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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 UK’s National Institute for Health and Care Excellence (NICE) is recommending that many more people should be prescribed cholesterol-lowering statins if they are at risk of heart disease, stroke or peripheral arterial disease. 12 February 2014
Pharmaceutical
The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca, the manufacturer of saxagliptin, to investigate a possible association between use of the type 2 diabetes drug and heart failure. 12 February 2014
Pharmaceutical
2014 will be marked as a transition year for the Japanese Pharma industry – but the year is bound to be painful both for innovators and generic companies due to the new regulations. 11 February 2014
Pharmaceutical
The US Food and Drug Administration Commissioner Margaret Hamburg has met with India’s Commerce and Industry Minister Anand Sharma on a visit to the country this week. 11 February 2014
Biotechnology
US biotech major Gilead Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration for a once-daily ledipasvir/sofosbuvir fixed-dose combination for genotype 1 hepatitis C. 11 February 2014
Biosimilars
Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan ), just as the companies were launching the world's first biosimilar version of Roche blockbuster breast cancer drug Herceptin (trastuzumab) in India (The Pharma Letter February 3), report the Economic Times and other media. 10 February 2014
Biotechnology
Swiss biotech firm Actelion (SIX: ATLN) has received approval of Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH) from the Therapeutic Goods Administration (TGA) of Australia. 7 February 2014
Generics
The US Food and Drug Administration’s Proposed Rule on prescription drug labeling would add $4 billion annually to the nation’s already high health care costs, undercutting the cost savings that generic medicines have brought to America’s patients and health care system, according to an analysis released by economic consulting firm Matrix Global Advisors (MGA). 6 February 2014
Pharmaceutical
As part of an ongoing effort to empower patients to be informed partners with their health care providers, the US Department of Health and Human Services (HHS) has taken action to give patients or a person designated by the patient a means of direct access to the patient’s completed laboratory test reports. 5 February 2014
Biosimilars
In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health advocacy organizations from across the country jointly submitted a letter to FTC Commissioner Edith Ramirez, urging her to give patient safety and consumer protection the important weight and priority they deserve. 4 February 2014
Pharmaceutical
Allergan says that Botox has been approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of ankle disability due to lower limb spasticity associated with stroke in adults. 4 February 2014
Pharmaceutical
The Drug Controller General of India (DCGI) has provided written confirmation to the pharmaceutical industry and investigators that clinical trial approval will be given within 180 days of submission of clinical trial application provided all the submitted documents are complete. Also clinical trial protocol amendments will be approved within 60 days, if consultation of the New Drugs Advisory Committee (NDAC) is not required. The notification was issued on January 24, 2014. 4 February 2014
Pharmaceutical
GlaxoSmithKline’s Tafinlar (dabrafenib) is now available for metastatic melanoma patients in England after it was approved by NHS England to be routinely funded by the Cancer Drugs Fund yesterday. 4 February 2014
Pharmaceutical
Privately-held US pharma company Edison Pharmaceuticals has announced that the US Food and Drug Administration has granted orphan status to vatiquinone for the treatment of Friedreich's ataxia. 4 February 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) said this morning that it is reviewing existing guidance on the use of Tarceva (erlotinib) from Roche and Iressa (gefitinib) from AstraZeneca for treating non-small-cell lung cancer. 4 February 2014
Biosimilars
The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for 2014, a year with significant opportunities to continue providing safe, affordable medicines of the highest quality that bring savings to patients and the health care system that will build on the many industry successes achieved in 2013. 4 February 2014
Biotechnology
US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission for relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis. 3 February 2014
Pharmaceutical
Global HIV company Viiv Healthcare has launched its first new treatment option for people with HIV today. 3 February 2014
Pharmaceutical
The US Food and Drug Administration has granted “Breakthrough Therapy” designation for UK pharma giant GlaxoSmithKline’s Promacta/Revolade (eltrombopag) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy (IST). 3 February 2014
Pharmaceutical
More than 40% of innovative medicines recommended for marketing authorization in the European Union between 2010 and 2012 originated from small or medium-sized enterprises (SMEs), academia, public bodies and public-private partnerships, according to an article published in Nature Reviews Drug Discovery and authored by staff members of the European Medicines Agency. 3 February 2014
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