Regulation
Refine Search
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
Generics
The US Food and Drug Administration yesterday approved the first generic versions of drug major Eli Lilly’s antidepressant Cymbalta (duloxetine delayed-release capsules). 12 December 2013
Pharmaceutical
In an 11 to one vote yesterday, the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee recommended the investigational drug metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD), from USA drug major Bristol-Myers Squibb and partner Anglo-Swedish pharma company AstraZeneca. 12 December 2013
Pharmaceutical
France’s Stallergenes said late yesterday that the Allergenic Products Advisory Committee (APAC) of the US Food and Drug Administration had voted that the available data support approval of Oralair, an investigational grass allergy immunotherapy tablet for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in adults and children aged five and older. 12 December 2013
Generics
Russia seems to be an attractive country for pharmaceutical contract manufacturing, chiefly because of the strict regulations implemented in recent years which compel manufacturers to tap into production opportunities in the country. 11 December 2013
Pharmaceutical
The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant Merck & Co’s Biologic License Application (BLA) for the investigational grass sublingual allergy immunotherapy (AIT) tablet on Thursday. 10 December 2013
Pharmaceutical
A US Food and Drug Administration advisory committee has recommended approval of vedolizumab from Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502). 10 December 2013
Pharmaceutical
Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon have filed Marketing Authorization Application for safinamide with the European Medicines Agency. 9 December 2013
Pharmaceutical
In an early benefit assessment under the Act on the German Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Xtandi (enzalutamide), from USA-based Medivation and Japanese drug major Astellas Pharma offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 9 December 2013
Pharmaceutical
The European Association for the Study of the Liver has today published its revised Clinical Practice Guidelines (CPGs) on the management of hepatitis C virus infection (HCV), which supersede the previous version published in 2011 and are designed to help physicians and other health care providers optimize their management of patients with acute and chronic HCV. 9 December 2013
Pharmaceutical
Stricter provisions on the promotion of prescription medicines to health care professionals are among others points included in the revised Code of Practice by the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA). 9 December 2013
Pharmaceutical
Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning that it has made a decision to approve a proposal to widen funded access to Swiss drug major Roche’s Tarceva (erlotinib). 9 December 2013
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the anticoagulants Kogenate (recombinant Factor VIII) from Germany’s Bayer and Helixate NexGen from CSL Behring, a unit of Australia's CSL Ltd), coming up with a favorable opinion. 8 December 2013
Pharmaceutical
In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi subsidiary Genzyme’s multiple sclerosis drug Aubagio (teriflunomide) for National Health Service use. 8 December 2013
Biotechnology
US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved its Sovaldi (sofosbuvir), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. 8 December 2013
Pharmaceutical
The US Food and Drug Administration has approved a new use for US company Auxilium Pharmaceuticals Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease. 7 December 2013
Biosimilars
Key clinical, corporate and regulatory events affecting the biosimilar industry have been identified by health care advisory group Decision Resources, which finds that 2013 was a pivotal year for biosimilars. 7 December 2013
Pharmaceutical
New Zealanders have gained greater access to medicines in 2013, and record numbers of New Zealanders received funded medicines in the past year. 7 December 2013
Pharmaceutical
The European Commission has granted Marketing Authorization to Fluenz Tetra, the product’s maker Anglo-Swedish drug major AstraZeneca announced this morning. 6 December 2013
Pharmaceutical
The Brazilian pharmaceutical market is considered the second with the greatest growth potential in the world after China. However, a survey conducted by the Brazilian Center for International Relations (CEBRI) reconfirms that Brazil's current regulations still function as a growth barrier for the pharmaceutical industry, reports Juliane Carvalho of Brazil Pharma News. 6 December 2013
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) concluded that no added benefit could be derived on the basis of the dossier submitted by Anglo-Swedish drug major AstraZeneca and US partner Bristol-Myers Squibb for their type 2 diabetes drug Onglyza (saxagliptin). 5 December 2013
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze