Regulation
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Biotechnology
US biotech firm ACADIA Pharmaceuticals says that the US Food and Drug Administration has granted Breakthrough Therapy designation to Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis. 3 September 2014
Pharmaceutical
US drug major Bristol-Myers Squibb has launched Daklinza (daclastavir) in the UK for chronic hepatitis C in adults. 3 September 2014
Biotechnology
Leading independent biotech firm Amgen has submitted a Marketing Authorization Application to the European Medicines Agency for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. 2 September 2014
Generics
UK-based Prosonix, a speciality pharmaceutical company developing a portfolio of inhaled respiratory medicines “by design,” says its Marketing Authorization Application for PSX1001 has been validated and is being assessed under the decentralized procedure. 2 September 2014
Pharmaceutical
Allergan revealed today that the European Commission has extended the marketing authorization for Ozurdex (dexamethasone 700mcg intravitreal implant in applicator). 2 September 2014
Generics
Under the auspices of the International Generic Drug Regulators Pilot , Australia’s Therapeutic Goods Administration is participating in a pilot of the Decentralized Procedure of the European Union, a collaboration on the evaluation of generic drug applications. 2 September 2014
Pharmaceutical
French drugmaker Ipsen has received priority review for its supplemental New Drug Application from the US Food and Drug Administration for Somatuline Depot injection. 1 September 2014
Pharmaceutical
The European Medicines Agency has updated its procedural guidance to ensure that marketing-authorization holders are prepared for the submission of periodic safety update reports (PSURs) for nationally authorized medicines subject to European Union single assessment. 1 September 2014
Pharmaceutical
Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. 1 September 2014
Pharmaceutical
Ophthalmic specialist ThromboGenics has received reimbursement in Spain from the Spanish Ministry of Health for its Jetrea. 1 September 2014
Pharmaceutical
Switzerland-based iron specialist Vifor Pharma says its Ferinject (ferric carboxymaltose) has met its primary endpoint in Phase III tests in patients with chronic heart failure and iron deficiency. 1 September 2014
Pharmaceutical
Swiss drug major Novartis on Saturday presented striking new data for its LZC696 heart drug at the European Society of Cardiology congress being held in Barcelona, Spain, and published simultaneously in the New England Journal of Medicine. 31 August 2014
Pharmaceutical
US firm Prestige Brands Holdings, the maker of Dramamine (dimenhydrinate), has agreed to divest assets and marketing rights for the over-the-counter motion sickness drug Bonine (meclizine) to settle US Federal Trade Commission charges that Prestige’s proposed acquisition of Insight Pharmaceuticals would likely be anticompetitive. 29 August 2014
Pharmaceutical
The US Food and Drug Administration has approved US pharma giant Pfizer’s Elelyso (taliglucerase alfa) for injection for pediatric patients with Type 1 Gaucher disease. 29 August 2014
Pharmaceutical
Japan’s largest drugmaker Takeda has completed the post-marketing commitment and data submissions to regulators including the US Food and Drug Administration and the European Medicines Agency from a 10-year epidemiology study for pioglitazone-containing medicines. 29 August 2014
Biotechnology
USA-based Amgen, the world's leading independent biotech firm, has filed a Biologics License Application to the US Food and Drug Administration for evolocumab seeking approval for the treatment of high cholesterol. 28 August 2014
Pharmaceutical
For more than two decades, the ratio of $50,000 per quality-adjusted life-year (QALY) gained by using a given health care intervention has played an important if enigmatic role in health policy circles as a benchmark for the value of care. 28 August 2014
Biosimilars
South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing authorization for Neulapeg (pegteograstim), a treatment for abnormally low level of neutrophils in patient undergoing chemotherapy. 28 August 2014
Pharmaceutical
The National Health Service England has pledged to boost the Cancer Drugs Fund by £160 million ($265 million) over two years. 28 August 2014
Pharmaceutical
In a new draft guidance issued today, the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has called for more evidence on type 2 diabetes drug Jardiance (empagliflozin), produced by German family-owned drug major Boehringer Ingelheim and partner Eli Lilly. 28 August 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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