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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 licensed Swiss pharma major Novartis’ manufacturing facility in Holly Springs, North Carolina, for the production of cell-culture influenza vaccines. 16 June 2014
Pharmaceutical
At its June 2014 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels). 16 June 2014
Pharmaceutical
Denmark-based allergy specialist ALK Abello partner for Japan, Torii Pharmaceutical, has completed its second of two Phase II/III trials into ALK’s sublingual allergy immunotherapy tablet (SLIT-tablet) for the treatment of house dust mite (HDM)-induced respiratory diseases, with mixed results. 16 June 2014
Biotechnology
USA-based Affymax and Japan's Takeda Pharmaceutical revealed on Friday that they have terminated their Omontys (peginesatide) product collaboration and license agreement, which will terminate effective September 10, 2014. 15 June 2014
Pharmaceutical
The European Medicines Agency management board agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA executive director Guido Rasi. 13 June 2014
Biotechnology
US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after the company revealed that the US Food and Drug Administration has removed the partial clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis, a rare form of blood cancer (Myelofibrosis IST). 13 June 2014
Pharmaceutical
New research indicates that global market access planning is growing in complexity as each country’s evolving regulations change the context in which pharmaceutical brands are entering and maximizing their presence. 13 June 2014
Biosimilars
Biosimilar medicines will deliver an opportunity for increased access to better healthcare for patients and significant cost savings, provided that policies supporting a sustainable biosimilar medicines market are in place, revealed a report from GfK Market Access. 13 June 2014
Pharmaceutical
People in England with advanced skin cancer should be able to receive ipilimumab as a first treatment under the National Health Service, the National Institute for Health and Care Excellence (NICE) proposes. 13 June 2014
Pharmaceutical
The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members yesterday voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. 13 June 2014
Pharmaceutical
Ireland-headquartered drugmaker Shire says it has agreed to a written request by the US Food and Drug Administration to conduct pediatric clinical studies to investigate the potential use of Vyvanse (lisdexamfetamine dimesylate) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pre-school-age children, aged four to five. 12 June 2014
Pharmaceutical
China's drug administration on Wednesday warned consumers not to purchase illegally imported cancer drugs online, as most of the drugs are fake, reports the state news agency Xinhau. 12 June 2014
Pharmaceutical
German pharma major Bayer has submitted an application to the European Medicines Agency seeking marketing authorization in the European Union for Eylea (aflibercept) injection for the treatment of macular edema following branch retinal vein occlusion. 11 June 2014
Pharmaceutical
Obesity-focused US biopharmaceutical company Orexigen Therapeutics says that the US Food and Drug Administration has extended its review of the resubmitted New Drug Application for its investigational medication Contrave (naltrexone SR and bupropion SR; NB32), being evaluated for weight loss. The company’s shares dropped 15% to $5.80 in premarket trading today. 11 June 2014
Biosimilars
The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected compound annual growth rate (CAGR) of 8.3%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019. 11 June 2014
Pharmaceutical
Swiss drug delivery specialist EffRx Pharmaceuticals says the US Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS). 11 June 2014
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations says it is concerned about a decision by the Italian health authority, which allows the reimbursement of off-label treatments for economic reasons when on-label alternatives are available. 11 June 2014
Biotechnology
US drugmaker Achillion has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase I clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014. 10 June 2014
Biotechnology
US biotech firm Immunomedics says that IMMU-132, its antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the US Food and Drug Administration for the treatment of pancreatic cancer. 10 June 2014
Pharmaceutical
Late last Friday afternoon, the US Food and Drug Administration issued a new guidance document describing the agency’s recommended practices for distributing reprints that convey new risk information for approved drug and biologic products, reports Anne Walsh writing on Hyman, Phelps & McNamara’s FDA Law Blog. 9 June 2014
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