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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 Cubist Pharmaceuticals’ New Drug Application for its investigational antibiotic ceftolozane/tazobactam with Priority Review. 20 June 2014
Generics
The US Federal Trade Commission has filed an amicus brief in the New Jersey US District Court explaining that a brand name drug manufacturer’s improper use of a restricted drug distribution program to impede generic competition could violate the antitrust laws. 20 June 2014
Biotechnology
RNAi therapeutics company Alnylam Pharmaceuticals and The Alpha-1 Project (TAP), the venture philanthropy subsidiary of the Alpha-1 Foundation, have entered into a collaboration for the continued advancement of ALN-AAT, a subcutaneously administrated RNAi therapeutic in development for the treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver disease. 19 June 2014
Generics
A survey co-released today by the USA’s Generic Pharmaceutical Association (GPhA) and the National Coalition on Healthcare reveals that the health care providers on which patients rely most to explain safety information about their prescription drugs have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling. 19 June 2014
Pharmaceutical
The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have resubmitted a New Drug Application for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes to the US Food and Drug Administration. 19 June 2014
Pharmaceutical
Privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals confirmed today that its drug Firmagon (degarelix) will be the subject of an appeal hearing by UK health care watchdog the National Institute for Health and Care Excellence (NICE) on June 25. 18 June 2014
Generics
The South American country Colombia has an attractive pharmaceutical market that should appeal to multinational companies looking for emerging growth opportunities. 18 June 2014
Pharmaceutical
The UK health care watchdog the National Institute of Health and Care Excellence (NICE) has released a Final Appraisal Determination recommending National Health Service use of US drugmaker Sucampo Pharmaceuticals’ Amitiza (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives. 18 June 2014
Pharmaceutical
Sanofi Pasteur MSD says that the European Commission has granted marketing authorization for the use of Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) for the prevention of anal precancerous lesions and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types in both males and females. 18 June 2014
Pharmaceutical
Thousands of people with atrial fibrillation could be saved from strokes, disability or death because of new guidance from the UK’s National Institute for Health and Care Excellence (NICE). 18 June 2014
Biotechnology
USA-based Mirati Therapeutics has been granted Orphan Drug designation by the US Food and Drug Administration for mocetinostat as a treatment for myelodysplastic syndrome. 17 June 2014
Biotechnology
Metabolism specialist Agios Pharmaceuticals says that its partner, biotech major Celgene Corp, has exercised its option to an exclusive worldwide license to AG-221, an oral, first-in-class, potent inhibitor of the mutant IDH2 protein. 17 June 2014
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) now examined whether canagliflozin alone (monotherapy) or in combination with other blood-glucose lowering drugs offers an added benefit over the appropriate comparator therapy. 17 June 2014
Generics
The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM). 17 June 2014
Pharmaceutical
The European Medicines Agency requires marketing-authorization holders to update the information on authorized medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. 17 June 2014
Pharmaceutical
US drugmaker AbbVie announced today that the Marketing Authorization Applications (MAAs) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been validated and are under accelerated assessment by the European Medicines Agency. 17 June 2014
Biotechnology
Swiss pharma major Novartis has submitted a Biologic License Application to the US Food and Drug Administration for marketing approval for the use of Bexsero (multicomponent meningococcal Group B vaccine [recombinant, adsorbed]) to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age. 17 June 2014
Biotechnology
US anti-virals major Gilead Sciences has released strong top-line results from a Phase III clinical trial (GS-US-337-0113) in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. 16 June 2014
Pharmaceutical
Steven Bradshaw, a UK-based drug policy expert and former ophthalmologist, is disappointed at the news of the Italian government’s decision to substitute wet age-related macular degeneration treatment drug, from Lucentis (ranibizumab) to Swiss drug major Roche’s Avastin (bevacizumab). 16 June 2014
Biotechnology
In draft recommendations published today, UK health care watchdog the National Institute for Health and Care Excellence (NICE) is asking US biotech firm Gilead Sciences for more information on its recently approved new drug Sovaldi (sofosbuvir), for the treatment of chronic hepatitis C. 16 June 2014
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