Regulation
Refine Search
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
Pharmaceutical
Following discussions with the US Food and Drug Administration, Bristol-Myers Squibb is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo (nivolumab) for previously treated advanced melanoma. 10 July 2014
Biotechnology
China-based stem cell research company Beike Biotechnology has been accepted into the approval process for the Chinese Food and Drug Administration which will enable the firm to use human umbilical cord-derived mesenchymal stem cells for treatment of systemic lupus erythematosus. 10 July 2014
Pharmaceutical
Although the pace of approvals for new orphan drugs - medicines that treat relatively rare conditions - have increased in the USA and Europe in recent years, patients are facing growing challenges accessing those drugs, a newly completed study by the Tufts Center for the Study of Drug Development at Tufts University has concluded. 10 July 2014
Pharmaceutical
The European Committee for Orphan Medicinal Products (COMP) gave a positive opinion recommending the approval of US drugmaker OPKO Health’s orphan drug designation for OPKO's long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B, with inhibitors to Factor VIII or Factor IX and congenital Factor VII deficiency. 10 July 2014
Pharmaceutical
Researchers have highlighted a flaw in the US Food and Drug Administration’s approval process for attention deficit/hyperactivity disorder (ADHD) medicine, according to a report published in PLOS ONE journal. 10 July 2014
Biotechnology
The US Food and Drug Administration (FDA) has informed US-based cardiovascular specialist Regado Biosciences that a clinical hold has been placed on all patient enrolling and dosing of either study drug in the ongoing Phase III REGULATE-PCI trial. 10 July 2014
Pharmaceutical
Japanese drug major Astellas Pharma has submitted a New Drug Application to the US Food and Drug Administration, seeking approval for its drug isavuconazole. 10 July 2014
Pharmaceutical
UK pharmaceutical company Proveca has reached its fourth key agreement with the European Medicines Agency (EMA) that will enable the development of a fourth drug designed specifically for children and young people. 10 July 2014
Pharmaceutical
In new draft guidance, the UK drug watchdog the National Institute for Health and Care Excellence (NICE) said today that Danish CNS drug specialist Lundbeck’s Selincro (nalmefene) should be available as an option for those who are heavy drinkers but not those who require immediate detoxification. 10 July 2014
Pharmaceutical
The European Medicines Agency management board has postponed formal adoption of the policy on publication of clinical trial data to its meeting on October 2. 10 July 2014
Pharmaceutical
The French National Assembly yesterday voted on the draft law proposal, which would potentially allow doctors to use off-label drugs even if there is an alternative drug approved. This draft law has still to be reviewed by the French Senate and a review by the French Constitutional Court is also possible. 9 July 2014
Pharmaceutical
Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa [recombinant]) has received approval for an additional indication in the USA. 9 July 2014
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC will be running a commercial process to fund medicines for rare disorders – a request for proposals (RFP). The objective of this process is to improve patients’ access to medicines for rare disorders. 9 July 2014
Biotechnology
The US Food and Drug Administration has approved privately-held US biotech firm Protein Sciences’ strain change amendment for its seasonal influenza vaccine, Flublok (trivalent recombinant hemagglutinin vaccine). 9 July 2014
Pharmaceutical
Privately held US drugmaker Purdue Pharma has been granted Priority Review designation by the US Food and Drug Administration for its once-daily, single-entity hydrocodone bitartrate tablet. 9 July 2014
Biotechnology
US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major Novartis in connection with the approval of Jakavi (ruxolitinib) in Japan for the treatment of patients with myelofibrosis. Incyte will record this amount as contract revenue in the third quarter. 8 July 2014
Pharmaceutical
US biopharma firm Sucampo Pharmaceuticals has received approval from Swissmedic, Switzerland’s Agency for Therapeutic Products, for Amitiza (lubiprostone) 24mcg for the treatment of opioid-induced constipation in adults with chronic, non-cancer pain. 8 July 2014
Generics
US generic drugmaker Mylan has launched Telmisartan Tablets USP, 20mg, 40mg and 80mg, the generic version of family-owned German pharma major Boehringer Ingelheim's Micardis tablets. 8 July 2014
Pharmaceutical
Swiss drug major Novartis has been granted Breakthrough Therapy designation for its leukemia treatment CTL019 from the US Food and Drug Administration. 8 July 2014
Biotechnology
The Scottish Medicines Consortium has issued guidance not to recommend US biotech company Celgene’s drug Imnovid (pomalidomide) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, while it has approved a multiple sclerosis treatment developed by Genzyme, a subsidiary of French drug major Sanofi. 8 July 2014
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