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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 granted drug major Bristol-Myers Squibb’s investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV). 24 February 2014
Pharmaceutical
Swiss drug major Novartis says it has received approval from Japanese regulatory bodies for a fourth indication for Lucentis (ranibizumab): the treatment of patients with diabetic macular edema (DME), a leading cause of vision loss among patients with diabetes. 24 February 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence is currently appraising Invokana (canagliflozin), from US health care giant Johnson & Johnson subsidiary Janssen-Cilag, when used in combination with other anti-diabetic drugs, including insulin, for the treatment of type 2 diabetes. 24 February 2014
Pharmaceutical
In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products in November 2013, the German Institute for Quality and Efficiency in Health Care has determined an added benefit for USA-based Medivation and Japanese partner Astellas Pharma’s Xtandi (enzalutamide) over the appropriate comparator therapy specified by the Federal Joint Committee. 24 February 2014
Generics
The strategic drug reviews, as well as mergers and acquisitions – such as Actavis buying out Forest for around $25 billion – that are playing out on the global stage have a bearing on India, with Big Pharma seeking to refocus operations and battle an imminent patent cliff, writes The Pharma Letter’s Indian correspondent. 24 February 2014
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Israel-based Teva Pharmaceutical Industries DuoResp Spiromax (budesonide & formoterol fumarate dihydrate) inhalation powder, a generic version of AstraZeneca's Symbicort. 22 February 2014
Biotechnology
The US Food and Drug Administration approved biotech firm Vertex Pharmaceuticals’ supplemental New Drug Application for Kalydeco (ivacaftor) for people with cystic fibrosis (CF) aged six and older who have one of eight additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 22 February 2014
Pharmaceutical
The Russian government has decided to postpone until 2016 the requirement of domestic pharmaceutical production to Good Manufacturing Practices (GMP)-standards, according to the press service of the Russian Ministry of Health. 21 February 2014
Generics
The US Food and Drug Administration’ Office of Generic Drugs acting director Kathleen Uhl, highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act (GDUFA) milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place in Orlando, Florida, on February 20. 21 February 2014
Pharmaceutical
Five European health care trade groups say they support the implementation of an effective pharmacovigilance system to ensure patient safety and recognize recent efforts which have been made to ensure greater fairness, proportionality and transparency in some aspects of the proposals for the mechanism of fees to be paid to the European Medicines Agency for these Pharmacovigilance activities. 21 February 2014
Pharmaceutical
BioMarin Pharmaceutical says that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for its Vimizim (elosulfase alfa) for the treatment of Morquio A syndrome, also called Mucopolysaccharidosis Type IVA (MPS IVA). 21 February 2014
Pharmaceutical
GlaxoSmithKline has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for Incruse for COPD. 21 February 2014
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) is calling on US biotech firm Biogen Idec to provide more information on its multiple sclerosis drug Tecfidera (dimethyl fumarate). 21 February 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for umeclidinium/vilanterol (UMEC/VI) under the proposed brand name Anoro. 21 February 2014
Pharmaceutical
The Ukrainian government is reducing the number of bureaucratic hurdles in the domestic pharmaceutical market, through the abolition of the procedure of drug re-registration. 20 February 2014
Pharmaceutical
The US Food and Drug Administration and the European Medicines Agency have set-up a new “cluster” on pharmacovigilance (medicine safety) topics, aiming to ensure the safety and quality of medicines. 20 February 2014
Pharmaceutical
The US Food and Drug Administration has accepted the filing of The Medicines Company’s New Drug Application for oritavancin, an investigational intravenous antibiotic, with priority review. 19 February 2014
Pharmaceutical
Ireland-headquartered drugmaker Shire has had an application for its once-daily attention deficit/hyperactivity disorder (ADHD) drug Elvanse (lisdexamfetamine dimesylate) accepted for an adult indication. 19 February 2014
Pharmaceutical
In an early benefit assessment under 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 the drug combination indacaterol/glycopyrronium (trade name: Ultibro Breezhaler, Xoterna Breezhaler) offers an added benefit over the appropriate comparator therapy. 19 February 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG), in an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), examined whether German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) offers an added benefit over the appropriate comparator therapy. 19 February 2014
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