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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
French molecular nuclear medicines specialist Advanced Accelerator Applications SA (AAA) has acquired Imaging Equipment and received orphan drug designation for Gallium-68 DOTATATE. 4 March 2014
Pharmaceutical
UK drug watchdog the National Institute for Health and Care Excellence (NICE) this morning published preliminary guidance which recommends US pharma giant Pfizer’s Inlyta (axitinib) as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first-line tyrosine kinase inhibitor or a cytokine. 4 March 2014
Pharmaceutical
Anglo-Swedish drug major AstraZeneca says the US Food and Drug Administration has approved the Bydureon Pen 2mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. 3 March 2014
Pharmaceutical
US biotech firm Regeneron Pharmaceuticals and partner Bayer’s Japanese subsidiary Bayer Yakuhin have submitted an application for marketing authorization for Eylea (aflibercept) injection for the treatment of patients with diabetic macular edema to the Japanese Ministry of Health, Labor and Welfare. 3 March 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and Drug Administration for Promacta (eltrombopag) for the treatment of cytopenias in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 2 March 2014
Generics
Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant Sanofi had filed suit on February 26, in the US District Court for the District of Delaware, seeking to prevent Actavis from commercializing its Abbreviated New Drug Application for a generic version of Multaq (dronedarone) prior to the expiry of certain US patents. 2 March 2014
Pharmaceutical
UK-based GW Pharmaceuticals says that the Food and Drug Administration has granted orphan drug designation for Epidiolex, GW’s product candidate that contains plant-derived cannabidiol (CBD) as its active ingredient. 28 February 2014
Pharmaceutical
UK health care guidance body the National Institute for Health and Care Excellence (NICE) has published final draft guidance that does not recommend US pharma major Eli Lilly’s Alimta (pemetrexed) for the maintenance treatment of locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in people whose disease has not progressed immediately following induction therapy with pemetrexed and cisplatin. 27 February 2014
Biosimilars
US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) have called on State Governor Mike Pence to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 27 February 2014
Biotechnology
Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity of Dynavax Technologies’ hepatitis B virus (HBV) vaccine Heplisav in specific adult populations, and the drug’s ability to address a key unmet need will lead to its “overwhelming approval” once legitimate safety concerns are alleviated, says an analyst with research and consulting firm GlobalData. 27 February 2014
Biotechnology
US biotech firm Cell Therapeutics has received positive news from the UK’s drugs watchdog for use of its lymphoma drug Pixuvri (pixantrone) on the National Health Service. 27 February 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has published final guidance recommending German drug major Bayer’s Eylea (aflibercept solution for injection) as an option for treating visual impairment caused by macular edema, a condition which affects a person’s ability to see detail and color. 26 February 2014
Pharmaceutical
US drugmaker Anika Therapeutics has received marketing approval for Monovisc from the US Food and Drug Administration. Monovisc is a single injection supplement to synovial fluid of the osteoarthritic joint, used to treat pain and improve joint mobility in patients suffering from osteoarthritis of the knee. 26 February 2014
Pharmaceutical
Over the past 12 months, a total of 12 medicines for the treatment of rare diseases were recommended for marketing authorization by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 26 February 2014
Pharmaceutical
The US Food and Drug Administration has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 26 February 2014
Pharmaceutical
A long list of trade organizations representing thousands of companies across all industry lines and sectors (including the research-based and generic drugs sectors), issued a joint statement welcoming today’s vote by the European Parliament of robust measures to fight the transit of trade m ark counterfeit goods in the European Union as part of a wider review of the European Union trade mark legislation. 25 February 2014
Pharmaceutical
US specialty drugmaker Iroko Pharmaceuticals has received approval from the US Food and Drug has approved Tivorbex (indomethacin) capsules, a non-steroidal anti-inflammatory drug (NSAID), at 20mg and 40mg doses for the treatment of mild to moderate acute pain in adults. 25 February 2014
Pharmaceutical
In the largest market for orphan drugs, the USA, there was a shortage of adequate therapies for treating many rare diseases. These therapies were not developed as companies did not expect these drugs to be highly profitable. 25 February 2014
Pharmaceutical
US drug major Bristol-Myers Squibb today expressed its disappointment that the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued draft guidance which effectively denies access to Yervoy (ipilimumab) for National Health Service patients with previously-untreated advanced (unresectable or metastatic) melanoma, not involved in clinical trials. 25 February 2014
Generics
The Food and Drug Administration’s Proposed Rule to change prescription drug label requirements risks the safety of millions of patients, according to the expert panel, Labeling: Patient Safety and Politics, convened at the US Generic Pharmaceutical Association annual meeting in Orlando. 24 February 2014
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