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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
In the third of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at the case for legalized medical marijuana. 16 October 2014
Pharmaceutical
The US Food and Drug Administration has approved Esbriet (pirfenidone), from Roche subsidiary Genentech, as a treatment for idiopathic pulmonary fibrosis (IPF). 16 October 2014
Pharmaceutical
Regulators from the European Medicines, the US Food and Drug Administration and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), welcomed the Drug Shortages Prevention Plan, which was released by the International Society for Pharmaceutical Engineering (ISPE) at its 2014 annual meeting in Las Vega, USA, and spoke about the importance of the industry approach. 16 October 2014
Biotechnology
In preliminary draft guidance issued this morning the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has not recommended US biotech firm Dendreon’s Provenge (sipuleucel-T) for prostate cancer. 16 October 2014
Pharmaceutical
There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted priority review for two of the companies products. 15 October 2014
Biotechnology
US biotech firm Northwest Biotherapeutics, which is developing DCVax personalized immune therapies for solid tumor cancers, says that the DCVax-L hospital exemption program that was approved by the German regulatory authority earlier this year is now under way. 15 October 2014
Generics
A federal judge from the US District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories. The US Department of Justice filed the consent decree on behalf of the Food and Drug Administration. 15 October 2014
Biotechnology
UK medical costs watchdog the National Institute for Health and Care Excellence (NICE) has issued preliminary draft guidance not recommending US biotech firm Celgene’s Imnovid (pomalidomide) for treating multiple myeloma. 15 October 2014
Pharmaceutical
Jean-Claude Juncker, President-elect of the European Commission, has backtracked on his decision to return control of medicines and pharma products to the Industry Commissioner. 14 October 2014
Pharmaceutical
Pfizer says that the New Drug Application for its investigational breast cancer treatment palbociclib has been accepted for filing and granted Priority Review by the US Food and Drug Administration. 13 October 2014
Biotechnology
Janssen-Cilag International says that a Type II Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 12 to 17 years old. 13 October 2014
Pharmaceutical
The US Food and Drug Administration has approved Japanese pharma major Eisai’s Akynzeo (netupitant and palonosetron) to treat chemotherapy-induced nausea and vomiting (CINV). 13 October 2014
Biotechnology
As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. 12 October 2014
Pharmaceutical
At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews. 10 October 2014
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with the local subsidiary of Swiss pharma giant Novartis involving the listing of nine new products and amendments to the listing of seven other products. 10 October 2014
Pharmaceutical
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Swiss pharma giant Novartis’ multiple sclerosis drug Gilenya (fingolimod) offers an added benefit over the appropriate comparator therapy in this patient group. 10 October 2014
Biotechnology
US biotech firm Biogen Idec has submitted a Marketing Authorization Application (MAA) for Elocta (rFVIIIFc; recombinant factor VIII Fc fusion protein) to the European Medicines Agency. 10 October 2014
Biotechnology
US privately-held oncolytic virus expert DNAtrix says that the US Food and Drug Administration has granted Orphan Drug Designation for DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. 9 October 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for the NHS’ management of multiple sclerosis. 9 October 2014
Biotechnology
One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive of Drayson Technologies and previous minister for science and innovation, was that the country needs to give incentives for investors to hold their investment for more than 10 years. 8 October 2014
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