Regulation
Refine Search
Pharmaceutical
Clinical-stage biopharma company Newron and its commercial development partner, fellow Italy-based pharma company Zambon, have re-submitted their New Drug Application for safinamide to the US Food and Drug Administration. 29 December 2014
Pharmaceutical
Swiss drug major Roche has received Emergency Use Authorization for its LightMix Ebola Zaire rRT-PCR Test from the US Food and Drug Administration. 29 December 2014
Biotechnology
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Swiss pharma giant Novartis’ Cosentyx (secukinumab) for the treatment of both psoriasis vulgaris and psoriatic arthritis. 26 December 2014
Pharmaceutical
The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known as MDX-8704), a fixed-dose combination (FDC) of memantine extended-release, a NMDA receptor antagonist, and donepezil, an acetylcholinesterase inhibitor, from Ireland-headquartered generics major Actavis and partner Adamas Pharmaceuticals. 26 December 2014
Pharmaceutical
The Food and Drug Administration has approved Israeli generics giant Teva Pharmaceutical Industries’ Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. 24 December 2014
Biosimilars
US politics will continue to be characterized by partisanship as the Republican majorities in the House and Senate will look to dismantle unpopular aspects of the Patient Protection and Affordable Care Act, the Obama Administration’s landmark health care reform legislation, says Steven Burrill, chief executive of Burrill LLC and Burrill Media in his annual predictions for the life sciences in the new year. 24 December 2014
Pharmaceutical
Continuing its rush of year-end drug approvals, the US Food and Drug Administration late yesterday approved Danish diabetes care giant Novo Nordisk’s New Drug Application for Saxenda (liraglutide 3mg) analogue for the treatment of obesity. 24 December 2014
Pharmaceutical
Swiss biotech company Actelion has submitted a New Drug Application to the US Food and Drug Administration seeking approval for its pulmonary arterial hypertension drug Uptravi (selexipag). 23 December 2014
Biotechnology
In draft guidance issued today, UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has not recommended Millennium Pharmaceuticals’ Entyvio (vedolizumab) to treat people with Crohn’s disease after deciding that the evidence for the drug is too uncertain. 23 December 2014
Pharmaceutical
Eyecare specialist Alcon, the second-largest division of Swiss drug major Novartis, has been granted an additional indication by the European Commission for Travatan (travoprost). 23 December 2014
Pharmaceutical
USA-based BioCryst Pharmaceuticals has received approval from the US Food and Drug Administration for its Rapivab (peramivir). 23 December 2014
Pharmaceutical
The US Food and Drug Administration yesterday granted accelerated approval to US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab), a new treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs. 23 December 2014
Pharmaceutical
At the instance of Association of Pharmaceutical Research and Development (APRAD), the Ministry of Health of Ukraine (MoH) held an official meeting with the international research-based pharmaceutical industry to discuss further cooperation as a part of essential health care reform. 22 December 2014
Pharmaceutical
The US Food and Drug Administration has granted accelerated approved for Anglo-Swedish drug major AstraZeneca’s Lynparza (olaparib). 20 December 2014
Pharmaceutical
The US Food and Drug Administration on Friday confirmed the much anticipated approval of US pharma company AbbVie’s Viekira Pak to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. 20 December 2014
Pharmaceutical
The US Food and Drug Administration has approved Cubist Pharmaceuticals’Zerbaxa (ceftolozane/tazobactam) to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). 20 December 2014
Pharmaceutical
Seven new drugs have been recommended for marketing authorization at the December 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings the total number of medicines recommended for approval by the CHMP in 2014 to 82. 19 December 2014
Pharmaceutical
Privately-held Polaris Group has received orphan drug designation for ADI-PEG 20 (pegylated arginine deiminase) from the US Food and Drug Administration. 19 December 2014
Pharmaceutical
USA-based CSL Behring, a unit of Australia’s CSL Ltd, has submitted a biologics license application (BLA) to the US Food and Drug Administration for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). 18 December 2014
Pharmaceutical
US pharma company Pozen has received a second complete response letter from the US Food and Drug Administration for Yosprala (aspirin/omeprazole delayed release tablets). 18 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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze