-Based Pharmaceutical Companies (AİFD) Osman Kara has underlined the importance of innovation in pharmaceuticals and recorded that there are new risks ahead of us in the field of health care towards 2050s. 5 January 2015
Pharmaceutical
Japanese drug major Daiichi Sankyo has received approval in Japan for the manufacture and marketing of the methemoglobinemia treatment, Methylene Blue Injection 50mg (methylthioninium chloride hydrate) for toxic methemoglobinemia. 5 January 2015
Pharmaceutical
Growing demand for access to health care alongside advances in science and technology has led to heightened scrutiny of whether or not new medicines provide clinical, economic and patient value, writes Louise Parmenter, global head of operations, Epidemiology and Outcomes Research, Real-World and Late Phase Research, and Anke van Engen, senior consulting director, practice leader HTA Solutions at contract research organization Quintiles. 5 January 2015
Pharmaceutical
The US Food and Drug Administration's Center for Drug Evaluation and Research approved 41 novel medicines in 2014, 14 more than a year earlier, according to the agency’s website. That total is second only to the all-time high of 53 approvals reached in 1996. 4 January 2015
Pharmaceutical
US injectable drugs and infusion technologies specialist Hospira has received approval from the US Food and Drug Administration for Dyloject (diclofenac sodium) Injection, a proprietary non-steroidal anti-inflammatory drug (NSAID) analgesic. 31 December 2014
Biotechnology
US biotech firm Vertex Pharmaceuticals says the US Food and Drug Administration has approved a supplemental New Drug Application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis (CF) aged six and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)gene. 30 December 2014
Pharmaceutical
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has today published its Final Appraisal Determination (FAD) which recommends that Abraxane (nab-paclitaxel), from US biotech company Celgene Corp, given with gemcitabine, should not be funded by the National Health Service for previously untreated metastatic pancreatic cancer, because it concluded that its benefits compared to current treatments do not justify its cost. 30 December 2014
Pharmaceutical
Japanese drug major Sumitomo Dainippon Pharma has released positive preliminary findings from a Phase III clinical study (PASTEL study) conducted for application for approval in Japan of lurasidone, an atypical antipsychotic in the treatment of patients with schizophrenia. 30 December 2014
Biotechnology
US biotech firm BioMarin Pharmaceutical has received approval from Japan’s Ministry of Health, Labor and Welfare for Vimizim (elosulfase alfa) for the treatment of patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. 29 December 2014
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical and partner Otsuka Pharmaceuticals have been granted approval for their Takecab (vonoprazan fumarate; formerly code-named TAK-438) by the Japanese Ministry of Health, Labor and Welfare (MHLW) for treating acid-related diseases. 29 December 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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