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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
Biosimilars
Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients with rheumatoid arthritis (RA) in Brazil and Mexico, which both have powerful mechanisms that drive use of lower cost options. 19 December 2013
Pharmaceutical
Swiss drug major Novartis' (NOVN: VX) generics unit Sandoz has received Danish marketing authorization for AirFluSal Forspiro inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD). 19 December 2013
Generics
In a joint statement, the US Food and Drug Administration and the European Medicines Agency revealed yesterday (December 19) that they have initiated an initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. 19 December 2013
Pharmaceutical
The US Food and Drug Administration late yesterday approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder), from UK pharma giant GlaxoSmithKline and US partner Theravance. 19 December 2013
Biosimilars
Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational cooperation with the Brazilian Association of Manufacturers of Generic Drugs (ProGenericos) which provides for study, research, information sharing, planning and common interest projects planning, writes Juliane Carvalho on Brazil Pharma News. 18 December 2013
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed Swiss drug major Roche’s Zelboraf (vemurafenib), in the treatment of adults with a certain type of advanced melanoma, and has concluded that, despite this dossier containing additional and more recent data, it did not provide any new findings. T 18 December 2013
Biotechnology
Kineret (anakinra), from Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI), has been licensed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for children and babies from eight months old with cryopyrin-associated periodic syndromes (CAPS). 18 December 2013
Pharmaceutical
The European Medicines Agency’s Management Board, at its meeting on December 11-12 adopted the Agency’s work program and budget for 2014. 18 December 2013
Pharmaceutical
Discussions on publication and access to clinical trial data are on schedule to be published in 2014 after the European Medicines Agency (EMA) said it has reviewed all comments on its draft policy. 17 December 2013
Pharmaceutical
US drugmaker Cubist Pharmaceuticals saw its shares jump 8.3% to $68 in premarket trading yesterday, when the company released positive top-line results from the pivotal Phase III clinical trial of its antibiotic candidate ceftolozane/tazobactam (also referred to as tol/taz and CXA-201) in complicated intra-abdominal infections (cIAI). 17 December 2013
Generics
Swedish contract development and manufacturing group Recipharm says its subsidiary RPH Pharmaceuticals has filed for regulatory approval for an infectious disease drug product in a range of European countries. The product has been developed through a partnership with privately-held Swedish drugmaker Astimex Pharma, which is set to market the product in the Nordic market. 16 December 2013
Biotechnology
US antiviral biotech specialist Gilead Sciences says that Health Canada has issued a Notice of Compliance for Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection. 16 December 2013
Pharmaceutical
US health care giant Johnson & Johnson has received a complete response letter from the Food and Drug Administration regarding its New Drug Application for a fixed-dose combination (FDC) of canagliflozin and immediate-release metformin to treat adults with type 2 diabetes requesting additional information. 16 December 2013
Pharmaceutical
Counterfeit drug operations that have been recently uncovered by police raids in various provinces across Turkey are an alarming concern, reports the country’s Association of Research-Based Pharmaceutical Companies (AIFD). 16 December 2013
Biotechnology
US biotech firm Gilead Sciences’ share closed up 1.6% at $71.40 on Friday, following the news of an additional indication in the USA for its single-pill combination HIV treatment for patients switching from a stable regimen. 14 December 2013
Biotechnology
The case for encouraging biopharma innovation was presented yesterday at the US House Committee on Oversight & Government Reform, Subcommittee on Energy Policy, Health Care & Entitlements held a hearing, titled, FDA Check-Up: Drug Development and Manufacturing Challenges. 13 December 2013
Pharmaceutical
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted 13 to one that the benefits of dapagliflozin use outweigh identified risks and support marketing of the drug as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 13 December 2013
Pharmaceutical
The Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration yesterday voted unanimously that the available data support the efficacy and safety of Merck & Co’s Grastek (Grazax) in patients aged five to 65 years. 13 December 2013
Pharmaceutical
US biopharma company Orexigen Therapeutics is having another stab at gaining approved for its weight-loss investigational drug Contrave (naltrexone sustained release (SR)/bupropion SR), resubmitting a New Drug Application to the US Food and Drug Administration. 12 December 2013
Generics
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that generics major Actavis proposed $8.5 billion acquisition of Warner Chilcott would reduce competition in the US markets for four current and future pharmaceuticals. They are: 12 December 2013
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