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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 first gut-selective treatment for ulcerative colitis and Crohn’s Disease is now available in the UK, following licensing by European regulators. 28 August 2014
Pharmaceutical
US pharma major Bristol-Myers Squibb says that the European Commission has approved Daklinza (daclatasvir), a pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1 - 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. 27 August 2014
Biotechnology
The US Food and Drug Administration has granted priority review designation for US biotech giant Amgen’s ivabradine for the treatment of chronic heart failure (HF). 27 August 2014
Biotechnology
The UK’s drugs watch dog, the National Institute for Health and Care Excellence (NICE), has recommended Biogen Idec’s Tecfidera in the treatment of multiple sclerosis. 27 August 2014
Pharmaceutical
Switzerland-based iron deficiency specialist Vifor has received European Union marketing authorization for its Velphoro (sucroferric oxyhydroxide). 27 August 2014
Pharmaceutical
The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug Application for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 27 August 2014
Biotechnology
Canadian regulator Health Canada has approved US Biotech major Biogen Idec’s Eloctate (antihemophilic factor [recombinant BDD], Fc fusion protein) for the control and prevention of bleeding episodes and routine prophylaxis in adults and children aged 12 and older with hemophilia A. 26 August 2014
Biotechnology
Ireland-headquartered biotech firm Alkermes has submitted a New Drug Application to the US Food and Drug Administration for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. 26 August 2014
Pharmaceutical
On Friday, the Obama Administration in the USA took several steps to help ensure women, whose coverage is threatened, receive coverage for recommended contraceptive services at no additional cost, as they should be entitled to under the Affordable Care Act, the Department of Health and Human Services Health and Human Services announced. 25 August 2014
Pharmaceutical
The US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets, from HIV/AIDS drug specialist Viiv Healthcare, for the treatment of HIV-1 infection. 23 August 2014
Generics
Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market rotigotine extended-release transdermal film. 23 August 2014
Pharmaceutical
The European Medicines Agency has accepted for review a Marketing Authorization Application by American biopharma company Cubist for its investigational antibiotic ceftolozane/tazobactam. 22 August 2014
Pharmaceutical
The US Drug Enforcement Administration (DEA) has today published in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II. 22 August 2014
article
The European Public Health Alliance has said it welcomes the European Commission’s proposal to improve health systems, and issued its own response, encouraging the EC to support new drugs coming to the market. 22 August 2014
Pharmaceutical
US pharma majors Bristol-Myers Squibb and Pfizer late yesterday said that the US Food and Drug Administration has approved a supplemental New Drug Application for their oral anticoagulant drug Eliquis (apixaban). 22 August 2014
Pharmaceutical
US pharma major Eli Lilly’s investigational medicine ixekizumab was superior to etanercept and placebo on all skin clearance measures in Phase III studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis. 21 August 2014
Pharmaceutical
US drugmaker Baxter International has announced positive results from its Phase III pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on Advate (antihemophilic factor [recombinant]). 21 August 2014
Biotechnology
US biopharma company Amicus Therapeutics has revealed positive 18-month data from its second Phase III study (Study 012) of the oral small molecule chaperone migalastat in Fabry patients with amenable mutations. 21 August 2014
Pharmaceutical
The US Food and Drug Administration recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling. 21 August 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline revealed late yesterday that the US Food and Drug Administration has approved its Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. 21 August 2014
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