Regulation
Refine Search
Pharmaceutical
In draft guidance published today for consultation, the UK’s health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended German pharma major Bayer’s Xarelto (rivaroxaban) as an option for preventing blood clots in people who have had a heart attack as a result of a blockage or narrowing in one of the blood vessels in the heart. 23 October 2014
Biotechnology
There was good news for US biotech firm Vertex Pharmaceuticals yesterday, as a US Food and Drug Administration advisory committee 13 to two to recommend approval of Kalydeco (ivacaftor) in cystic fibrosis (CF) patients aged six and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory (CFTR) gene, which is the indication being reviewed by the FDA. 22 October 2014
Pharmaceutical
The UK National Institute for Health and Care Excellence (NICE) has issued final guidance recommending UK pharma giant GlaxoSmithKline’s Tafinlar (dabrafenib for the treatment of melanoma which has spread or cannot be completely removed by surgery, and which tests positive for the BRAF V600 mutation. 22 October 2014
Pharmaceutical
According to the findings of an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) says that no added benefit was proven for UK pharma major GlaxoSmithKline's Anoro Ellipta (vilanterol/umeclidinium). 21 October 2014
Pharmaceutical
The EFPIA has published an open letter to the European Parliament, member states and the Commission on the EU trade mark reform. 21 October 2014
Pharmaceutical
The European Medicines Agency is aiming to encourage developers of treatments or vaccines against Ebola to apply for orphan designation. 21 October 2014
Biotechnology
Specialty biopharma company Auxilium Pharmaceuticals has received approval from the US Food And Drug Administration for a supplemental Biologics Application for its drug Xiaflex. 21 October 2014
Pharmaceutical
The Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration yesterday voted unanimously to support the approval of Swiss pharma major Novartis’ secukinumab (AIN457), a selective interleukin-17A (IL-17A) inhibitor. 21 October 2014
Pharmaceutical
The US Food and Drug Administration has granted Fast Track designation for TAS-102 (trifluridine and tipiracil hydrochloride), an oral combination anticancer drug under investigation by Taiho Oncology. 20 October 2014
Pharmaceutical
Japanese drug major Eisai has had a supplemental New Drug Application for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary generalized tonic-clonic seizures accepted by the US Food and Drug Administration. 20 October 2014
Pharmaceutical
US drugmaker Pharmacyclics has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Imbruvica (ibrutinib) in the treatment of Waldenstrom’s macroglobulinemia (WM). 20 October 2014
Biotechnology
USA-based Amgen, the world’s leading independent biotech firm, has indicated that it plans to work with other stakeholders to manufacture the investigational Ebola treatment ZMapp, developed by Mapp BioPharmaceutical, according to Bloomberg. 20 October 2014
Pharmaceutical
New Zealand's Pharmaceutical Managment Agency PHARMAC has agreed to fund four new medicines for which there are currently limited medicine options. 20 October 2014
Pharmaceutical
Swedish ophthalmic specialist Clanotech, which is 80% owned by Karolinska Development, has received orphan drug designation from the European Medicines Agency for its anti-fibrotic and anti-angiogenic candidate drug CLT-28643. 20 October 2014
Pharmaceutical
The US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies. 19 October 2014
Pharmaceutical
US drugmaker Pharmacyclics has received marketing approval from the European Commission for Imbruvica (ibrutinib) throughout the 28 member states of the European Union. 17 October 2014
Pharmaceutical
The Australian Competition and Consumer Commission (ACCC) is proposing to grant conditional authorization to edition 18 of trade group Medicines Australia’s Code of Conduct for five years. 17 October 2014
Pharmaceutical
The US Food and Drug Administration's advisory panel has voted to keep a black box warning on US pharma major Pfizer’s smoking cessation drug Chantix (varenicline). 17 October 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance proposing to recommend Swiss pharma major Novartis’ Glivec (imatinib) people who have had a gastro-intestinal stromal tumor (GIST) removed and who are at high risk of the cancer recurring. 17 October 2014
Generics
Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a methylphenidate for extended-release oral suspension. 16 October 2014
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
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