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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
The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, the company announced this morning. 8 July 2014
Biotechnology
Australian health care regulator the Therapeutic Goods Administration (TGA) has approved the use of US anti-virals specialist Gilead Sciences’ Sovaldi (sofosbuvir) for the treatment of hepatitis C in Australia. 8 July 2014
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra (asunaprevir), a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. 7 July 2014
Pharmaceutical
US-based pharmaceutical company CASI, which develops therapeutics for the treatment of cancer and other diseases, has received Orphan Drug designation from the US Food and Drug Administration for its orally-active treatment of hepatocellular carcinoma (HCC). 7 July 2014
Pharmaceutical
USA-based AcelRx Pharmaceuticals revealed this morning that its partner, family-owned German drugmaker Grunenthal, has submitted a Marketing Authorization Application (MAA) to the European Medicines Authority for Zalviso (ARX-01) for the management of moderate to severe acute pain in adult patients in a medically supervised environment. 7 July 2014
Pharmaceutical
China's national vaccine supervision system has met or passed all the standard requirements of the World Health Organization, according to a WHO statement on Friday. 6 July 2014
Pharmaceutical
The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s Mekinist (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 4 July 2014
Pharmaceutical
Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, Canaglu (canagliflozin hydrate) Japan, for the treatment of patients with type 2 diabetes mellitus. 4 July 2014
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib for the treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). 4 July 2014
Pharmaceutical
Canada’s Valeant Pharmaceuticals International and its takeover target Precision Dermatology have agreed to sell or relinquish rights to the latter’s branded single-agent topical tretinoins and generic Retin-A, common acne treatments, to settle Federal Trade Commission charges that Valeant’s proposed $475 million acquisition of Precision would likely be anticompetitive, it was announced on Thursday. 4 July 2014
Pharmaceutical
The Brazilian National Health Surveillance Agency, ANVISA, has initiated a public consultation to review the RDC 103/2003. The regulation establishes the procedures and requirements for the certification of research centers conducting bioavailability and bioequivalence studies for the purpose of registration of pharmaceutical drugs in Brazil, reports Juliane Carvalho of Brazil Pharma News. 4 July 2014
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in a referral procedure regarding the authorization of Israel-based generics giant Teva Pharmaceutical Industries extended-regimen oral contraceptive, Seasonique for the prevention of pregnancy. 4 July 2014
Pharmaceutical
Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum Pharmaceuticals’ Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). 4 July 2014
Pharmaceutical
The European Commission has granted marketing authorization for a new indication for the use of UK pharma giant GlaxoSmithKline and Danish partner Genmab’s Arzerra (ofatumumab), a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. 3 July 2014
Pharmaceutical
Teva Pharmaceutical Industries says it has filed a citizen petition regarding the approvability of purported generic versions of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate). 3 July 2014
Pharmaceutical
The European Commission has issued Marketing Authorization Approval (MAA) for Halaven (eribulin) from Japanese drug major Eisai in the treatment of patients with locally advanced or metastatic breast cancer (MBC) who have progressed after at least one chemotherapeutic regimen for advanced disease. 3 July 2014
Pharmaceutical
US specialty pharma firm Insys Therapeutics yesterday revealed that the US Food and Drug Administration has granted orphan drug designation for its pharmaceutical cannabidiol (CBD) for the treatment of Dravet syndrome, a rare pediatric-onset epilepsy. 3 July 2014
Pharmaceutical
The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application for its investigational compound nintedanib has been accepted for filing by the US Food and Drug Administration and granted priority review designation. 2 July 2014
Biosimilars
A total of 32 organizations have signed a letter calling on the US Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name (INN), a practice currently in use in Europe and other markets. 2 July 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications (MAAs) in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol Respimat as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). 2 July 2014
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