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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
Biotechnology
The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week in a push for drug safety as well as increased government transparency. 19 February 2014
Pharmaceutical
The US Food and Drug Administration is initiating a Secure Supply Chain Pilot Program to enhance the security of imported drugs. 19 February 2014
Biotechnology
Shares of US biotech firm Chelsea Therapeutics soared 38% to $6.75 in after-hours trading yesterday, when the US Food and Drug Administration approved the company’s Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). 19 February 2014
Biotechnology
US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application (MAA) for Heplisav, its investigational hepatitis B vaccine. 18 February 2014
Pharmaceutical
The US Food and Drug Administration’s visit to India concluded with roundtable meetings organized by the Federation of Indian Chambers of Commerce and Industries. 18 February 2014
Pharmaceutical
Children with cancer are being denied potentially life-saving drugs because European Union rules are allowing companies to trial some drugs only in adults, leading cancer experts warn today. 18 February 2014
Pharmaceutical
European experts have claimed as unlawful the measures introduced by the amendments to the Act for Medicinal Products in Human Medicine which applies a new licensing regime for export. 17 February 2014
Pharmaceutical
UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody for the treatment of metastatic melanoma by the US Food and Drug Administration. 17 February 2014
Pharmaceutical
The US Food and Drug Administration on Friday (February 14) approved BioMarin Pharmaceutical’s Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). 17 February 2014
Pharmaceutical
There was further negative news for Germany’s Bayer and partner US health care giant Johnson & Johnson, with the US Food and Drug Administration announcing a further delay in the use of Xarelto (rivaroxaban) for an additional indication. 14 February 2014
Pharmaceutical
Here's our take on the week's top stories. 14 February 2014
Pharmaceutical
Germany’s Bayer says it has successfully concluded the decentralized European registration procedure for its new transparent low dose contraceptive patch (gestodene/ethinylestradiol). 14 February 2014
Biotechnology
Swiss biotech firm Actelion announced today that SwissMedic has approved Opsumit (macitentan) for pulmonary arterial hypertension (PAH) patients within Switzerland. 14 February 2014
Pharmaceutical
Israel-based Teva Pharmaceutical Industries says the US Food and Drug Administration has granted full approval of leukemia drug Synribo (omacetaxine mepesuccinate) for injection, to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. 14 February 2014
Pharmaceutical
US drugmaker Durect Corp says that the US Food and Drug Administration has issued a Complete Response Letter for Posidur (SABER-bupivacaine), the firm’s investigational drug for post-surgical analgesia. 13 February 2014
Pharmaceutical
The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday against approval of the intravenous antiplatelet agent cangrelor made by US health care company The Medicines Company. 13 February 2014
Pharmaceutical
The US Food and Drug Administration yesterday expanded the approved use of US health care giant Johnson & Johnson and Pharmacyclics' Imbruvica (ibrutinib) for chronic lymphocytic leukemia, a rare blood and bone marrow disease, patients who have received at least one previous therapy. 13 February 2014
Biotechnology
Regulatory agency Health Canada has approved US biotech firm Celgene’s drug Pomalyst (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. 12 February 2014
Pharmaceutical
US privately-held sexual health specialists Sprout Pharmaceuticals has received ‘clear guidance’ from the US Food and Drug Administration after a Formal Dispute Resolution was filed in December 2013. 12 February 2014
Pharmaceutical
A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family Welfare and US Food and Drug Administration Commissioner Margaret Hamburg, she reported yesterday. 12 February 2014
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